ANSI B11.0-2023

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ANSI B11.

0 – 2023

American National Standard

Safety of Machinery
ANSI-Accredited Standards Developer and Secretariat:

B11 Standards, Inc.


Houston, Texas - USA

APPROVED: 27 JUNE 2023


by the American National Standards Institute
Board of Standards Review

COPYRIGHT PROTECTED DOCUMENT


Copyright © 2023 by B11 Standards, Inc.
All rights reserved. Printed in the United States of America
No part of this publication may be reproduced in any form, in an electronic retrieval system or
otherwise, without the prior written permission of B11 Standards, Inc.
AMERICAN NATIONAL STANDARD B11.0 – 2023

AMERICAN NATIONAL STANDARDS


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Published by: B11 Standards, Inc.,


POB 690905, Houston, TX - USA
Copyright © 2023 by B11 Standards Inc.
All rights reserved. Printed in the United States of America
No part of this publication may be reproduced in any form, in an electronic retrieval system or otherwise, without the prior
written permission of the publisher.

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AMERICAN NATIONAL STANDARD B11.0 – 2023

TABLE of CONTENTS PAGE

FOREWORD ........................................................................................................................................... 8
Overview and History..................................................................................................................... 8
Changes from prior edition ........................................................................................................... 8
Application ..................................................................................................................................... 9
General ........................................................................................................................................... 9
Objective ...................................................................................................................................... 10
Alignment ..................................................................................................................................... 10
New Terminology ......................................................................................................................... 11
Context ......................................................................................................................................... 11
Effective Date ............................................................................................................................... 11
Development ................................................................................................................................ 12

INTRODUCTION ................................................................................................................................... 13

1 SCOPE .......................................................................................................................................... 17
2 NORMATIVE REFERENCES......................................................................................................... 18
3 DEFINITIONS ................................................................................................................................ 19
4 RESPONSIBILITIES ...................................................................................................................... 32
4.1 General ............................................................................................................................... 32
4.2 Collaborative efforts .......................................................................................................... 32
4.3 Responsibilities of the component supplier and component user / machine supplier .. 33
4.3.1 Integration............................................................................................................. 34
4.3.2 Documentation ...................................................................................................... 34
4.3.3 Engineering controls ............................................................................................. 34
4.4 Responsibilities of the Integrator / modifier / rebuilder.................................................... 35
4.5 Responsibilities of the machine user ................................................................................ 35
4.5.1 Training of user personnel ..................................................................................... 35
4.5.2 Cleaning ............................................................................................................... 35
4.5.3 Operational working space .................................................................................... 36
4.6 Specifications for custom machinery ............................................................................... 36
4.7 Responsibilities of co-manufacturers ............................................................................... 36
4.7.1 General ................................................................................................................. 36
4.7.2 Supplying an entire machine or system ................................................................. 36
4.7.3 Training personnel ................................................................................................ 36
4.8 Machinery as a Service ...................................................................................................... 37
4.9 Purchasers of used machinery ......................................................................................... 37
4.10 Personnel responsibilities ................................................................................................. 37
5 LIFECYCLE REQUIREMENTS AND RESPONSIBILITIES ............................................................ 38
5.1 General ............................................................................................................................... 38
5.2 Design, construction and information for operation and maintenance........................... 40
5.4 Operation and maintenance .............................................................................................. 40
5.5 Modifying or rebuilding existing (legacy) machinery ....................................................... 41
5.6 Decommissioning .............................................................................................................. 41

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AMERICAN NATIONAL STANDARD B11.0 – 2023

6 THE RISK ASSESSMENT PROCESS ........................................................................................... 42


6.1 General ............................................................................................................................... 42
6.1.1 Qualified personnel ............................................................................................... 42
6.1.2 Goal ...................................................................................................................... 42
6.1.3 Fundamental steps of the risk assessment process ............................................... 42
6.2 Prepare for and set scope (limits) of the assessment ...................................................... 44
6.3 Identify tasks and hazards................................................................................................. 44
6.3.1 Identify affected persons ....................................................................................... 45
6.3.2 Identify tasks ......................................................................................................... 45
6.3.3 Identify hazards and hazardous situations ............................................................. 46
6.3.4 Similar machines................................................................................................... 46
6.4 Assess initial risk............................................................................................................... 46
6.4.1 Select a risk scoring system .................................................................................. 47
6.4.2 Assess risk ........................................................................................................... 47
6.4.3 Derive risk level..................................................................................................... 48
6.5 Reduce risk ........................................................................................................................ 48
6.5.1 Use the hazard control hierarchy ........................................................................... 48
6.5.2 Select feasible risk reduction measures................................................................. 51
6.5.3 Check for new hazards.......................................................................................... 52
6.6 Assess residual risk .......................................................................................................... 52
6.7 Achieve acceptable risk..................................................................................................... 52
6.8 Check, test and confirm (validate and verify) risk reduction measures .......................... 53
6.9 Document the process....................................................................................................... 54
6.9.1 Content ................................................................................................................. 54
6.9.2 Document retention ............................................................................................... 54

7 GENERAL RISK REDUCTION REQUIREMENTS ......................................................................... 55


7.1 Access to machinery ......................................................................................................... 55
7.2 Control systems performing a safety function ................................................................. 55
7.2.1 General ................................................................................................................. 56
7.2.2 Cybersecurity ........................................................................................................ 56
7.2.3 Monitoring functions .............................................................................................. 56
7.2.4 Stop functions ....................................................................................................... 56
7.2.5 Safety-related reset ............................................................................................... 57
7.3 Control systems design requirements .............................................................................. 57
7.3.1 Operator interaction .............................................................................................. 57
7.3.2 Operator interface / controls .................................................................................. 57
7.3.3 Remote control functions ....................................................................................... 58
7.3.4 Layout analysis (control zones) ............................................................................. 58
7.3.5 Span of control...................................................................................................... 58
7.3.6 Energy sources ..................................................................................................... 59
7.3.7 Selection of operating modes ................................................................................ 59
7.3.8 Manual and special mode(s) ................................................................................. 59
7.3.9 Wireless control .................................................................................................... 60
7.4 Whole body access ............................................................................................................ 60
7.4.1 General ................................................................................................................. 60
7.4.2 Openings defined by the physical obstruction ........................................................ 60
7.4.3 Risk reduction measures to minimize risks derived from whole body access .......... 61
7.5 Access to the hazard zone associated with openings ..................................................... 61
7.6 Material/part conveyance................................................................................................... 62

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7.7 Electromagnetic compatibility (EMC)................................................................................ 62


7.8 Electrostatic hazards ......................................................................................................... 62
7.9 Electrical............................................................................................................................. 62
7.10 Control of hazardous energy (lockout / tagout / alternative methods) ............................ 62
7.11 Ergonomics / human factors ............................................................................................. 63
7.12 Engineering controls ......................................................................................................... 63
7.12.1 General ................................................................................................................. 63
7.12.2 Additional considerations ...................................................................................... 63
7.13 Handling of machines, component parts, tooling and materials ..................................... 64
7.14 Hydraulic and pneumatic (including vacuum) systems ................................................... 64
7.14.1 General ................................................................................................................. 64
7.14.2 Safety shut-off and exhaust valve.......................................................................... 64
7.14.3 Pressure vessels................................................................................................... 65
7.14.4 Air valve mufflers .................................................................................................. 65
7.14.5 Air preparation components .................................................................................. 65
7.14.6 Pressure intensification ......................................................................................... 66
7.14.7 Hydraulic accumulators ......................................................................................... 65
7.14.8 Actuators .............................................................................................................. 65
7.15 Ladders and platforms....................................................................................................... 66
7.16 Large machines.................................................................................................................. 66
7.17 Lasers, radiation and magnetic fields ............................................................................... 66
7.17.1 Lasers................................................................................................................... 66
7.17.2 Radiation and magnetic fields ............................................................................... 66
7.18 Lubrication ......................................................................................................................... 68
7.19 Machines and machinery systems .................................................................................... 68
7.20 Mechanical power transmission........................................................................................ 69
7.21 Modified atmospheres ....................................................................................................... 69
7.22 Noise................................................................................................................................... 70
7.23 Sanitation and hygiene ...................................................................................................... 70
7.24 Stability............................................................................................................................... 70
7.25 Thermal systems................................................................................................................ 71
7.26 Heating Systems and related Equipment for Processing of Materials ............................ 71
7.27 Explosive Atmospheres - Hazardous (Classified) Locations ........................................... 71
7.28 Visibility .............................................................................................................................. 71
7.29 Ventilation of airborne contaminants ................................................................................ 71

8 INFORMATION FOR USE ............................................................................................................. 72


8.1 General ............................................................................................................................... 72
8.2 Manuals .............................................................................................................................. 72
8.3 Safety signs and labels...................................................................................................... 72
8.4 Nameplate .......................................................................................................................... 72
8.5 Information for personal protective equipment (PPE) ...................................................... 72

9 SUPERVISION .............................................................................................................................. 73

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10 TRAINING ..................................................................................................................................... 73
10.1 General ............................................................................................................................... 73
10.2 Training elements .............................................................................................................. 73
10.2.1 General ................................................................................................................. 73
10.2.2 Training program(s)............................................................................................... 74
10.2.3 Trainer qualifications ............................................................................................. 75
10.3 Operator training ................................................................................................................ 75
10.4 Maintenance personnel training ........................................................................................ 76
10.5 Supervisor training ............................................................................................................ 76
10.6 Retraining ........................................................................................................................... 76

ANNEX A — APPROACHES TO RISK REDUCTION ........................................................................... 77


ANNEX B — TRANSFERRING INFORMATION ABOUT RESIDUAL RISK .......................................... 81
ANNEX C — GUIDANCE FOR THE RISK ASSESSMENT PROCESS .................................................. 82
ANNEX D — PARTIAL LIST OF MACHINERY HAZARDS ................................................................... 85
ANNEX E — ADDITIONAL INFORMATION ON ASSESSING RISK (RISK ESTIMATION) ................... 89
ANNEX F — RISK ASSESSMENT MATRICES..................................................................................... 96
ANNEX G — ADDITIONAL INFORMATION ON ACHIEVING ACCEPTABLE RISK ........................... 100
ANNEX H — SAMPLE RISK ASSESSMENT ...................................................................................... 103
ANNEX I — SAMPLE STATEMENT OF CONFORMITY ..................................................................... 104
ANNEX J — LAYOUT ANALYSIS ...................................................................................................... 105
ANNEX K — SPECIAL MODE ............................................................................................................ 107
ANNEX L — USING ALTERNATIVE METHODS FOR CONTROLLING HAZARDOUS ENERGY ....... 110
ANNEX M — INFORMATION FOR USE – MANUAL CONTENT OUTLINE ........................................ 111
ANNEX N — GENERAL GUIDELINES FOR OPERATOR TRAINING ................................................. 114
ANNEX O — COMPARABLE STANDARDS BY TOPIC ..................................................................... 117
ANNEX P — TERMS FOR PERSONS AS USED IN B11 STANDARDS ............................................. 121
ANNEX Q — CONTROL DEVICES ..................................................................................................... 122
ANNEX R — ACHIEVING A SAFE CONDITION WITH REDUCED-ENERGY ..................................... 123
ANNEX S — INFORMATIVE REFERENCES ...................................................................................... 133

LIST of FIGURES
Figure 1 — Illustration of relationship between ISO 12100 and ANSI B11.0 10
Figure 2 — Organization of the B11 Series of Documents 13
Figure 3 — How to use type-C standards 14
Figure 4 — Example of Machinery Lifecycle Responsibilities 33
Figure 5 — Machinery and equipment lifecycle stages 38
Figure 6 — The Risk Assessment Process 43
Figure 7 — Elements of Risk 46
Figure 8 — Two Stage Iterative Approach to the Hierarchy of Controls and Risk Reduction 77
Figure 9 — Illustration of the process of the supplier and user risk reduction efforts 79
Figure 10 — Layout Analysis Process 106
Figure 11 — Risk reduction for special mode 108
Figure 12 — ANSI standards applicable in the United States 118

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AMERICAN NATIONAL STANDARD B11.0 – 2023

Figure 13 — EN Norms (EU standards) applicable in the European Union 119


Figure 14 — International standards (ISO & IEC only; other international standards may apply) 120
Figure 15 — Terms for Persons used in the B11 series of machinery safety standards 121
Figure 16 — Control devices 122
Figure 17 — Burn threshold when skin contacts smooth, hot, bare metal surface 129

LIST of TABLES
Table 1 — Requirements for New and Existing Machinery 39
Table 2 — Example Risk Scoring System 47
Table 3 — The Hazard Control Hierarchy 49
Table 4 — Example of relations between Hazard, Safety Function and Risk Reduction 55
Table 5 — Noise Source and Noise Reduction Methods (Informative) 70
Table 6 — Potential Effects/Additional Characteristics of Risk Reduction Measures 80
Table 7 — Machinery Hazards 85
Table 8 — Guidance for Estimating Injury Severity 90
Table 9 — Considerations for Probability of Occurrence 95
Table 10 — MIL-STD-882E Risk Scoring System [4x5] 96
Table 11 — RIA TR R15.306-2016 Risk Level Decision Matrix 97
Table 12 — RIA TR R15.306-2016 Injury Severity, Exposure, and Avoidance Categories 98
Table 13 — ANSI / ASSP Z10 Risk Scoring Matrix 99
Table 14 — Sample Risk Assessment 103
Table 15 — Manual Content 111
Table 16 — Low / Reduced Speed Values in Ascending Order with References 125
Table 17 — Low / Reduced Force Values in Ascending Order with References 127
Table 18 — Low/reduced kinetic energy values in ascending order with references 128
Table 19 — Low / Reduced Pressure Values in Ascending Order with References 128
Table 20 — Recommended Performance of Safety Levels for Reduced-Energy Operating Modes 130

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AMERICAN NATIONAL STANDARD B11.0 – 2023

FOREWORD (This Foreword is not part of the requirements of this ANSI B11.0 standard on Safety of Machinery)

Overview and History


The B11 series of machinery safety standards are over 100 years old, beginning with the first standard on the
safety requirements for power presses in 1922. Since that time, safety requirements for a variety of machines
have been developed and are continually updated/revised to become the current series of ANSI B11 American
National Standards and Technical Reports on machinery safety.

This American National Standard was promulgated by the B11 Standards Development Committee as a
voluntary consensus standard to establish and specify general safety requirements for the design,
construction, operation and maintenance (including installation, dismantling and transport) of machinery and
machinery systems. This standard also applies to devices that are integral to these machines.
This standard was first published in 2008 as ANSI B11.GSR (General Safety Requirements). It was
substantively revised and re-designated as ANSI B11.0 in 2010. The standard was again revised and
published in 2015; that third edition of this standard added responsibilities related to machinery components,
clarified the relationship between the risk assessment for the machine and the design specification for control
systems, provided additional information on documentation requirements, included new subclauses on
supervision and training, presented new annexes correlating machinery safety standards in the U.S. and
EN/ISO, and generally clarified and simplified text in the standard. The 2020 edition of B11.0 provided
additional or improved guidance in several key areas such as existing (legacy) equipment, prevention through
design, how to achieve acceptable risk and validate/verify (check, test, confirm) risk reduction measures. It
also included new content on alternative methods for the control of hazardous energy, manual and special
operation modes, and machinery systems dealing with aspects such as layout analysis and spans of control.

Changes from prior edition


The current edition of this American National Standard on the Safety of Machinery (ANSI B11.0-2023) includes
updates / content in the following areas:
• clarified text related to responsibilities of machinery suppliers, users, modifiers, purchasers of
used machinery, and other entities;
• introduced concepts of co-manufacturer(s) and their associated responsibilities;
• updated and clarified responsibilities for existing (legacy) machinery;
• included requirements for when whole body access situations exist and/or apply;
• improved the information about validation;
• improved information related to remote / tele–operations of machinery;
• expanded requirements for radiation hazards and associated risk reduction measures;
• added a new section for heated systems and related equipment for processing of materials;
• updated requirements for Information for Use and manuals, consistent with ISO 20607;
• reorganized clauses 4 (Responsibilities) and 5 (Lifecycle Requirements);
• added new definitions and updated existing ones (e.g., recognizing distinctions between, and
characterizing energy as hazardous, non-hazardous, or beneficial);
• updated and improved existing Annexes to assist the reader in applying the content of the
standard;
• clarified content of Table D1 on estimating severity of harm;
• added a new annex on Control Devices.

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AMERICAN NATIONAL STANDARD B11.0 – 2023

Application
The concepts and principles contained in this standard can be applied very broadly to a wide variety of systems
and applications. Documented risk assessments were first introduced to the machine tool industry in 2000
with the publication of (ANSI) B11.TR3 – Risk Assessment and Risk Reduction – A Guide to Estimate, Evaluate
and Reduce Risks Associated With Machine Tools; to the robot industry in 1999 with the publication of
ANSI/RIA R15.06-Requirements for Industrial Robots and Robot Systems; and to the packaging machinery
industry in 2006 with the publication of ANSI / PMMI B155.1-Safety Requirements for Packaging Machinery
and Packaging-Related Converting Machinery. Since that time, the principles of the risk assessment process
have been employed in a wide variety of diverse applications – including traffic control, consumer products,
process safety, incident investigations and, of course, machinery. Interested readers are encouraged to apply
these principles and concepts to other systems in addition to machinery as suits their needs.

General
“Safe” is the state of being protected from recognized hazards that are likely to cause physical harm. There
is no such thing as being absolutely safe, or in other words, a complete absence of risk. In turn, there is no
machine that is absolutely safe. All machinery contains hazards, and some level of residual risk. However,
the risk associated with those hazards should be reduced to an acceptable level.

This standard guides machinery suppliers and users through a risk assessment process that identifies hazards
and reduces corresponding risks to an acceptable level. In this standard, the terms “acceptable” and
“tolerable” are used as synonyms. Although engineers have long applied an informal risk assessment
framework, this standard includes a formal method to conduct and document the risk assessment process.
This standard identifies some preparations that need to be made before a risk assessment begins, and
presents the basic risk assessment process in a step by step approach to assist in achieving this goal.
The outcome of completing the risk assessment process should be:
• a clear understanding of risk(s) including the potential severity of harm and the probability of the
occurrence of harm;
• risk reduction measures appropriate to the circumstances;
• machinery with risks reduced to an acceptable level;
• documentation of the risk assessment.

This standard reflects the best industry practice at the time of its approval. The inclusion or omission of
language relative to any evolving technology, either in the normative or informative areas of this standard, in
no way infers acceptance or rejection of such technologies. The presentation style used in this standard mixes
both informative and explanatory text with normative requirements and was chosen to enhance the readability
of the information. The distinction between these texts is illustrated as follows:
The normative text (requirements) appears aligned to the left margin. To meet the requirements of this
standard, machinery suppliers and users need to conform to these normative requirements. These
requirements typically use the verb “shall.” Informative text (recommendations and/or guidance) appears as:

Informative text
The informative or explanatory text in this standard appears as indented Informative Notes in italics, in a reduced
font size, left justified (vs. full justification), and colored purple (for those with electronic or color printed versions),
all of which are in an effort to provide a strong visual signal/reminder to the reader that this is informative text, not
normative text, and is not to be considered part of the requirements of this standard; this text is advisory in nature
only. The suppliers, the users and the machines themselves are not required to conform to the informative text.
The machine-specific “base” (type-C) safety standards all use the more traditional ANSI two-column format, and
the informative text appears as the right-hand column and is titled “Explanatory Information.” This standard uses
the single column format common to many international standards. The informative text is presented in this
manner in an attempt to enhance readability and reduce confusion.

Prevention Through Design or PTD is a recent term in industry. The objectives of risk assessment, risk
reduction and elimination of hazards as early as possible are integral and not new to this document. The
phrase "Prevention Through Design" is used within this document, as are other equivalent terms such as
“elimination by design,” "design out," and "substitution" to thoroughly address risk assessment and apply it to
the lifecycle and operations of the machine.

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AMERICAN NATIONAL STANDARD B11.0 – 2023

Objective
The objective of the B11 series of standards is to eliminate injuries to personnel working with or around
machinery or machinery systems by establishing requirements for the design, construction, reconstruction,
modification, installation, set–up, operation and maintenance of machinery or machine systems. This standard
should be used by suppliers and users, as well as by the appropriate Authority Having Jurisdiction (AHJ).
Responsibilities have been assigned to the supplier (i.e., manufacturer, the re-constructor, and the modifier),
the user, and the user personnel to implement the requirements of this standard. This standard is not intended
to replace good judgment and personal responsibility. Personnel skill, attitude, training and experience are
safety factors that need to be considered by the user.

Applying risk reduction measures to machinery is complicated by the wide variety of operations and operating
conditions, including, but not limited to the following:
• the variations in size, speed, and type of machinery used;
• the size, thickness, and kind of pieces to be worked;
• the required accuracy of the finished work; the skill of operators;
• the length of run; and
• the method of feeding, including part and scrap removal.

Because of these varying factors in the operations and in the workplace, a wide variety of risk reduction
measures have been covered in this standard as well as the machine-specific “base” (type-C) safety standards.
Alignment
This standard has been aligned with international standards (primarily ISO, but ASTM and IEC as well) and
European (EN) standards by the introduction of hazard identification and risk assessment as the principal
method for analyzing hazards to personnel to achieve a level of acceptable risk. This standard integrates the
requirements of ISO 12100:2010, as well as selected U.S. standards.

In 2012, ISO 12100 was adopted as an American National Standard and re-designated as ANSI / ISO 12100-
2012 IDT (the “IDT” in the official alpha-numeric ANSI designation means identical and virtually unchanged
from the ISO version).

ISO 12100 was used as one of the principal resource documents in developing ANSI B11.GSR (and by
extension, ANSI B11.0). However, the technical requirements of ISO 12100 have undergone little change
since the early 1990s (the content of ISO 12100:2003 parts 1 and 2, and ISO 14121:2007 were editorially
combined without ANY technical changes to create ISO 12100:2010).

In addition, ISO 12100 applies ONLY to the suppliers of machinery and includes NO requirements for users of
machinery. ISO 12100 also applies only to new machinery and excludes machinery made prior to its
publication in 2010. ANSI B11.0 differs from ISO 12100 in that it specifically includes requirements for both
suppliers and end users of machinery. It also includes numerous requirements and informative guidance and
other information related to the safety of machinery which goes beyond that which is contained in ISO 12100.
As a result, conforming with the requirements of ISO 12100 will not assure conformance to the requirements
of ANSI B11.0. Conversely, conforming with the requirements of ANSI B11.0 will automatically result in
conformance to the requirements of ISO 12100. Figure 1 on the following page is a simplistic illustration of
the relationship between these two standards in terms of the ISO vice versa principle.

ANSI B11.0

ISO
12100

Figure 1 — Illustration of relationship between ISO 12100 and ANSI B11.0

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AMERICAN NATIONAL STANDARD B11.0 – 2023

This standard contains references to federal Occupational Safety and Health Administration (OSHA)
standards. OSHA standards represent the minimum level of regulatory compliance requirements within the
United States. Federal OSHA-approved individual state safety and health programs/agencies (of which
approximately half of the U.S. states have (e.g., Michigan OSHA, known as MIOSHA, and California OSHA,
known as Cal-OSHA) have standards that may exceed these minimum requirements. Accordingly, the
appropriate standards need to be used. Voluntary consensus standards such as this one represent state of
the art industry practices and often exceed federal regulatory requirements, and these can be, and often are,
used by OSHA compliance officers to augment their dated regulatory standards.

New Terminology
Historically, terms have been used in the B11 community to describe requirements for the safety of machinery.
Experience has shown that certain terms (e.g., safeguarding, or complementary equipment) are often used
imprecisely, even by technical experts. This revision of B11.0 includes an effort to bring better precision to
certain technical terms and has resulted in the deletion of other terms. Although no longer included in B11.0,
these terms should still be used in conversations or communications with audiences that have a shared
understanding of the intended meaning. In addition, some terms are commonly used but not necessarily with
common meanings. As a result, this edition of B11.0 has transitioned to certain new terms, including the
following:

Previous term Current term


Safeguarding Risk reduction measures / Engineering controls
Guards / safeguarding devices Engineering controls - guards / Engineering controls - devices
Awareness devices Awareness means
Complementary equipment Term no longer used
Safeguarding methods Part of risk reduction measures

The terms repair, rebuild, refurbish, remanufacture, reconstruct and others are used to describe work done on
existing (legacy) equipment. These terms have been defined for use in this standard, and the requirements
for the work on existing machinery are described in clause 4.
Context
The writers of this standard understand that the reader/user of this American National Standard is unlikely to
read it cover-to-cover but instead (for example), might use the Table of Contents as a sort of ‘roadmap’ to find
a very specific topic and then review only that topic. However, the reader/user of this standard is informed
that the elements (clauses, subclauses, etc.) of these documents are sequenced and often interrelated in such
a way as to state requirements that may very well be dependent on text in a section(s) that precedes the actual
requirement. It therefore becomes vital and important for the user of this standard to ensure they understand
the depth, range and especially the context of the section or topic in which the actual requirement appears.

Effective Date
The following information on effective dates is informative guidance only, and not a normative part of this
standard. The subcommittee recognizes that some period of time after the approval date on the title page of
this document is necessary for suppliers and users to develop new designs, and/or modify existing designs or
manufacturing processes in order to incorporate the new and/or revised requirements of this standard into
their product development or production system.

The subcommittee recommends that suppliers complete and implement design changes for new machinery
and machinery systems within 30 months of the approval of this standard.

The subcommittee recommends that users evaluate whether existing machinery and machinery systems
implement this edition within 30 months of the approval date of this standard using generally recognized risk
assessment methods. If the risk assessment shows that modification(s) is necessary, refer to the requirements
of this standard or the machine-specific “base” (type-C) safety standard to implement risk reduction measures
(protective measures) for appropriate risk reduction.

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AMERICAN NATIONAL STANDARD B11.0 – 2023

Development
At the time this standard was approved as an American National Standard, the ANSI-accredited consensus body (B11
Standards Development Committee) was composed of the following Members:
Alan Metelsky, FS, Eng., Chair / Anne Mathias, PE, Vice-Chair / David Felinski, Secretariat
Organizations Represented Delegate Alternate
Aluminum Extruders Council Mel Mitchell, CSP Brad Wyatt, CSP
Amazon Jeread Sines, B11 LMSS, FS Eng Josh Owens, B11 LMSS, FS Eng
American Society of Safety Professionals Ted Sberna, Sr. Anne Mathias, PE
Association for Advancing Automation Carole Franklin Jeff Fryman
Association For Manufacturing Technology Russ Bensman Alan Metelsky, FS Eng
Assoc. for Packaging & Processing Tech. Bruce Main, PE, CSP Tom Egan
The Boeing Company Rhiannon McPherson Mark Ellingson
Bridgestone Kenji Furukawa, FS Eng Joey Hinson, FS Eng
Canadian Standards Association Ana Andronescu, P.Eng. Walter Veugen
Deere & Co. Tony Beeth Scott Winter
Euchner Andy Smith Jilani Bouchane
Exponent Steve Andrew, PE, CSM Alex Zelhofer, PhD, PE
FDR Safety Mike Taubitz Luke Contos, Joe Wolfsberger
Fortress Safety Jenny Tuertscher, B11 LMSS, FS Eng Josh Hill
Honda Development & Mfg. of America Todd Dickey Doug Titus, Tyler Willis
General Motors Corporation Tony Ross Mike Douglas
IDEM Safety Mark Witherspoon Amir Mohtasham
Komatsu America Industries George Schreck James Landowski
Liberty Mutual Craig Karasack, CSP Julie Thompson, CSP
MAG Automotive Erik Carrier Doug Watts
Metal Powder Industries Federation Bill Edwards James Adams
National Inst. for Occupational Safety & Health Rick Current, PE
Occupational Safety & Health Administration Ken Stevanus Mary Bauer, CIH, CSP, B11 LMSS
Omron Scientific Technologies Incorporated Tina Hull, FS Exp
Pilz Automation Safety, LP Mike Beerman, CMSE Dino Mariuz
Plastics Industry Association Jeff Linder Dale Bartholomew
Precision Metalforming Association Jim Barrett, Jr. PhD David Klotz
Presence–sensing Device Manufacturers Assn. Jim Kirton Mike Carlson
Rockwell Automation Darin Magnuson, FS Eng Jonathan Barrett, FS Eng
Rockford Systems Brian Boes Matt Brenner
Safe–T–Sense Mike Poynter, FS Eng Federico Badillo
SICK Product & Competence Centers America Chris Soranno, FS Exp Nate Gose, FS Eng
Sheet Met. & Air Cond. Contract. Nat’l. Assoc. Justin Crandol, CSP Rick Di Ioli
Toyota Motor Manufacturing North America Chip Boertlein Mike Collier, B11 LMSS

At the time this standard was approved, the B11.0 Safety of Machinery Subcommittee had the following
members who participated in and contributed to the development of this American National Standard:
Bruce Main, PE, CSP – Chair design safety engineering, inc. Chris Felinski, Secretary B11 Standards, Inc.
Anne Mathias, PE – Vice-Chair Engineering Systems, Inc. David Felinski, Secretariat B11 Standards, Inc.
Steve Andrew Exponent Brandon Miller Henkel NA
Jim Barrett Link Systems John Piampiano International Paper
Mike Carlson Banner Engineering Pat Rockey Rockwell
Eddie Crawford Rockwell Ted Sberna, Sr. White Horse Safety
Eric Cummings Ross Controls Jeread Sines Amazon
Rick Current NIOSH Chris Soranno SICK PCA
Todd Dickey Honda Marco Tacchini GT Engineering
Mike Douglas General Motors Mike Taubitz FDR Safety
Bryant Eismeier Flexware Innovations Doug Titus Honda
Kenji Furukawa Bridgestone Jenny Tuertscher Fortress Safety
Chris Gerges DAK Machine Safety Jim Van Kessel JVK Safety
Bryan Harrell Eli Lilly Mark Witherspoon IDEM Safety
Heinz Knackstedt Machine Control Safety Scott Whittington Cincinnati
Rhiannon McPherson Boeing Paul Wozniczka MTS Systems
Alan Metelsky Gleason Works

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AMERICAN NATIONAL STANDARD B11.0 – 2023

Introduction
Organization and Application of B11 Documents
The B11 series of machinery safety standards and technical reports has aligned with the ISO “type A-B-C”
structure of categorizing standards as described immediately below (and shown in Figure 2).

Type-A standards (basis safety standards) give basic concepts, principles for design, and
general ‘foundational’ aspects that can be applied broadly across different types of machinery;
Type-B standards (generic safety standards) deal with one or more safety aspects or one or
more types of risk reduction measure that can be used/applied across a wide range of machinery
(ISO further divides type-B standards into B1 on safety aspects and B2 on safeguards);
Type-C standards (machine-specific safety standards) deal with detailed safety requirements
for a particular machine or “group of machines” (meaning machines having a similar intended
use and similar hazards, hazardous situations or hazardous events).

The B11 Standards Development Committee recognizes that an additional type of standard has emerged -
these ‘Hybrid’ standards represent an evolutionary development in machinery safety standardization that
combine some unspecified percentage of the typical content and requirements found in any two (or even all
three) of the standard types described above. Usually, they are some combination of requirements generally
found in type-A and type-C standards. With the possible exception of this standard, none of the other
documents in the B11 portfolio fit into this new type, numerous examples of these hybrid machinery safety
standards exist outside of ANSI B11.

This ANSI B11.0 standard on machinery safety is predominantly a “type-A” standard in that it applies to an
extremely broad array of machines and contains general requirements. However, in some sections, it also
contains very specific requirements, hence, the “exception” noted in the paragraph above. B11.19, B11.20,
B11.21, B11.25, B11.26 and the entire B11 series of Technical Reports are all typical “type-B” documents
addressing general safety concepts, subjects and/or elements that can be used across a wide range of
machinery (such as B11.19 on risk reduction measures, B11.26 on functional safety or (ANSI) B11.TR1 on
ergonomics) or as a standard to be used when integrating machinery into a system (B11.20). The B11 series
of Technical Reports are informative documents that may be generally applied to many different machines,
and as such, would all fall within the “type-B” category. The machine-specific “base” (type-C) B11 standards
contain detailed safety requirements for a particular machine type or group of machines (see the list of machine
and machinery system safety standards in subclause 7.19).

Figure 2 — Organization of the B11 Series of Documents

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Machinery safety depends on the practical application of the risk assessment process. The type-A (B11.0)
and type-B standards are intended to be used concurrently with the type-C (machine-specific) standards during
the risk assessment process, by the supplier and user of machines. See Figure 3.

Figure 3 — How to use type-C standards

If a type-C standard exists, for a particular machine or group of machines, the hazards and risk reduction
measures identified in the type-C standard assists the standards user in applying the risk assessment process.
Readers may rely on the type-C standard for this information, subject to any application-specific hazards. If
no type-C standard exists, the reader needs to identify the hazards for the particular application and apply risk
reduction measures accordingly.

When a type-C standard deviates from one or more provisions dealt with by this standard or by a type-B
standard, the type-C standard requirement generally takes precedence. Any deviation in conforming to a
requirement of any standard should be carefully evaluated and based on a documented risk assessment.

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This standard is intended for readers with differing levels of familiarity with the B11 series of safety standards
and the risk assessment process. Readers new to these standards may benefit from starting with the B11.0
and then reading the applicable machine-specific B11.x standard, B11.19, and other relevant or appropriate
standards and technical reports. More experienced users may find efficiencies in beginning with the machine-
specific B11.x standard and then reviewing relevant portions of the ANSI B11.0 standard as necessary.

The requirements of the machine-specific ANSI standards are grouped according to those that apply to the
supplier (i.e., manufacturer, rebuilder, modifier) and those that apply to the user. Some are shared between
the supplier and user and are so indicated.

Risk assessment is a scalable process, which simply means that risk assessment can be applied to a single
hazard, to multiple hazards of a simple machine, or to hazards on more complex (automated) machine
systems.

Risk assessment can be applied to new machines, to existing machines, or modified machines. To facilitate
the process, the risk assessment leader may need to create ad hoc teams that meet together, or with
individuals that meet at different times to capture the appropriate information. Much of the risk assessment
process can be conducted quite effectively at the shop floor level in the environment where the tasks and
hazards occur.

New technologies, or new applications of existing technologies rarely have existing industry standards to
describe the hazards and risk reduction measures that can be applied to them. The risk assessment process
as described in ANSI B11.0 may be used to achieve acceptable risk under these circumstances.

The writers of this standard recognize that zero risk does not exist and cannot be attained. However, a good
faith approach to risk assessment and risk reduction should achieve an acceptable risk level.

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As of the date of approval of this standard, the ANSI B11 series of American National Standards and Technical
Reports on machinery safety consisted of the following documents shown in the list below. The user should
check a licensed reseller such as ANSI (www.ansi.org) for the current versions of any of these documents. All
archival / historical versions of the documents are available at www.b11standards.org.

List of the ANSI B11 Series of Safety Standards and Technical Reports
# SHORT TITLE / TOPIC YEAR TYPE
B11.0 Safety of Machinery 2023 A
B11.1 Mechanical Power Presses 2009 (R20) C
B11.2 Hydraulic & Pneumatic Power Presses 2013 (R20) C
B11.3 Power Press Brakes 2022 C
B11.4 Shears 2003 (R20) C
B11.5 Ironworkers 1988 (R20) C
B11.6 Manual Turning Machines (Lathes) with or without Auto Control 2001 (R20) C
B11.7 Cold Headers and Cold Formers 2020 C
B11.8 Manual Milling, Drilling, & Boring Machines 2022 C
B11.9 Grinding Machines 2010 (R20) C
B11.10 Sawing Machines 2003 (R20) C
B11.11 Withdrawn (Gear and Spline Cutting Machines; use B11.0 and B11.19) 2001 (R20) C
B11.12 Roll Forming and Roll Bending Machines 2005 (R20) C
B11.13 Single & Multiple-Spindle Automatic Bar and Chucking Machines 2020 C
B11.14 Withdrawn (Coil Slitting Machines; combined into B11.18) (1996) C
B11.15 Pipe, Tube and Shape Bending Machines 2001 (R20) C
B11.16 Powder / Metal Compacting Presses 2014 (R20) C
B11.17 Horizontal Hydraulic Extrusion Presses 2023 C
B11.18 Machines Processing or Slitting Coiled or Non-Coiled Metal 2006 (R20) C
B11.19 Performance Requirements for Risk Reduction Measures (Safeguarding) 2019 B
B11.20 Integration of Machinery into a System 2017 B
B11.21 Machine Tools Using Lasers for Processing Materials 2006 (R20) B
B11.22 Turning Centers and Automatic Numerically Controlled Turning Machines 2002 (R20) C
B11.23 Machining Centers & CNC Milling, Drilling & Boring Machines 2002 (R20) C
B11.24 Transfer Machines 2002 (R20) C
B11.25 Large Machines 2022 B
B11.26 Functional Safety for Equipment / Machine Control Systems 2018 B
B11.27 Electro-Discharge Machines 2020 C
B11.TR1 Ergonomics 2016 B
B11.TR2 Metal Working Fluids 1997 (R16) B
B11.TR3 Withdrawn (Risk Assessment / Risk Reduction Guide; use B11.0) 2000 (R15) B
B11.TR4 Selection of Programmable Electronic Systems (PES/PLC) 2004 (R15) B
B11.TR5 Noise Measurement 2006 B
B11.TR6 Withdrawn (Safety Control Systems for Machines; revised as B11.26) (2010) B
B11.TR7 Integration of Lean and Safety 2007 (R17) B
B11.TR8 Guide to Inspection of Risk Reduction Measures 2022 B
B11.TR9 Cybersecurity 2019 B
B11.TR10 Guidance on Artificial Intelligence into Machinery Safety Applications 2020 B
ANSI / ISO 12100 Safety of machinery (identical adoption of ISO 12100-2010) 2012 A

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Safety of Machinery
1 Scope
This type-A standard applies to new, existing, modified or rebuilt power-driven machines, not portable by hand
while working, that are used to process materials by cutting; forming; pressure; electrical, thermal or optical
techniques; lamination; or a combination of these processes. This includes associated equipment used to
transfer material or tooling (including fixtures) to assemble/disassemble, and to inspect or test. The associated
equipment, including logic controller(s) and associated software or logic, together with the machine actuators
and sensors, are considered a part of the machinery.

This can be a single machine or a machinery system(s).


Informative Note 1: As used in this standard, a machine can be an assembly of linked parts or components (at
least one of which moves) with the appropriate actuators, control and power circuits, etc., that are joined
together for a specific application such as, for the processing, treatment, marking, or moving of material.
Informative Note 2: To improve readability, the terms “machine,” “machinery,” “machine tool” or “machinery
system(s)” are used interchangeably throughout the document, either in singular or plural form.
Informative Note 3: A machine system is a systematic array of one or more machines that is not portable by
hand while working and includes any associated material handling, manipulating, gauging, measuring, or
inspecting equipment.
Informative Note 4: See ANSI B11.20 for additional information on the safety requirements and interactions
for when machinery is integrated into a cohesive system.

This standard specifies basic terminology, principles and a methodology for achieving acceptable risk in the
design and the use of machinery. It specifies principles of risk assessment and risk reduction to help designers,
integrators and users of machinery in achieving this objective. These principles are based on knowledge and
experience of the design, use, incidents, accidents and risks associated with machinery. Procedures are
described for identifying hazards and estimating and evaluating risks during relevant phases of the machine
lifecycle, and for the elimination of hazards or the provision of sufficient risk reduction. Guidance is given
regarding the documentation and confirmation of the risk assessment and risk reduction process.

Other industry sectors can benefit from applying this standard. A risk assessment may be required to
determine if a machine-specific “base” (type-C) safety standard adequately covers the hazards associated
with the specific application of a machine.

Where a machine-specific (type-C) safety standard exists, the requirements of the machine-specific “base”
(type-C) safety standard shall generally apply.

Deviations from the requirements of this standard or from any machine-specific (type-C) safety standard shall
be based on a documented risk assessment.
Informative Note 1: Deviating from the requirements of this document should be considered only when it is not
feasible to apply the requirements.
Informative Note 2: See clause 6 for additional information on risk assessment.
Informative Note 3: See 7.19 for a list of example machines covered by other specific standards.

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2 Normative References
The following standards contain provisions either in whole or in part which constitute additional requirements
of this American National Standard and are incorporated into this standard by reference. At the time of
publication, the editions indicated below were current.

All standards are subject to revision, and parties to agreements based on this American National Standard are
encouraged to investigate the possibility of applying the most recent editions of the standards indicated below.
Informative Note 1: Not all of the normative standards below will necessarily apply to a specific application.
The reader is responsible for determining and obtaining the normative references that apply to the particular
situation under consideration.
Informative Note 2: The normative standards cited by reference, in turn, include other normative standards.
The reader is responsible for determining and obtaining those ‘secondary’ normative references that may
apply to the particular situation under consideration.

ANSI B11.19–2019 Performance Requirements for Risk Reduction Measures: Safeguarding and other
Means of Reducing Risk
ANSI B11.20–2017 Safety Requirements for the Integration of Machinery into a System
ANSI B11.26–2018 Functional Safety for Equipment: Design Principles and the Practical Application of ISO
13849-1.
NFPA 70–2023 National Electrical Code
NFPA 79–2021 Electrical Standard for Industrial Machinery
NFPA 70E–2024 Standard for Electrical Safety in the Workplace
ANSI / ASSP Z244.1–2016 Control of Hazardous Energy – Lockout/Tagout and Alternative Methods.
ISO 4413–2010 Hydraulic fluid power - General rules and safety requirements for systems and their
components Pneumatic fluid power – Systems Standard for Industrial Machinery
ISO 4414–2010 Pneumatic fluid power - General rules and safety requirements for systems and their
components
ANSI Z535 series on safety signs, labels, symbols, product manuals and instructions.

In addition to the normative references listed above, see Annex R for a list of potentially useful informative
references.

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3 Definitions
The following definitions are common within the B11 community and the portfolio of its ANSI standards and
technical reports, as well as the general machinery/machine tool industry. The definitions of the terms in this
clause are applied in a consistent manner throughout the entire B11 portfolio of ANSI standards and technical
reports. Where a machine– or industry–specific definition exists and the definition conflicts with the definition in
this clause, the definition of the machine– or industry–specific standard shall apply.

3.1 acceptable risk: A risk level achieved after risk reduction measures have been applied. It is a risk
level that is accepted for a given task (hazardous situation) or hazard. For the purpose of this standard and
the entire B11 series, the terms “acceptable risk” and “tolerable risk” are considered to be synonymous.
Informative Note 1: The expression “acceptable risk” usually, but not always, refers to the level at which
further technologically, functionally, and financially feasible risk reduction measures or additional expenditure(s)
of resources will not result in significant reduction in risk. The decision to accept (tolerate) a risk is influenced
by many factors including the culture, technological and economic feasibility of installing additional risk
reduction measures, the degree of protection achieved through the use of additional risk reduction measures,
and the regulatory requirements or best industry practice.
Informative Note 2: The user and supplier may have a differing ‘level’ of acceptable risk.
Informative Note 3: A similar phraseology used in some ISO standards is as follows: “the risk has been
adequately reduced.”

3.2 accumulator: A vessel containing fluid under pressure and used as a source of stored energy.

3.3 affected person: An individual who operates, services and/or maintains a machine, or others who
are in proximity to the machine.
Informative Note: See also, Annex P.

3.4 alternative method: A means of controlling hazardous energy (other than energy isolation) to reduce
risk to an acceptable level.

3.5 anti-repeat: The part of the control system designed to limit the machine to a single cycle if the
actuating control is maintained in an operating position. Anti-repeat requires release of all actuating controls
before another cycle can be initiated.
Informative Note: The function of anti-repeat is to prevent successive cycles that could occur if the anti-repeat
control did not exist.

3.6 Authority Having Jurisdiction (AHJ): An organization, office, or individual having the authority to
enforce the requirements of a code, law, regulation or standard, or to approve equipment, materials, an
installation, or a procedure. This can include Federal, State or Local Regulators, as well as organizations
responsible for product or equipment listing or approval.

3.7 authorized personnel: Qualified personnel identified by the user (employer) or supplier to perform
a specific task. See qualified personnel (3.74).
Informative Note: See also, Annex P.

3.8 awareness means: A barrier, signal, sign, or marking that warns individuals of an impending,
approaching or present hazard.

3.9 bed: The stationary member of the machine that supports the tooling and other associated equipment.

3.10 bypass: See manual suspension (3.53).

3.11 chuck: A clamp-like device used for gripping a workpiece or tool.

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3.12 clutch: A mechanism that, when engaged, transmits torque to impart motion from a driving member
to a driven member.
3.12.1 full revolution clutch: A type of clutch that, when engaged, cannot be disengaged until the
machine has completed a single cycle.
3.12.2 part revolution clutch: A type of clutch that may be engaged or disengaged during the
machine cycle.

3.13 co-manufacturer: One or more users who share the duties of industrial production using machinery.

3.14 concurrent: Acting in conjunction with another and used to describe a situation where two or more
controls exist in an operated condition at the same time (but not necessarily simultaneously).

3.15 control device: A device connected into the control circuit and used for controlling the operation of
the machine (e.g., position sensor, manual control switch, relay, magnetically operated valve).
Informative Note: See also, Annex Q.
3.15.1 actuating control [actuating means]: An operator control used to initiate or maintain machine
motion(s) or other machine function(s). Also referred to as: foot control, hand control, pedal,
presence sensing device initiation, treadle bar, two-hand control, or two-hand trip.
Informative Note 1: For a motor driven direct mechanism, the motor would be the actuator.
Informative Note 2: For a flywheel/clutch driven mechanism, the clutch would be the actuator and not
the motor that is driving the flywheel.
3.15.2 enabling device: A manually actuated control device which, when continuously activated
and used in conjunction with a separate actuating control, will allow the machine to function.
3.15.3 foot control: A foot-operated mechanism or device used as a control device.
Informative Note: Also referred to as: foot pedal, foot treadle, foot treadle bar, pedal, single
control device, or single trip device.
3.15.4 hand control: A hand-operated mechanism or device used as a control device.
Informative Note: Also referred to as: actuating control, two-hand control device, two-hand trip
device, single control device, or single trip device.
3.15.5 hold-to-run control device: Manually actuated control device which initiates and maintains
machine functions only as long as the manual control device is actuated.
Informative Note: Examples include two-hand control devices and single control devices (hand- or
foot-operated).
3.15.6 reset device: A manually actuated control device which, when operated, initiates a reset
function(s).
3.15.7 safety-related manual control device: Control device which requires deliberate human
action that may cause or result in potential harm to individuals.
Informative Note: Examples include actuating devices such as pushbuttons, selector switches, or
foot pedals designed for functions like reset, start/restart, guard unlocking or hold-to-run control (e.g.,
jog, inching).
3.15.8 safety-related reset: A function within the SRP/CS used to restore one or more safety
functions before restarting a machine.
Informative Note: This can be automatic or manual.
3.15.9 single control device: An actuating control used to initiate and maintain hazardous machine
function(s).
Informative Note: Single control devices only provide risk reduction for the person operating the
actuating control.
3.15.10 single trip device: An actuating control which initiates hazardous machine function(s) and
then can be released.
Informative Note: Single trip devices only provide risk reduction for the person operating the
actuating control.
3.15.11 stop control: A control device or function which, when actuated, initiates an immediate stop
command or a stop at a predefined position in a cycle.

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3.15.12 two-hand control device (THCD): An actuating control that requires the simultaneous
operation by both hands to initiate and maintain hazardous machine function(s).
Informative Note: Two-hand control devices only provide risk reduction for the person operating the
actuating control.
3.15.13 two-hand trip device (THTD): An actuating control that requires the simultaneous operation
by both hands to initiate hazardous machine function(s) and then can be released.
Informative Note: Two-hand trip devices only provide risk reduction for the person operating the
actuating control.

3.16 control reliability: The capability of the [machine] control system, the engineering control – devices,
other control components and related interfacing to achieve a safe state in the event of a failure within the
safety-related parts of the control system.
Informative Note: For additional information about performance of safety functions, see ANSI B11.19, ANSI
B11.26, IEC 62061, IEC 61508, and ISO 13849.

3.17 control system: Sensors, manual input and mode selection elements, interlocking and decision-
making circuitry and output elements to the machine actuators, operating devices and mechanisms.

3.18 counterbalance: Means provided to balance the reciprocating mass of the slide/ram drive members
and slide/ram attachments.

3.19 cycle: A complete movement of a machine, from the initial start position back to the same start
position, which may include feeding and removal of the material or workpiece.

3.20 design: To plan and develop the machine to meet the intended purpose and function during its
lifecycle.

3.21 energy: As used in this document, energy refers to electrical, mechanical, hydraulic, pneumatic,
chemical, nuclear, thermal, gravity or other forms of energy to power a machine or system, or as a waste or
byproduct.
3.21.1: beneficial energy: Energy that is required or essential to reduce risk to personnel when
performing a task.
Informative Note: Examples include, but are not limited to:
• energy that offsets gravity and does not pose a hazard during performance of a task(s)
(e.g., counterbalances);
• maintaining power to a processor, HMI or input devices to facilitate a specific task(s)
(e.g., troubleshooting);
• energy necessary to maintain control of potential energy (e.g., wound coil material).
3.21.2: hazardous energy: Any energy that could cause harm to personnel.
3.21.3: non-hazardous energy: Energy that does not expose personnel to harm when performing
a task.
Informative Note: Energy that can be considered as non-hazardous for a particular task might be
considered hazardous for a different task.

3.22 energy-isolating device: A means of preventing the transmission or release of energy.


Informative Note 1: An example is a manually operated switch (e.g., electrical circuit breaker or a disconnect
switch) by which the conductors of a circuit can be disconnected from all ungrounded supply conductors and no
pole can be operated independently.
Informative Note 2: The means of preventing the transmission or release of energy can be, but not
necessarily limited to mechanical or electro-mechanical, such as a line valve or a block (e.g., chains, die block,
pin, restraint).
Informative Note 3: System isolation equipment that incorporates control lockout stations and is listed for
disconnection purposes when located on the load side of the main supply circuit disconnecting means and over-
current protection can be an energy-isolating device(s). See also, NFPA 79.
Informative Note 4: See also, ANSI / ASSP Z244.1.

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3.23 engineering controls: Guards or devices and associated safety-related parts of the control system
(SRP/CS) used to reduce risk.
Informative Note: See also, ANSI B11.19 and 6.5.1.3.
3.23.1 engineering controls – control functions: Safety functions associated with engineering
controls (guards or devices) intended to reduce risk.
Informative Note: Examples of these include the following:
• stopping functions;
• safety-related reset;
• suspension of safety functions (manual suspension, muting);
• variable sensing functions (sensing field switching, blanking);
• presence-sensing device initiation (PSDI).
3.23.2 engineering controls – devices (safeguarding device): A device that provides protection
from a hazard(s) by preventing or detecting exposure to the hazard zone.
Informative Note 1: Engineering controls – devices, when used for detection, typically provide an
output(s). Examples of these include the following:
• interlock devices;
• movable barrier devices;
• presence-sensing devices;
• actuating controls;
• enabling devices;
• emergency stop devices.
Informative Note 2: These do not include personal protective equipment (e.g., safety
glasses/goggles, face shields, safety shoes, etc.). See also, ANSI B11.19.
3.23.3 engineering controls – guards: A barrier that provides protection from a hazard.
Informative Note: Examples of these include the following:
• fixed guards;
• movable guards;
• interlocked guards;
• adjustable guards;
• self-adjusting guards;
• partial guards;
• perimeter guards;
• nip guards;
• power transmission guards.

3.24 ensure: To reasonably establish, maintain, and monitor requirements of this standard or other
standards within the B11 series of American National Standards.
Informative Note: In the context of B11 documents, ensure is not synonymous with “guarantee.”

3.25 fail-to-safe: A design or event such that a failure or fault within the system causes the hazardous
situation to achieve a safe state.
Informative Note: The term “fail-to-safe” is not the same as fail-safe and does not guarantee complete
freedom from failure, e.g., from multiple failures. The term “fail-safe” is typically used in the process control
industry where the process needs to continue to run or function. Fail-safe is not typically used in the
machinery or machine tool industry.

3.26 failure: Termination of the ability of an item to perform a required function.


Informative Note: After one or more failures, the item has a fault. “Failure” is an event, as distinguished from
“fault,” which is a state. The concept as defined does not apply to items consisting of software only.

3.27 fault: The state of an item characterized by the inability to perform a required function after a failure.
Informative Note 1: A fault does not include the inability to perform during preventive maintenance or other
planned actions, or due to lack of material, product, utilities or other external resources.
Informative Note 2: A fault is often the result of a failure of the item itself but may exist without prior failure. In
this standard, “fault” means a random fault.

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3.28 feasible: Reasonably capable of being done, put in [into] practice or carried out.
Informative Note 1: Not all potential risk reduction measures are feasible. Many factors determine if the risk
reduction measure is feasible. It is necessary to evaluate the application of the risk reduction measure against
the following factors:
• regulatory obligations;
• introduction of new hazards;
• effectiveness;
• machine performance;
• usability;
• productivity;
• durability;
• maintainability;
• ability to clean;
• ergonomic impact;
• economic feasibility;
• technological feasibility.
Informative Note 2: The terms “feasible” and “possible” are not considered to be synonymous.
Informative Note 3: In this standard, the terms “feasible” and “practicable” are considered to be synonymous.

3.29 feasibility: The practicability of implementing a risk reduction measure(s) in an actual application to
reduce risk to an acceptable level.
Informative Note 1: See also, 6.5, 6.7 and the definition for acceptable risk (3.1).
Informative Note 2: The terms “feasibility” and “possibility” are not considered to be synonymous.
Informative Note 3: In this standard, the terms “feasibility” and “practicability” are considered as synonymous.

3.30 fixture: A means used to locate or support the material, workpiece or tool during operation.

3.31 guard: See engineering controls – guards (3.23.3).

3.32 hand tool: Any device used for manual feeding, or for freeing a stuck workpiece or scrap.

3.33 harm: Physical injury or damage to the health of people.


Informative Note: Harm may result from direct interaction with the machine, or indirectly as a result of
damage to property or to the environment.

3.34 hazard: A potential source of harm.

3.35 hazardous event: An event that can cause harm.


Informative Note: A hazardous event can occur over a short period of time or over an extended period of time.

3.36 hazardous situation: A circumstance in which an individual is exposed to a hazard(s).


Informative Note 1: The exposure can result in harm immediately or over a period of time.
Informative Note 2: A hazardous situation can also be referred to as a task/hazard pair (combination).

3.37 immediate stop command: See stop command (3.114).

3.38 inadvertent contact: When a person touches or otherwise contacts a hazard accidentally or
unintentionally.

3.39 individual: A person, including personnel, who may or may not be under the direct control of the
supplier or user. See also, personnel.
Informative Note: See also, Annex P.

3.40 inherently safe by design: a design measure that reduces risk, which is not susceptible to a
malfunction that will increase the risk of harm.
Informative Note: See also, 6.5.1.

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3.41 in-running nip point: Any location between a rotating machine member and another rotating or fixed
member, or the material where a part of the body could be drawn in and injured. Also referred to as: in-going
nip point.
Informative Note 1: Examples of in-running nip points include:
a) two or more counter-rotating surfaces, whether powered or unpowered;
b) surfaces rotating in the same direction, but with different peripheral speeds;
c) surfaces rotating in the same direction, but with different surface properties (such as frictional or
entanglement characteristics);
d) one surface rotating toward an adjacent fixed object or part of the machine;
e) open drive belts, chains or webs, contact rollers, or gears and sprockets;
f) non-powered rollers (riding rollers, guide rollers) driven by movement of the product.
Informative Note 2: See also, “nip points” in Table 7 of Annex D.

3.42 installer: An individual, partnership or corporation responsible for placement and preparation for use
of a machine.
Informative Note: Responsibility for installation of the machine usually depends on the terms
specified in the purchase agreement.

3.43 integrator: An entity that designs, provides, manufactures, or assembles a machine, machinery
system or related equipment, and oversees the safety strategy, including the risk reduction measure(s) (guards
and devices), control interfaces, or interconnections of the control system into a machinery system. See also,
supplier (3.116) and user (3.126).
Informative Note: Under certain circumstances, the user becomes the integrator.

3.44 intended use (of a machine): The use for which a machine is suited according to the information
provided by the supplier, or which is deemed usual according to its design, construction, and function.
Informative Note 1: Intended use should be consistent with the supplier’s instructions, which should take into
account, reasonably foreseeable misuse. The intended use may be determined by the user.
Informative Note 2: This may include situations where engineering controls need to be suspended by qualified
and authorized persons to perform a task.

3.45 interlock: Mechanical, electrical, fluid power or other type of device or means to prevent a hazardous
situation(s) under specified conditions.

3.46 layout analysis: The process by which the intended use of the machine or machinery system is
evaluated to determine task zones, control zones and appropriate risk reduction measures.

3.47 lifecycle (of a machine): The phases of a machine including but are not necessarily limited to:
• concept;
• design and construction;
• reconstruction;
• modification;
• transport;
• set-up;
• installation;
• operation;
• maintenance;
• dismantling;
and/or
• disposal.
Informative Note: See also, clause 5.

3.48 local control: A mode that provides the operator with direct control of machines and related
equipment or cells within the machinery system.

3.49 machine (machinery; machine tool): An assembly of linked parts or components (at least one of
which moves) with the appropriate actuators, control, and power circuits, etc., that are joined together for a
specific application, such as for the processing, treatment, marking, or moving of material.

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3.50 Machinery as a Service: Industrial machinery or equipment that is in use in the user’s facility, but
not owned by the user.
Informative Note: In some instances, the user can be prohibited from operating, maintaining, or
modifying the machinery.

3.51 machinery system: A machine(s) with ancillary equipment such as a material handling system, tool
change equipment, gaging, etc. A machinery system may be an integrated manufacturing system (see ANSI
B11.20).

3.52 maintenance personnel: Qualified personnel trained and authorized to maintain the machine,
including the engineering controls and awareness means.
Informative Note: See also, Annex P.

3.53 manual suspension: A suspension that is actuated or selected by an individual that disables or
renders ineffective, one or more safety function(s).
Informative Note: This has been known as overriding or bypassing.

3.54 manufacturer: See supplier (3.116).

3.55 mechanical power transmission apparatus: The mechanical components that, together with a
source of power, provide the motion to an element of a machine or equipment, e.g., shafts, gears, belts,
pulleys, couplings.

3.56 mode: The operation of a machine or machinery system as determined by the state or condition of
the control system. Specific operating modes are defined in the machine-specific “base” (type-C) safety
standards and may include the following examples:
3.56.1 automatic mode: An operating mode that produces continuous cycling, automatically
initiated single cycles, or intermittent continuous cycling on an automatic basis.
3.56.2 continuous mode: Continuous cycling, initiated by an operator and maintained by the
machine control system, without further operator interaction.
3.56.3 jog/inch mode: To impart motion by momentary manual operation of the jog/inch control
device.
Informative Note: As a function, inch is synonymous with jog. However, inch mode and jog mode
are not the same. Traditionally, inch mode uses a clutch to effect motion whereas jog mode uses the
motor to effect motion.
3.56.4 manual mode: Any operating mode of the machine that requires the operator to initiate
and/or maintain motion of the machine during the cycle, or portion of the cycle, by use of the
actuating control.
Informative Note: Other manual modes may be developed for a particular machine or task, based on
the risk assessment (e.g., single block mode in NC machines, maintenance, or a machine-specific mode
to complete a task).
3.56.5 normal operation: The operating condition where the machine or production system
performs the intended production function(s).
3.56.6 run mode: The operating modes, whether automatic, continuous, or manual, used for
production operations on a machine.
3.56.7 semi-automatic mode: The operating mode requiring one or more control actions by the
operator per machine cycle.
3.56.8 special mode: A mode specifically designed to allow a given task to be performed.
Informative Note: “Special Mode” is a generic term used within this and other standards. See also,
7.3.8 and Annex K.

3.57 mode selector: One or more means used to establish the machine operating mode.

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3.58 modification: Change made to the machine or machinery system that alters its original purpose,
function, capacity, operation or risk reduction measures.
Informative Note 1: A modification is considered a change that potentially impacts the safety of a machine.
Informative Note 2: An upgrade is typically considered to be a modification.

3.59 modifier: Any entity that changes the original purpose, function or capacity of the machine or
machinery system by design or construction. See also, supplier (3.116), user (3.126) and modification.
Informative Note: Under certain circumstances, the user becomes the modifier.

3.60 monitoring: The checking of system components to detect a failure or fault of a component,
subassembly or module that affects the performance of the safety functions.

3.61 muting: The automatic temporary suspension of any safety-related function(s) of the control system
or engineering controls – device. See manual suspension (3.53).

3.62 normal stop command: See stop command (3.113).

3.63 operator: Personnel who perform production work on a machine or who control the machine.
Informative Note: See also, Annex P.

3.64 personnel: Individuals who are employed by or on behalf of the user or supplier.
Informative Note 1: The term “personnel” includes subcontractors, consultants, or other contract workers,
under the direct or indirect control of the supplier or user.
Informative Note 2: See also, Annex P.

3.65 pinch point: Zone or area in which the human body or parts of the human body are exposed to a
crushing hazard.

3.66 point of operation: The location in the machine where the material or workpiece is positioned and
where work is performed on the material or workpiece.

3.67 practicable: See feasible (3.28).

3.68 practicability: See feasibility (3.29).

3.69 presence-sensing device: A device that creates a sensing field, area or plane to detect the presence
of an individual or object and provides an output signal(s).

3.70 Presence Sensing Device Initiation (PSDI): An operating mode that utilizes a presence sensing
device to actuate a single machine cycle.
Informative Note: This operating mode is also known as “ESPE used as a machine re-initiation device” (IEC
61496-1) and “sensitive protective equipment when used for cycle initiation” (ISO 12100). See also, ANSI B11.19.

3.71 production system: The machine(s), tooling, methods of feeding, auxiliary equipment and risk
reduction measures established for production operations.

3.72 programmable electronic system (PES): An electronic system that performs logical, decision-
making, or arithmetic functions by executing instructions in a specified manner. The system usually includes
input and output elements (ports) and is usually reprogrammable.

3.73 protective measure: See risk reduction measure (3.93).

3.74 qualified personnel: Persons who, by the application of knowledge, training, and experience,
demonstrate an understanding and ability to competently perform the responsibilities or tasks assigned to them
involving the design, construction, operation or maintenance of the machinery and the associated hazards.
Informative Note: See also, Annex P.

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3.75 ram: A machine member(s) that reciprocates linearly. It may also be referred to as slide (3.110).

3.76 readily accessible: Capable of being reached quickly without having to remove obstacles or
obstructions.

3.77 reasonably foreseeable misuse: The use of a machine in a way not intended by the supplier or
user, but which may result from readily predictable human behavior.
Informative Note: A risk assessment should address the following human factors (this is not intended as an
all-inclusive list):
• Inappropriate actions because of mistakes, errors, and poor judgment, excluding deliberate
abuse of the machine;
• Inappropriate actions or reactions taken in response to unusual circumstances, such as
equipment malfunction;
• The tendency to take the “path of least resistance” in carrying out a task;
• Misreading, misinterpreting, or forgetting information.

3.78 rebuilder (reconstructor): An entity who partially or completely rebuilds or reconstructs a machine
or machinery system, or any portion thereof. See also, rebuilding; supplier (3.116).
Informative Note 1: Under certain circumstances, the user becomes the rebuilder.

3.79 rebuilding / reconstruction / refurbish: Restoring the machine or the machinery system to its
original design, purpose, capacity, and function. Sometimes also referred to as retool.
Informative Note: Rebuilding involves the restoration or replacement of major components of the machine or
the machinery system and is not considered a maintenance or repair activity.

3.80 reconfigure: A machine whose components have been rearranged so that the layout is different from
the original installation. A machine might be reconfigured several times over its lifecycle; also, it might be both
reconfigured and relocated at the same time.

3.81 relocate: To move a machine to a different location with no changes to operation, process, equipment
arrangement, or risk reduction measures.

3.82 remanufacture: Modification of a machine by replacing worn-out or failed components (which may
include the controller) with new or used parts, resulting in different machine specifications from the original.
Also referred to using terms such as upgrade or modified.

3.83 reset: A function that initializes or returns a device, circuit, or other measure to its operating or
enabling state.
Informative Note: The function can be either safety-related or unrelated to safety.

3.84 restraint mechanism: A physical element (mechanical obstacle) that restricts hazardous movement
by virtue of its own strength.
Informative Note: Previously referred to as safety blocks, chain locks, locking pins, limiting/blocking pins. Not
to be confused with hold out (restraint) device.

3.85 redundancy: The use of multiple means to perform the same function.
Informative Note: Redundancy is typically used to improve the reliability of the system.

3.86 repair: To restore a machine by replacing a part or putting together that which is broken without
altering its original purpose, function, capacity, operation, or risk reduction measures.

3.87 repeat: An unintended or unexpected successive cycle of the machine.


Informative Note: This typically results from, or in conjunction with, a malfunction.

3.88 residual risk: The risk remaining after risk reduction measures (protective measures) are applied.

3.89 risk: The combination of the probability of occurrence of harm and the severity of that harm.

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3.90 risk assessment: The process by which the intended use of the machine, the tasks and hazards,
and the level of risk are determined.

3.91 risk assessment process: The entire process of identifying hazards, assessing risk, reducing risk,
and documenting the results (see Figure 6).

3.92 risk reduction: That part of the risk assessment process involving the elimination of hazards or the
selection of other appropriate and feasible risk reduction measures (protective measures) to reduce the
probability of harm or its severity.

3.93 risk reduction measure (protective measure): Any action or means used to eliminate hazards
and/or reduce risks.
Informative Note 1: Risk reduction measures follow the hazard control hierarchy and can include but are not
limited to:
• inherently safe by design (elimination or substitution);
• engineering controls, including:
o guards;
o control functions;
o devices.
• administrative controls, including:
o awareness means;
o training and procedures;
o personal protective equipment (PPE).
Informative Note 2: This document uses the term “risk reduction measure(s)” as a synonym for the ‘outmoded’
term “protective measure(s)” due to its improved clarity of meaning and increasing adoption/use internationally.

3.94 safe condition monitoring system: A sensor, system or device used to monitor the performance of
the machine to achieve a safe condition.
Informative Note: This was previously referred to as stopping performance monitor or brake monitor. This
also includes zero speed monitors. See also, ANSI B11.19.

3.95 safe-work procedure(s): Formal written documentation developed by the user that describes steps
that are to be taken to safely complete tasks where hazardous situations may be present or hazardous events
are likely to occur.

3.96 safeguarded space: An area or volume enclosing a hazard zone(s) where engineering controls are
intended to protect individuals.

3.97 safeguarding: See risk reduction measure (3.93).


Informative Note: The historical term safeguarding has largely been replaced by the term risk reduction
measure in this document; see the Foreword for further information. See also, ANSI B11.19.

3.98 safeguarding device: See engineering control – device (3.23.2).

3.99 safety block: A prop that is inserted between opposing tooling or machine members to prevent
closing of machine members or tooling components. Also referred to as: die block or restraint mechanism.

3.100 safety distance: The minimum distance an engineering control (guard or device) is installed from a
hazard such that individuals are not exposed to the hazard.
Informative Note 1: See also, ANSI B11.19.
Informative Note 2: This is referred to as “safety distance” for guards in ISO 13857 and “minimum
distance” for devices in ISO 13855.

3.101 safety function: A function of a machine, the malfunction of which would increase the risk of harm.

3.102 safety pin: A physical object to prevent movement of a machine or machine part. Also referred to as
restraint mechanism.

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3.103 safety-related part of the control system (SRP/CS): Part of a control system that responds to
safety-related input signals and generates safety-related output signals.
Informative Note 1: SRP/CS are those part(s) of the machinery control system that provides safety functions
which can consist of separate components of the hardware and software and can either be separate from the
machine control or be an integral part of it.
Informative Note 2: The combined safety-related parts of a control system start at the point where the safety-
related input signals are initiated (including, for example, the actuating cam and the roller of the position switch)
and end at the output of the power control elements (including, for example, the main contacts of a contactor).
Informative Note 3: If monitoring systems are used for diagnostics, they are also considered as SRP/CS.
Informative Note 4: For additional information, see ANSI B11.26, IEC 61508, IEC 62061, and ISO 13849.

3.104 set-up: The process of changing over or adjusting the machine parameters, work holding devices,
tooling, and risk reduction measures for proper operation of the machine or machinery system that may require
personnel to work on or near energized equipment/machinery.
Informative Note 1: Also referred to as tryout.
Informative Note 2: Set-up may include checking the initial part quality and producing test parts.

3.105 shall: The word “shall” is to be understood as denoting a mandatory requirement.

3.106 shear point: Other than the point of operation, the immediate area where two or more machine
elements pass in close contact, creating a shearing action.
Informative Note: The elements may be in any form of motion, or one may be stationary.

3.107 shield: A barrier used to contain anticipated materials and energies (e.g., chips, coolant, radiation,
atmosphere, noise, temperature, and hazardous substances) and is not intended to contain parts, workpieces
or tooling that are ejected as a result of faults or failures.
Informative Note 1: This excludes PPE such as face shields.
Informative Note 2: A shield is not considered to be a guard.
Informative Note 3: Due to the energies involved, containing ejected workpieces etc. is often not feasible.
Informative Note 4: For further information, see ANSI B11.19.

3.108 should: The word “should” is to be understood as denoting a recommendation.

3.109 simultaneous: Actuation where the start of two separate input signals is at the same time.
Informative Note: This term is rarely applied to actuation of signals in ANSI standards which typically use
“concurrent” or “synchronous,” but is often used in ISO/IEC standards to describe that function.

3.110 slide: The machine member(s) that reciprocates linearly. It may also be referred to as ram (3.75).

3.111 span of control: The predetermined portion of the machinery under control of a specific device or
safety function.

3.112 stop: Immediate or controlled cessation of machine motion or other hazardous situations. There are
many terms used to describe the different kinds of stops, including user- or supplier-specific terms, the
operation and function of which is determined by the individual design. See ANSI B11.19 and the machine-
specific “base” (type-C) safety standard. Definitions of some of the more commonly used “stop” terminology
include:
3.112.1 controlled stop: The stopping of machine motion while retaining power to the machine
actuators during the stopping process. Also referred to as Category 1 or Category 2 stop.
3.112.2 emergency stop: The stopping of a machine, manually initiated, for emergency purposes.
3.112.3 normal stop: The stopping of a machine, initiated by the control system, at the completion
of a cycle.
3.112.4 protective stop: The stopping of a machine initiated by an engineering control - device for
risk reduction purposes.

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Informative Note: This type of stop allows the orderly cessation of motion or the hazardous situation
and allows for the retention of program logic to facilitate restarting of the machine. This type of stop
includes stop categories 0, 1 and 2 as defined in 9.2.2 of NFPA 79.
3.112.5 uncontrolled stop: The stopping of machine motion by removing power to the machine
actuators, all brakes or other mechanical stopping devices being activated. Also referred to as:
Category 0 stop.

3.113 stop command: An action to cause a safe condition (including cessation of machine motion) either
automatically or through human intervention. The stop command can be immediate or normal.
3.113.1 immediate stop [stopping] command: A command that initiates an action(s) to stop
motion(s) or situation(s) at any point in the machine cycle.
3.113.2 normal stop command: A command that initiates an action(s) to achieve a safe
condition at the end of a machine cycle or at other points required by the machine functions.

3.114 supervised: A means or method whereby the user exercises control of the operation of the machinery
system. Also referred to as supervisory control.

3.115 supervisor: An individual authorized to act on behalf of the user and to direct the activities of other
personnel.
Informative Note: See also, Annex P.

3.116 supplier: An individual, corporation, partnership or other legal entity or form of business that provides
equipment or services.
Informative Note 1: A supplier can include but not be limited to any of the following: the manufacturer;
manufacturer’s agent, representative or distributor; reseller; installer; modifier; rebuilder; integrator.
Informative Note 2: When the user provides equipment or services, the user is considered to be the supplier
within the scope of that work activity.

3.117 suspension: When the function of one or more engineering controls or safety functions are disabled or
rendered ineffective in order to perform a task.
Informative Note: See also, manual suspension (3.53) and muting (3.61).

3.118 swarf: Chips, shavings, and other fine particles removed from the workpiece by a cutting or grinding
tool.

3.119 synchronous (actuation): Concurrent actuation where the time lag between the start of one input
signal and the start of the other is less than or equal to a predetermined time.
Informative Note: For two-hand control and/or two-hand trip devices, the time lag is less than or equal to 500
milliseconds.

3.120 task: Any specific activity that is done with, on or around the machine during its lifecycle.

3.121 tolerable risk: See acceptable risk (3.1).

3.122 tool [tooling]: A punch, die, knife, cutting tool, blade, or abrasive wheel used in the manufacture of
production parts. Also referred to as die(s) and tooling.

3.123 trip [tripping]: The initiation of a machine cycle.


Informative Note: The initiation of a machine cycle may be by manual operator controls or by signal(s) from
automation.

3.124 unexpected start: Any start-up which, because of its unexpected nature, generates a risk to
individuals.
Informative Note: Machine start-up during normal sequence of an automatic cycle is not unintended but can
be unexpected from the point of view of the operator.

3.125 unintended actuation: The inadvertent initiation or actuation of the machine which could create a
hazardous condition. Also referred to as unintended operation.

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3.126 user: An individual, corporation, partnership, other legal entity, or form of business that utilizes a
machine, machine production system or related equipment.
Informative Note 1: Under certain circumstances (i.e., while acting as a builder, modifier, integrator), the user
is considered a supplier.
Informative Note 2: See also, Annex P.

3.127 validation: Confirmation, through the provision of testing on the as-built machine, that the risk
assessment requirements have been fulfilled.
Informative Note 1: Validation can involve answering two questions:
1. Are we doing the right things? (Is the risk reduction measure appropriate?);
2. Are we doing things right? (Is the risk reduction measure used properly?).
Informative Note 2: “Validate” as used in this standard means to check and test, to confirm and document, but
does not imply formal validation as used, for example, in the pharmaceutical industry.
Informative Note 3: For additional information about the process of validation, see IEC 61508, IEC 62061, and
ISO 13849-2.

3.128 verification: The process of checking that the design and development outputs have met the
requirements of the risk assessment during the design phase.
Informative Note 1: For example: Evaluation of components to confirm they meet the requirements of the
safety functions; analysis of the safety circuits to confirm that the performance achieves the requirements of the
risk assessment.
Informative Note 2: For additional information about the process of verification, see IEC 61508, IEC
62061, and ISO 13849-2.

3.129 warning: A means used to call attention to a hazard (see also, ANSI Z535.4).

3.130 work(ing) envelope: An area in which motion can occur due to part of the machine or workpiece
moving within its normal operating range.

3.131 workpiece: Any material placed into the machine for the purpose of having work performed upon it.

3.132 zone: A segmented space within the machine(s).


Informative Note: Machines may be segmented into zones for specific purposes.

3.132.1 control zone: An identified portion of a production system coordinated by the control
system.
3.132.2 hazard zone: Any space within or around a machine(s) in which an individual can be
exposed to a hazard.
Informative Note: Also referred to as hazard area or hazard space.

3.132.3 task zone: Any predetermined space within or around a machine(s) in which personnel
can perform work.
Informative Note: Task zones are used as an interim step of zone determination.

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4 Responsibilities
Machinery suppliers and machinery users have responsibilities for defining and achieving acceptable risk.

4.1 General
The supplier and the user, either separately or jointly, shall identify hazards, assess risks, and reduce risks to
an acceptable level within the scope of their respective work activities as described in this standard.
Informative Note: Under some circumstances, the results of the risk assessment process can indicate
unacceptable risk. A task should not be undertaken until appropriate risk reduction measures have been
applied to achieve acceptable risk.

Suppliers and users shall involve qualified personnel in meeting their respective obligations and
responsibilities. The supplier and user shall use the relevant regulations and standards applicable to their
work activity.
Informative Note: This may include regulations and standards for a specific location and/or for a specific
application.

4.2 Collaborative efforts


The supplier shall advise the user of the residual risk that may exist at the conclusion of its risk assessment
and risk reduction process. The user shall then apply additional risk reduction measures as determined by its
risk assessment and the appropriate machine-specific “base” (type-C) safety standard. Risk that is transferred
between the supplier and user shall be documented and communicated by identifying tasks and their
associated hazards – see clause 8 and Annex B. When the supplier is not available to participate with the
user in the risk assessment for the machinery, the user assumes that responsibility.
Informative Note 1: Suppliers and users should collaborate on the risk assessment process, to attain the goal
of acceptable risk. Effective communication between suppliers and users is recommended where possible.
Informative Note 2: Figure 4 (next page) presents a general overview of the lifecycle responsibilities for
machinery. This figure is only illustrative and is not prescriptive. The risk assessment process is not a single
event that occurs separate from the machinery development. Risk assessment should begin early in the
concept design and be updated, checked, and confirmed as the design matures.
Informative Note 3: Figure 4 illustrates that in some instances, suppliers and users interact during the
development of an application as implied by the dotted lines. In an “off-the-shelf” purchase of a machine, there
is often very little interaction between the supplier and user. In turn-key or customized and/or complicated
machine-builds, the interaction can be extensive.

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Figure 4 — Example of Machinery Lifecycle Responsibilities

4.3 Responsibilities of the component supplier and component user / machine supplier
The component supplier and machine supplier shall be responsible for achieving acceptable risk within the
scope of their work activity.
Informative Note 1: In general, the component supplier is responsible for the component it supplies, but not for
how the component is integrated into a machine or how it is used / maintained.
Informative Note 2: In general, the machine supplier is responsible for the machine it supplies and for the
integration of the component parts it selects, but not for the components themselves or for how the machine is
used.

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Informative Note 3: If more than one entity is involved in the design, construction, integration or installation of
the machine, each entity is responsible for the scope of its work activity.
Informative Note 4: Suppliers of stock-built machines (generic or off-the-shelf) rely on the user to define
intended use and provide suitable risk reduction measures.

The supplier shall provide risk reduction measure(s) as determined in the supplier risk assessment and the
appropriate machine-specific “base” (type-C) safety standard.
Informative Note: See Annex A, Section A1 (classification of risk reduction measures).

Where applicable, the supplier shall consider cleaning during the design of the machinery and construct the
machinery to enable proper and/or appropriate cleaning.
Informative Note: Examples include but are not limited to:
• radius corners rather than sharp joints;
• no level surfaces to avoid pooling of fluids;
• opening or removal of guards to improve access;
• slip resistant walking/working surfaces; etc.

4.3.1 Integration
The machine supplier shall determine what risk reduction measures, if any, are required to achieve acceptable
risk with any components it integrates into the machine.
Informative Note: Particular attention should be paid to instances where engineering controls are removed
from individual components in order to achieve the desired integration.

Specific types of machines used as part of machinery or incorporated into machinery may be treated as a
component. The risks of specific types of machines used as a component shall be reduced to an acceptable
level in accordance with the requirements of either ANSI B11.0, ANSI B11.19 and ANSI B11.20; or their
machine-specific “base” (type-C) safety standard.
Informative Note 1: An industrial robot is an example of a specific type of machine that could be used as a
component.
Informative Note 2: Equivalent ISO standards may also be applied.

4.3.2 Documentation
The machine supplier shall obtain documentation from the component supplier as required for the
component(s), including installation requirements, operating instructions, and maintenance requirements.

The component part supplier shall furnish documentation as required for the risk reduction measures, including
installation requirements, operating instructions, and maintenance requirements.
Informative Note: The documentation from both the machine supplier and the component part supplier should
include the following, where applicable:
• performance specifications;
• electrical or fluid power schematics and diagrams;
• physical environment for which the component was designed;
• function and location of the operator controls, indicators, and displays;
• schedules for periodic maintenance, lubrication, and inspection;
• signs and warnings.
See also, ANSI Z535.6 for additional guidance.

4.3.3 Engineering controls


When an engineering control (guards, control functions or devices) is provided, the component user / machine
supplier shall be responsible for ensuring that it is integrated and installed in accordance with the requirements
of this document.
Informative Note: The component user / machine supplier should consider the component part supplier’s
performance specifications, schematics, and diagrams, operating and maintenance instructions and warnings
when installing, operating, and maintaining the component.

When components are ordered/purchased without engineering controls, the component user / machine
supplier shall provide engineering controls as determined by this document and other applicable safety
standard(s).

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4.4 Responsibilities of the Integrator / modifier / rebuilder


An integrator, modifier or rebuilder of a machine shall meet the requirements of 4.3.

4.5 Responsibilities of the machine user


The machine user shall be responsible for the use of the machine and for ensuring that supervisors, operators,
maintenance, and service personnel are trained in the proper installation, adjustment, operation and
maintenance of the machine and its component(s), within the scope of their work activity.
Informative Note 1: The user should direct operators and service personnel to take corrective action and/or
immediately report to supervision, any apparent malfunction or improper operation of a machine or its
component(s).
Informative Note 2: The user should consider the machine supplier’s and component part supplier’s
performance specifications, schematics, and diagrams, operating and maintenance instructions, and warnings
when developing installation and operation procedures or instructions.
Informative Note 3: In general, the machine user is responsible for how the machine is operated and
maintained, but not for the design or construction of the machine or the components.

The user shall provide and install additional risk reduction measure(s) as determined in the user risk
assessment. The user shall ensure that risk reduction measure(s) are properly used, maintained and
functional.
Informative Note: See Annex A, Section A1 (classification of risk reduction measures).

The machine user shall check and confirm that when any change to the tooling, process or procedures occurs,
the machine and any affected component(s) continues to meet the requirements of this standard and the
applicable ANSI B11 machine-specific “base” (type-C) safety standard.
Informative Note 1: Changes in the production system that may affect the machine and its components
include, but are not limited to:
• tooling changes;
• addition or removal of auxiliary equipment;
• modification of the machine;
• modification of machine systems;
• operating method (program);
• change in operating personnel;
• adjustment / location of engineering controls;
• part configuration.
Informative Note 2: Adjustments to the machine and its components or additional risk reduction measures
may be necessary.

4.5.1 Training of user personnel


The user shall determine that appropriate policies, procedures, training, and instructions are in place and
consistently applied to reduce the risk to personnel to an acceptable level.

The user shall ensure that all personnel that work on, with or around machinery are trained in accordance with
the results of the risk assessment and the appropriate machine-specific “base” (type-C) safety standard.
Informative Note: The training should be consistent with the supplier’s information for use.

If the user deviates from the supplier’s information, the user shall use the risk assessment process to develop
the training needed to maintain risk at an acceptable level. The training shall be documented. See clause 10
for additional information.
Informative Note: Different levels of training can be required based on tasks (installation, adjustment,
operation and maintenance) and levels of risk.

4.5.2 Cleaning
The user shall ensure that the risk level is maintained at an acceptable level during the cleaning of the
machinery. Except as provided below, the user shall clean the machinery in accordance with the established
procedures and supplier information for operation and maintenance.

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The user shall establish and follow a program of periodic and regular cleaning to ensure that all parts, auxiliary
machinery, and risk reduction measures are in a safe operating condition, in accordance with the supplier
information for operation and maintenance.

If the user deviates from the supplier information for operation and maintenance or the established cleaning
procedures, the user shall use the risk assessment process to maintain risk at an acceptable level.

4.5.3 Operational working space


The user shall provide and maintain sufficient access and working space around the machinery to permit safe
operation and maintenance of the machine.

4.6 Specifications for custom machinery


For custom machinery, the user shall communicate its specific safety requirements as part of the machinery
purchase (e.g., local electric codes). The supplier and user shall develop a set of specifications suited to the
user’s location and application specifics of the machine.
Informative Note: Users should inform the machine supplier if the material to be processed can create an
explosive, combustible or hazardous atmosphere or products/byproducts, or if the machine will be operated in a
hazardous (classified) location. See clause 2 and Annex S for additional references.

4.7 Responsibilities of co-manufacturers


4.7.1 General
Within the scope of their respective work activities, co-manufacturers shall reduce the risks to an acceptable
level.
Informative Note 1: Examples of co-manufacturing include but are not limited to:
• equipment loaned or provided by a third party and located in a user facility;
• supplying personnel to perform packaging or processing functions;
• packing a small run product for a test market.
Informative Note 2: In a co-manufacturing application, the user of the machinery may or may not own the
machinery or have permission to evaluate or modify the risk reduction measures of the machinery.

Responsibilities for co-manufacturing machinery shall be defined between the machine owner, the machine
supplier (if different), and the machine user. The entities involved in supplying and using machinery in a co-
manufacturing application shall clearly communicate the scope of the work activities and the associated
responsibilities for the risk assessment process.
Informative Note 3: Examples include:
• clarifying which safety rules and safe work procedures apply (those of the co-manufacturers, the
facility, or the user);
• procedures for the control of hazardous energy (lockout/tagout);
• responsibilities for training.

4.7.2 Supplying an entire machine or system


When a co-manufacturers supplies a packaging or processing machine or system, the co-manufacturers shall
meet the requirements of a machine supplier per subclause 4.3.

4.7.3 Training personnel


The co-manufacturers is responsible for meeting the requirements for training personnel, including temporary
workers (see clause 10).

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4.8 Machinery as a Service


Within the scope of their respective work activities, the user and supplier of Machinery as a Service shall
reduce the risks to an acceptable level.
Informative Note 1: Examples of Machinery as a Service include but are not limited to:
• equipment loaned or provided by a third party and located in a user facility;
• machine tools and/or dies;
• microbrewery canning;
• mobile platforms/robots used for logistics, cleaning, etc.
Informative Note 2: The requirements of B11.0 apply to Machinery as a Service in the same manner as other
systems or machines. However, the entities involved in supplying and using Machinery as a Service need to
communicate the scope of the work activities and the associated risk assessment responsibilities clearly.

Responsibilities for Machinery as a Service shall be defined between the machine supplier, the service supplier
(if different), and the machine user.

See also 7.2.2 and 7.3.3 for further guidance on cybersecurity and remote/tele-operated control function.

4.9 Purchasers of used machinery


In addition to the responsibilities of the machinery user in clause 4, a user that purchases used machinery
shall fulfill the requirements of the machinery supplier as defined in this document. See also the definition of
“supplier.”

The user shall ensure that the original machinery supplier’s risk reduction measures are installed on the
machine and functional, or that other measures are provided to achieve acceptable risk.

Where practical, the user shall contact the original machinery supplier and obtain any missing manual(s),
warning labels, and other information for use.

4.10 Personnel responsibilities


Personnel shall not circumvent, remove, or otherwise disable an existing risk reduction measure required on
the machine without utilizing alternate risk reduction measures as identified in the risk assessment.

Personnel shall not wear clothing, jewelry, or unrestrained hair styles that will be hazardous to personal safety.

Personnel shall follow appropriate training, policies, procedures, and instructions provided by the user and/or
machine supplier in performing their work activities.
Informative note: The Occupational Safety and Health Act of 1970 – Public Law 91-596, states in section 5(b),
“Each employee shall comply with occupational safety and health standards and all rules, regulations and
orders issued pursuant to this Act which are applicable to his own actions and conduct.”

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5 Lifecycle requirements and responsibilities


This clause specifies the requirements and responsibilities associated with the concept, design, construction,
reconstruction, modification, transport, set-up, installation, operation, maintenance, dismantling, and/or
disposal of machines.

5.1 General
Risks associated with the concept, design, construction, reconstruction, modification, transport, set-up,
installation, operation, maintenance, dismantling and disposal of machinery shall be reduced to an acceptable
level.
Informative Note 1: In general, the machinery supplier is responsible for the design, construction and
providing information for operation and maintenance of the machine, while the user is responsible for the
operation and maintenance of the machine. Responsibility for installation of the machinery usually depends on
the terms of the purchase agreement.
Informative Note 2: The machinery lifecycle progression from concept through decommissioning is shown in
Figure 5. Although the responsibilities of the supplier and the user differ over the lifecycle of the machinery,
each uses the risk assessment process (see clause 6).

Figure 5 — Machinery and equipment lifecycle stages

The requirements for risk assessment and applicable standards for machinery shall be determined by Table
1. The scenarios 2-5 require that the machine be maintained in accordance with the original design and
information for use, and that the risk reduction measures have been periodically inspected. See also, (ANSI)
B11.TR8.

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Table 1 — Requirements for New and Existing Machinery


Scenario and Description Requirements
1. New Machinery / System Perform a risk assessment to confirm that the risks are at an
(created utilizing new or used acceptable level. Conform to the requirements of current applicable
components) standard(s).
Check that the risk reduction measures meet the requirements of
the risk assessment.
Test all safety functions for proper functionality.
2. Repair / Rebuild / Refurbish
Machinery
2.1 Utilizing components that No risk assessment required. Conform to the requirements of
do not change the function of applicable standard(s) existing at time of manufacture or initial
the component or the safety installation.
performance of the machinery Check that the component meets the requirements of the original
design and is installed correctly.
Test the affected safety functions for proper functionality.
2.2 Utilizing components that Perform a risk assessment to determine the impact to the machine
do change the function of the and to confirm that the risks are at an acceptable level. Conform to
components or the safety the requirements of applicable standard(s) on any new hazards.
performance of the machinery Check that the component meets the requirements of the new
design and is installed correctly.
Test all potentially impacted safety functions for proper functionality.
3. Reconfigure / Relocate Perform a risk assessment on any hazards created by the new
Existing Machinery layout or change in spatial configuration to confirm the risks
(existing machinery is relocated associated with the reconfigured or relocated machinery are at an
or layout is reconfigured) acceptable level.
Conform to the requirements in current applicable standard(s) for
any new hazards associated with modification / reconfiguration
/remanufacture.
Conform to the requirements in applicable standards existing at the
time of manufacture or initial installation for other (pre-existing)
hazards.
Check to confirm the risk reduction measures meet the
requirements of the risk assessment.
Test all safety functions for proper functionality.
4. Modify, Reconfigure, or Perform a risk assessment on any hazards created by the
Remanufacture Existing modification / reconfiguration / remanufacture of the machine to
Machinery confirm that the risks are at an acceptable level.
(machinery or components are Conform to the requirements in current applicable standard(s) for
added to or removed from an any new hazards associated with modification/reconfiguration
existing machinery system, or /remanufacture.
are modified to introduce new
features) Conform to the requirements in applicable standards existing at the
time of manufacture or initial installation for other (pre-existing)
hazards.
Test all safety functions for proper functionality.

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5.2 Design, construction and information for operation and maintenance


To meet the requirements of 5.1, machinery suppliers shall use a risk assessment process such as the one
described in clause 6 in the design, construction, reconstruction and modification of machinery to meet the
applicable requirements of clause 7 and any applicable machine-specific “base” (type-C) safety standard.

The supplier shall use the risk assessment process in designing and constructing the machine and for
developing the information for operation and maintenance of the machinery, considering the lifecycle of the
machine.
Informative Note: Suppliers should consider applicable waste and recycling issues over the machine lifecycle.

5.3 Installation, commissioning and start-up


To meet the requirements of 5.1, machinery users and suppliers shall jointly, separately or contractually
together, use a risk assessment process such as the one described in clause 6 in the installation,
commissioning and start-up of machinery to meet the applicable requirements of clause 7 and any applicable
machine-specific “base” (type-C) safety standard.

Within the scope of their respective work activities, the user and supplier shall reduce the risks associated with
the installation, commissioning, and start-up of the machinery to an acceptable level.

The installation, commissioning and start-up shall be accomplished in accordance with, but not limited to, the
following:
• appropriate regulatory standards (e.g., hazardous energy control [lockout / tagout / alternative
methods] regulations, construction safety);
• accepted industry practices as detailed in applicable voluntary consensus standards;
• recommendations for use of machine features that can facilitate installation, such as lifting bolts
and transportation means;
• supplier installation instructions;
• recommendations for supplier and/or user-supplied interim risk reduction measures used during
installation and commissioning, prior to installation, testing and confirmation of the designed
solution(s);
• recommendations for supplier and/or user-supplied energy control procedures and signage;
• user installation instructions.

Before being placed into production, the user shall check and/or test the risk reduction measures of the
machine.
Informative Note 1: The user may need the supplier to assist in meeting this requirement.
Informative Note 2: In complex installations with multiple production zones, multiple validations may be
required.

5.4 Operation and maintenance


To meet the requirements of 5.1, machinery users shall use a risk assessment process such as the one
described in clause 6 in the operation and maintenance of machinery to meet the applicable requirements of
clause 7 and any applicable machine-specific “base” (type-C) safety standard.

During the operation and maintenance of the machinery, the user shall ensure that the risk level is maintained
at an acceptable level, as determined by the risk assessment or the appropriate machine-specific “base” (type-
C) safety standard. The user shall operate and maintain the machinery within the established operating limits,
and consistent with the supplier information for operation and maintenance.

The user shall establish and follow a program of periodic and regular inspection and maintenance such that
all parts, auxiliary machinery, and risk reduction measures are in a state of safe operating condition,
adjustment, and repair, in accordance with the supplier information for operation and maintenance.

If the user deviates from the supplier information for operation and maintenance or the established operating
limits, the user shall consult with the supplier and/or component supplier(s) and shall use the risk assessment
process to maintain risk at an acceptable level.

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The user shall be responsible for controlling hazardous energy (lockout / tagout / alternative methods) in the
use of a machine or machinery system. See ANSI / ASSP Z244.1 and see also, 7.9.

5.5 Modifying or rebuilding existing (legacy) machinery


When non-standard uses or modifications of the machine, machine control system or the risk reduction
measures can create additional hazards, a modifier and/or rebuilder of machinery shall use the risk
assessment process to reduce those risks to an acceptable level.

Modifiers and/or rebuilders shall, where feasible, solicit the original supplier’s recommendations regarding any
proposed modification to a machine that may affect the safe operation prior to making any such changes.

Where modifications are made to the machinery (e.g., intended use, tasks, hardware, and software), a risk
assessment shall be repeated for those parts of the machinery being modified or affected.

The user shall confirm that acceptable risk is maintained after modifying and/or rebuilding is complete, and
maintain updated risk assessment documentation for both historical purposes as well as future use for potential
additional modifications to the machine (see 6.9.1 and 6.9.2).

When evaluating existing machinery, the risk assessment process shall include but not be limited to the
following where available:
• input of personnel experienced in operation, set-up and maintenance;
• experience in the field;
• history of past incidents;
• similar machinery and processes;
• reports of near misses;
• number of machines in the field;
• lifespan of the equipment;
• new information regarding hazards;
• internal safety audits or regulatory visits;
• Information for Use for the machine;
• safe work procedures.
Informative Note 1: This standard presents a standardized risk assessment process that can be used to
evaluate existing machines and/or systems. The supplier and/or user should decide when and what existing
machinery should be evaluated.
Informative Note 2: Relocation of existing machinery may create additional hazards stemming from the
relocation.
Informative Note 3: When evaluating existing machinery where upgrading of engineering controls is not
feasible, the supplier and/or user should evaluate use of additional administrative controls (e.g., awareness
means, posted written procedures, etc.) to further reduce risk.

5.6 Decommissioning
The supplier shall consider decommissioning during the design of the machinery and provide information on
known hazardous components or processes regarding decommissioning of machinery.

The user shall ensure that acceptable risk is maintained during decommissioning of machinery.
Informative Note 1: Typically, a decommissioned machine needs to be cleaned, stripped, and drained of any
potential hazards that could cause injury or environmental damage.
Informative Note 2: The risk assessment should take into account special disposal and recycling requirements
for the machine and/or instructions associated with the SDS (safety data sheet; formerly called material safety
data sheet or MSDS) on materials in the equipment.

The means to disconnect, isolate and dissipate all sources of hazardous energy of the machine shall be
identified and the hazardous energy controlled.
Informative Note: Often during this phase of the machine lifecycle, other types of hazardous energy could be
encountered that would not have been foreseen through the normal maintenance procedures and energy
control methods. Proper dismantling techniques and control of gravity and various other hazards should be
reviewed to check that they meet the needs for decommissioning.

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6 The risk assessment process


6.1 General
Suppliers and users are required to perform a risk assessment (see clause 5) to reduce risk to an acceptable
level. The method selected shall conform to the requirements of clause 6. There are a number of methods
available to conduct a risk assessment and many companies/industries use different risk assessment
methodologies. Regardless of whichever method is chosen and used, it shall include the fundamental steps
of 6.1.3 and the applicable requirements of clauses 7 through 10.
Informative Note 1: For further information, see Annexes A through Q.
Informative Note 2: In order to determine which equipment to analyze first, it is sometimes advantageous to
perform a preliminary informal risk assessment to evaluate the hazards that create the highest risk.
Informative Note 3: This document provides examples of risk assessment processes that can be adopted by
large or small organizations. Flexibility (scalability) can be built into the process so that it fits into a particular
organization and its culture, whether the organization conducting the risk assessment is a supplier (modifier,
rebuilder etc.) or user. Variables related to scalability may include but are not limited to:
• size / complexity of the project;
• conducted on-location vs. off-site;
• formal (multi-discipline) vs. informal;
• ease of use of the risk assessment process;
• cultural norms.

6.1.1 Qualified personnel


Technically competent and skilled personnel shall be involved in the risk assessment process so that the
fundamentals listed in 6.1.3 are adequately addressed and documented.
Informative Note 1: Estimating risk relies on the reasoned judgment and expertise of individuals familiar with
the system/process and/or the tasks and hazards associated with the particular system or process.
Informative Note 2: Although an individual may be responsible for coordinating the analysis, a team of
contributors (e.g., operators, maintenance or engineering personnel) may participate in the risk assessment and
reduction effort(s). At a minimum, the risk assessment should be performed with an experienced and
knowledgeable worker providing input.
Informative Note 3: See Annex C for additional information.
6.1.2 Goal
The goal of risk assessment is to reduce risks to an acceptable level(s). The risk assessment process shall
continue until acceptable risk is achieved (see 6.7). See subclauses 6.2 through 6.9 for additional risk
assessment requirements.
Informative Note 1: Iterations of the risk assessment process may be required over time to address changes.
Informative Note 2: Obtaining management support can be a critical factor in achieving acceptable risk
decisions.

6.1.3 Fundamental steps of the risk assessment process


The risk assessment process shall include a series of logical steps to systematically examine the hazards
associated with machinery. Application-specific risk assessments for machinery shall include the fundamental
steps in the overall risk assessment process as shown in Figure 6.
Informative Note 1: “Application-specific” refers to the particular process, use, installation or integration of the
machinery.
Informative Note 2: The risk assessment process includes the following 8 steps:
1) Prepare for and set limits of the assessment (see 6.2);
2) Identify tasks and hazards (see 6.3, and Annex D);
3) Assess initial risk (see 6.4, Annex E, and Annex F);
4) Reduce risk (see 6.5 and Annex A);
5) Assess residual risk (see 6.6);
6) Achieve acceptable risk (see 6.7 and Annex G);
7) Check, test and confirm solutions (see 6.8);
8) Document the process (see 6.9 and Annex B).

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Figure 6 — The Risk Assessment Process

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6.2 Prepare for and set scope (limits) of the assessment


Suppliers and users, either jointly or separately, shall adequately prepare for, set limits on, document the
parameters of the assessment, and establish the level(s) of acceptable risk.
Informative Note: There are no strict requirements on preparations or setting limits. The scope of the
assessment is often determined by available time and personnel. See Annex C.

6.3 Identify tasks and hazards


The reasonably foreseeable tasks, interactions and associated hazards shall be identified for the applicable
phases of the lifecycle of the machine.
Informative Note 1: See Annex D for a list of hazards potentially applicable to machinery.
Informative Note 2: Identifying tasks and hazards is a critically important part of the risk assessment process
because hazards not identified can create substantial unknown risks. There are many different approaches to
identifying hazards. Depending on the complexity of the machinery, useful methods may include but are not
limited to:
• using intuitive operational and engineering judgment;
• examining system specifications and expectations;
• reviewing codes, regulations, and consensus standards;
• interviewing current or intended system users and/or operators;
• gaining input from experienced operators and service personnel;
• consulting checklists;
• reviewing studies from other similar systems;
• evaluating the potential for unwanted energy releases/exposures to hazardous environments;
• reviewing historical data and/or industry experience, incident investigation reports (including accident or
near-miss events), OSHA Bureau of Labor Statistics, National Safety Council data, manufacturer’s
literature, etc.;
• considering potential mishaps with surrounding equipment and operations;
• brainstorming.
Informative Note 3: The risk assessment process includes identifying hazards regardless of the existence of
risk reduction measures. The machine should not be considered harmless as shipped and guarded. To verify
that all hazards are included, hazard identification should be conducted with all risk reduction measures
(including engineering controls and specialized training) conceptually removed. This is to confirm that hazards
are not ignored due to an assumption that the risk reduction measures supplied are adequate for all tasks,
including reasonably foreseeable misuse. Existing risk reduction measures that help achieve acceptable risk
can be retained after evaluating their performance. This decision will be confirmed during the
check/test/confirm portion of the risk assessment (see 6.8). If a thorough risk assessment is delivered with the
machine, it may be used as a starting point for the user’s risk assessment.

Identifying hazards shall take into account the different tasks, operating modes and intervention procedures, in
particular when the machine does not perform the intended function (i.e., it malfunctions).
Informative Note 1: This can be due to a variety of reasons, including but not limited to the following:
• variation of a property or dimension of the processed material or product;
• failure of one (or more) of its component parts or services;
• external disturbances (e.g., shocks, vibration, electromagnetic interference);
• interruption of its power source.
Informative Note 2: For lean manufacturing, identifying forms of waste can improve system performance and
safety performance. See (ANSI) B11.TR7 for additional information.
Informative Note 3: When identifying hazards, variables impacting tasks should be identified (e.g., changes in
product weight/size, tendency of certain product runs to create jams, and type of material).

Task identification shall include identifying:


• affected persons (see 6.3.1);
• the tasks they perform (see 6.3.2);
• the hazards associated with those tasks (see 6.3.3 – 6.3.4).
Informative Note: Task identification focuses on how people interact with the machine, or how the
machine interacts with people, in order to identify how they could be harmed.

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6.3.1 Identify affected persons


Identify persons who interact either directly or indirectly with the machine or who might otherwise be affected.
Informative Note: These may include but are not limited to:
• cleaning personnel;
• contract / service personnel;
• engineer;
• installation and removal personnel;
• leader / supervisor;
• maintenance personnel;
• manager / administrative personnel;
• materials handler and/or temporary / stand-in operator;
• operator / helper;
• public / passer-by / non-user;
• set-up personnel;
• trainee.

6.3.2 Identify tasks


All tasks associated with the intended use and reasonably foreseeable misuse of the machine shall be
identified.
Informative Note: Task categories include but are not limited to:
• packing and transportation;
• unloading / unpacking;
• systems installation and assembly;
• start-up / commissioning;
• set-up / changeover;
• operation (all modes);
• maintenance (including maintenance tasks where engineering controls may require manual
suspension / override);
• shutdown;
• lockout / tagout / alternative methods;
• recovery from jams;
• troubleshooting;
• cleaning;
• decommissioning, dismantling, and disposal.

Identifying tasks shall include modes of operation and work methods during which it is necessary to suspend
or modify one or more risk reduction measures.
Informative Note 1: Behaviors such as the following should be considered in a task-based risk assessment:
• incorrect behaviors (errors);
• reflexive and/or reactive behavior of a person in case of malfunction, incident, failure, etc.;
• behavior resulting from taking the "path of least resistance" in carrying out a task;
• behavior when a risk reduction device or method impedes a task;
• reasonably foreseeable behavior of unauthorized or untrained persons.
Informative Note 2: Examples of actions that could be reasonably foreseeable misuse include, but are not
limited to:
• attempting to clean under a machine in operation;
• removing debris from a moving roller;
• standing on part of a machine to reach a filter;
• loading an incorrect recipe or program.
Informative Note 3: Intentional misuse or abuse of a machine is outside the scope of a risk assessment.
Informative Note 4: Examples of action that could be intentional misuse/abuse (not reasonably foreseeable
misuse) include, but are not limited to:
• not locking out for tasks that require lockout;
• climbing on a machine while in operation;
• sleeping on/under/in/behind a machine;
• horseplay;
• at-risk behaviors;
• defeating, bypassing or circumventing a risk reduction measure (e.g., utilizing a spare
interlock actuator as a “cheater key” or crawling through a tunnel guard).

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6.3.3 Identify hazards and hazardous situations


Hazards and hazardous situations shall be identified.
Informative Note 1: Hazards may include but are not limited to:
• mobile machinery;
• mechanical hazards;
• energy sources (e.g., electrical, hydraulic, pneumatic, etc.);
• slips and falls;
• hot surfaces;
• sharp edges;
• chemical, biological.
Informative Note 2: See Annex D for a list of hazards potentially applicable to machinery.
Informative Note 3: Hazardous situations may include but are not limited to:
• unexpected starts;
• flammable and combustible atmospheres;
• operational events (e.g., process upsets, mechanical failures, etc.).

The tasks identified in 6.3.2 shall be used to identify hazards associated with those tasks. Hazards that are
not related to tasks shall also be identified.
Informative Note 1: Examples include but are not limited to:
• explosive environment;
• noise;
• instability;
• equipment failures or operational errors such as using an inappropriately sized workpiece;
• mechanical failure of a chuck;
• operating at incorrect speed, etc.
Informative Note 2: Some hazards may impose risk(s) beyond a simple contact point, for example,
gaseous exposure, electrical discharge, explosion, or fire.

6.3.4 Similar machines


Information from risk assessments on similar machines may be used as a starting point when tasks and
hazards are comparable. Using this information does not eliminate the need to follow the risk assessment
process as described in this document for the specific conditions of use (e.g., when a shear that is used for
cutting plastic is compared with a shear that is used for cutting metal, the risks associated with the same
fundamental operation performed on different materials should be assessed).

6.4 Assess initial risk


The risks associated with each hazard shall be assessed using the following steps:
1) Select a risk scoring system (6.4.1);
2) Assess the risk using the risk factors of the risk scoring system (6.4.2);
3) Derive a risk level (6.4.3).
Informative Note: The elements of risk are shown in Figure 7. Additional information appears in Annex E.

Risk Severity of harm Probability of


related to the that can result from the occurrence
considered is a function of considered hazard and of that harm
hazard

Figure 7 — Elements of Risk

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6.4.1 Select a risk scoring system


Risks shall be assessed using a risk scoring system.
Informative Note 1: A risk scoring system, whether qualitative or quantitative, is a tool used to characterize
how these risk factors combine to determine a risk level. The risk factors typically evaluated are the severity of
harm and the probability of occurrence of that harm. In selecting a risk scoring system, one or more of the
following criteria should be considered:
• specified by the user;
• developed for the industry application;
• published by an industry trade organization in the technical literature;
• best suits the safety / health objectives of the organization;
• in addition to assessing risk, best prioritizes actionable risk reduction measures.
Informative Note 2: The selected system should appropriately address high severity of harm even when the
probability of that harm is thought to be low. Severe injuries may occur during infrequent tasks, such as
maintenance, machine jams, troubleshooting, etc.
Informative Note 3: An example of a two-factor risk scoring system using severity and probability is shown in
Table 2. Other risk scoring systems may be used (see Annex F).

Table 2 — Example Risk Scoring System


Severity of Harm
Probability of
Catastrophic Serious Moderate Minor
Occurrence of Harm
Very Likely High High High Medium
Likely High High Medium Low
Unlikely Medium Medium Low Negligible
Remote Low Low Negligible Negligible
See 6.4.2.1 and 6.4.2.2 for additional information.

6.4.2 Assess risk


The risks shall be assessed for each hazard or task/hazard pair using the selected risk scoring system.
Informative Note 1: Assessing risk should occur both before and after risk reduction measures are
implemented (see also, 6.6).
Informative Note 2: As an example, subclauses 6.4.2.1 and 6.4.2.2 explain the risk scoring system from Table
2. These risk levels are referred to as the initial risk level and the residual risk level, respectively.
Informative Note 3: Risk assessment often relies on subjective decisions. These decisions should be
supported by qualitative methods that are complemented, as far as feasible, by quantitative methods.
Quantitative methods are particularly appropriate when useful data are available. However, in most
applications, only qualitative risk assessment will be feasible.
Informative Note 4: Specialized training as a risk reduction measure should not be applied when assessing
the initial risk.

6.4.2.1 Assess severity


For each hazard or task/hazard pair, the severity of harm that could result shall be assessed. When estimating
severity, the highest credible level of severity of harm shall be selected.
Informative Note 1: Severity of harm addresses the degree of injury or illness that could occur. Severity may
be qualitatively described and estimated with the following example levels as used in Table 2:
• Catastrophic – death or permanently disabling injury or illness (unable to return to work);
• Serious – severe debilitating injury or illness (able to return to work at some point);
• Moderate – significant injury or illness requiring more than first aid (able to return to the same job);
• Minor – no injury or slight injury requiring no more than first aid (little or no lost work time).
Informative Note 2: Severity may be semi-quantitatively estimated by correlating measurable energy to a
resulting degree of harm that may occur. Measurable energies to consider include, but are not limited to, those
shown in Annex E, Table 8.
Informative Note 3: Events with consequences that have wide-spread impacts and/or effects may require
more specialized risk assessments.

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6.4.2.2 Assess probability


For each hazard or task/hazard pair, the probability of occurrence of harm shall be assessed. When estimating
probability, the highest credible level of probability shall be selected.
Informative Note 1: It can be difficult to predict the probability of harm. Unless quantitative data are available,
the process of selecting the probability of harm occurring will be subjective (qualitative). There are many variables
that could influence probability which can be considered, including, but not limited to (see also, Annex E):
• frequency, duration and extent of exposure;
• speed at which the hazard presents itself;
• variations between individuals as well as conditions;
• individual’s ability to recognize and react to a hazardous situation;
• errors related to human and organizational performance;
• characteristics of the hazard.
Informative Note 2: The probability of occurrence of harm may be qualitatively described with the following
example levels as used in Table 2:
• Very likely – near certain to occur;
• Likely – may occur;
• Unlikely – not likely to occur;
• Remote – so unlikely as to be near zero.

6.4.3 Derive risk level


For each hazard or task/hazard pair, an initial risk level shall be derived using the risk scoring system.
Informative Note: Once the initial risk is estimated, the risk level can be compared to acceptability levels. If
the risk is not acceptable, the next step is to reduce the risk.

6.5 Reduce risk


If the level of risk is not acceptable, feasible risk reduction measures shall be implemented to reduce that risk
(see clause 7 for additional information on risk reduction measures). Risks shall be reduced using the hazard
control hierarchy described in 6.5.1 and shown in Table 3.
Informative Note: Risk reduction measures are a combination of the measures taken by the supplier and/or
the user. Measures which can be incorporated at the design stage of the machine or the design of the
manufacturing process are generally more effective than, and preferable to, those which are implemented at a
later stage (see Figures 4, 9 and Table 3).

6.5.1 Use the hazard control hierarchy


When selecting the most appropriate risk reduction measure(s), the risk reduction measure(s) shall be applied
in the following order of hierarchy (6.5.1.1 through 6.5.1.6).
Informative Note 1: Risks can be reduced by:
• reducing the potential severity of harm presented by the hazard;
• improving the possibility of avoiding the harm; and/or
• reducing the need for access to the hazard zone.
Informative Note 2: Hazards that present a higher risk of harm should not be addressed using a less preferred
risk reduction measure (administrative control) alone unless no other solution is feasible.
Informative Note 3: See also, Annex A for additional information on risk reduction and the impacts on risk.
Informative Note 4: Not all potential risk reduction measures are feasible. Many factors determine if the risk
reduction measure is feasible; the terms “feasible” and “possible” are not considered to be synonymous.
It is necessary to evaluate the application of the risk reduction measure against the following factors:
• regulatory obligations;
• introduction of new hazards;
• effectiveness;
• machine performance;
• usability;
• productivity;
• durability;
• maintainability;
• ability to clean;
• ergonomic impact;
• economic feasibility;
• technological feasibility.

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Table 3 — The Hazard Control Hierarchy


Risk Reduction
Classification Examples Influence on Risk Factors
Measures
Most • eliminate pinch points (increase • impact on overall risk
Preferred clearance) (elimination) by affecting
• intrinsically safe (energy containment) severity and probability of
Design Out • automated material handling (robots, harm
Inherently conveyors, etc.) • may affect severity of harm,
Safe (Elimination • redesign the process to eliminate or frequency of exposure to
reduce human interaction the hazard under
by Design or
• reduce force, speed, etc. through consideration, and/or the
Substitution) selection of inherently safe components possibility of avoiding or
• substitute less hazardous chemicals limiting harm, depending on
which method of
substitution is applied
• guards
• interlock devices
• presence sensing devices (light • greatest impact on the
Guards, Control curtains, safety mats, area scanners, probability of harm
Engineering etc.) (occurrence of hazardous
Functions and
Controls • two-hand control and two-hand trip
events under certain
Devices circumstances)
devices
• alternative methods to control • minimal if any impact on
the severity of harm
hazardous energy besides lockout (an
administrative control)
• potential impact on the
• lights, beacons, and strobes probability of harm
Awareness • computer warnings (avoidance)
Means • signs and labels • no impact on the severity of
• beepers, horns, and sirens, etc. harm
• potential impact on the
Information for probability of harm
Use • safe work procedures (avoidance and/or
(Training and • training exposure)
Procedures) • no impact on the severity of
harm
Administrative
Safeguarding • safe-holding safeguarding method • potential impact on the
Methods probability of harm
Administrative • supervisory control of configurable (avoidance and/or
Supervision elements occurrence)
Controls
Control of • no impact on the severity of
Hazardous • lockout / tagout harm
Energy
Least • potential impact on the
Preferred probability of harm
• workholding equipment (avoidance and/or
Tools
• hand tools occurrence)
• potential impact on the
severity of harm
• safety glasses and face shields • potential impact on the
Personal
• ear plugs probability of harm
Protective
• gloves (avoidance)
Equipment • potential impact on the
• protective footwear
(PPE) • respirators severity of harm

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6.5.1.1 Hazard Elimination / Prevention Through Design


Where feasible, hazards shall be eliminated in the design stage.
Informative Note 1: Inherently safe by design is the first and most important step in reducing risk. Eliminating
the hazard or reducing the risk by design provides the highest degree of risk reduction because risk reduction
measures designed into the machine are likely to remain effective. Experience has shown that even well-
designed engineering controls can fail, be rendered ineffective, be defeated or information for use may not be
followed. Example methods to eliminate hazards by design include but are not limited to:
• eliminating dangerous parts, conditions, and events;
• reducing energy, force, and/or speed available or accumulated through means which are not
susceptible to a malfunction that will increase the risk of harm;
• modifying, containing, or redirecting how/where energy is released (safety valve);
• re-routing processes or hazards;
• locating inside an inaccessible, permanent, and substantial section of the machine, or locating in an
elevated area or on an inaccessible balcony (safe-location safeguarding method);
• re-designing or automating tasks to eliminate human interaction or direct handling;
• re-configuring or modifying machinery or equipment;
• eliminating pinch or nip points by increasing clearances;
• ergonomically correct design (i.e., lowering the mass, preventing awkward postures, etc.);
• eliminating sharp edges, shear points or offset edges.
Informative Note 2: For a given task, energy sources should be identified as hazardous, non-hazardous, or
identified as beneficial energy. Non-hazardous or beneficial energy can require different control measures.
Informative Note 3: See ANSI Z590.3 (Prevention through Design) for additional information on eliminating
hazards through design.
Informative Note 4: Improving the design can eliminate hazards as well as reduce risk and waste. See (ANSI)
B11.TR7 for additional information for integrating the lean concepts into safety.

Design changes to how a task is performed shall be identified and implemented to reduce risk by eliminating
or reducing exposure to a hazard where feasible.
Informative Note: Changes to tasks can include:
• moving the location of personnel where the work is done;
• redesigning the machine layout to reduce risk by enabling a task to be performed from outside the
hazard zone.

6.5.1.2 Substitution
Where feasible, alternative materials, methods or energy levels shall be substituted to reduce the risk of harm
from hazards.
Informative Note 1: Some examples include but are not limited to:
• substituting less toxic or hazardous materials and substances;
• substituting automated material handling instead of manual material handling.
Informative Note 2: See also, Annex R.

6.5.1.3 Engineering controls


Where feasible, engineering controls (guards, control functions and devices) shall be provided to reduce risk.
See ANSI B11.19 and/or the machine-specific standard (or other relevant safety standards) for details on
engineering controls.
Informative Note 1: Where hazards cannot be eliminated, guards and devices and administrative controls are
usually used together to reduce risk to an acceptable level.
Informative Note 2: See also, 7.2 and Annex R.

Functional safety requirements are separate from a risk assessment of a machine. Functional safety shall
be taken into account when a risk reduction measure requires a control system, according to 7.2.
Informative Note 1: A common error occurs when the functional safety specifications are mistaken to be the
risk assessment of a machine. Functional safety is a subset of risk reduction but is not a risk assessment of the
machine.
Informative Note 2: See also ISO/TR 22100-2 (2013).
Informative Note 3: A common error is to attribute a functional safety design specification to an entire
machine, rather than to a safety function. Different levels of functional safety are frequently applicable within a
single machine.

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6.5.1.4 Awareness means


Awareness means shall be used where appropriate to inform affected individuals of hazards. See ANSI
B11.19 for additional detail on awareness means.
Informative Note: Awareness means serve to inform users of any significant residual risks which have not
been sufficiently reduced by design or engineering controls. Awareness means include barriers, signals (lights,
alarms, etc.), signs, or markings. Visual signals (such as flashing lights) and audible signals may be used to
warn of an impending hazardous event such as machine start-up or over-speed. Such signals may also be
used to warn the operator before initiating automatic risk reduction measures.

6.5.1.5 Training and procedures


Training and procedures shall be used in conjunction with existing risk reduction measures. Training and
procedures shall be used to explain:
• the potential hazards;
• the purpose and function of risk reduction measures, particularly engineering controls;
• safe work procedures to avoid hazards.

The machine supplier shall inform the user of specialized procedures and training necessary for using the
machine. See clause 8.
Informative Note 1: Procedures and training should be provided for the operation of the machine, the
application, use and adjustment of engineering controls, and for awareness means.
Informative Note 2: Procedures and training may include but are not limited to:
• formal or informal training;
• standard operating procedures;
• checklists;
• personnel certifications;
• lockout / tagout / alternative methods.

6.5.1.6 Personal protective equipment (PPE)


PPE shall be used in conjunction with – but not in lieu of – other risk reduction measures, or when no other
control method is available or feasible.
Informative Note: PPE includes safety glasses, hearing protection, gloves, non-slip footwear, etc. Consult
applicable PPE standards when selecting these products.

6.5.2 Select feasible risk reduction measures


Suppliers and users shall select feasible risk reduction measures to reduce risk to an acceptable level.
Informative Note: Not all potential risk reduction measures are feasible. Many factors determine if the risk
reduction measures are feasible or infeasible. It is necessary to evaluate the application of the risk reduction
measures against the following factors:
• regulatory obligations;
• effectiveness;
• durability and maintainability;
• ergonomic impact;
• introduction of new hazards;
• productivity / machinery performance;
• technological feasibility;
• usability;
• economic feasibility;
• ability to clean.

The incentive to defeat or circumvent risk reduction measures shall be considered when selecting them.
Informative Note 1: The incentive, or necessity, to defeat or circumvent risk reduction measures depends on
both the circumstances considered and the design details of the risk reduction measure(s). Incentives to defeat
or circumvent a risk reduction measure may include but are not limited to factors such as:
• the risk reduction measure prevents the task from being performed;
• there is a need to perform a task that was not identified and assessed for hazards and risks;
• the risk reduction measure slows down production or interferes with any other activities or preferences of
the user;
• the risk reduction measure is difficult to use;

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• additional personnel other than the intended operator(s) perform the task, for example:
– operator resets engineering controls - devices while maintenance personnel are inside the hazard zone;
– engineering controls intended to protect an individual are inappropriately used for multiple personnel.
• the risk reduction measure and/or its associated hazard is not recognized as such by personnel;
• the risk reduction measure is not accepted as suitable, necessary, or appropriate for its function.
Informative Note 2: The use of programmable systems introduces an additional possibility to defeat or
circumvent provisions for access to programmable systems if not properly applied or supervised. This is
particularly important when remote access for diagnostic or process correction purposes is required.
Informative Note 3: The organizational culture towards safety has bearing on the tendency to defeat or
circumvent risk reduction measures.

6.5.3 Check for new hazards


Suppliers and users shall determine if risk reduction measures introduce new hazards, and if so, reduce the
associated risks to an acceptable level. New task/hazard combinations introduced during the risk reduction
process shall be assessed by repeating the risk assessment process for the task/hazard combinations being
evaluated.

6.6 Assess residual risk


The selected risk reduction measures shall be assessed to confirm they are appropriate for the application and
that they effectively reduce risk.

Specialized training alone shall not be used as a means of reducing the probability of a hazardous event if it
cannot be confirmed that all individuals exposed to the hazard will have that level of training/knowledge.
Informative Note 1: In assessing the residual risk, the risk factors are estimated assuming that the selected
risk reduction measures are in place.
Informative Note 2: Severity and probability of harm are assessed and combined to obtain a residual risk level
using the selected risk scoring system.
Informative Note 3: See also, Annex E for additional information concerning assessing probability.

6.7 Achieve acceptable risk


Once the residual risk has been established for each hazard, a decision shall be made to accept the residual
risk, or to further reduce it.

Achieving acceptable risk will depend on:


• the application of the hierarchy of controls (6.5.1.1 through 6.5.1.6);
• the feasibility of the selected risk reduction measure(s).

Risk reduction is complete when risk reduction measures are applied and acceptable risk for the identified
hazards has been achieved.
Informative Note 1: The decision to accept (tolerate) a risk is influenced by many factors including the culture,
technological and economic feasibility of installing additional risk reduction measures, the degree of protection
achieved through the use of additional risk reduction measures, and the regulatory requirements or best
industry practice.
Informative Note 2: In all machinery applications, some level of residual risk exists. It is possible that high or
medium residual risk remains after all reasonable and feasible risk reduction measures have been applied. The
user and supplier may have different tolerance(s) of acceptable risk.
Informative Note 3: This document does not establish a definitive threshold for acceptable risk. Achieving
acceptable risk will depend on:
• complying with national, regional, and local regulations as required;
• the application of the hierarchy of controls (6.5.1.1 through 6.5.1.6);
• the feasibility of the selected risk reduction measure(s) (see Informative Note under 6.5.2);
• the level at which further technologically, functionally, and financially feasible risk reduction measures or
additional expenditure of resources will not result in significant reduction in risk;
• the operator’s personal responsibility and ability to work in conjunction with the selected risk reduction
measures.
Informative Note 4: Risk assessment should facilitate a consistent decision-making process. Qualified
personnel are particularly important in decision making about acceptable risk.

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Informative Note 5: Acceptable risk is fundamentally a decision made by each supplier or user in the context
of their own unique circumstances. The following structure is one example of a practical application of
acceptable residual risk to relevant stakeholders:
• High residual risk: only acceptable when all reasonable alternatives/options (risk reduction
measures) have been reviewed and formally deemed infeasible. It is recommended that the group
performing the risk assessment seek advice from additional safety or subject matter experts.
• Medium residual risk: acceptable only when all reasonable alternatives/options (risk reduction
measures) have been formally deemed infeasible.
• Low residual risk: usually acceptable.
• Negligible residual risk: acceptable.
Informative Note 6: See also, Annex G for additional information on achieving acceptable risk.

6.8 Check, test and confirm (validate and verify) risk reduction measures
Prior to the installation of the risk reduction measures, the design shall be checked to confirm that once
implemented, the design is capable of meeting the functionality and reliability specification determined by the
risk assessment process.

After the risk reduction measures have been implemented, their effectiveness shall be validated and verified
by checking, testing and confirming as described below.
Informative Note 1: Checking can include but is not limited to:
• presence of administrative controls;
• presence of hazardous energy (lockout / tagout / alternative methods) procedures and safe job
procedures;
• review of installation per the design;
• analysis of design per the requirements of this document and other applicable standards.
Informative Note 2: Testing can include but is not limited to:
• physically trying the operation of engineering control devices and safety-related parts of the control
system;
• operational models;
• effectiveness of training;
• review overall operation.
Informative Note 3: Confirming can include but is not limited to:
• documentation of the results of check and test;
• tracking training effectiveness.

The review of the risk reduction measure(s) shall answer three questions (at a minimum):
A. Check:
• Are we doing the right things? (is the risk reduction measure appropriate?)
• Are we doing things, right? (is the risk reduction measure used appropriately?)
B. Test:
• Do the safety functions work correctly?

Testing of the risk reduction measures shall not expose an individual to potential harm should the risk reduction
measure not provide the protection expected.
Informative Note: The checking, testing and confirmation should include:
• what actions should be conducted;
o physical location and presence;
o functional operation in use in all operating modes;
o reasonably foreseeable failures;
• how the actions may be done safely;
• what the expected and required results / reaction of each action should be;
• a record of the results.

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6.9 Document the process


6.9.1 Content
The outcome of a risk assessment shall be documented. The documentation shall demonstrate the procedure
that has been followed, the hazards identified, and the risk reduction measures employed to reduce risks to
an acceptable level.
Informative Note: The risk assessment documentation is not the same as Information for Operation and
Maintenance (e.g., manuals, see clause 8). The risk assessment documentation should be used to help create
the Information for Operation and Maintenance.

Documentation of the risk assessment shall include, but not be limited to:
• the machinery for which the assessment has been made (e.g., specifications, limits, intended use),
(see 6.2);
• the information on which the risk assessment was based (see 6.2);
• any relevant assumptions which have been made (e.g., loads, strengths, safety [design] factors);
• names of the risk assessment team;
• date(s) of the risk assessment;
• the tasks and hazards identified (see 6.3);
• initial risks associated with the machinery (see 6.4);
• the risk reduction measures implemented to eliminate identified hazards or to reduce risk (e.g., from
standards or other specifications) (see 6.5);
• residual risks associated with the machinery (see 6.6);
• the confirmation of risk reduction measures, including the responsible individual and the date of
confirmation (see 6.8).
Informative Note 1: An example of risk assessment documentation is shown in Annex H.
Informative Note 2: When applicable as determined by the supplier and user, a statement of conformity
should be documented and provided. An example Statement of Conformity is attached at Annex I.
Informative Note 3: The risk assessment documentation should be reviewed:
• periodically to confirm risk reduction measures are still effective and in place;
• following an incident or near miss;
• whenever new tasks or activities are required;
• whenever there are modifications to the machine, equipment, or process.

In addition to the above, where practical the supplier documentation shall include recommendations for
additional risk reduction measures to be implemented by the user, system integrator or other entity involved in
machine utilization.

6.9.2 Document retention


The risk assessment documentation shall be retained as provided by an organization’s document retention
policy and, as a minimum, for the intended life of the machine.

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7 General risk reduction requirements


This clause identifies general requirements for the design of machines and machinery systems to help achieve
acceptable risk. Not all risk reduction measures will apply to a particular machine. Conformance to these
requirements will generally yield acceptable risk, however, achieving acceptable risk shall be confirmed for
each application. Deviations from the risk reduction requirements of this clause shall be based on a
documented risk assessment demonstrating acceptable risk.
Informative Note: See Annex O for correlation of risk reduction requirements by topic for other world regions.

7.1 Access to machinery


Machinery shall be designed, constructed, and used to allow access to the machine in order to enable all
tasks, including maintenance, to be carried out with acceptable risk. Where personnel are required to enter
or climb on the machine, one or more means of protection shall be provided.

7.2 Control systems performing a safety function


Some risk reduction measures involve safety functions which are performed/executed by a system of controls.
The control system elements responsible for the safety function are considered to be the safety-related parts
of the control system (SRP/CS).
Informative Note 1: SRP/CS can be electrical, electronic, hydraulic, and/or pneumatic, or any combination
thereof (see ISO 13849-1 and ANSI B11.26). The SRP/CS may be composed of sensors, logic solvers and
actuators.
Informative Note 2: Not all control systems are safety-related (e.g., a position sensor, unit counter, vision
system, etc.). This subclause only addresses safety-related aspects of control systems.
Informative Note 3: Some examples of safety functions are shown in Table 4.

Table 4 — Example of relations between Hazard, Safety Function and Risk Reduction
Task / Hazard Description of the safety function Risk reduction measure
(What does it have to do?)
Access to clear jam Prevent contact with the hazard Movable guard
Open guard to clear jam Stop hazardous motion when the Interlock device
guard is opened
Unexpected start-up – entanglement Prevent unexpected start-up when the Interlock device
hazard guard is opened

For each safety function identified as part of the risk assessment, a design specification shall be determined.
Informative Note 1: The design specification both indicates how the function is to operate, and the required
safety level needed to execute the safety function to an appropriate level of reliability to achieve acceptable risk
for that task / hazard pair.
Informative Note 2: A reliability design specification may be selected for a circuit using one of the following
three methodologies:
• Performance level (PL) as contained in ISO 13849-1 and described in ANSI B11.26;
• Categories as originally contained in EN 954-1 and described in ANSI B11.26, and also described in
clause 6 of ISO 13849-1;
• Control reliability as used in the B11 series of documents and described in ANSI B11.19 and B11.26.
Informative Note 3: Other methods may also satisfy the requirements, including Safety Integrity Levels (SILs)
per IEC 61508 and IEC 62061.
Informative Note 4: The design specification for a control system is not the same as a risk assessment for a
machine.

The design of control systems performing a safety function shall comply with the principles and methods
presented in 7.2.1 through 7.2.5 and 7.3. These principles and methods shall be applied singly or in
combination as appropriate to the circumstances.

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7.2.1 General
The design and performance of the safety-related parts of the control system (SRP/CS) shall be commensurate
with the risk reduction provided by the safety function (see clause 6). The SRP/CS shall be appropriate for
the intended use. The integrity of the safety components and/or systems shall be determined by the
appropriate product, system, and/or application safety standard / technical report.
Informative Note 1: Control system standards and technical reports include: ANSI B11.26, (ANSI) B11.TR4,
ANSI B11.19, NFPA 79, ISO 13849-1, ISO 13849-2, ISO 13850, IEC 62061, IEC 60204-1, and IEC 61508.
Informative Note 2: Examples of methods used to increase reliability in designing SRP/CS include one or
more of the following:
• certified components or systems suitable for the application;
• fail-to-safe components or systems;
• redundant components or systems;
• diverse components or systems;
• equipment and devices with an acceptable probability of failure (for additional information, see IEC 61508);
• automatic monitoring (for additional information, see IEC 62061).

The SRP/CS shall be installed, checked and tested to confirm that the specified performance has been
achieved according to 6.8.
Informative Note: Confirmation can include, but not be limited to, the following:
• the circuit was designed and implemented correctly;
• the wiring was checked after installation and before commissioning;
• the functionality of the safety system(s) was validated by the integrator and/or the user;
• the safety function was tested to confirm the specified performance was achieved.

The user shall test the SRP/CS periodically to confirm that it is functioning according to the specifications as
determined by the risk assessment.

7.2.2 Cybersecurity
Cybersecurity shall be considered as part of the overall machine risk assessment. If the risk assessment
identifies that a threat/failure mode exists where cybersecurity issues would result in unacceptable risk,
cybersecurity measures shall be provided to address the cybersecurity safety risks.
Informative Note: Cybersecurity is a dynamic field subject to rapid changes. For further information,
see (ANSI) B11.TR9, and the IEC 62443 series.

7.2.3 Monitoring functions


Where a safety function relies on limit value(s) for any parameter(s), the maximum tolerance(s) for the limit
value(s) shall be defined (see also, Annex R).
Informative Note: Examples of established parameters which may serve a safety function include but
are not limited to:
• time;
• speed;
• acceleration;
• incremental motion;
• direction;
• distance;
• force;
• kinetic or thermal energy;
• contact force applied by an object on an individual.

7.2.4 Stop functions


When pneumatic, hydraulic, or mechanical elements are incorporated into a safety stopping function, the circuit
design and component selection shall be appropriate for the required level of safety performance.

The control system, programmable electronic system, and input devices that may remain energized during a
stop function shall not create a hazardous situation(s) as a result of their energized state.
Informative Note: Retention of power for certain portions of the system may be necessary to prevent
hazardous motion, to maintain program logic, or to provide braking during stopping.

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7.2.4.1 Emergency stop


Electrical, pneumatic and hydraulic emergency stops shall conform to the requirements in ANSI B11.19 and
NFPA 79.
Informative Note: An emergency stop does not prevent or detect access to a hazard.

7.2.4.2 Protective stop


Where required by the risk assessment, the SRP/CS of the machine shall have one or more protective stop
functions. The protective stop circuit function shall be appropriate for the required level of safety performance,
as determined by the risk assessment.
Informative Note: Protective stops are typically actuated by engineering controls such as interlocked guards
and presence sensing devices (see NFPA 79 and ANSI B11.19).

The protective stop shall safely control the hazard or hazardous situation.
Informative Note: The intent of this requirement is to separate the safeguarding function from the emergency
stop function due to differing safety performance requirements.

7.2.5 Safety-related reset


Manual and automatic safety-related resets shall be in conformance with ANSI B11.19 – 2019 subclauses
9.5, 9.11 4 and 9.11.5.

Automatic reset of a safety function shall not be used when whole body access exists (see 7.4).

Manual reset of a safety function shall be used in situations where:


• there is whole body access to the hazard zone(s);
or
• the reset function is required to prevent hazardous situation(s).

7.3 Control systems design requirements


7.3.1 Operator interaction
Control systems shall be designed to enable the operator to perform the required task(s) with the machine.
Informative Note: Example solutions include but are not limited to one or more of the following:
• systematic analysis of start and stop conditions;
• provision for specific operating modes (e.g., start-up after normal stop, restart after cycle interruption
or after emergency stop, removal of the product contained in the machine, operation of a part of the
machine in case of a failure of a machine element);
• clear display of the faults (e.g., diagnostic measures to aid troubleshooting);
• measures to prevent unexpected start and/or operation direction;
• delayed start or restart with audible and/or visible alarm (annunciator distance);
• cycle on demand indicator(s);
• engineering controls.

7.3.2 Operator interface / controls


Operator interfaces shall be:
• designed, located and shall function according to the relevant ergonomic principles (see also, (ANSI)
B11.TR1);
• designed to accommodate the reasonably foreseeable use of personal protective equipment (such as
footwear and gloves);
• located so that the operator is able to observe the working area and/or hazard zone, or other means
shall be provided to reduce risk to an acceptable level;
• located, positioned or safeguarded to prevent unintentional activation;
• located so that access to the operator interface is not impeded by the machinery or other equipment;
• functionally grouped and permanently identified;
• located out of reach of the hazard zones except for certain controls which may be located within a
hazard zone, such as some emergency stop or set-up controls.
Informative note: See ANSI B11.19 for guidance on location of safety-related manual control devices.

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Operator interfaces that can impact safety functions and can be changed (e.g., via keyboards or displays),
shall be subject to the risk assessment process and may require restrictions, confirmation, limitation, and/or
security access.

A stop control device shall be placed near each start control device. Where the start/stop function is performed
by means of a hold-to-run (jog) control, a separate stop control device shall be provided when a risk can result
from the hold-to-run control device failing to deliver a stop command when released (see also, ANSI B11.19).

7.3.3 Remote control functions


If a machine may be remotely controlled by personnel who are physically away from the machine, the following
requirements shall be fulfilled:
a) remote control shall only be possible when appropriate risk reduction measures are functional;
b) all functions that can cause a hazardous situation shall be possible only from the selected single-point-
of-control;
c) remote control shall not override local selection and cause any local hazardous situation(s) (in
accordance with 7.3.7);
d) loss of connection of the remote control shall not cause a hazardous situation(s);
e) remote changes to safety related parameters shall not be possible without local action to confirm the
acceptability of the change and that the change(s) do not create any hazardous situations;
f) any machines, equipment and sub-assemblies that could create a hazard and that are not needed for
remote control shall be in a safe state;
g) the requirements of 7.3.9;
h) A means for indicating when the machine is in remote control shall be provided.
Informative Note: For cybersecurity issues of unauthorized remote-control access, see also, 7.2.2.

7.3.4 Layout analysis (control zones)


Each machine or system shall be designed to facilitate manual interventions with acceptable risk, including
maintenance. For some manual interventions, it may be impractical to stop the whole machine, in which case
the machine shall be segregated into control zone(s) where personnel can perform their tasks with acceptable
risk. A control zone may include:
• space within or around the machine which is used by personnel to access a specific location, an
operating position or a servicing point;
• space within or around the machine in which personnel perform standard production operations or
other tasks.

Where control zones are used, a layout analysis shall be carried out according to ANSI B11.20 for a machine
or machine system to obtain an overall understanding of the impact of the foreseeable tasks on the functional
performance of the machine based on operational requirements. This analysis should take into account all
machine configurations and operating modes, including production mode and any special modes (see 7.3.8
and Annex K). See Annex J for further information on layout analysis.

7.3.5 Span of control


The span of control of any engineering control – devices shall be determined by a layout analysis as described
in 7.3.4. See also, ANSI B11.20.

The level of performance of the safety-related function(s) of a control device and its associated SRP/CS shall
meet or exceed the highest level of safety performance for the risks identified within its span of control.

The span of control shall be clearly distinguishable or identifiable so as not to be confused with other spans of
control.
Informative Note 1: Means of identifying span of control may include placards, color-coding, signage, shapes,
layout and location, etc.
Informative Note 2: When placards are used, they should be distinguishable from placards used for other
purposes, such as lockout.
Informative Note 3: When color-coding for parts of the enclosure is used for identifying span of control, the
yellow background of emergency stop devices needs to be maintained as required by ANSI B11.19 and NFPA 79.

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Informative Note 4: Functionality, including the span of control of the HMI, should be appropriate to the
specific tasks (i.e., production, set-up and maintenance troubleshooting) and should be considered in risk
reduction measures.
7.3.6 Energy sources
Activating an internal or external energy source, including re-energizing after a power interruption, shall not
result in a hazardous condition.

Machinery shall be designed to prevent hazardous conditions resulting from interruption or excessive
fluctuation of the energy source (e.g., electrical, pneumatic, hydraulic). In the event of loss of energy, the
following minimum requirements shall be met:
• the stopping function of the machine shall remain available;
• all devices whose permanent operation is required for safety shall operate in an effective way to
maintain safety (e.g., locking, clamping devices, cooling or heating devices, braking);
• hazardous stored energy shall be safely controlled or dissipated.

7.3.7 Selection of operating modes


If the control system has multiple operating modes, the selection of the operating mode shall:
• by itself, not generate hazardous situations;
• require a deliberate action to initiate operation;
• automatically group operational capabilities with risk reduction measures;
• be accomplished outside the hazard zone;
• be clearly indicated;
• be indicated in a consistent manner.
Informative Note: Each mode may require restrictions, confirmation, and/or security access.

7.3.8 Manual and special mode(s)


When an engineering control has been manually suspended during the manual and special mode(s), alternate
risk reduction measures shall be required, as determined by a risk assessment.
Informative Note 1: Special modes are specific to a given task and provide the necessary power source and
safety function by their selection. Particular attention should be given to removing hazardous energy from
adjacent machines or auxiliary functions which can then create a hazardous situation.
Informative Note 2: See also, Annex K for further guidance on special modes.
Manual and special modes shall:
a) allow for the performance of manual or other specific identified tasks with acceptable risk. This
includes removal of hazardous energy from adjacent machines or auxiliary functions which can create
a hazardous situation;
Informative Note: Tasks during manual or special mode may include but are not limited to:
• set-up;
• teach;
• jog;
• adjustment;
• testing;
• process observation;
• maintenance;
• recovery from a jam;
• troubleshooting;
• cleaning.
b) provide access to perform the tasks in (a) above with acceptable risk;
c) include alternate risk reduction measures when the risk reduction measures used during other modes
are suspended;
d) be manually selected and initiated;
e) prevent a hazardous situation from being remotely initiated;
f) prevent an external hazard from entering the task zone(s) unless under local control.
Informative Note: Examples include automated guided vehicles and other automatic material handling
processes.

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7.3.9 Wireless control


Wireless (“cableless”) control systems shall comply with the requirements of NFPA 79.

7.4 Whole body access


7.4.1 General
Exposure to a hazard represents a potential risk when an individual(s) gains access to a hazard zone beyond
an engineering control device (e.g., passes through a presence-sensing device or interlocked guard) after
initiating the safety function to control the hazard. A hazardous situation arises when the individual(s) is no
longer detected and the hazardous machine function resumes while an individual(s) is within the safeguarded
space.
Informative Note: The requirements for whole body access may not apply if an engineering control – device is
not part of the application. However, the risk reduction measures in 7.4 can be applied to applications where the
perimeter is established by awareness barriers.

Whole body access is often associated with the provision of protection around the perimeter of a hazard zone,
such that an individual(s) could enter the hazard zone beyond the perimeter of protection. Whole body access
also occurs when an engineering control device is located at a separation distance from the hazard zone(s)
and individuals are not detected between the engineering control device and the hazard zone.

The requirements for whole body access apply only to means of entry that are considered intentional use or
reasonably foreseeable misuse.
Informative Note: An example of intentional or unforeseeable misuse includes difficult access through an
opening intended for product entry, exit or rejection when an interlocked access gate is part of the machinery.

For whole body access, both of the following parameters shall be considered:
1. an opening defined by the physical obstructions (e.g., opening in a guard) which permits the entire
body to enter the area (see 7.4.2);
and
2. an area within the safeguarded space which permits an individual to remain undetected (see 7.4.3).
Where the separation distance allows an individual to remain undetected inside the safeguarded space,
additional engineering controls – devices or other risk reduction measures shall be provided to prevent
reasonably foreseeable hazardous situations according to 7.4.2.3.

7.4.2 Openings defined by the physical obstruction


7.4.2.1 Access over physical obstruction
Physical obstructions (such as protective structures) less than 1,000 mm (~39 in) in height do not sufficiently
restrict movement of the body, and therefore allow the entire body to enter the area.
Informative Note: Protective structures less than 1,400 mm (55 in) in height should not be used without
additional risk reduction measures. See also, ANSI B11.19.

7.4.2.2 Access around, through or under physical obstruction


To prevent the entire body from entering an accessible area, openings established by physical obstructions
shall not exceed the following dimensions:
• square or round openings with diameter (e) > 240 mm (9.5 in), see ANSI B11.19 (see also ISO 13857);
• rectangular openings with height (h) > 180 mm (7 in) and width (w) > 300 mm (12 in);
• rectangular openings with height (h) > 800 mm (31.5 in) and width (w) > 180 mm (7 in).
Informative Note: These values are derived from ISO 13857 and ISO 7250-3.

The dimensions presented above consider reasonably foreseeable behavior of individuals. Smaller
dimensions may allow intentional whole body access but are not considered in this document.

7.4.2.3 Area within the safeguarded space where individuals can remain undetected
Hazardous situations where safety functions can be restored or re-enabled (reset) include but are not limited
to:
• an individual inside the safeguarded space but no longer being detected by the presence-sensing
device;
• a closed interlocked guard with an individual inside the safeguarded space.

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See ANSI B11.19-2019, subclause 9.11.1 for guidance to determine dimensions where individuals can remain
undetected within the safeguarded space.

7.4.3 Risk reduction measures to minimize risks derived from whole body access
To prevent the required restart interlock being re-enabled while an individual is inside a safeguarded space,
at least one of the following risk reduction measures in 7.4.3.1, 7.4.3.2 or 7.4.3.3 shall be applied.

7.4.3.1 Isolation and dissipation of hazardous energies (see ANSI / ASSP Z244.1).

7.4.3.2 Automatic detection of an individual(s) within the safeguarded space by means of a presence-sensing
device(s). If some locations within the safeguarded space are not covered by this presence-sensing device,
at least one of the following measures shall be used:
a) additional presence-sensing device(s) to provide detection of an individual(s) within the entire
safeguarded space that allows whole body access;
or
b) physical obstructions to force part(s) of the body of the individual into the sensing field of the presence-
sensing device(s);
or
c) manual reset of the safety function (restart interlock) as described in 7.4.3.3.
Informative Note: The application of one of these measures may not be sufficient and additional measures
may be required.

7.4.3.3 Manual reset (see 7.2.5) of the safety function initiated by the engineering control device(s) that detect
access by an individual to the hazard zone with the addition of the following:
a) activation of safety-related manual control devices from inside the safeguarded space shall be
prevented;
EXCEPTION: When the safety-related manual control device is intended to be used within the
safeguarded space, it should be used in conjunction with other risk reduction measures (e.g., hold-to-
run control on a pendant utilizing an enabling device and speed monitoring function); see ANSI B11.19.
b) when an individual(s) may be present in undetected areas, one or more of the following shall be used:
i. sequential time-limited reset function;
ii. automatic detection of the individual(s) within the safeguarded space;
iii. provision of means for further visibility of the span-of-control (e.g., physical obstruction;
mirrors or vision systems, such as video monitoring or CCTV);
iv. inhibit functions: if a proactive inhibit function cannot be implemented and reactive inhibit
function is provided, an initiation warning system shall also be provided.
Informative Note: A proactive inhibit function allows the person to inhibit the reset of the restart interlock
before entering the safeguarded space. A reactive inhibit function allows the person to interrupt the reset of the
restart interlock with a stop command actuated from inside the safeguarded space.
c) Provision of at least one of the following measures to address the possibility when an individual can
be trapped inside the guards that define the safeguarded space:
i. proactive inhibit functions;
ii. movable guards capable of internal opening and an initiation warning system. An escape
release of guard locking devices shall be provided if applicable.

For further information see ANSI B11.19-2019, subclause 9.11.

7.5 Access to the hazard zone associated with openings


Where whole body access is possible through the opening, risk reduction measures shall meet the
requirements of subclause 7.4.
Informative Note: Requirements to prevent access to a hazard zone through an opening depend on the
dimensions of the opening, the height of the opening from the nearest access platform, the risk reduction
measures associated with the opening, and the presence of an obstruction (e.g., a conveyor) in the opening.

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When openings are smaller than those defined in subclause 7.4.2, the engineering controls (guards or
devices) shall be located at a distance from any associated hazard(s) within the span of control such that
individuals will not be exposed to a hazard(s) according to ANSI B11.19-2019, subclause 9.6. Means to
achieve this include:
• initiating a protective stop when opening an interlocked guard or movable barrier device prior to the
individual reaching the hazard;
• providing an engineering controls – devices that initiates a protective stop when an individual is
detected; or
• providing an engineering controls – guard that prevents an individual from accessing the hazard by
reaching over, under, around, or through.
Informative Note 1: One method of achieving safety distance is by the use of tunnel guards. Bends in tunnel
guards can further restrict access.
Informative Note 2: When the product is considered part of the risk reduction measure, any remaining
opening(s) shall prevent individuals from reaching the identified hazard(s). See ANSI B11.19 -2019 clause 7.3.

7.6 Material/part conveyance


Material/part conveyance systems that interface with machinery shall be designed, constructed, installed,
integrated, maintained, inspected and operated in accordance with risk reduction measures resulting from the
risk assessment process.
Informative Note: For conveyors, see ASME B20.1.

7.7 Electromagnetic compatibility (EMC)


Electromagnetic compatibility of a machine and controls shall meet the requirements of the applicable sections
of NFPA 79.
7.8 Electrostatic hazards
On machines where hazards may arise from the generation of static electricity, bonding and/or static
elimination shall be provided.
7.9 Electrical
The electrical design and construction of a machine and a machinery system shall conform to the requirements
in NFPA 79, NFPA 70E, and the applicable sections of NFPA 70.
7.10 Control of hazardous energy (lockout / tagout / alternative methods)
The machinery and/or machinery system shall be provided with adequate means to control hazardous energy.
See ANSI / ASSP Z244.1.
Informative Note 1: Lockout / tagout is not a substitution for engineering controls, but rather is a procedure
that is relatively low on, and is to be used within, the hierarchy of controls. Other techniques such as alternative
methods that design out this hazard (or hazards) are preferable. See Table 3.
Informative Note 2: The choice between lockout / tagout and alternative methods of energy control depends
upon the task being performed and the SRP/CS. See also, 7.11.
Informative Note 3: The risk assessment can be used to determine when these alternative methods may be
appropriate.

The machinery user shall control hazardous energy to protect personnel using lockout, tagout, or alternative
methods.
Informative Note: See also Annex L and ANSI / ASSP Z244.1.

The user shall be in corformance with the energy control documentation, training, and authorization
requirements of ANSI / ASSP Z244.1.

Where applicable, the user shall identify energies as being hazardous, non-hazardous, or beneficial for specific
tasks to be performed on a machine.
Informative Note 1: Not all energies are hazardous for certain tasks. Some energies are beneficial and
enhance the safety of tasks, e.g., hold down arms on coiling machines or counterbalance systems on presses.
Informative Note 2: Non-hazardous or beneficial energies for certain tasks can be hazardous for other tasks.
For example, energies for hold down arms or counterbalance systems could be hazardous for tasks working on
those systems, but non-hazardous or beneficial during set-up, diagnostics or other tasks.

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Energy that is non-hazardous for a specific task shall be maintained to achieve acceptable risk.
Informative Note: Pre-task planning is often used to identify hazardous and non-hazardous energies.

Energy that is beneficial for a specific task shall be controlled to complete the task with acceptable risk.
Informative Note: Beneficial energy that is not adequately controlled could become hazardous energy.

Alternative methods shall be provided for personnel safety when it is necessary for machinery to remain partially
energized (e.g., to hold parts, save information, retain heat or provide local lighting). See ANSI / ASSP Z244.1.
Informative Note 1: Maintaining power to the controller can avoid problems associated with restarting the
machine.
Informative Note 2: For span of control, see 7.3.4.

7.11 Ergonomics / human factors


Risks associated with ergonomics / human factors of machines and material handling equipment shall be
reduced to an acceptable level.
Informative Note 1: For informative guidance, see (ANSI) B11.TR1, the annexes of this document, and/or other
appropriate reference materials.
Informative Note 2: When feasible, users and suppliers should collaborate in conducting an ergonomic hazard
analysis.

7.12 Engineering controls


7.12.1 General
The engineering controls (guards, control functions and devices) on machinery shall conform to the applicable
machine-specific “base” (type-C) safety standard and/or ANSI B11.19.

7.12.2 Additional considerations


The specific risk reduction measures shall be based on the risk assessment and the applicable machine-
specific “base” (type-C) safety standard. Where engineering controls are employed, the requirements of
7.12.2.1 through 7.12.2.4 shall be applied.

7.12.2.1 Removing, disabling or suspending engineering controls


When tasks such as start-up, set-up, repair, adjustment, or maintenance require removing, disabling, or
suspending one or more engineering controls, alternative risk reduction measures shall be provided. Only
properly trained and authorized personnel shall be allowed access to a hazard zone. The manual suspension
(bypass) process shall be authorized, documented, and shall include task-specific procedures and appropriate
training of personnel.
Informative Note: See also, ANSI B11.19 and ANSI / ASSP Z244.1.

Removed, disabled, manually suspended (bypassed) or suspended engineering controls shall be restored to
full operational status prior to the resumption of normal operation. Where feasible, the suspending shall be a
defined mode that shall suspend the appropriate engineering controls as well as allow for activation of the
alternative risk reduction measures.

7.12.2.2 Visibility
Engineering controls, awareness means, and risk reduction measures shall not cause undue obstruction to
the view of the production process.
Informative Note: Polycarbonate or other plastic materials often used for viewing panels may be subject to
degradation from exposure to the environment, lubricants, metalworking/metal removal fluids, etc., and the
conditions of use. The degradation is not always visible and can impact the ability to view the process. See
also, Annex G of ANSI B11.19.

7.12.2.3 Creating hazards


Risk reduction measures should not create additional hazards. When a hazard is created by the application
of a risk reduction measure, then appropriate risk reduction measures shall be implemented to attain
acceptable risk.

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7.12.2.4 Stopping time / time to achieve a safe condition


When the effectiveness of the engineering controls – devices is dependent on the time to achieve a safe
condition (zero speed, safe speed, force, torque, or position), the supplier shall provide information concerning
the reaction time of the machine. See also, ANSI B11.19 and any of the relevant machine and machinery
system safety standards listed in 7.19.
Informative Note: Factors such as machine speed, tooling, air pressure and wear may affect the reaction time
of the machine beyond that as stated by the manufacturer. Active monitoring of the reaction time of the
machine may be needed to confirm continued safe application of the safety function.

7.13 Handling of machines, component parts, tooling and materials


When a lifting hazard has been identified, a means that reduces risk to an acceptable level shall be provided
for loading, removing or replacing machinery, component parts and/or materials.
Informative Note: Means can include lifting point features such as:
• swivel hoist ring / eye–bolt attachment holes;
• permanent hook(s);
• other suitable component features to which lifting equipment can be attached;
• instructions in the operation, maintenance and safety manual for the machine (see also, Annex M).

Where applicable, a lifting point(s) on the load shall be identified. Transport personnel shall be able to reach
the attachment devices safely. Weight, and center of gravity (where applicable) details shall be given on the
machine, in operations manuals, on its packaging, and/or on transportation documents.

7.14 Hydraulic and pneumatic (including vacuum) systems


7.14.1 General
Hydraulic systems shall conform to the applicable sections of ISO 4413. Pneumatic systems shall conform to
the applicable sections of ISO 4414. All system components shall be selected to be in accordance with the
manufacturer’s specifications and instructions.
Informative Note: See also, ANSI B11.26.

Regulators shall be used for air controlling equipment and pneumatic actuators requiring less than line
pressure or variable pressure settings.

When pressure (vacuum) adjustments can lead to unacceptable risk, pressure control components shall be
permanently marked to indicate the allowable pressure range and should be lockable. If appropriate, fixed
pressure relief valves or rupture discs are preferred. Machinery design shall minimize potential hazards from:
• overpressure;
• pressure surges or pressure increase;
• pressure loss or underpressure;
• high pressure injection;
• stored energy;
• sudden hazardous movement of a hose resulting from leakage and/or component failures.
Informative Note: Components with an adjustable range that is within the allowable pressure range of the
system are preferred.

Overpressure protection (e.g., regulator, relief valve, pressure switch, bypass) shall be provided on all
hydraulic power sources. The pressure adjustment on a pressure compensated pump shall not be the
protective device. An additional relief valve downstream from the pump shall be provided.

Pressure relief valves shall operate in such a way that reduces risk to an acceptable level.
Informative Note: Nothing in this subclause is meant to circumvent or supersede the requirements of the
ASME Boiler and Pressure Vessel Code, or other applicable specifications or requirements.

7.14.2 Safety shut-off and exhaust valve


An energy isolating device to shut off and release pressure from the various systems shall:
• be provided and located outside of the hazardous area(s);
• be capable of being locked in the OFF (closed) position only;
• be easy to operate (e.g., a simple pull/push action for pneumatics);

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• have a properly sized exhaust port equal to or greater than its supply port;
• have a pressure indicator (i.e., a gauge) that is visible to the operator to indicate that the line is relieved
of pressure.
Informative Note: The above list is intended for fluid power specific isolating devices, where used, and is not
intended to preclude the use of electrical isolation devices on the fluid energy source, provided they meet the
intent of this subclause.

7.14.3 Pressure vessels


All pressure vessels with an inside diameter larger than 150 mm (6 in) shall conform to the ASME Boiler and
Pressure Vessel Code Section VIII Division 1 and be equipped with a pressure relief valve in the event of over-
pressurization.
Informative Note 1: A pressure vessel is a storage tank or container for a fluid (gas or liquid) under pressure
above 100 kPa (15 psig) intended as a means of energy storage or control and has a cross section larger than
the system tubing or piping. In most cases, the machinery supplier will not actually manufacture the pressure
vessel. However, the machinery supplier should procure a pressure vessel that has been manufactured
according to that Code, and which should contain a permanent marking or label identifying it as being in
conformance to the code.
Informative Note 2: A pressure vessel smaller than 150 mm (6 in) in diameter should be evaluated using NFPA
T2.6.1. See also, Annex S.

7.14.4 Air valve mufflers


Air valve mufflers for safety systems and air dumps shall have sufficient capacity so as not to restrict the
exhausting of the system and shall not be prone to contamination over time. Elements that allow contamination
to increase back pressure and effect exhaust time shall not be used (e.g., paper or sintered bronze).

7.14.5 Air preparation components


The air supply shall be sized so that, during the operation of various components, there is not a hazardous
pressure drop in the system.
Informative Note: Hazards generated due to either inadequate pressure or volume should be minimized.
Pneumatic systems, including air preparation components, should be designed such that minimum specified air
volume and air pressure requirements are maintained. Minimum system volume and pressure requirements
should be based on the maximum cumulative demands and limitations of the pneumatic components.

The air shall be filtered, and excessive moisture removed before it enters the system. Lubrication shall be
provided only for components that require it. The lubrication can be of the single point type which applies
lubrication directly to the actuator.

Lubricators shall be set so as to provide sufficient lubrication but not so as to over lubricate, thereby causing
excessive oil to be discharged into the atmosphere or create valve malfunction.
Informative Note: Lubricated systems should have a re-classifier installed into the exhaust port of the valve
controlling the lubricated actuator.

7.14.6 Hydraulic accumulators


Accumulators shall be charged with inert gas (such as nitrogen). Provision shall be made to discharge
pressurized hydraulic fluid when necessary and within parameters for acceptable risk. A pressure indicator
shall be provided to allow for verification of the release of the pressure.

7.14.7 Actuators
If rapid system pressurization causes hazardous movement, additional risk reduction measures shall be
provided.
Informative Note 1: Some examples include but are not limited to:
• soft start-type valves;
• counterweights / springs;
• open centered valves;
• flow restrictors;
• rod brakes;
• shot pins and slide locks.
Informative Note 2: See ANSI B11.26 for additional information.

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7.14.8 Pressure intensification


Hydraulic and pneumatic circuits shall be designed so as to avoid hazardous effects of pressure intensification.

7.15 Ladders and platforms


Fixed ladders shall be constructed in conformance with the requirements in ANSI A14.3. Platforms shall be
constructed in conformance with the requirements in ANSI A1264.1 and A1264.2.

7.16 Large machines


Large machines where personnel are regularly required to enter into the working envelope to perform work or
tasks shall comply with ANSI B11.25.
Informative Note: Large machines are machines typically covered by type-C standards but are excluded by the
size limitation in the scope of the standard or that, by the nature of the size of the workpiece, tooling, or process
travels, require entry into the work envelope to perform normal process tasks. Entering into the “working
envelope” typically means walking or stepping into the envelope (whole body access), as opposed to accessing
the area with a hand or arm.

7.17 Lasers, radiation and magnetic fields


7.17.1 Lasers
Lasers used with machinery shall comply with ANSI Z136.9, ANSI B11.21, ANSI Z136.1 and 21 CFR Parts
1000-1005, 1010, 1040.10 and 1040.11. See also, 7.19.21.
Informative Note 1: A manufacturing process incorporating the use of lasers to perform work may generate
hazardous vapors that require ventilation and/or exhaust systems.
Informative Note 2: In most cases, the machinery supplier will not actually manufacture the laser. However, the
supplier should procure a laser that has been manufactured according to the above standards and specifications.
Informative Note 3: Lasers on part marking machinery and similar applications should be enclosed with no
openings other than those required to allow product to enter and exit. Openings to allow workpieces to enter and
exit should be designed to prevent personnel from reaching into the normal beam path and also designed so that
a single incidental reflection will not create a hazardous condition outside the enclosure. See 21 CFR
1040.10(b)(15) Laser products.

7.17.2 Radiation and magnetic fields


Where practical, hazardous radiation emissions from a machinery system shall be reduced at the source.
Informative Note: Radiation emissions may include ionizing radiation sources (X-rays and gamma rays)
and/or non-ionizing radiation sources (ultraviolet, infrared, microwave, and laser emissions).

The supplier of components or machinery that generates electromagnetic hazards shall advise users of the
strength of the electromagnetic field at a given distance(s).

Energy control procedures shall be developed for radiation energy sources.

Before releasing to operations, equipment incorporating radiation energy sources shall be tested and
confirmed to determine that the equipment is within the intended limits. Procedures for periodic confirmation
shall be developed to ensure that radiation energy conditions have not changed (settings, effectiveness of
guarding, bonding).

Residual risks associated with radiation energy sources shall be communicated to the machinery user.
Informative Note: Examples include, but are not limited to:
• warning labels;
• warning signs;
• instructions in a manual;
• messages on an HMI;
• audible alarms;
• visual alarms.

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If the measures for the reduction of emissions at the source are not practical and/or adequate, the machine
shall be provided with additional risk reduction measures.
Informative Note: Examples include, but are not limited to the following:
• avoiding the use of hazardous radiation sources;
• use of filtering and/or absorption;
• use of attenuating screens and/or guards;
• limiting radiation power to the lowest level sufficient for the proper functioning of the machine;
• designing the source so that the beam is concentrated on the target;
• increasing the distance between the source and the operator;
• labeling or instructions;
• providing for remote operation of the machine.

Where practical, hazardous radiated emissions from a machine or machinery system shall be reduced at their
source, to the level and concentration necessary for reliable functioning.
Informative Note: Radiation emissions may include ionizing radiation sources (e.g., X-rays and gamma rays) or
non-ionizing radiation sources (e.g., lasers, magnetic or electromagnetic fields, ultraviolet, infrared, microwave
and laser emissions), induction heating and sealing).

Where practical, the area of the equipment where radiation is present shall be limited and minimized.
Guards shall be provided to isolate the radiation to only the intended area.

Where practical, shielding, bonding and grounding shall be provided to reduce susceptibility and to neutralize
radiation.

The supplier of components or machinery that generate hazardous electromagnetic or magnetic fields shall
advise users of the strength of the hazardous field at a given distance.
Informative Note: For additional guidance see EN 50527-2-1, EN 50499, or IEEE C95.1, and Annex R.

If the measures for the reduction of emissions at the source are not practical or adequate, the machine shall
be provided with additional risk reduction measures.
Informative Note: Examples of risk reduction measures include, but are not limited to the following:
• use of filtering or absorption;
• use of attenuating screens or guards;
• de-energizing radiation sources when not in use;
• designing the source so that the beam is concentrated on the target;
• increasing the distance between the source and the operator;
• using automatic functions to limit the exposure of personnel to the shortest time needed to perform
required tasks;
• labeling and instructions.

Before releasing machinery to operations or production, equipment incorporating radiation energy sources
shall be validated to determine that the equipment is within the intended limits. Procedures for periodic
confirmation shall be developed to ensure that radiation energy conditions have not changed (settings,
effectiveness of guarding, bonding).

When applicable, machinery users shall monitor radiation energy exposure and accumulated radiation in
personnel (e.g., dosimeters).

Residual risks associated with radiation energy sources shall be communicated to the machinery user.
Informative Note 1: Examples include: warning labels or signs, instructions in a manual, messages on an
HMI, audible or visual alarms, etc.
Informative Note 2: Natural magnets and electromagnetic fields can present a hazard to persons with an
implantable medical device(s).
Informative Note 3: Risks can include:
• corruption of critical signals;
• interruption of communications;
• premature degradation of materials.

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7.18 Lubrication
Where feasible, lubrication points shall be located so that personnel are not exposed to unacceptable risks
during access.
Informative Note 1: Where access is difficult, remote, or self-lubrication methods should be considered.
Informative Note 2: On machines where an automatic lubrication system failure could cause a hazard, the
system should incorporate an indication of its correct functioning or a warning of a malfunction.

7.19 Machines and machinery systems


Suppliers and users of the machines and machinery systems shall conform with the applicable requirements
of those specific American National Standards.
Informative Note: This list is not intended to be comprehensive. The user of this document is encouraged to
determine whether a standard exists for their specific machine application.
7.19.1 Mechanical presses
ANSI B11.1 (type-C) Safety Requirements for Mechanical Power Presses.
7.19.2 Hydraulic and pneumatic presses
ANSI B11.2 (type-C) Safety Requirements for Hydraulic and Pneumatic Power Presses.
7.19.3 Press brakes
ANSI B11.3 (type-C) Safety Requirements for Power Press Brakes.
7.19.4 Shears
ANSI B11.4 (type-C) Safety Requirements for Shears.
7.19.5 Iron workers
ANSI B11.5 (type-C) Safety Requirements for Iron Workers.
7.19.6 Manual turning machines (Lathes)
ANSI B11.6 (type-C) Safety Requirements for Manual Turning Machines.
7.19.7 Cold headers and cold formers
ANSI B11.7 (type-C) Safety Requirements for Cold Headers and Cold Formers.
7.19.8 Manual milling, drilling and boring machines
ANSI B11.8 (type-C) Safety Requirements for Manual Milling, Drilling and Boring Machines.
7.19.9 Grinding machines
ANSI B11.9 (type-C) Safety Requirements for Grinding Machines.
7.19.10 Sawing machines
ANSI B11.10 (type-C) Safety Requirements for Sawing Machines.
7.19.11 Gear/spline cutting machines
ANSI B11.11 (type-C) Safety Requirements for Gear Cutting Machines (withdrawn; use ANSI B11.0,
ANSI B11.19, and when applicable, ANSI B11.23).
7.19.12 Roll forming and roll bending machines
ANSI B11.12 (type-C) Safety Requirements for Roll forming / Roll Bending Machines.
7.19.13 Automatic bar and chucking machines
ANSI B11.13 (type-C) Safety Requirements for Automatic Bar and Chucking Machines.
7.19.15 Pipe, tube and shape bending machines
ANSI B11.15 (type-C) Safety Requirements for Pipe, Tube and Shape Bending Machines.
7.19.16 Metal powder compacting presses
ANSI B11.16 (type-C) Safety Requirements for Powder Metal Compacting Presses.
7.19.17 Horizontal hydraulic extrusion presses
ANSI B11.17 (type-C) Safety Requirements for Horizontal Hydraulic Extrusion Presses.
7.19.18 Machines processing or slitting coiled or non-coiled metal
ANSI B11.18 (type-C) Safety Requirements for Coil Slitting / Coil Processing Equipment.
7.19.19 Risk reduction measures (safeguarding)
ANSI B11.19 (type-B) Performance Requirements for Risk Reduction Measures: Safeguarding and
Other Means of Reducing Risk.
7.19.20 Integration of machinery into a system
ANSI B11.20 (type-B) Safety Requirements for the Integration of Machinery into a System.
7.19.21 Machine tools using lasers for processing equipment
ANSI B11.21(type-C) Safety Requirements for Machine Tools Using Lasers for Processing
Equipment. Also, ANSI Z136.9-2013 (type-B) American National Standard for Safe Use of Lasers in
Manufacturing Environments.

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7.19.22 Turning centers and automatic NC turning machines


ANSI B11.22 (type-C) Safety Requirements for Turning Centers and CNC Turning Machines.
7.19.23 Machining centers & automatic NC milling, drilling and boring machines
ANSI B11.23 (type-C) Safety Requirements for Machining Centers and Automatic CNC Milling, Drilling and
Boring Machines.
7.19.24 Transfer machines
ANSI B11.24 (type-C) Safety Requirements for Transfer Machines.
7.19.25 Large machines
ANSI B11.25 (type-B) Safety Requirements for Large Machines.
7.19.26 Functional safety for control systems
ANSI B11.26 (type-B) Functional Safety for Equipment: General Principles for the Design of Safety
Control Systems Using ISO 13849-1.
7.19.27 Industrial robots
ANSI / RIA R15.06 (type-C) Safety Requirements for Industrial Robots and Robot Systems.
7.19.28 Packaging machinery
ANSI / PMMI B155.1 (type-A) Safety Requirements for Packaging Machinery and Packaging-Related
Converting Machinery.
7.19.29 Injection molding machines
ANSI / PLASTICS B151.1 (type-C) Safety Requirements for Horizontal/Vertical Injection Molding
Machines.
7.19.30 Extrusion machines
ANSI / PLASTICS B151.7 (type-C) Safety Requirements for Extrusion Machines.
7.19.31 Blowmolding machines
ANSI / PLASTICS B151.31 (type-C) Safety Requirements for Blow Molding Machines.
7.19.32 Plastic sheet production machines
ANSI / PLASTICS B151.20 (type-C) Safety Requirements for Plastic Sheet Production Machinery.
7.19.33 Conveyors
ANSI / ASME B20.1 (type-C) Safety Requirements for Conveyors.
7.19.34 Woodworking machines
ANSI O1.1 (type-B) Woodworking Machines - Safety Requirements
7.19.35 Other machines
Other machines included in a machinery system shall conform with the requirements in the applicable
standards. Where a machine-specific “base” (type-C) safety standard exists and the requirements of that
standard conflict with the requirements in this document, the requirements of the machine-specific “base”
(type-C) safety standard shall generally apply.

7.20 Mechanical power transmission


Risk reduction for mechanical power transmission apparatus shall be by an engineering control (guard or
device) or safe-location (as per 6.5.1.1) to prevent contact with hazardous machinery motion. See ANSI
B11.19 for additional information.
Informative Note 1: Risk reduction measures may not be required for certain mechanical power transmission
apparatus based on the results of a documented risk assessment.
Informative Note 2: Power transmission apparatus may lack sufficient energy to create a hazardous situation.

Hazards associated with the operation of mechanical power transmission apparatus shall be eliminated by
design of the equipment or the risk reduced by an engineering control (guard or device) or safe-location.

Where feasible, mechanical power transmission apparatus shall be located within the structure of the machine,
equipment, or system. Where breakage of a mechanical power transmission component can result in injury,
provision shall be made for appropriate containment of components.
7.21 Modified atmospheres
Machinery that uses or that creates modified atmospheres shall prevent accumulation of gases at hazardous
levels, by providing adequate ventilation and/or eliminating the potential hazard by design, or provide for
detection, warning and evacuation of unsafe gas levels.

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Informative Note: Modified atmospheres can be created due to normal operations, maintenance, nearby
machining operations or a fault condition. Machinery that uses modified atmospheres can create a hazard
within a facility and can require an additional risk reduction measure(s) by the user.

7.22 Noise
Machines shall be so designed and constructed that risks from noise emission produced by the machines are
reduced to the extent practical. Exposure to the noise level of a machine and/or machinery system shall be
reduced to an acceptable level.
Informative Note 1: Noise levels should be measured in accordance with (ANSI) B11.TR5.
Informative Note 2: Design or construction methods could include sound absorption materials, covers,
silencers, vibration damping or selection of component materials or other methods.
Informative Note 3: Table 5 presents some sources of machine noise and corresponding examples of noise
reduction methods.

Table 5 — Noise Source and Noise Reduction Methods (Informative)


Source Noise reduction method
Product to product contact spacing, dampening guards/enclosures
Vibration staggering teeth on milling cutters, enclosures, isolation, stepping punches
Pneumatics end-of-stroke cushions, internal bumpers, external shock absorbers, repair leaks
Transmission noise gearbox dampening, enclosures
Pneumatic exhaust silencers
Power generation source dampening, absorber, enclosure
Informative Note: Noise levels of individual machines can increase the cumulative noise level to an
unacceptable level when combined into a machinery system.

7.23 Sanitation and hygiene


Machines used in certain industries with sanitization requirements (e.g., food and pharmaceuticals) shall
provide means to allow ready cleaning with acceptable risk.

For machines used in certain industries, lubricants from machine elements such as gears, bearings,
hydraulics, pneumatics, compressors, slideways and chains shall not contaminate the product or the
packaging. In all cases where product and lubricant contact cannot be fully prevented, lubricants that are
acceptable for that particular use shall be used.
Informative Note: Requirements and/or guidance for the sanitary design of machinery may be found
in ANSI / PMMI B155.1, ISO 14159, ISO 21469, EN 1672 Parts 1 and 2 and the American Meat
Institute principles of sanitary design.

7.24 Stability
A machine shall have sufficient stability to allow it to be used safely under the conditions of use and reasonably
foreseeable misuse.
Informative Note: A machine may become unstable due to one or more of the following:
• geometry of the base;
• weight distribution, including loading;
• dynamic forces due to movements of parts of the machine, movement of the machine itself, or of
elements held by the machine which may result in an overturning movement;
• vibration;
• oscillation of the center of gravity;
• characteristics of the supporting surface in case of traveling or installation on different sites (e.g.,
ground conditions, slope, etc.);
• external factors (e.g., air movement, manual or seismic forces, mishandled loading, worker bumping,
cart incidents, other nearby equipment or work operations not directly related, etc.).

If stability cannot be achieved by design, other risk reduction measures shall be used.
Informative Note: Risk reduction measures for improved stability may include but not be limited to:
• anchorage bolts;
• locking devices;
• movement limiters or mechanical stops;

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• acceleration or deceleration limiters;


• load limiters;
• load balancing, etc.

Means shall be provided so that stability of a machine is maintained during transport.

7.25 Thermal systems


A machine shall be designed and used to minimize hazards from hot and cold temperatures.
Informative Note 1: Contact with a hot (above 60°C (140°F)) or cold (below 0°C (32°F)) surface may
result in injury due to physical harm and/or reflexive reaction causing falls and/or unintended
movement into a hazard. See also, Annex E.
Informative Note 2: Additional information may be found at ISO 13732-1 (hot) and ISO 13732-3
(cold). Risk reduction measures for thermal hazards may include:
• venting and/or air movement;
• insulation;
• guarding;
• location and/or isolation;
• labeling;
• personal protective equipment (e.g., gloves, face shield).

7.26 Heating Systems and related Equipment for Processing of Materials


Ovens, dryers, furnaces, thermal oxidizers, and other heating equipment used for processing of materials,
shall be designed, constructed and used only in a manner that achieves acceptable risk. See also, NFPA 86.

7.27 Explosive Atmospheres - Hazardous (Classified) Locations


In explosive atmospheres (Classified locations) where fire or explosion hazards may exist due to flammable
gases, flammable liquid-produced vapors, combustible liquid-produced vapors, combustible dusts, or ignitable
fibers/filings that could be present, and the likelihood that a flammable or combustible concentration or quantity
is present, the equipment shall be designed, constructed, equipped, maintained, and operated to achieve an
acceptable risk level related to fire, deflagration, or explosion.
Informative Note 1: Hazardous locations are classified based on the presence and properties of the explosive
hazards, and likelihood that a flammable or combustible concentration or quantity is present in accordance with
NFPA 70: Article 500.
Informative Note 2: Both the product being processed and the environment in which it is operated should be
taken into consideration in the equipment design, construction, configuration, maintenance, and operation.
Informative Note 3: Equipment requiring explosion prevention should be protected by containment,
suppression, rendering inert, or explosion venting. Suppression, containment, or inertial systems should be
designed in accordance with NFPA 69. Explosion venting should be designed in accordance with NFPA 68.
Informative Note 4: See NFPA 61, NFPA 70, NFPA 86, NFPA 497, NFPA 499, NFPA 652, NFPA 654, IEC
60079 and other applicable standards.

7.28 Visibility
Visibility required for the safe operation and/or adjustment of the machine shall be provided. Machines shall
be designed and used to minimize hazards from the lack of visibility of portions of the machine.
Informative Note: Risk reduction measures may include:
• audible and/or visual alarms;
• remote vision systems or cameras and external or remote adjustments and/or lubrication access;
• use of transparent materials;
• mirrors.
7.29 Ventilation of airborne contaminants
For machinery and production systems that generate particles, mists, vapors, fumes or dust, appropriate
control technology or where necessary, the means to connect to a user’s fume/dust collection system, shall
be provided. The user shall appropriately control particles, mists, vapors, fumes or dust.

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8 Information for use


8.1 General
The supplier shall provide information for the operation and maintenance of machinery that consists of
documents, signs, signals, symbols and/or diagrams used to convey information to the user. This information
shall be conveyed in English, and/or in the official, native, or predominant language as determined by the user.
Information shall be provided to the user about the intended use of the machinery during the applicable phases
of the lifecycle of the machine. Information for operation and maintenance shall inform and warn the user
about residual risk. Information for operation and maintenance shall be based on the daily use of the machine,
scheduled and unscheduled maintenance, and other tasks identified in a risk assessment.
Informative Note: Where applicable, the supplier should provide information regarding any implemented
cybersecurity measures.

The user shall provide information to personnel for operation and maintenance. The user shall determine the
need for additional information beyond that provided by the supplier. The user shall determine the need for
required information in an additional language(s).
Informative Note: The information for use should be updated based on machine modification(s).

8.2 Manuals
One or more manuals (instruction handbook) shall be supplied with machinery that addresses as applicable,
the subjects of Safety, Installation, Operation, Maintenance, Parts and Checking / Testing / Confirming of the
safety related systems describing the intended use(s) of the machinery. The manual(s) shall also inform and/or
warn personnel about the residual risks (see 6.6 and Annex D), and conform to ANSI Z535.6.
Informative Note: The manual should include the sections shown in Annex M, as applicable. The order of the
information shown in Annex M is recommended but not required. The manual should be written for the
intended audience. Safety information should appear prominently and be easy to read. See also, ISO 20607.

8.3 Safety signs and labels


Safety signs and labels shall:
• conform to the requirements of ANSI Z535.4 or ISO 3864;
• be suitable for the conditions of use;
• be duplicated or appear in the manual.
All energy isolating devices shall be adequately labeled or marked to indicate their function. The identification
shall include the equipment controlled, the energy type, and energy magnitude.

Information to conform to the labeling requirements of NFPA 70E shall be provided by the user.

8.4 Nameplate
The machine shall have a nameplate that includes at a minimum:
• name and address or location of the manufacturer;
• designation of series or type;
• serial number, if any.
Informative Note: The nameplate should be permanent and remain legible throughout the expected life of the
machine (see also, NFPA 79). Machine specific “base” (type-C) standards may have additional requirements.

8.5 Information for personal protective equipment (PPE)


The machinery supplier shall inform the user(s) of any machine-specific PPE requirements.

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9 Supervision
The user shall confirm that the operation and maintenance of the machine is supervised only by qualified
personnel. An individual must meet the requirements of a qualified person before a user assigns tasks to
either operate or supervise the operation of a machine.
Informative Note: Anyone who is trained and authorized by the user may perform the “supervisory” function.
There is no intent to imply that only a person with a title such as “supervisor” may assume that function. See
also, Annex P.

The designated supervisor shall ensure that changes affecting risk reduction measures are only made by
authorized personnel. Where applicable, means to prevent unauthorized changes shall be implemented and
maintained in a manner(s) that is effective and commensurate with the risk.
Informative Note: See ANSI B11.19 for further details regarding avoidance of unauthorized changes.

The designated supervisor shall confirm that the user's operating procedures are within the guidelines as
described in the supplier's operating manual or according to the updated information provided with the
modification.

10 Training
The supplier shall provide materials (written, electronic or video) for the user to incorporate into its training
program(s) (see clause 8). Where training materials or information are not available, the user shall develop
appropriate training materials or obtain them from other sources.

10.1 General
All personnel shall be trained to perform the functions for which they are responsible. Users shall confirm that
personnel working with machines are properly trained in safe working procedures and are qualified to perform
the functions to which they are assigned.
Informative Note: The user should refer to the supplier’s recommendations when establishing a
training program. Examples of training program elements include:
• description of the assigned task;
• hazards associated with the assigned task;
• designated risk reduction measures;
• function of operator controls to be encountered in performing the assigned task;
• methods of function-testing or otherwise assuring the proper function of engineering controls.

As required by assigned functions, personnel shall be trained in the safe working procedures for controlling
hazardous energy sources (lockout / tagout / alternative methods). See ANSI / ASSP Z244.1.
Informative Note: See Annex N for additional guidance on training. See also, 29 CFR 1910.147 and
1910.333.

10.2 Training elements


10.2.1 General
Training shall include identification of hazards associated with tasks performed in the installation, set-up,
operation and maintenance of machines or machinery systems.
Informative Note: The training should focus on hazards associated with personnel actions necessary to
perform required tasks on the machinery.

Training shall include the identification and proper use of appropriate risk reduction measures necessary to
reduce the risk of injury to personnel.

The requirements for personal protective equipment shall be determined. Personnel shall be trained in the
proper donning/doffing, use and maintenance of this equipment and such use shall be enforced by the user.

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Training shall include the following as appropriate:


• the functions and locations of manually operated controls;
• safe methods for installing, removing, and adjusting tooling;
• the location of all emergency stop devices;
• the location and method for installation and adjustment of all protective devices and guards;
• the use of safety procedures (e.g., fire prevention equipment);
• procedures for maintaining a safe work area;
• procedures for inspecting and maintaining machinery systems;
• the proper method for each production set-up;
• procedures to safely perform necessary tasks that require personnel to be inside the machine envelope
with the energy enabled;
• require that all operators demonstrate their knowledge of the proper operation of the machine.
Informative Note 1: The user should place particular emphasis on the training, instruction, and supervision of
workers who are inexperienced in the operation of the machine or have difficulty communicating.
Informative Note 2: Instructions should include guidelines to check that:
• all individuals are in a safe location before operating the machine;
• operators know and understand the start-up and stopping procedures;
• operators know and understand the safe working procedures established by the user;
• operators know the risk reduction measures required for the operation and understand their function;
• operators know they should report to their supervisor any apparent defect, damage, malfunction or
inconsistent or unpredictable performance of the machine.

10.2.2 Training program(s)


A training program(s) shall be developed which encompasses all safety-related information relevant for the
machines. Training shall be in the English language or in the official, native or predominant language.

Aspects of the training program shall include the following elements, as appropriate:
a) information on the risk reduction measures used;
Informative Note: Topics include but are not limited to:
• types;
• capabilities / options;
• description for a specific application;
• function and functional tests;
• limitations.
b) task/hazard combinations associated with the system;
c) system set-up;
Informative Note: Topics include but are not limited to:
• procedures for all set-ups;
• procedures for changing, replacing and adjusting fixtures / tooling;
• transport, and storage of fixtures / tooling;
• hazards associated with alternate risk reduction measures.
d) system operation;
Informative Note: Topics include but are not limited to:
• machine tasks;
• hazards related to each task;
• response to abnormal / unexpected events;
• recovery of operation;
• use of auxiliary equipment.
e) system maintenance;
Informative Note: Topics include but are not limited to:
• applicable system training;
• emergency operations;
• hazards associated with:
– preventive maintenance / calibrations;
– troubleshooting;
– repair;
– operational checks;

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– malfunctioning safety devices;


– malfunctioning communication systems;
– process variables;
– process materials;
– procedures on live systems versus systems disabled by lockout / tagout / alternative methods;
– auxiliary equipment.
f) supplier safety recommendations;
g) procedures that contain steps related to safety actions;
h) lockout / tagout / alternative methods;
i) emergency procedures;
Informative Note: These should include span of control for engineering controls, including emergency stop devices.
j) general workplace safety procedures;
k) following all recommended safety practices and procedures;
l) proper engineering controls; and
m) removal, transport, and storage of fixtures/tools.

10.2.3 Trainer qualifications


The trainer shall have proficient knowledge of the:
• training elements listed in subclause 10.2.2;
• machine hazards;
• machine functions;
• machine safety systems;
• limitations of machine safety systems.

The trainer shall also:


• be able to communicate effectively to the trainee(s);
• have relevant experience and proficiency in the subject(s) of the training.
Informative Note: To train a new machine operator, the trainer should be experienced in operating the
machine. A maintenance trainer should have maintenance experience.

10.3 Operator training


Operator training shall include assessment of knowledge and proficiency through testing on how to operate
the machine safely.
Informative Note: The training should include time spent working with one or more experienced operators of
machines to enhance learning.

Operators of machines shall demonstrate their proficiency and knowledge of safe procedures by practical /
actual demonstrated performance and proficiency.
Informative Note: Demonstration of proficiency is necessary in order to check the effectiveness of training.

Operators of a machine shall be trained in cross-discipline specializations as necessary to safely perform the
tasks associated with a particular machine.
Informative Note: For example, machining, material handling, fork truck operation.

Where necessary, certification in certain skills shall be required.


Informative Note: In some instances, certification(s) of operators of machines may be necessary, e.g., crane
or rigging operations, fork truck operation, etc.

Completion of the training shall be documented.


Informative Note: See Annex N for a sample quiz for operator training.

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10.4 Maintenance personnel training


Maintenance personnel shall be sufficiently trained so that they are aware of the hazards associated with both
routine and non-routine maintenance of the machine.
Informative Note: The user should make the supplier(s) instructions and recommendations readily available to
maintenance personnel.

Training shall cover the workings of the machine, sub-components, and ancillary components, even if these
sub-components and ancillary components were supplied by other than the Original Equipment Manufacturer
(OEM). Training shall include safe work procedures and practices.

10.5 Supervisor training


Supervisors shall be appropriately trained in the use, function, operation and safe working procedures for
inspecting and maintaining machines and machinery systems.

10.6 Retraining
The user shall provide periodic retraining to individuals responsible for the supervision, set-up, operation,
maintenance and inspection of the machine or machinery system on safety issues related to assigned tasks.
Informative Note 1: Reasons for retraining may include but are not limited to:
• system changes (i.e., reconfiguring or reprogramming the system);
• after an incident;
• refreshment / enhancement.
Informative Note 2: This training is best presented when integrated with operational training.

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AMERICAN NATIONAL STANDARD B11.0 – 2023 (Annex – A)

Annex A — Approaches to Risk Reduction


(Annex A is Informative; the reference subclause is 6.5.1)
This Annex is intended to provide guidance to suppliers and users about reducing risk associated with
identified hazards. The risk reduction measures described in this Annex are intended as general guidance.
Many combinations of technologies and/or methods are available and may be used as risk reduction measures
in order to achieve an acceptable residual risk. Acceptable risk can only be achieved through the application
of an appropriate combination of risk reduction measures including both those supplied with the machine and
those implemented by the user of the machine as appropriate in the circumstances under consideration.

A.1 Illustrations of Selecting Risk Reduction Measures


The selection of risk reduction measures can be illustrated in two ways. The traditional hierarchy of controls
is shown in Table 3. There are many variations of this hierarchy available in the safety literature. A more
recent application of this hierarchy is referred to as the two-stage approach and is shown in Figure 8 below.
In order to effectively implement a safety application using the hierarchy of controls, it is necessary to
implement the hierarchy in two stages. “Stage 1” has two elements with a goal of eliminating the hazard(s)
under analysis. The second stage “Stage 2” has five elements that need to be implemented in a balanced
approach to reach the desired goal of reducing all remaining hazards or risks under evaluation to an acceptable
level. See also, the description of its implementation below.

Table 3 and Figure 8 and Figure 9 stress prevention through design (PtD) as the best option, especially when
performed early in the system lifecycle. They both emphasize designing out the hazards or hazardous situations
where feasible (Stage 1). If that is not feasible, use the hierarchy of controls to combine or balance the lower-
level options in order to reduce risk to a safe and acceptable level (Stage 2).

Action Steps Goal Result

Stage 1
• Change task, function,
location etc... Eliminate Hazards Eliminated

• Substitution of materials

• Engineering controls (guards,


devices and control functions)

• Awareness (warnings, signs,


devices, placards, etc.)
Reduce Risks to a Safe
Stage 2 • Safe operating procedures Balance / and Acceptable Level
(Culture Drives the Mix)
Optimize

• Training (operator,
maintenance, etc.)

• Personal Protective
Equipment

Figure 8 — Two Stage Iterative Approach to the Hierarchy of Controls and Risk Reduction

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AMERICAN NATIONAL STANDARD B11.0 – 2023 (Annex – A)

Stage 1 – Description
Stage 1 aims to eliminate hazards through either changing the design or through substitution with something
less hazardous.
Stage 1.1 – Elimination: Determine if any actions can be taken to change the task, function, location of
the equipment or the worker (operator, maintenance, cleaning crew, etc.) that would result in the
elimination of the hazard from the area under analysis. This is critical to perform early in the design
stage when all associated geometries of the machinery and equipment or system under analysis is still
flexible. Significant efforts need to be made to eliminate all identified hazards by changing geometries
(tooling layout, equipment layout, traffic flow interactions from pedestrians, and ancillary mobile facility
equipment, etc.).
Stage 1.2 – Substitution: If the hazard cannot be eliminated, determine if substitution is an option that
will result in reducing the risk. Substitution often is useful when considering chemicals, hazardous
materials, etc. If elimination or substitution is not feasible, move to Stage 2.

Stage 2 – Description
Stage 2 requires an equilibrium of five elements to achieve an overall safety balance. All five elements need
to be considered in this stage.
Stage 2.1 – Engineering controls: Engineering controls need to be considered and analyzed and typically
take the form of guards, devices and control functions as described in ANSI B11.19.
Stage 2.2 – Awareness means: Determine what awareness means are required based on the design
configuration for each specific application. Each unique design and configuration will determine (through
the risk assessment and associated hazards identified with each task) which awareness device
combination is appropriate.
Stage 2.3 – Procedures: Identify procedures and instructions for use that are required for the personnel
to safely use the system as intended, and also to point out any reasonably foreseeable misuse of the
system.
Stage 2.4 – Training: A training package for proper use and for reasonably foreseeable misuse needs to
be supplied.
Stage 2.5 – PPE: The system needs to be analyzed for remaining hazards and any appropriate personal
protective equipment (PPE) shall be required and applied to reduce residual risks to an acceptable level.

Situations where elimination could not be attained typically require a balance or mix of actions shown in Figure
9. For example, installing a controlled access system also requires awareness placards, safe operating
instructions, personnel protective equipment as required, and initial (as well as refresher or periodic) training
for all affected workers in the area. Notice that engineering controls alone are not sufficient to reduce the
residual risk to an acceptable level. It requires some effort at all five steps to achieve the desired result.

A.2 – Potential Effects/Additional Characteristics of Risk Reduction Measures


Various risk reduction measures can have different potential effects on severity and probability risk factors.
See Table 6.

Most risk reduction measures are susceptible to failure if not properly inspected, maintained and used within
proper design parameters.

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AMERICAN NATIONAL STANDARD B11.0 – 2023 (Annex – A)

Figure 9 — Illustration of the process of the supplier and user risk reduction efforts
This figure is an illustrative depiction of Table 3 and is not to scale.

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AMERICAN NATIONAL STANDARD B11.0 – 2023 (Annex – A)

Table 6 — Potential Effects/Additional Characteristics of Risk Reduction Measures


Possible Effect on Risk Possibly
Risk Reduction Measures Factors susceptible to:
Probability (even when properly applied)

Severity
Hierarchy

Occur-
Avoid-
Expo-

rence
Examples Error /

ance
sure
Failure
Misuse
Classification Type

Limiting Interaction modify the process to eliminate/reduce human interaction • • •


replace task, increase clearance • •
Elimination
Inherently Safe energy magnitude reduction • • •
by Design
(Redesign) automated material handling • • • • • •
Substitution use less hazardous chemicals • • •
reduce force, speed, etc. through selection of inherently safe components • •
Separation fixed guards, shields • • • •
Engineering
Detect / Control Access Interlock devices, presence sensing devices • • • •
Controls two-hand / single actuating controls • • • • •
(Guards, Control Hazardous Motion
Devices and
enabling devices, jog controls • • • •
Control Restricting Operation controlled selection of operating modes • •
Functions)
Monitor / Limit Hazards speed / force monitoring and limiting • • • •
Emergency Action emergency stop devices • • • •
awareness barriers • • • •
Awareness Means (Warnings &
Instructions)
awareness signals (audible and/or visible) • • • •
awareness signs / markings • • •
Information for Use
(Training & Procedures)
safe work procedures, training • • •
Administrative
Controls Administrative Methods safe-holding safeguarding method • • •
Supervision supervisory control of configurable elements • • •
Control of hazardous energy isolation of hazardous energy • • • •
Tools hand tools • • • • •
PPE safety glasses, hearing protection, gloves • • • • •

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AMERICAN NATIONAL STANDARD B11.0 – 2023 (Annex – B)

Annex B — Transferring Information about Residual Risk


(Annex B is Informative; reference subclauses are 4.2 and 6.1.3)
In the lifecycle of machinery, information about residual risk should be communicated from one entity to
another. For example, if risks from hazards are not adequately reduced during the engineering design of a
machine, the machinery user will have to reduce the risk to an acceptable level – the responsibility for the risk
is transferred or shifted to the user. In practice, risk transfer should be used conservatively. Risk transfer only
should be exercised once the initial risk is established and all feasible means to reduce risk through the
application of inherently safe by design and engineering controls have been considered.

Transferring information about residual risk can be accomplished through communication between suppliers
and users as to the circumstances surrounding the transfer (see subclause 4.2 and clause 8 for further
information). Risk that is transferred may require the user of the system or process to implement further risk
reduction measures based on the use of the machine.

Some examples of transferring information about residual risks include but are not limited to:
• from supplier (or rebuilder) to user:
- instruction manuals;
- warning labels;
- information about point of operation engineering controls.
• from user to personnel:
- lockout / tagout / alternative methods;
- periodically testing controls;
- live troubleshooting of an electrical panel.
• from supplier to integrator:
- instruction manuals;
- assembly sequence;
- temporary construction or installation of risk reduction measures.
• from user to third party service providers (cleaning, maintenance, rigging etc.):
- special cleaning procedures;
- information on lockout / tagout / alternative methods;
- preventative maintenance requirements.
• from user to decommissioning:
- special disposal and recycling requirement;
- notifying affected parties;
- SDS (safety data sheet) on materials in the equipment.

Information on transferring risk has limitations. Some risks may exceed capabilities to be effectively managed.
Some risks can never be transferred completely. Failures in transferring risks which may result in inappropriate
risk exposure include but are not limited to:
• risks that may not be completely understood or known by the supplier and/or user;
• risks that may not be accepted by the risk transferee;
• documentation that does not include all of the relevant assumptions that have been made;
• information that may not be received by the appropriate parties.

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AMERICAN NATIONAL STANDARD B11.0 – 2023 (Annex – C)

Annex C — Guidance for the Risk Assessment Process


(Annex C is Informative; reference subclauses are 6.1 and 6.2)

C.1 – General Preparations


The purpose of risk assessment is to identify hazards in order to facilitate risk reduction through either
elimination of the hazard or reducing the risk, as well as to provide information regarding residual risk. There
are many methods and tools available for this purpose and several are described in this document. Which
method(s) or tool(s) is chosen is largely a matter of personal, company or industry preference.

The choice of a specific method or tool is less important than the process itself. The benefit of risk assessment
comes from the discipline of the process rather than the precision of the results. A systematic approach using
due diligence should be used to proceed from identifying hazards to reducing risk. Risk assessment can focus
on the system or process as a whole, or the individual elements within that system or process. Application-
specific risk assessments for the machine address the particular process, use, installation, or integration of the
machine.

Risk assessment can also be used as a system design tool to identify a variety of issues, or to identify
opportunities to optimize the system or process. Issues take many forms based on the point in the lifecycle at
which the risk assessment is performed, such as:
• injury;
• waste (as used in lean manufacturing);
• quality;
• business interruption;
• financial;
• environmental.

Adding risk reduction measures to a design can increase costs and can restrict ease of use of the machine if
they are added after a design has been finalized or the machinery has been built. Changes to machinery are
generally less expensive and more effective at the design stage, so risk assessment should be initiated during
the machinery design. The individuals conducting the risk assessment should use due diligence throughout
the process in order to achieve a high level of confidence in the results. Confidence can be improved by
consulting others with the appropriate knowledge and expertise, and by having other competent personnel
review the risk assessment.

C.2 – Set the Scope of the Assessment


Before the team begins a risk assessment, the parameters of the project should be clearly understood. Project
parameters can be set by management with input from the risk assessment team who examine the machinery
functions and the tasks associated with using the machinery. The scope of the risk assessment can be
expanded or narrowed to include:
• operational states (e.g., shut down);
• specific tasks;
• a specific portion of the lifecycle;
• who can be harmed (e.g., public, personnel);
• what can be damaged (e.g., property, equipment, productivity, the environment).

Where appropriate, reasonably foreseeable uses of the machinery by persons identified by sex, age, culture or
language, dominant hand usage, limiting physical abilities (e.g., visual or hearing impairment, size, strength),
or other human factors may be included.
Setting the scope of the risk assessment also includes determining the limits and intended use of the machine.
This step can include describing the purpose of the machine, its use(s), reasonably foreseeable misuse(s),
human factors (see also, (ANSI) B11.TR1), and the type of environment in which it is likely to be used and
maintained. The limits of the assessment need not only have a physical constraint, such as a machine floor
plan, but may also have virtual constraints such as including processes, methods, programs, logic diagrams,
and electrical systems.

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Depending on the timing of the risk assessment within the machine lifecycle, the limits can include, but are not
limited to:
• use limits (such as the intended use of the machine / operating modes / number of persons);
• space limits (such as floor plan / maintenance access / material flow);
• time limits (such as production rates / cycle times / maintenance and wear of components);
• environmental limits (such as temperature / noise / lighting / corrosion);
• interface limits (such as other machines or auxiliary equipment / energy sources);
• human factors limits (ergonomics / cognitive capabilities / time requirements).

When setting the scope of the assessment, the team may focus on one or more of the following:
• a single machine;
• the operators / immediate workers at a single machine;
• a system of multiple machines;
• the interactions with nearby machines;
• the interactions with the overall plant site / other buildings;
• the interactions with the local community.

Although the risk assessment is generally limited to the machine, the interaction with other machines,
architectural walls, and hazards from other systems in the areas should also be considered.

C.3 – Form a Team


Assessing risk relies on the reasoned judgment and expertise of individuals familiar with the tasks and hazards
associated with a machine. To minimize individual biases (e.g., an individual attuned to noise hazards), a team
approach is recommended. However, a team that is too large can lead to difficulty in remaining focused or
reaching consensus.

The size and composition of a team varies according to:


• the stage in the lifecycle (see Figure 6);
• the risk assessment approach selected;
• the complexity of the machine / system;
• the process within which the machine is utilized.

The team should bring together knowledge of different disciplines and a variety of experience and expertise.

Team members should be selected according to the skills and expertise required for the risk assessment. The
team should include those people who:
• can answer technical questions about the design and functions of the machinery;
• have actual experience of how the machinery is operated, set-up, maintained, serviced, etc.;
• have knowledge of processes and other dependent hardware / items;
• have knowledge of the incident history of this type of machinery;
• have a good understanding of the relevant regulations, standards, and any specific safety issues
associated with the machinery;
• understand human factors (see (ANSI) B11.TR1).

The team members may include (but are not limited to):
• workers, customers and/or end users;
• maintenance and/or field service personnel;
• team leader, management;
• engineers and/or safety practitioners;
• representatives from component suppliers and/or machine users;
• legal counsel and/or consultants;
• insurers, insurance brokers, and others.

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AMERICAN NATIONAL STANDARD B11.0 – 2023 (Annex – C)

C.4 – Gather Appropriate Information


To conduct the risk assessment, the team should obtain necessary resource information. The information for
risk assessment may include but not be limited to the following:
• the function or purpose of the machinery;
• the agreed set of specifications for the particular application of the machinery;
• list of affected persons and their interaction(s) with the machinery;
• limits of the machinery;
• requirements for the lifecycle of the machinery;
• design drawings, sketches, system descriptions or other means of establishing the nature of the
machinery;
• design layout and proposed system(s);
• information concerning energy sources;
• any accident and incident history, including a near miss(es);
• any information about impairment to health;
• information on product materials to be used;
• system layout and proposed building / existing system(s) integration;
• integration of subsystems and other equipment;
• applicable local regulations for the machinery and process.

The information should be updated throughout the lifecycle of the system or process, and a new risk
assessment may be necessary as this information changes. Information on accident / incident history can be
very useful in identifying hazards. A “near miss” recording system that captures details surrounding these
events should be deployed as an integral part of an accident / incident reporting program. “Close Calls” and
“Near Misses” should be included in the risk assessment process. While not leading directly to an injury, “Close
Calls” and “Near Misses” are frequently indicative of the potential or presence of a hazardous situation(s) which,
with continued exposure, will likely lead to an injury.

Before beginning a new assessment, the risk assessment team should identify any existing risk assessment
conducted on prior version(s) or for similar products that might be applicable. For improved efficiency of the
risk assessment process, the risks of one machine can be compared with risks of a similar machine provided
the following criteria apply:
• the similar machinery has risks reduced to an acceptable level;
• the intended use and the operational characteristics of the machinery are comparable;
• the hazards and the elements of risk are comparable;
• the technical specifications are comparable;
• the conditions for use are comparable.

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AMERICAN NATIONAL STANDARD B11.0 – 2023 (Annex – D)

Annex D — Partial List of Machinery Hazards


(Annex is D Informative; reference subclauses are: 6.1.3 / 6.3 / 6.3.3 / 8.2 / 10.3)
This Annex identifies specific hazards that should be considered when designing, constructing, reconstructing, modifying,
using and/or maintaining machinery (see 6.3). The list is in alphabetical order. Not all hazards will apply to a particular
machine. This list is not all-inclusive.

Table 7 — Machinery Hazards


Hazard Potential hazards Notes
category
Chemical, • acute health affects (e.g., ammonia); Chemical hazards can result from the
material or • chemical emissions / splash; product being handled, the machine
substance • chronic health affects; itself, or machines nearby.
hazards • delayed effects of chemical exposure found
in or used by the machine (e.g., mercury,
alcohol);
• generated by the machine (e.g., emissions,
radiation, mist);
• handled by the machine (e.g., flammable,
toxic, flour dust);
• mixing incompatible chemicals;
• metalworking fluids.
Control • dropping or ejection of a mobile part of the The correct design of machine control
systems machine or of a workpiece clamped by the systems can avoid unforeseen and
machine; potentially hazardous machine
• failure to stop moving parts; behavior. Typical causes of hazardous
• machine action resulting from defeating or machine behavior are:
failure of the engineering controls; • an unsuitable design or
• uncontrolled speed change; modification (accidental or
• unintended / unexpected start-up; deliberate) of the control system
• software errors. logic;
• a temporary or permanent defect
or failure of one or several
components of the control system;
• a variation or a failure in the power
supply of the control system;
• inappropriate selection, design and
location of the control devices.
Electrical / • direct contact with normally energized Electric hazards can also cause falls of
electronic machines (e.g., direct contact from personnel (or of objects dropped by
hazards normally live parts); personnel) as a result of the surprise
• electrical noise; reaction induced by electric shock or
• electrostatic discharge; arc flash.
• arc flash hazard;
• improper wiring / grounding;
• inadvertent contact;
• insulation failure (e.g., from vibration or
thermal cycling);
• liquid / wet locations;
• overvoltage / overcurrent;
• parts remaining live after a fault condition
(indirect contact);

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AMERICAN NATIONAL STANDARD B11.0 – 2023 (Annex – D)

Hazard Potential hazards Notes


category
• shorts / arcing / sparking;
• undervoltage (e.g., unpredictable machine
operation);
• unexpected start-up / motion.
Environmental • asphyxiants;
• carcinogens;
• corrosion;
• emissions;
• hazardous waste or hazardous byproducts;
• ozone depleting substances;
• poisons;
• solvents;
• trace metals.
Ergonomics / • controls that are difficult to understand / Ergonomics / human factors should be
human factors read / operate (e.g., foreign language; considered by the supplier and user
confusing symbols or displays; hardware or during the design phase and in
controls physically difficult to operate); developing work practices. Operator
• excessive reach, bending, crouching or and maintenance personnel activities
stooping; required for normal operation change-
• language / cultural difficulties (e.g., over, setting up and routine
translations, communications); maintenance should be considered.
• lifting / bending / twisting (e.g., dynamic
movements to do work, excessive See also, (ANSI) B11.TR1 for
exertion); additional information on ergonomic
• poor access / clearance; hazards.
• repetition / personnel fatigue
• static posture (e.g., static standing
positions, awkward to get to);
• vibration (whole body or hand / arm).
Fire and • dust;
explosion • electrical arcs;
• explosion / implosion;
• flames;
• flammable vapors / gas;
• hot surfaces;
• smoke;
• sparks;
• spontaneous combustion;
• static electricity;
• improperly designed electrical / electronic
systems;
• combustible metals.
Fluids • absorption;
• degradation of materials due to contact with
fluids;
• fluid injection (pneumatic or hydraulic;)
• liquid / vapor hazards;
• rupture / leakage;
• surges / sloshing.

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AMERICAN NATIONAL STANDARD B11.0 – 2023 (Annex – D)

Hazard Potential hazards Notes


category
Handling of • handling of container;
container, • handling of product and/or material.
product or
material
Heat / • burns / scalds;
temperature / • cold material / severe cold;
thermal • cold work environment;
• hot material / severe heat;
• hot work environment.
Lasers • eye / retinal exposure;
• laser generated air contaminants (LGACs);
• skin exposure.
Material • high speed operations;
handling • lifting / moving equipment;
• unknown center of gravity;
• unknown weight;
• robot movements;
• unstable stacking / storage.
Mechanical • broken or falling machine components Mechanical hazards associated with
hazards (e.g., breakage, loosening, falling, or the machinery can include machine parts
release of mechanical energy); or surfaces, tools, workpieces, loads,
• component fatigue / wear; and/or projected solid or fluid materials
• crushing / impact; such as:
• cutting / severing; • gears;
• entanglement; • chains;
• friction / abrasion; • belts;
• head bump; • handcranks;
• in-running nip points; • power-driven handwheels;
• intermittent / on-demand cycle (e.g., a • grippers;
machine that cycles automatically); • projecting shaft ends;
• machine instability; • knives, shears, and cutters;
• magnetic attraction / movement; • power driven rollers;
• pinch points; • starwheels;
• stabbing / puncture; • turntables;
• unexpected start. • augers;
• screwfeeds;
• ejected objects or materials.
Natural • humidity;
hazards / • loss of power / control / lighting;
Environment • moving / overturning equipment;
of use • seismic events or lightning.
Nip points Examples of nip points (and the graphic
depiction of same in the diagram immediately
below) include the following:
a) two counter-rotating surfaces (powered or
unpowered) are close enough to each
other to create a hazardous situation;
b) surfaces are rotating in the same direction,
but with different peripheral speeds;

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AMERICAN NATIONAL STANDARD B11.0 – 2023 (Annex – D)

Hazard Potential hazards Notes


category
c) surfaces are rotating in the same direction,
but with different surface properties (i.e.,
different frictional characteristics);
d) one surface is rotating toward an adjacent
fixed object or part of the machine;
e) driven contact rollers for belts, chains or
webs, gears and sprockets;
f) non-powered rollers (riding rollers, guide
rollers) driven by movement of the product.

Noise • continuous or intermittent noise level; Noise/sound can be measured


• instantaneous / impulse noise level; according to (ANSI) B11.TR5
• interference with communications and/or
awareness means;
• noise level over an 8-hour workday.
Radiation • infrared radiation;
• interference from other equipment (e.g.,
cardiac pacemaker, magnetizable
prostheses);
• non-ionizing;
• other uncontained ionizing particles;
• radio frequency / microwave energy;
• ultraviolet radiation (UV-A or UV-B);
• uncontained x-rays;
• visible (intense) light;
• α-or ß-particles, electron or ion beams,
neutrons.
Slips / trips / • debris;
falls / egress • fall hazard from elevated work;
• floor / wall openings;
• poor lighting;
• slippery surface (low coefficient of friction).
Ventilation / • air contaminants / smoke;
confined • inadequate ventilation;
space • inadequate oxygen (generally < 16%);
• wrong airflow direction (e.g., back drafts,
underpressure, recirculating air).

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AMERICAN NATIONAL STANDARD B11.0 – 2023 (Annex – E)

Annex E — Additional Information on Assessing Risk (Risk Estimation)


(Annex E is Informative; reference subclauses are: 6.1.3 / 6.4 / 6.4.2.1 / 6.6 / 7.25)

The purpose of assessing risk is to estimate the risk magnitude expressed as a level, index, score or injury
rate for each hazardous situation to which a person could be exposed. The risk associated with a particular
hazardous situation depends on the following elements:
a) the severity of harm;
b) the probability of occurrence of that harm, which is a function of:
• the exposure of a person(s) to the hazard,
• the occurrence of a hazardous event,
• the technical and/or human possibilities of avoiding or limiting the harm.

Risk reduction efforts may not be completely effective or may result in excessive risk reduction measures if
the level of risk has not been estimated.

E.1 Estimating the Level of Risk


In order to support a risk estimation process, a risk scoring system should be selected and used. Most of the
available risk scoring systems use one of the following methods:
• a risk matrix;
• a risk graph;
• numerical scoring;
• a quantified risk estimation.

There are also hybrid systems that use a combination of methods or methods not listed above.

The choice of a specific risk scoring system is less important than the process itself. The benefit of risk
assessment comes from the discipline of the process rather than in the absolute precision of the results, as
long as all the elements of risk are fully considered. Moreover, resources are better directed at risk reduction
efforts rather than towards an attempt to achieve absolute precision in risk estimation.

In practice, qualitative analysis is often used first to rank the risks in relation to one another, indicate the level
of risk and to reveal the most significant risks. Once risks have been broadly assessed, a more detailed
quantitative or qualitative approach can be used in order to assist the organization in making decisions
regarding whether risk levels are acceptable or require additional attention or risk reduction.

E.2 Assess Severity of Harm


Severity of harm addresses the degree of injury or illness that could occur. The degrees are based on extent
of injury or illness (ranging all the way from death to no injury at all), and extent of any treatment involved.
Severity may be estimated either qualitatively or semi-quantitatively.

There are many variables that can influence the severity potential, including anthropometrics and
biomechanics. In most instances, where forces and energies are used to estimate severity potential, the
lowest value should be a pain threshold above which increasing degrees of harm may occur.

When determining risk, the most credible severity of harm should be selected rather than the extremes (the
worst or least possible severity). The selection of the severity level needs to be made in an objective and
realistic manner. For example, a minor laceration can potentially become fatal if it becomes septic, but death
is a rare outcome of this type of injury.

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AMERICAN NATIONAL STANDARD B11.0 – 2023 (Annex – E)

Table 8 — Guidance for Estimating Injury Severity


Table 8 illustrates one way that forces and energies can be used to estimate increasing severity potential. This informative table provides guidance
on evaluating severity and has been developed based on “post incident” and test data.

The values in the table are rooted in research and various studies conducted over the last several decades and have been shown to be valuable
time-tested guidance, however, the values should not be used as precise classifications of severity. Values may differ based on a variety of factors,
not the least of which are application specific data or individual susceptibilities. Some detailed injury information presented below may be useful in
evaluating historical data with known hazardous events. Variations to this table are acceptable.

Injury Type Catastrophic Serious Moderate Minor


Bruising For example: For example: Major; Contusions and skin
(abrasion, contusion, swelling, edema) • brain stem; • trachea; > 25 cm2 (~4 in2) on face; abrasions typically
• spinal cord causing • internal organs (minor); > 50 cm2 (~8 in2) on body. caused by loads
paralysis. • heart; between 83 kPa (12 psi)
• brain; and 297 kPa (43 psi)
• lung, with blood or air under certain test
in chest. conditions. Typically,
no physical signs are
caused by loads less
than 83 kPa (12 psi)
under certain test
conditions.
Superficial (≤ 25 cm2 on
face; ≤ 50 cm2 on body.
Burns (hot surface) * 3rd degree burns typically 3rd degree burns typically 2nd degree burns typically 1st degree burns
The severity of injury is relative to the caused by temperatures > caused by temperatures > caused by temperatures typically caused by
amount of body surface area, the duration 68º C (>154º F) with 68º C (>154º F) with 60º - 68º C (140º F – 154º temperatures (44º C -
of exposure, and the temperature of the exposure durations of one exposure durations of one F) with exposure durations 59º C (111º F – 139º F)
hot surface. second, and on skin second, and on skin surface of one second or longer. with exposure durations
surface areas over more areas less than 1% of the of one second or longer.
than 15% of the body. body, e.g., palm of hand.
Burns (vapor or splash of viscous 3rd degree burns typically 3rd degree burns typically 2nd degree burns typically 1st degree burns
material) caused by temperatures > caused by temperatures > caused by temperatures typically caused by
Vapor exposure assumes instantaneous 60º C (>140º F) and on skin 60º C (>140º F) and on skin 44º C - 59º C (111º F – temperatures 38º C –
contact; viscous materials assume surface areas over more surface areas less than 1% of 139º F). 43º C (100º F – 110º F).
continuous contact greater than 1 second. than 15% of the body. the body, e.g., palm of the
Inhalation burns requiring hand.
respiratory assistance. Inhalation burns not requiring
respiratory assistance.

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AMERICAN NATIONAL STANDARD B11.0 – 2023 (Annex – E)
Burns (wave energy) Burns, injury, or wave Loss of eye, vision Temporary loss of vision. Superficial, peripherally
energy exposure that could impairment or amputation. located corneal
result in death or a Typically caused by Class abrasion, ulceration,
permanent disabling injury, Central corneal abrasion. 3B Laser, UV-B Lamps burn or foreign object.
such as blindness. (280-320 nm).
Typically caused by Class 4 Typically caused by
Laser or High Pressure Class 3A Laser, Class 2
Xenon Arc Lamp (intense UV Laser, UV-A Lamps
/ Visual / IR emitted energy, (320-400 nm).
and potential for bulb
explosion).
Concussion Coma. Prolonged unconsciousness. Brief unconsciousness No loss of
(seconds to a few consciousness
minutes).
Crushing For example: For example: --- ---
• spinal cord; • trachea;
• mid-low neck; • larynx;
• chest; • pelvis;
• brain stem. • extremities
– upper (shoulder, arm,
elbow, forearm, wrist,
hand, fingers);
– lower (upper leg,
knee, lower leg, ankle,
foot, toes).
Dislocation Spinal column. For example: For example: ---
• ankle; • finger / thumb;
• wrist; • toe;
• elbow; • jaw;
• shoulder; • loosening of tooth.
• hip;
• knee;
• spine.
Electrical **** Major burns and irreversible Breathing difficulties / Painful shock at 3 mA; No physical signs but
Shock factors affecting the human body body damage at several unconsciousness at 30 mA; Muscle contractions at 5 threshold of feeling,
include current & voltage, resistance, path amps. Possible heart fibrillation at mA (above 6 mA a person tingling sensation can
through the body, duration of contact, 50 – 100 mA (fatal if may not be able to let be felt at 1 – 2 mA.
individual’s health and promptness of first continued); go***).
aid. Refer to NFPA 70E and 29 CFR Severe burns and muscle
1910.333. contractions at 200 – 300 mA.

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AMERICAN NATIONAL STANDARD B11.0 – 2023 (Annex – E)
Entrapment / pinching Fatal suffocation / (Use as appropriate, the final --- Minor pinching.
strangulation. outcomes of bruising,
crushing, fracture, dislocation,
amputation, as applicable).
Ergonomics --- --- --- ---
Refer to (ANSI) B11.TR1 Ergonomic
Guidelines for additional information.
Eye injury, foreign body in eye Permanent loss of sight Partial loss of sight. Temporary loss of sight. Temporary pain in eye
(one or both eyes). without need for
treatment.
Ear injury, foreign body in ear Complete loss of hearing Partial loss of hearing. Temporary impairment of Temporary pain in ear
(one or both ears). hearing. without need for
treatment.
Sound --- --- --- ---
The degree of hearing hazard is related to
the level of the noise, frequency of the
noise, as well as the duration of exposure.
Noise levels below 80 dBA are not
normally associated with hearing damage.
Refer to OSHA (29 CFR 1910.95) and
(ANSI) B11.TR5 for additional details.

Fracture ** Fracture of major skeletal Fracture of long bones in Fracture of small bones, Contusions and skin
support structures typically arms, legs or fracture of the typically caused by loads abrasions typically
caused by loads exceeding skull or spine, typically between 297 kPa (43 psi) caused by loads
399.9 kPa (58 psi) under caused by loads exceeding and 399.9 kPa (58 psi) between 83 kPa (12 psi)
certain test conditions. 297 kPa (43 psi) and 399.9 under certain test and 297 kPa (43 psi)
kPa (58 psi) under certain conditions. under certain test
For example, fracture of the test conditions. conditions. No physical
spinal column. For example: signs typically caused
For example: • extremities (finger, by dynamic loads less
• ankle; toe, hand, foot); than 83 kPa (12 psi)
• leg (femur or lower leg); • wrist; under certain test
• hip; • arm; conditions.
• skull; • rib;
• spine (minor • sternum;
compression fracture); • nose;
• jaw (severe); • tooth;
• larynx; • jaw;
• multiple rib fractures • bones around eye.
leading to a hemo- or
pneumothorax.

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AMERICAN NATIONAL STANDARD B11.0 – 2023 (Annex – E)
Lacerations or Amputations ** Lacerations or amputations Lacerations of the head or Lacerations, not involving Minor/superficial cuts
that could result in death or face requiring sutures or the face, requiring sutures requiring bandaging
a permanent disabling other means of closure and or other means of closure treatment, and typically
injury such as blindness or typically caused by: and typically caused by: caused by:
amputation. • flying projectiles; • stationary sharp • stationary blunt
• stationary sharp edges; edges; surfaces;
For example: • blunt, sharp edges. • blunt, sharp edges. • offset, blunt edges
• hand; with loads less than
• foot; Amputation of finger(s) or External (deep) 28 kPa (4 psi).
• arm; toe(s), typically caused by: lacerations (> 10 cm [4 in]
• leg; • sharp edges long on body; > 5 cm [2 in]
• eye. mechanically in motion long on face) requiring
(e.g., rotating, sutures or other means of
reciprocating, shearing); closure.
• set, blunt edges w/ loads
over 28 kPa (4 psi).
Neurological disorders --- Triggering an epileptic --- ---
seizure.
Piercing, puncturing For example: For example: For example: Limited depth, skin only
• aorta; • eye (with no permanent • subcutaneous involved.
• heart; loss of sight); (beneath skin) but
• bronchial tube; • internal organs; not pericardium or
• deep injury to organs • chest wall. peritoneum (no
(e.g., liver, kidney, organ involvement).
intestines, etc.).
Sprain, strain, musculoskeletal --- For example: Knee ligaments strain. For example:
disorder • ligament or tendon • extremities;
rupture / tear; • joints;
• muscle tear; • spine (no
• whiplash. dislocation or
fracture).

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AMERICAN NATIONAL STANDARD B11.0 – 2023 (Annex – E)

Substances For example: For example: For example: Local slight irritation.
Irritation, dermatitis, inflammation or • lungs, requiring • lungs, respiratory • reversible eye
corrosive effect of substances (inhalation, respiratory insufficiency, chemical damage;
dermal) assistance; pneumonia; • reversible systemic
• asphyxia; • partial loss of sight; effects;
Refer to OSHA, NIOSH, ACGIH, NFPA • irreversible systemic • corrosive effects. • inflammatory
45-2011, and EPA for details concerning effects. effects.
specific substances.

Allergic reaction or sensitization For example: For example: For example: Mild or local allergic
• anaphylactic • strong sensitization • allergic reaction; reaction.
Refer to OSHA, NIOSH, ACGIH, NFPA reaction; that provokes allergic • widespread allergic
45-2011, and EPA for details concerning • shock; reactions to multiple contact dermatitis.
specific substances. • fatality. substances.

* Note: Contact with a hot surface is based upon contact with aluminum less than 1 second. Temperature threshold will vary and which are dependent upon the material contacted
and the duration of contact. For data on burn thresholds of contact with other materials, and for more information on assessing the risk of burning, see ISO 13732-1.
** Note: Fracture and amputation force are derived from a literature search that identified pain and fracture thresholds at 150 N, (33.7 lbf), 400 N (89.9 lbf), and 2000 N (449.6 lbf) using
an 80 mm (3.15 in) diameter load cell.
*** Note: “Let Go Current” is a term of art that refers to the maximal current at which a person can withdraw or “let go” voluntarily.
**** Note: Contact with High Voltage/Low Current may result in injury due to physical harm and/or reflexive reaction causing falls and/or unintended movement into a hazard.

For additional information, see the following:


Chengalur, R. Kodak’s Ergonomic Design for People at Work. New York: Van Nostrand Reinhold, 2004.
Mewes, D. and F. Mauser. “Safeguarding Crushing Points by Limitation of Forces.” International Journal of Occupational Safety and Ergonomics. 9(2003): 177-191.
ANSI Z136.1, Safe Use of Lasers, New York: ANSI 2022
Hagan, P.; Accident Prevention Manual for Business & Industry – Engineering & Technology. 12th Edition. NSC, Itasca, IL 2001
Official Journal of the European Union L22, 26.1, 2010 p. 64, “Table 3 Severity of Injury.”

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AMERICAN NATIONAL STANDARD B11.0 – 2023 (Annex – F)

E.3 Assessing Probability of Occurrence of Harm


The probability of personnel being exposed to the hazard and the probability of the hazardous situation
occurring should be considered when determining the probability of occurrence of harm. As described in the
beginning of Annex E, the probability of occurrence of harm is a function of three factors. Various parameters
can affect each of these factors; see Table 9 for further information.

Table 9 — Considerations for Probability of Occurrence


Probability of Occurrence Factors Considerations
Frequency of the task
Duration of the task
Exposure of a person(s) to the hazard Workplace environment (e.g., ease of
access, lighting, temperature, noise level)
Machine / task history (incident or near miss)
Reliability of safety functions (mechanical,
electrical, electronic, hydraulic, and
pneumatic control systems)
Ability to maintain risk reduction measures
Occurrence of a hazardous event Likelihood that the risk reduction measures
will be defeated or circumvented (how easy is
it to defeat or circumvent? Does the nature
of the task and/or design of the machine
encourage defeating or circumventing safety
measures?)
Human factors (hazard perception)
Technical and human possibilities of avoiding Possibilities of avoiding or limiting harm
or limiting the harm (ability to recognize and react)
Personnel who perform tasks (qualifications)

The absence of an incident history or a small number of incidents should not be taken as an automatic
presumption of a low probability of harm without confirming the existence of risk reduction measures or
identifying other existing mitigating factors. Information on “near misses” and “close calls” should be assessed
with the same significance as injury data with a judgment of the extent of the injury which most likely would
have occurred under slightly different circumstances. Where hazards exist and exposure continues without
risk reduction measures, the continued exposure can lead to injury.

Evaluating the probability of the occurrence of harm is a subjective evaluation based on the information
available. Achieving precision in probability estimates provides little value. Time, energy and resources are
better spent on reducing risk than on estimating probability.

When assessing the initial risk, the tendency is to assume the probability of occurrence is very likely since risk
reduction measures have not yet been applied. However, Table 9 provides some examples of considerations
for initial risk assessment when evaluating the probability of occurrence.

The hierarchy of controls can be used as a means to estimate the probability of the occurrence of harm after
risk reduction measures have been applied. When properly designed, applied, and maintained, higher order
risk reduction measures typically have a lower probability of failures to danger than lower order risk reduction
measures.

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AMERICAN NATIONAL STANDARD B11.0 – 2023 (Annex – F)

Annex F — Risk Assessment Matrices


(Annex F is Informative; reference subclauses are 6.1.3 and 6.4.1)
F.1 Introduction
One of the major concerns of safety and design engineers is developing a risk reduction strategy which is
appropriate for the risk. This strategy may include both physical guarding techniques as well as the structure
and performance of the safety-related part(s) of the control system (SRP/CS) when an engineering control,
such as an interlocked guard, is selected as the risk remediation means. Mechanical guards are primarily
rated by their fastening methods and physical robustness. In a control system safety strategy, the concern is
primarily with the performance and response of the system when a component fails. There is a level of design
robustness appropriate for a given level of required risk reduction. The risk assessment matrix facilitates a
systematic means to identify and select those risk reduction measure(s) most appropriate for the level of
reduction required. When this relative risk is paired with a series of potential remediation strategies for a risk
level, each may be evaluated, and the most applicable solution applied.

There are many different risk rating systems available and in use, but there is no universally accepted
approach. Some systems contain both the risk matrix as well as remediation strategies, while others may not.
It is left to the organization to choose a technique which best fits its business model and risk tolerance. Some
organizations have chosen to take the matrix from one source and the remediation from another. Others have
taken a system which has both, as presented, or have modified it to suit their specific needs or concerns.
Again, it should be emphasized that the ultimate value of the risk assessment is in the structure and discipline
of the process and not in the absolute accuracy of the results. It has been shown that various instruments
lead to very similar results both in risk levels as well as in remediation performance requirements.

In addition to the examples below, there are other rating and evaluation systems which may meet the needs
of the organization. Some practical examples of real risk assessments using these are given in Annex H.

F.2 Risk Assessment Scoring Systems


F.2.1 MIL-STD-882 Two-Factor Risk Scoring System

Table 10 — MIL-STD-882E Risk Scoring System [4x5]


Severity
Probability Catastrophic Critical Marginal Negligible
Frequent High High Serious Medium
Probable High High Serious Medium
Occasional High Serious Medium Low
Remote Serious Medium Medium Low
Improbable Medium Medium Medium Low

The risk scoring system in Table 10 defines the probability and the severity in a “two-factor” (severity and
probability) chart. The majority of rating systems result in either four or five risk categories. In most cases,
the remediation design variations between the lowest and next higher risk level in a five-category system are
slight and are frequently lumped together with only minor discretionary design variations into what ultimately
becomes a four-category stratification.

F.2.2 RIA TR R15.306 Three-Factor Risk Scoring Systems


Tables 11 and 12 show the risk scoring method developed in the robotics industry as presented in the RIA TR
R15.306.

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AMERICAN NATIONAL STANDARD B11.0 – 2023 (Annex – F)

Table 11 — RIA TR R15.306-2016 Risk Level Decision Matrix


Severity of Exposure to Avoidance of Risk Level
Injury the Hazard the Hazard

E0 - Prevented
NEGLIGIBLE
A1 - Likely
S1 - Minor E1 - Low
A2/A3 - Not
likely/possible
E2 - High
LOW
E0 - Prevented

E1 - Low
S2 - Moderate
MEDIUM
A1 - Likely
E2 - High
A2/A3 - Not likely/possible
HIGH
E0 - Prevented
LOW
E1 - Low
S3 - Serious
HIGH
A1/A2 - Likely/Not likely
E2 - High
A3 - Not possible
VERY HIGH

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AMERICAN NATIONAL STANDARD B11.0 – 2023 (Annex – F)

Table 12 — RIA TR R15.306-2016 Injury Severity, Exposure, and Avoidance Categories


Criteria (Examples) – choose most likely
Factor Rating
Read criteria from the top for each factor
Normally non-rev ersible; lik ely will not return to the s ame job after
recov ery from incident:
– fatality
Serious – limb amputation
S3 – long term disability
– chronic illness
If any of the abov e are applicable, the rating is SERIOUS
Normally rev ersible; lik ely will return to the s ame job after recovery from
incident:
– brok en bones
Injury – severe laceration
Moderate – short hospitalization
Severity S2 – short term dis ability
– loss time (multi-day)
– fingertip amputation (not thumb)
If any of the abov e are applicable, the rating is MODERATE
First aid; no rec overy required before returning to job:
– bruising
Minor – small cuts
S1 – no loss time (multi-day)
– does not require attention by a medical doctor
If any of the abov e are applicable, the rating is MINOR

– exposure to hazard(s) is effectiv ely mitigated by design.


– use of guards prevents ex pos ure or access to the hazard(s) (see part
2, 5.10). if an interlocked guard is selected, the third bullet mus t als o
Prevented be met
E0 – if functional safety is used as a risk reducti on meas ure, the functional
safety performance (PL) meets or exceeds the required functional
safety performanc e (PL r ). See Part 2, 5.2
If any of the abov e are applicable, the rating is PREVENTED
Exposure – typic ally more than once per hour
– frequent or multiple s hort duration
High – durations/situations whic h c ould lead to task creep and does not
E2 include teach
If any of the abov e are applicable, the rating is HIGH
– typic ally less than or onc e per day or s hift
Low – occasional short duration
E1 If either of the abov e is applic able, the rating is LOW

– Insuffic ient clearance to mov e out of the way and safety -rated reduc ed
speed control is not used
– the robot system layout causes the operator to be trapped, with the
Not possible escape route toward the hazard
A3 – safeguarding is not expected to offer protection from the pr oc ess
haz ard (e.g., ex plosion or eruption haz ard)
If any of the abov e are applicable, the rating is NOT POSSIBLE
– insufficient c learanc e to move out of the way and s afety -rated reduced
speed control is used
– obstructed path to move to safe area
Avoidance Not likely – haz ard is moving faster than reduc ed speed (250 mm/sec ; 10 in/s ec)
A2 – inadequate warning/reaction time
– might not perceiv e the haz ard ex ists
If any of the abov e are applicable, the rating is NOT LIKELY
– sufficient clearance to move out of the way
– haz ard is incapable of moving greater than reduced speed (25 0
Likely mm/sec; 10 in/sec)
A1 – adequate warning/reaction time
– positioned in a safe loc ation away from the hazard
If any of the abov e are applicable, the rating is LIKELY

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AMERICAN NATIONAL STANDARD B11.0 – 2023 (Annex – F)

F.2.4 Risk scoring matrix from ANSI / ASSP Z10-2012 (R2017) [4 x 5]


Table 13 presents an example of a Risk Assessment Matrix Combining Event Probability and Severity
Indicators with Risk and Action Levels.

Table 13 — ANSI / ASSP Z10 Risk Scoring Matrix


Activity --------Severity of Injury or Illness Consequence------→
Likelihood of OCCURRENCE
or EXPOSURE for selected NEGLIGIBLE MARGINAL CRITICAL CATASTROPHIC
Unit of Time or Activity
Frequent MEDIUM SERIOUS HIGH HIGH
Probable MEDIUM SERIOUS HIGH HIGH
Occasional LOW MEDIUM SERIOUS HIGH
Remote LOW MEDIUM MEDIUM SERIOUS
Improbable LOW LOW LOW MEDIUM

Likelihood:
FREQUENT: Likely to occur repeatedly
PROBABLE: Likely to occur several times
OCCASIONAL: Likely to occur sometimes
REMOTE: Not likely to occur
IMPROBABLE: Very unlikely to occur – may assume exposure will not happen

Severity/Consequence:
NEGLIGIBLE: First Aid or minor medical treatment
MARGINAL: Minor injury, lost workday accident
CRITICAL: Disability in excess of three months
CATASTROPHIC: Death or permanent total disability

Risk Level:
LOW: Risk acceptable, remedial action discretionary
MEDIUM: Take remedial action at appropriate time
SERIOUS: High priority remedial action
HIGH: Operation not permissible

NOTE: These definitions are provided for illustrative purposes only and each organization will need to define
these terms for their own purposes and/or process.

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AMERICAN NATIONAL STANDARD B11.0 – 2023 (Annex – G)

Annex G — Additional Information on Achieving Acceptable Risk


(Annex G is Informative; reference subclauses are 6.1.3 and 6.7)

G.1 Achievement of Acceptable Risk


The risk reduction process is complete when risk reduction measures consistent with clause 6 are applied
and acceptable risk has been achieved for the identified hazards and/or task/hazard combinations and the
machine as a whole.
The ANSI B11 series of machine safety standards recognizes that flexibility is needed in achieving
acceptable risk because of how machines are built and used.
Differences across industries, corporations, production methods, workplace organization and across
individual operators and maintenance personnel need to be recognized.
a) Acceptable risk is a designation assigned to an estimated risk by the risk assessor that
indicates that adequate risk reduction has been applied at that point in the lifecycle of the
machine. Risk acceptance is based on a state of knowledge about the severity and probability
of a dangerous outcome.
b) Risk management is an orderly process for taking action to determine acceptable risk and for
executing the associated risk reduction. Risk management is primarily shaped by
organizational culture but can also be influenced by other factors, both internal and external to
the organization.
c) Acceptable risk is not a universal characteristic. The same hazard / exposure may be judged
acceptable by some and not acceptable by others. An estimated risk that is high, medium, or
low may be judged acceptable at any of these levels. Non-assessed risks cannot be classified
as acceptable risks.
d) To achieve acceptable risk, appropriate standards need to be met. Additional risk reduction
measures not in the standards may also be necessary.
e) Acceptable risk should consider the benefits to, and the impacts on productivity and workflow.
f) The machine user should check that acceptable risk is maintained. Risk assessment should be
a continuous process. On a periodic basis, the user should confirm that the risk reduction
measures which have been put in place continue to provide acceptable risk.
g) Those responsible for initiating and completing modification or rebuilding of a system are
responsible for achieving acceptable risk. Changes made to the system should be evaluated
with respect to new hazards, new tasks, and new risks.
h) Documentation is central to keeping decision making about acceptable risk a rational,
reasonable and realistic process. Documentation aids in making acceptable risk decisions on
similar machines and on future designs of the same machine type. Documentation provides a
guideline toward accomplishing risk reduction tasks.
i) A decision-making method for assigning acceptable risk that is appropriate to the workplace
should be used. The variety of methods include, but are not limited to:
o consensus;
o majority;
o expert;
o distributed;
o computer assisted.

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AMERICAN NATIONAL STANDARD B11.0 – 2023 (Annex – G)

G.2 Risk Acceptance Decisions


The decision to accept a risk should take into account the likelihood that the risk reduction measures will
be fully implemented and maintained. In addition, risk acceptance decisions should consider the
following:

a) Hazard recognition / severity potential recognition


o Will affected persons comprehend and avoid the hazardous situation, not initiate the
hazardous situation, or stop the hazardous situation in a given circumstance?
o Will affected persons be distracted, inadvertently activate the hazardous situation or react
too slowly to eliminate or avoid the hazardous situation?

b) Task zone location


o If task zones are typically located at a distance from the hazard zone, what happens
when an unanticipated situation causes personnel to be closer to the hazard zone than
determined by the layout analysis?

c) Task frequency and duration


o If the task is not performed often, will personnel recognize the potential hazards and
understand the potential consequences?
o If the task is performed frequently, will complacency set in and inadvertent contact with
the hazard result?
o If the task is short in duration, is there less opportunity for exposure to the hazard?

d) Few or no known incidents or near misses


o Have no incidents or near misses occurred, or have none been reported?
o Have the “right” combination of variables that could cause the incident not yet happened?
o Have higher order risk reduction measures prevented incidents?

e) Organization culture
o Is the risk level consistent with corporate policy?
o Are personnel encouraged to watch out for each other?
o Do personnel have the ability/motivation to share their methods for improving safety and
efficiency?

f) Personnel experience
o Are personnel experienced in the recognition of how and when hazardous situations
emerge?
o Can human factors or ergonomics such as fatigue, distraction or complacency impact
personnel?

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AMERICAN NATIONAL STANDARD B11.0 – 2023 (Annex – G)

G.3 Evaluation of Feasibility


When evaluating the feasibility of risk reduction measures, the following factors should be considered when
determining acceptable risk:
a) Management support is important as resource allocation is a key issue in any business.
Worker time, budget and management time all have to be managed. Managers and
supervisors play a key role in making resources available. Managers and supervisors should
be well-attuned to the concept of acceptable risk, how it is achieved and how to maintain it.
b) A balancing of many inter-related factors is part of achieving acceptable risk. If a risk reduction
option fails on one aspect, then that risk reduction option may not be the best choice.
c) Risk reduction benefit. At some point, further reduction of risk may not be significant. The
relative effectiveness between different risk reduction measures is worth considering. A
minimal incremental increase in the amount or level of risk reduction to be gained from a risk
reduction measure may be a reason to reject that alternative.
d) Technological considerations should include the durability and maintainability of the risk
reduction measures.
e) Economic impact should be evaluated as budgeting is necessary to keep a workplace in
operation. Limits can exist on what resources a supplier or user can commit to risk reduction.
Expenditures in relation to the survival of the business need to be taken into account. Machine
risk decisions take place in relation to the overall business operation. Business cycles, meeting
payroll, regulatory requirements, and legal obligations need to be considered.
f) Ergonomic impact needs to be considered. Risk assessment has a wide scope with respect to
individual machines. The tendency may often be to focus only on potential fatalities. Less
severe injuries and illnesses, some of which may relate to ergonomic (strain) factors should be
included in acceptable risk determination.
g) The operating conditions and intervention procedures are taken into account.
h) The risk reduction measures do not generate new hazards.
i) The users are sufficiently informed and warned about the residual risks.
j) The risk reduction measures are compatible with each other.
k) The risk reduction measures do not adversely affect the operator’s working conditions or the
usability of the machine.

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AMERICAN NATIONAL STANDARD B11.0 – 2023 (Annex – H)

Annex H — Sample Risk Assessment


(Annex H is Informative; reference subclause is 6.9.1)
Note: This example presents sample documentation of one of the many methods of risk assessment. Other formats, presentations and content can be used.
Table 14 — Sample Risk Assessment

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AMERICAN NATIONAL STANDARD B11.0 – 2023 (Annex – I)

Annex I — Sample Statement of Conformity


(Annex I is Informative; reference subclause is 6.9.1)

Statement of Conformity:
The following text is a sample Statement of Conformity. The wording can be adjusted as appropriate to
meet the needs of a particular machine supplier or application. The machine supplier should list only the
standards by which the supplier is confident that conformance to their requirements is complete. Some
standards can be incorporated by reference (for example, ASME B20.1 is referenced in ANSI B11.0, thus,
listing B11.0 may be sufficient).

STATEMENT OF CONFORMITY (example)


Manufacture
Company name
Address etc.
The product covered by this statement
Model: yyy
Serial Number: xxx
Description of the Machine: Model xxx, Serial # xxx is a

The XYZ Company, declares that the above machine conforms to the provisions of the following Standards and
Regulations: [include examples of regulations and or applicable standards specifically included in the contract]:

ANSI B11.0 – 2023 Safety of machinery


ANSI B11.19 – 2019 Performance Requirements for Risk Reduction Measures:
Safeguarding and other Means of Reducing Risk
NFPA 79 – 2021 Electrical Standard for Industrial Machinery
ISO 13849-1: 2023 Safety of machinery - Safety-related parts of control systems - Part 1: General
principles for design
ANSI B11.26 – 2018 Functional Safety for Equipment: General Principles for the Design of Safety
Control Systems Using ISO 13849-1

Based on the application of these standards an acceptable level of risk has been achieved.

Name Company Date

Title Address

Declaration Signature/Date: _______________________________


(Company Authority for Declaration of Machine)

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AMERICAN NATIONAL STANDARD B11.0 – 2023 (Annex – J)

Annex J — Layout Analysis


(Annex J is Informative; reference subclause is 7.3.4)
Layout analysis includes the following steps (see Figure 10):
a) specification of the limits;
b) task/hazard identification and task zone identification;
c) selecting risk reduction measures;
d) identify control zone(s) and span(s) of control (see 7.3.5).
Note: Typical engineering control – devices which may have span of control include, but are not
limited to:
• interlock devices;
• presence-sensing devices;
• emergency stops;
• enabling devices;
• hold-to-run controls;
• resets.
The following aspects shall be identified during the layout analysis:
a) the portion(s) of the machine that can be stopped during the time needed to perform the
intervention without preventing the rest of the machine from performing its function;
b) the critical portion(s) of the machine that prevents the rest of the machine from performing its
function when those critical portions are stopped. The functions are critical because each
intervention will have a direct impact on the production level of the machine;
c) the servicing locations and the operating locations;
d) the routes into the machine to access the servicing points or operating locations;
e) the location of energy isolation devices or application of alternative methods for the control of
hazardous energy (see ANSI / ASSP Z244.1).

After identifying the above elements, the machine can be divided into appropriate control zones to:
• accommodate the task zones;
• allow a portion of the machine to continue production while tasks are carried out within an
individual zone.

Layout analysis is an iterative process and part of risk reduction. Layout analysis may result in one or
more of the following:
a) modification of the layout, the machine functionality or the machine limits;
b) modification or addition of new special modes of operation (see 7.3.9 and Annex K);
c) change or modification of some equipment in order to suppress or modify some tasks;
d) determination of new access means;
e) modification of the means by which tasks are performed.

Design reviews are part of the iterative process described above. When acceptable risk and machine
functionality have been achieved, layout analysis is complete.

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AMERICAN NATIONAL STANDARD B11.0 – 2023 (Annex – J)

Figure 10 — Layout Analysis Process

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AMERICAN NATIONAL STANDARD B11.0 – 2023 (Annex – K)

Annex K — Special Mode


(Annex K is Informative: reference subclause is 7.3.8)

K.1 – General
Operating a machine under special mode is a combination of specific risk reduction measures and safe
work procedures to provide protection to the operator when the special mode is active.

A special mode usually limits potentially hazardous situations by restricting operating parameters such as
velocities, movement, torque, access, etc., and restricts potential hazards that are not required for the
special mode (e.g., allowing slow speed motion of an auger to permit cleaning but prohibiting all other
motions or transfers).

Operation under special mode (e.g., temporary observation of automatic processes) should occur while
associated risks are reduced to an acceptable level by applying alternative risk reduction measures.

Risk reduction measures should be implemented in such a way that reasonably foreseeable misuse will
also be prevented.

This form of action should be the subject of focused communication between the supplier and user in order
to analyze the requirements for the safe work procedures for personnel and then translate the requirements
into the risk assessment (see 4.2).

If a special mode of the machine or of parts of the machine is necessary, a decision process according to
Figure 11 should be applied.

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AMERICAN NATIONAL STANDARD B11.0 – 2023 (Annex – K)

Figure 11 — Risk reduction for special mode

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AMERICAN NATIONAL STANDARD B11.0 – 2023 (Annex – K)

K.2 – Considerations on Risk Reduction for Special Mode (see Figure 11)
a) Evaluate the requirement for personnel to be “closer” to the working process. Determine if the
working process can be controlled by the relevant modes of operation described in the appropriate
machine-specific “base” safety standards. Consider if additional systems may eliminate or reduce tasks
requiring special mode (e.g., video cameras, remote detection or measurement devices). Conduct
discussions between the supplier and the user. The user should sufficiently explain that a special mode of
operation is absolutely necessary for the intended task (e.g., due to considerably varying tolerances,
correction of manufacturing, quality check, etc.).
b) Document the results of the discussions and, in particular, the reasons for the special mode of
operation. Restrict special modes of operation to only the specific task in the scope of the intended use.
c) The intended use of the machine with application of the special mode of operation should be
specifically identified and included in the technical documentation. The risk reduction measures should
include the intended use for the task identified for the risk assessment (see clause 6), and the particular
conditions (e.g., personnel close to the process) should be taken into account.
d) The reduction of risk by means of design measures according to the hierarchy of controls is of
highest priority for the risk reduction strategy.
e) When design measures are not feasible, engineering controls (guards, control functions and
devices) for risk reduction should be considered. The engineering controls should reduce the risks and
restrict the special mode of operation to the required minimum extent in order to prevent misuse, for
example by:
• safe limiting of speed and transverse paths to the required level only;
• manual restart of moving parts;
• control of hazardous situations (e.g., movements/axes) not required for the special mode;
• prevention of automatic tool changing;
• prevention of pallet changing;
• control of external hazards, such as automated guided vehicles (AGVs), robots, gantries,
conveyors and storage / retrieval systems;
• prevention of putting fluids (e.g., cooling, lubricant, metal removal fluid) under high pressure;
• manual acknowledgement of cooling agent release;
• easy accessibility of emergency stop devices for stopping in case of emergency; and
• authorized access only (e.g., by key operated control or password).
f) additional risk reduction measures by administrative controls should also be applied as necessary,
such as:
• restricting access to qualified personnel;
• providing regular training (see clause 10);
• personal protective equipment (e.g., protective glasses/shoes, wearing of suitable clothing);
• posting operating instructions concerning the special mode of operation at the machine; such
measures should be documented and included as a requirement in the operation manual and
as markings or warning signs on the machine.
g) The iterative process should be continued until acceptable risk is achieved.
h) Risk reduction measures used for special mode should be reviewed against regulatory
requirements as applicable, such as:
• international;
• regional;
• local.
i) All information relating to the special mode of operation should be documented in the operating
manual, including:
• intended use;
• precautions against reasonably foreseeable misuse;
• description of operation and functions;
• other requirements concerning maintenance and control.
j) If sufficient risk reduction has been achieved, the special mode of operation may be provided. If
the residual risk is not acceptable, no special mode of operation should be provided for the machine.

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AMERICAN NATIONAL STANDARD B11.0 – 2023 (Annex – L)

Annex L — Using Alternative Methods for Controlling Hazardous Energy


(Annex L is Informative: reference subclauses are 7.10)

Lockout or tagout is the primary method of hazardous energy control. Lockout or tagout is used to secure
the energy isolating device(s) to control hazardous energy to the machinery, equipment, or processes from
the energy source. Tagout is a less preferred method for controlling hazardous energy. The control of
hazardous energy includes isolation, de-energization, and checking and testing which takes into account
the impacts of residual energy.

This annex describes considerations related to implementing alternative methods to control hazardous
energy rather than lockout or tagout. This annex is for users who face the following question:
“What do we do if a task:
• requires manual suspension of engineering controls?
• requires service and maintenance but also requires power?
• may not qualify for the Minor Servicing Exception to lockout or tagout under OSHA?”

L.1 – Lockout or Tagout


Lockout is required in the following situations:
• when no risk assessment has been completed;
• when the tasks and/or hazards are unknown;
• during assembly and disassembly of the machine, equipment or process;
• when energy is not required to perform the task;
or
• for major repairs.

However, lockout or tagout is not always feasible. Some tasks require power. Other tasks could
theoretically be performed under lockout or tagout, but are truly impractical to complete under full lockout
or tagout. Still other tasks can be completed more effectively, efficiently and with reduced risk using
alternative methods.

L.2 – Alternative Methods


Alternative methods is a term defined in ANSI / ASSP Z244.1 – 2016, The Control of Hazardous Energy,
Lockout, Tagout and Alternative Methods, as follows:

3.4 Alternative Methods


A means of controlling hazardous energy (other than energy isolation) to reduce risk to an acceptable
level.

Other terms used include “alternative measures” and “alternative protective methods.” There are no
differences in the meaning of these terms.

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AMERICAN NATIONAL STANDARD B11.0 – 2023 (Annex – M)

Annex M — Information for Use – Manual Content Outline


(Annex M is Informative: reference subclauses are 8.2)
Table 15 contains headings that are generally applicable to machinery manuals. Manuals should contain
the following or similar section or chapter headings, where applicable. The order of the information shown
below is recommended but not required. The manual should contain information about the residual risks.
Table 15 — Manual Content
Section Content
Introduction Title page
Table of contents
Introduction to/purpose of this manual
Safety General safety information and general safety instructions
Machine overview Warranty
Machine description
Intended use
Controls and displays descriptions
Programmed hardware and software overview (if applicable)
System hardware and software security
Floor plan / layout
Transportation, handling Transporting, handling and storing the machine and/or the
and storage components
Assembly, installation Assembly / Integration of the machine
and commissioning Positioning the machine
Mechanical, pneumatic, hydraulic and electrical installation
Check and test of safety systems
Installation check
Commissioning
Original equipment Mechanical timing
manufacturer settings Safety-related (setting) parameters
Pneumatic, hydraulic, electrical, and vacuum settings
Other settings
Operation Operating modes
Machine start-up and shutdown
Sequence or chronology of operations
Other operating instructions (if applicable)
Product or capacity General changeover information
changeover Product-specific set-up information
Inspection, testing and Maintenance (plus any inspection or testing) instructions
maintenance
Cleaning and sanitizing Cleaning and/or sanitizing of the machine
Fault finding/ General fault finding / troubleshooting and repair information
troubleshooting and Troubleshooting chart (electrical engineering)
repair Troubleshooting of electrical sensors, vacuum systems, and
pneumatic systems
Decommissioning Decommissioning the machine
Documents and Drawings Documents, drawings, and parts list
Check / Test / Confirm Information for the operation, maintenance, and
checking/testing/confirmation of the safety related parts of the control
systems

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The manual should include but not be limited to the following, where applicable:
• performance specifications;
• appropriate schematics and diagrams;
• physical environment for which the machine is designed;
• function and location of the operator controls, indicators, and displays;
• schedules for periodic maintenance, lubrication, and inspection;
• application of risk reduction measures;
• auxiliary equipment.

The manual and/or other written instructions (e.g., on the packaging) may contain:
a) Information relating to transport, handling and storage of the machine, for example:
• storage conditions for the machine;
• dimensions, mass value(s), position of the center(s) of gravity;
• indications for handling (e.g., drawings indicating application points for lifting equipment).

b) Information relating to installation and commissioning of the machine, for example:


• securing / anchoring and vibration dampening requirements;
• assembly and mounting conditions;
• space needed for use and maintenance;
• permissible environmental conditions (e.g., temperature, moisture, vibration,
electromagnetic radiation);
• instructions for connecting the machine to a power supply (and protection against
electrical overloading);
• advice about waste removal / disposal;
• if necessary, recommendations about risk reduction measures which have to be
taken by the user; for example, additional engineering controls, safety distances,
safety signs and signals.

c) Information relating to the machine itself, for example:


• detailed description of the machine, its fittings, and its engineering controls;
• range of applications for which the machine is intended;
• diagrams (especially schematic representation of safety functions);
• data about noise and vibration generated by the machine, about radiation, gases,
vapors or mists, and dust emitted by the machine, with reference to the measuring
methods used;
• technical documentation about electrical equipment;
• documents attesting that the machine complies with mandatory requirements.

d) Information relating to the use of the machine, for example:


• intended use;
• description of manual controls (actuators);
• setting and adjustment;
• modes and means for stopping (especially emergency stop);
• risks which could not be eliminated by the risk reduction measures implemented by
the designer;
• particular risks which may be generated by certain applications, by the use of
certain fittings, and about specific risk reduction measures which are necessary for
such applications;
• reasonably foreseeable misuse and prohibited applications;
• fault identification and location, for repair, and for re-starting after an intervention;
• control of hazardous energy;
• human factors (ergonomics) assumptions about the intended user;
• special operator training or skills required;
• personal protective equipment which needs to be used and training required.

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e) Information for maintenance, for example:


• nature and frequency of inspections for machines and safety functions;
• instructions relating to maintenance operations which require technical knowledge
and/or particular skills and hence, should be carried out exclusively by qualified
personnel (e.g., maintenance staff, specialists);
• instructions relating to maintenance actions (e.g., replacement of parts) which do
not require specific skills and hence, may be carried out by users (e.g., operators);
• controlling hazardous energy (lockout / tagout / alternative methods) guidance,
signs, and devices;
• drawings / diagrams enabling maintenance personnel to perform their tasks
(especially fault-finding tasks to isolate conditions that caused the fault).

f) Information for emergency situations, for example:


• type of fire-fighting equipment to be used;
• warning about possible emission or leakage of harmful substance(s), and if possible,
indication of means to counteract or neutralize their effects;
• means to rescue entrapped person(s).

g) Information relating to decommissioning, dismantling and disposal:


• disposal and recycling recommendations.

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AMERICAN NATIONAL STANDARD B11.0 – 2023 (Annex – N)

Annex N — General Guidelines for Operator Training


(Annex N is Informative; reference subclause is 10.1)

To assist the user in developing an operator training program, the following guidelines are recommended:
1. “Tell the operator” – Have the operator(s) read and understand the manual. Provide adequate verbal
and written instructions to the operator(s). Evaluate the operator’s understanding of the instruction before
proceeding.
2. “Show the operator” – Have the operator(s) observe an experienced operator(s) or supervisor running
the equipment.
3. “Let the operator do it” – After steps 1 and 2 have been satisfactorily completed, let the operator(s)
run the equipment under close supervision.
4. “Correct the operator, if necessary” – Having observed the operator(s) running the equipment, make
recommendations and corrections, if necessary.
5. “Evaluate and assign the operator” - After steps 1 through 4 have been satisfactorily completed,
assign to the operator the responsibility of running the equipment.
6. “Follow up on instructions” – At specified intervals, observe the operator(s) and review performance
to ensure compliance with instructions, operating procedures, and safety guidelines.
7. “Revise, update, re-train” – Keep instructions current. Any revisions should be reviewed with the
operator(s) to assure safe operation of the equipment.
The following guidelines are recommended to help ensure safe operation of machines:
• The user should have job descriptions that outline the skills required for each operator;
• The training of operators should be of the "On-The-Job" type. Trainees should be initially assigned
to work with experienced personnel or under the direct supervision of a knowledgeable individual until
the trainee has gained sufficient familiarity to work independently;
• A training schedule should be established by each user. This schedule should outline the progression
of advancement through the necessary trainee and operator positions as covered by the job
descriptions. A training timetable can be a part of this training schedule, but the emphasis should be
on actual skills acquired rather than the elapsed or prescribed time in an individual's training history.

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AMERICAN NATIONAL STANDARD B11.0 – 2023 (Annex – N)

OPERATOR TRAINING KNOWLEDGE QUIZ


[Multiple Choice quiz; may be administered written or orally; answer key appears below]

The following generic example questions may be administered to machine operators as a means of
reviewing their knowledge. A quiz may be administered in writing or orally. User organizations may wish
to expand upon this basic content to provide questions relating to unique machine tasks or procedures. A
quiz should be given during initial operator training and periodically thereafter.

1. As a newly assigned operator in training, you must:


(a) Read the machine manual.
(b) Understand all safety devices and their proper operation.
(c) Understand how to shut the machine down safely in an emergency.
(d) All of the above.

2. As a newly assigned operator, after training is completed, you must:


(a) Check all safety devices for proper operation.
(b) Check machine for proper operation.
(c) Visually check machine for leaks and proper set-up.
(d) All of the above.

3. As a qualified operator, you must:


(a) Check all safety devices for proper operation.
(b) Check machine for proper operation.
(c) Visually check machine for leaks and proper set-up.
(d) All of the above.

4. If the safety devices are not operational, you must:


(a) Continue working and report at the end of your shift to your supervisor/team leader.
(b) Shut off the machine immediately until it can be repaired.
(c) Continue working until the machine can be repaired.
(d) None of the above.

5. If the machine does not function properly, you must:


(a) Continue working and report the malfunction to your supervisor/team leader at the end of your shift.
(b) Continue working until the machine can be repaired.
(c) Stop production, shut off your machine immediately, and alert your supervisor/team leader.

6. If during a visual inspection, leaks in the air or hydraulic system are detected, you must:
(a) Shut off the machine immediately until it can be repaired/checked for safe operation.
(b) Continue working until the machine can be repaired.
(c) Continue working and report at the end of your shift to your supervisor/team leader.
(d) None of the above.

7. Before cycling the machine at the start of each shift, you must:
(a) Check all safety devices for proper operation.
(b) Visually inspect machine for leaks and proper set-up.
(c) Make sure all personnel are clear of the machine.
(d) None of the above.
(e) (a), (b) and (c).

8. When an emergency exists, what method is used to shut down the machine?
(a) Finish the cycle and turn off the machine.
(b) Finish the part and turn off the machine.
(c) Activate the emergency stop device.
(d) None of the above.

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9. How do you recognize the emergency stop pushbutton?


(a) Look for a black button marked E-STOP.
(b) Look for a red mushroom button with a yellow background marked E-STOP.
(c) Look for a key switch marked E-STOP.
(d) None of the above.

10. Safety on this machine depends on:


(a) The company.
(b) The supervisor/team leader.
(c) The maintenance department.
(d) The operator.
(e) The manufacturer.
(f) All of the above.

11. You must check the tooling set-up:


(a) After each set-up.
(b) At the start of your shift.
(c) At the end of your shift.
(d) After each set-up and at the start of your shift.

12. Before initial Start-up of a new job/part, you must:


(a) Check all safety devices for proper operation.
(b) Check machine for proper operation.
(c) Visually inspect machine for leaks and proper set-up.
(d) Make sure all personnel are clear of the machine.
(e) All of the above.

Answer Key for the Operator Training Knowledge Quiz:

1. (d)
2. (d)
3. (d)
4. (b)
5. (c)
6. (a)
7. (e)
8. (c)
9. (b)
10. (f)
11. (d)
12. (e)

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AMERICAN NATIONAL STANDARD B11.0 – 2023 (Annex – O)

Annex O — Comparable Standards by Topic


(Annex O is Informative)
There are many standards that apply to the safety of machinery. This Annex contains a visual presentation
of many of the more common type-B standards used in the safe design and use of machinery across various
regions of the world.

The reader is cautioned to note that this listing is not intended to be a completely comprehensive one, nor
is it intended to imply a direct correlation between similar standards in different regions.

Other standards may apply to a specific machine or application.

The information contained in this annex was current as of the date of publication.

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AMERICAN NATIONAL STANDARD B11.0 – 2023 (Annex – O)

Figure 12 — ANSI standards applicable in the United States

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AMERICAN NATIONAL STANDARD B11.0 – 2023 (Annex – O)

Figure 13 — EN Norms (EU standards) applicable in the European Union

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AMERICAN NATIONAL STANDARD B11.0 – 2023 (Annex – O)

Figure 14 — International standards (ISO & IEC only; other international standards may apply)

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AMERICAN NATIONAL STANDARD B11.0 – 2023 (Annex – P)

Annex P — Terms for Persons as used in B11 Standards


(Annex P is Informative)
In the B11 series of machinery safety standards, different terms (defined in clause 3) are used to describe
persons who may interact with machinery and are impacted by safety standards. Figure 15 illustrates the
different terms and roles persons may have as these terms are used in the B11 series of documents.
Note – Although efforts were made to harmonize these terms and definitions with usage in other standards
and regulatory requirements, other documents may have slightly different definitions than those herein.

Figure 15 — Terms for Persons used in the B11 series of machinery safety standards
• Individuals may enter an industrial environment (workplace). They become Affected Persons
when they are in proximity to a machine or equipment.
• Certain Individuals are considered Personnel if they are employed or contracted to work in the
industrial environment (workplace). Personnel may or may not be under the direct control of the
machinery supplier or user. Personnel may include operators, maintenance personnel and
others. Although not explicitly defined in B11 standards, “Other” as used in Figure 15 may
include service personnel, contractors, subcontractors, etc.
• With appropriate training, personnel can become Qualified Personnel.
• With permission from the machinery supplier or user, Qualified Personnel can become Authorized
Personnel.
• A Supervisor oversees the work of various Personnel.

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AMERICAN NATIONAL STANDARD B11.0 – 2023 (Annex – Q)

Annex Q — Control Devices


(Annex Q is Informative)

Figure 16 — Control devices

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AMERICAN NATIONAL STANDARD B11.0 – 2023 (Annex – R)

Annex R — Achieving a Safe Condition with Reduced-Energy


(Annex R is Informative)

R.1 – Introduction
Achieving acceptable risk is the purpose of risk assessment and application of risk reduction measures.
Whenever possible, elimination and isolation of hazardous energy is the preferred method to reduce risk to
individuals. However, certain tasks require partial (or full) energization to perform the task. Energy control
is not required for activities where power is required to perform a task, as long as risk reduction measures
are provided to achieve acceptable risk. See also, ANSI / ASSP Z244.1.

In these situations, a risk assessment will determine if reduced-energy applied as a risk reduction measure
– typically with additional risk reduction measures, such as engineering controls or administrative controls
– will result in acceptable risk (e.g., a ‘safe condition’ as addressed in this document). For reduction of risk
to individuals, reduced-energy modes of operation typically apply to speed, force, pressure and temperature
values. When reduced energy is utilized as a risk reduction measure, the condition is a safety function and
must meet the requirements of ANSI B11.19.

A review of available literature published in February 2017 by The Institut de recherche Robert-Sauvé en
santé et en sécurité du travail (IRSST) in Quebec, Canada revealed a wide variety of recommendations
with respect to reduced-energy levels (see also, IRSST R-956 [0]). The abstract of the study describes
the research:

ABSTRACT
The hazards associated with the moving parts of industrial machines are known to be the
source of serious and even fatal accidents. The purpose of section 189.1 (previously 186)
of the Quebec Regulation respecting Occupational Health and Safety (ROHS) is to provide
guidance for machine maintenance, repair and adjustment work, further to section 182,
which governs production work by prohibiting access to hazard zones and ensuring that
moving parts are stopped when workers enter these zones. The focus of this research
project was the application of ROHS section 186. The first objective was to assess the
state of knowledge and recommendations in the literature on reduced-energy modes of
operation, especially in terms of speed, force, pressure, and temperature values. The
second objective was to understand, through factory visits, how ROHS section 186 is being
implemented.

A review of the literature revealed a wide variety of recommendations with respect to


reduced energy levels. The recommendations, chiefly based on standards and closely
related to a specific context, are generally presented with accompanying supplementary
conditions. A reduction in energy alone is often not sufficient to reduce the risk. Factory
visits have shown that the various conditions prescribed in ROHS section 186 are
sometimes hard to meet simultaneously. Safeguards, including the reduction of energy
levels, are therefore a compromise between different constraints (related to job needs, the
machine itself, production requirements, etc.) and risk reduction in order to prevent or
reduce potential harm.

Last, the study revealed that reduced-energy values depend on many factors and that the wide variety of
possible situations makes it necessary to conduct an in-depth risk analysis. The application of ROHS
section 186 is therefore an integral part of the risk assessment and reduction process for tasks where
workers have no alternative but to enter the zone where machine parts are in motion. The purpose of this
process is to achieve a level of risk comparable to that contemplated in ROHS section 182, by taking
protective measures that will compensate for opening a guard or starting up the machine. These protective
measures are based on three principles: reduce harm, increase the possibility of avoiding harm and reduce
exposure to the hazard. Yet the issue of determining reduced-energy levels remains unresolved.

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AMERICAN NATIONAL STANDARD B11.0 – 2023 (Annex – R)

Generally speaking, when the literature recommends values, if the situation in question corresponds exactly
to the context described in the literature, then designers may use these same values. On the other hand,
when no reference is available, the determination of a tolerable energy level must be based on more
extensive thought and analysis. Only a thorough comparison of the context of the proposals made in the
literature and that of the real situation will allow extrapolation of the recommendations to comparable, but
not identical situations. A risk analysis must be conducted. The study identified some reference points or
factors that will provide guidance to designers and users as they analyze specific cases and try to decide
on the most appropriate values for reduced speed, force, kinetic energy and contact pressure.

The recommendations, based primarily on standards and closely related to a specific context, often require
additional risk reduction measures since a reduction in energy alone is often not sufficient to achieve
acceptable residual risk. The latest edition of the source document should be referenced before any
determination is made. Combining reduction of energy levels with additional risk reduction measures is a
compromise between different application constraints (related to task requirements, machine design,
production requirements, etc.) and risk reduction in order to reduce potential harm. Acceptable reduced-
energy values depend on many factors. Therefore, a comprehensive risk assessment is required to identify
the wide variety of possible situations in order to determine applicable values to achieve acceptable risk
where personnel must perform tasks with full or partial energy available.

A risk reduction process is based on eliminating hazards and/or reducing risk to individuals. However, the
issue of determining acceptable reduced-energy levels remains unresolved. Generally speaking, when
literature recommends a specific value, the specific application must correspond exactly to the context
described in order for the identified values to be applicable. Furthermore, when no reference is available,
the determination of a tolerable energy level must be based on more extensive evaluation of the risk factors;
probability of occurrence of harm and the severity of that harm. A thorough comparison of the context of
the proposals made in literature and that of the real situation will allow extrapolation of the recommendations
to comparable, but not identical situations. The IRSST study identified some reference points or factors
that will provide guidance to analyze specific cases and determine the most appropriate values for reduced
speed, force, kinetic energy and contact pressure.

The primary objective of the peer-reviewed IRSST study was to review the knowledge of reduced-energy
operating modes and recommendations on standard practices in industry, including a characterization of
the energy levels of various hazards: mechanical (speed and force), hydraulic and pneumatic (pressure),
and thermal (temperature). The data provided below are excerpts from the IRSST study, and they are
provided in this Annex as informative only; a thorough risk assessment is required for each hazardous
situation.

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AMERICAN NATIONAL STANDARD B11.0 – 2023 (Annex – R)

R.2 – Reduced Speed


Table 16 lists all reduced-speed values identified in the IRSST study in ascending order, with references to
the documents from which the values were taken. The latest edition of the source document should be
referenced before any determination is made.

Table 16 — Low / Reduced Speed Values in Ascending Order with References


Prescribed Speed 1
Industry Machines – Machine Part (if specified) Source
mm/s in/s
Printing Printing press 8 0.31 [2]
Printing Sheet-printing press and varnishing machine 8 0.31 [3]
Printing Printing and paper converting machine – Embosser 8 0.31 [4]
Corrugator – Double-face gluer
Folder-gluer
Printing 8 0.31 [5]
Online machine – Feeder
Auto-feed platen press – Feeder
Printing Embosser 8 0.31 [6]
Manufacturing Hydraulic press brake 10 0.39 [7]
Manufacturing Press 10 0.39 [8]
Manufacturing Hydraulic press brake 10 0.39 [9]
Manufacturing Hydraulic press brake 10 0.39 [10]
Manufacturing Hydraulic press brake 10 0.39 [11]
Textile industry Weaving machine 10 0.39 [12]
Manufacturing Integrated manufacturing system 10 0.39 [13]
Manufacturing Plastic injection molding machine 10 0.39 [14]
Printing Printing press 17 0.67 [2]
Printing Binding and finishing system 17 0.67 [6]
Printing Printing and paper converting machine – Common requirements 17 0.67 [15]
Industrial robots Robot 17 0.67 [16]
Pulp and paper Winder 17 0.67 [17]
Manufacturing Plastic injection molding machine 25 0.98 [18]
Manufacturing Plastic injection molding machine 30 1.18 [14]
Printing Printing press 33 1.30 [2]
General – Parts with rollers (nip points)
Textile industry 33 1.30 [19]
Winding machine
Manufacturing High-speed machining center 33 1.30 [20]
Printing Unwinder/rewinder 33 1.30 [15]
Manufacturing Integrated manufacturing system 33 1.30 [13]
Manufacturing Machining center 33 1.30 [21]
Printing Printing press 50 1.97 [2]
Printing Guillotine cutter 50 1.97 [22]
Printing Rotary printing press and varnishing machine 50 1.97 [3]
Printing Straight guillotine cutter – Paper end stop 50 1.97 [23]
Printing Paper converting machine – Lengthwise folding unit 50 1.97 [4]
Manufacturing High-speed machining center 67 2.64 [20]
Pulp and paper Cutter – Unwinding unit 80 3.15 [24]
Printing Printing press 83 3.27 [25]

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Prescribed Speed 1
Industry Machines – Machine Part (if specified) Source
mm/s in/s
Printing Embosser – Rolls, backing rolls, laminating rolls 83 3.27 [6]
Printing and paper converting machine –
Printing Common requirements 83 3.27 [15]
Unwinder/rewinder
Printing Printing press (with varnishing sheets) 83 3.27 [3]
Horizontal rotary bobbin unwinder
Printing 83 3.27 [4]
Litho-laminators
Printing Corrugator – Preheater 83 3.27 [5]
Manufacturing Machining center 83 3.27 [21]
Printing Envelope-making machine – Printer group 100 3.94 [4]
Printing Corrugator, single-sided 100 3.94 [5]
Printing Rotary printing press and varnishing machine 133 5.24 [3]
Manufacturing Machining center 133 5.24 [21]
Printing Printing press 167 6.57 [2]
Printing Binding and finishing system 167 6.57 [6]
Textile industry Textile industry – Gill box 167 6.57 [26]
Printing Glue binder machine 167 6.57 [4]
Industrial robots Robot 170 6.69 [27]
Industrial robots Robot 200 7.87 [28]
Pulp and Paper Calender 200 7.87 [29]
Industrial robots Robot 250 9.84 [30]
Manufacturing Integrated manufacturing system 250 9.84 [13]
Textile industry Air transportation of processed materials 250 9.84 [19]
General General 250 9.84 [1]
Printing Corrugator – Splicer 250 9.84 [5]
Pulp and paper Paper making and finishing machine – General requirements 250 9.84 [31]
Pulp and paper Cutter 300 11.81 [24]
Printing Printing Press 330 13.00 [2]
Mining Roof bolter 330 13.00 [32]
Printing Unwinder/rewinder 330 13.00 [15]
Printing Hardcover book production line 330 13.00 [4]
Printing Corrugator – Stacker 1 500 59.06 [5]
1 The prescribed speeds are linear (speed of an object in translational motion or peripheral speed of a rotating object).

R.3 – Reduced Force


Table 17 lists all reduced-force values identified in the IRSST study in ascending order, with references to
the documents from which the values were taken. The latest edition of the source document should be
referenced before any determination is made.

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Table 17 — Low / Reduced Force Values in Ascending Order with References


Machines – Machine Part – Hazard Prescribed Force
Industry Source1
(if specified) Newtons (N)
Printing Manual-feed platen press 20 [5]
Printing Printing press 50 [25]
Printing Binding and finishing system – Movable guards 50 [6]
Printing Printing press – Motorized movable guards 50 [3]
Wire-stitching machine, riveting machine, eyeletting machine,
stapling machine (manual feed)
Printing 50 [4]
Saddle stitcher
Envelope-making machine – Conveyor with separating disks
Printing Folder-gluer – Traction belt 70 [5]
General General 75 [32]
General General 75 [33]
Printing Folder-gluer – Press zone 100 [5]
Building Elevator – Door 135 [35]
General General 150 [33]
Printing press – Motorized movable guards
Printing 150 [3]
Screen-printing machine
Printing Directory-printing and –cutting machine 150 [23]
Printing Corrugator – Double-face gluing device 150 [5]
Building Elevator – Horizontally sliding automatic doors 150 [46]
Paper matching and finishing machine – Prescriptions
Pulp and paper 150 [31]
against crushing hazard
Printing Gluing laminating machine 200 [4]
Printing Binding and finishing system – Counter-stacker 200 [6]
Printing Printing press 300 [2]
Corrugator – Splicer
Printing 300 [5]
Online machine – Feeder
Printing Binding and finishing system 300 [22]
Printing Paper cutting machine 300 [37]
Printing Unwinder/rewinder 300 [15]
Printing Screen-printing machine 300 [3]
Printing Paper cutting machine – Paper press 300 [23]
Printing Binding and finishing system 500 [22]
Printing Straight guillotine cutter 500 [37]
Paper cutting machine – Paper press
Printing 500 [23]
Paper cutting machine – Built-in feeder and receiving device
Printing Folder-gluer – Press zone 500 [5]
1 Some sources may cover several machines or variations on machines and recommended the same value multiple times.

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R.4 – Reduced Kinetic Energy


Table 18 lists all reduced-kinetic energy values identified in the IRSST study in ascending order, with
references to the documents from which the values were taken. The latest edition of the source document
should be referenced before any determination is made.
Table 18 — Low/reduced kinetic energy values in ascending order with references
Machines – Machine Part – Hazard Prescribed Energy
Industry Source 1
(if specified) Joules (J)
Building Elevator – Door 3.5 [35]
General General 4 [33]
General General 4 [34]
General General – Movable guards 4 [36]
Building Elevator – Door 4 [46]
General General 10 [33]
General General 10 [34]
General General – Movable guards 10 [36]
Building Elevator – Door 10 [46]
1 Some sources may cover several machines or variations on machines and recommended the same value multiple times.

R.5 – Reduced Pressure


Table 19 lists all reduced-pressure values identified in the IRSST study in ascending order, with references
to the documents from which the values were taken. The latest edition of the source document should be
referenced before any determination is made.
Table 19 — Low / Reduced Pressure Values in Ascending Order with References
Machines – Machine Part – Hazard Prescribed Pressure
Industry Source 1
(if specified) N/cm2
General [40]
General 10
Packaging machines [41]
General [40]
General 20
Packaging machines [41]
Packaging Strapping machine 25 [38]
Packaging Group and secondary packaging machines 25 [45]
General [40]
General 25
Packaging machines [41]
General [40]
General 30; 35; 45
Packaging machines [41]
General General 50 [33]
Packaging Group and secondary packaging machines 50 [45]
General [40]
General 50
Packaging machines [41]
General [40]
Building 60; 70; 75; 80
Packaging machines [41]
1 Some sources may cover several machines or variations on machines and recommended the same value multiple times.

R.6 – Reduced Thermal Energy


The temperature of a machine part may be a hazard that can cause serious injuries to individuals. Like
other forms of energy, reducing the temperature of hazardous parts may be considered an effective way to
reduce risk.

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Standard ISO 13732-1 [39] gives temperature thresholds that can cause burns when the skin of an
individual is in contact with a hot surface for 0.5 seconds or more. The latest edition of the source document
should be referenced before any determination is made.

As shown in Figure 17, temperatures and exposure times have been defined and may be used to determine
the severity of harm to individuals based on exposure.

Figure 17 — Burn threshold when skin contacts smooth, hot, bare metal surface
[from ISO 13732-1]

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R.7 – Combining Reduced-Energy with Additional Risk Reduction Measures


In addition to making recommendations about speed and force limits in order to reduce risks when working
in hazardous areas of a machine while it is in operation, the literature also proposes complementary
safeguards or protective measures associated with reduced speeds and forces.

The additional risk reduction measures most frequently discussed in literature in order of frequency are
listed below (see also, ANSI B11.19):
• hold-to-run control;
• emergency stop accessible nearby;
• automatic opening device (or reversal of movement device);
• safe clearance;
• enabling device;
• minimum distance between a fixed component (e.g., built) and a movable component;
• sound signal;
• operating mode selector switch;
• training; and
• placement of control device so that hazard zone can always be seen by person operating control
device.

There are a variety of risk reduction measures associated with reduced-speed/force mode and their
effectiveness varies. Manual or hold-to-run controls are the most common engineering controls – device
which are generally recommended for machine start-up, as they allow personnel to retain control over
hazardous situations at all times during exposure. In addition, in all cases, and especially when several
individuals are present in the hazard zone simultaneously, it is recommended that the safety-related manual
control device be located so that the hazard(s) within the span of control can always be seen by the
individual controlling the hazard [3]. Similarly, some standards contain recommendations about the level
of safety performance for the additional engineering controls – devices and its associated SRP/CS, such
as hold-to-run controls. The recommendations proposed in the literature on the level of safety performance
are listed in Table 20. The latest edition of the source document should be referenced before any
determination is made.
Table 20 — Recommendations on Performance of Safety Levels for Reduced-Energy
Operating Modes
Recommendations for Level
Industry Machines (if specified) Standard
of Safety Performance
Printing and paper converting Common requirements Category 1, EN 954-1:1996 EN 1010-5:2005
ANSI B65.1:2005
Printing Printing press Category 3, ISO 13849-1:1999
ANSI B65.2:2005
PLr d, ISO 13849-1:1999, or
Printing Binding and finishing system ANSI B65-1:2011
SIL 2, IEC 62061
Printing Binding and finishing system Category B, EN 954:1996 EN 1010-4:2004
Textile industry Fabric manufacturing Category 3 or 4, ISO 13849-1:1999 ISO 11111-6:2009
Manufacturing Machining center Category 3, EN 954:1996 EN 12417+A2:2009
Pulp and paper Sheeter Category 1, EN 954:1996 EN 1034-5+A1:2010
NOTE The Categories of EN 954-1:1996 [42] are the same as those of ISO 13849-1:1999 [43].

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R.8 – IRSST Study Bibliography The sources referenced in this Annex are listed below:
[0] Chinniah, Y., Aucourt, B., Bourbonnière, R. (2015). “Study of machine safety for reduced-speed or reduced-
force work,” Robert Sauvé Research Institute in Occupational Health and Safety, Québec, Canada, Report R-
956.
[1] ISO, “Safety of machinery: Risk assessment. Part 2, Practical guidance and examples of methods,” ISO/TR
14121-2, 2007.
[2] ANSI, “American national standard: graphic technology - safety standard - printing press systems,” ANSI B65.1,
2005.
[3] AFNOR, “Safety of machinery: Safety requirements for the design and construction of printing and paper
converting machines. Part 2, Printing and varnishing machines including pre-press machinery,” EN 1010-2,
2010.
[4] AFNOR, “Safety of machinery: Safety requirements for the design and construction of printing and paper
converting machines. Part 4, Bookbinding, paper converting and finishing machines,” EN 1010-4, 2010.
[5] AFNOR, “Safety of machinery: Safety requirements for the design and construction of printing and paper
converting machines - Part 5: Machines for the production of corrugated board and machines for the conversion
of flat corrugated board,” EN 1010-5, 2005.
[6] American National Standards Institute, “American national standard: graphic technology: Safety requirements
for binding and finishing systems and equipment,” ANSI B65.2, 2005.
[7] "Health and safety self-diagnostic grid of work – Folding Presses,” Joint Sectoral Association for Occupational
Health and Safety in the Metal Product Manufacturing, Electrical Products and Clothing Industries (ASPHME)
sector, Québec, Canada.
[8] CSA, “Code for power press operation: Health, safety, and safeguarding requirements,” CSA Z142, 2010.
[9] Burlet-Vienney, D., Jocelyn, S., Daigle, R., Massé, S., “Safeguarding of hydraulic power press brakes,” Robert
Sauvé Research Institute in Occupational Health and Safety, Québec, Canada, Guide RF-651, 2010.
[10] Bello, J.-P., Cazin, B., Caillet, J.-P., Hue, G., “Working safely of hydraulic folding presses,” French National
Research and Safety Institute for the Prevention of Occupational Accidents and Diseases, France, Guide ED-
879, 2011.
[11] Gillot, J., Baudoin, J., Bello, J.-P., Blaise, J.-C., “Hydraulic bending presses for cold metal work – improved safety
on machinery – technical specifications for use by users, inventors and innovators,” French National Research
and Safety Institute for the Prevention of Occupational Accidents and Diseases, France, Guide ED-927, 2010.
[12] ISO, “Textile machinery: Safety requirements. Part 6, Fabric manufacturing machinery,” ISO 11111-6, 2009.
[13] ISO, “Safety of machinery: Integrated manufacturing systems: Basic requirements,” ISO 11161, 2007.
[14] AFNOR, “Plastics and rubber machines: injection moulding machines: Safety requirements,” EN 201, 2009.
[15] AFNOR, “Safety of machinery – Safety requirements for the design and construction of printing and paper
converting machines – Part 1: Common requirements,” EN 1010-1+A1, 2011.
[16] Beauchamp, Y., Jaraiedi, M., Etherton, J., “Manual Control of Industrial Robots: Slow Speed,” Proceedings of
the 20th Annual meeting of the Canadian Ergonomics Association, vol. 20, pp. 31-34, 1987.
[17] AFNOR, “Safety of machinery: Safety requirements for the design and construction. Part 3, Rereelers and
winders,” EN 1034-3, 2012.
[18] ASSE, “Control of hazardous energy lockout/tagout and alternative methods,” ASSE/ANSI Z244.1, 2008.
[19] ISO, “Textile machinery: Safety requirements. Part 1, Common requirements,” ISO, ISO 11111-1, 2009.
[20] Lupin, H., “High-speed machining centres (UGV centres),” French National Research and Security Institute,
Guide ND-2138, 2003.
[21] AFNOR, “Machine tools: Safety: Machining centres,” EN 12417+A2, 2009.
[22] ANSI, “Graphic technology: safety requirements for graphic technology equipment and systems. Part 3, binding
and finishing equipment and systems,” ANSI B65-3, 2011.
[23] AFNOR, “Safety of machinery: Safety requirements for the design and construction of printing and paper
converting machines. Part 3, Cutting machines,” EN 1010-3, 2010.
[24] AFNOR, “Safety of machinery: Safety requirements for the design and construction of paper making and finishing
machines. Part 5, Sheeters,” EN 1034-5+A1, 2010.
[25] ANSI, “American national standard: graphic technology: safety requirements for graphic technology equipment
and systems. Part 1, general requirements,” ANSI B65.1, 2011.
[26] ISO, “Textile machinery: Safety requirements. Part 2, Spinning preparatory and spinning machines,” ISO 11111-
2, 2009.

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[27] Beauchamp, Y., Stobbe, T.J., Ghosh, K., Imbeau, D., “Determination of a Safe Slow Robot Motion Speed Based
on the Effect of Environmental Factors,” Human factors, vol. 33, no. 4, pp. 419-427, 1991.
[28] Karwowski, W., Parsaei, H., Soundararajan, A., Pongpatanasuegsa, N., “Estimation of Safe Distance from the
Robot Arm as a Guide for Limiting Slow Speed of Robot Motions,” Proceedings of the Human Factors Society
36th Annual Meeting, vol. 2, pp. 992-996, 1992.
[29] AFNOR, “Safety of machinery. Safety requirements for the design and construction of paper making and finishing
machines. Part 6, Calender,” EN 1034-6+A1, 2010.
[30] ANSI, “American National Standards for industrial robots and robot systems: safety requirements,” ANSI / RIA
R15.06, 1999.
[31] AFNOR “Safety of machinery: Safety requirements for the design and construction of paper making and finishing
machines. Part 1, Common requirements,” EN 1034-1+A, 2010.
[32] Ambrose, D.H., Bartels, J.R., Kwitowski, A.J., Gallagher, S., Battenhouse Jr., T.R., “Computer simulations help
determine safe vertical boom speeds for roof bolting in underground coal mines,” Journal of safety research, vol.
36, pp. 387-397, 2005.
[33] "Prevention of mechanical risks, practical solutions,” International Association of Social Security (ISSA)
prevention series, no. 2014, Genève, 1994.
[34] Lupin, H., Marsot, J., “Safety of machinery and work equipment: means of protection against mechanical
hazards,” French National Research and Safety Institute for the Prevention of Occupational Accidents and
Diseases, France, Guide ED-807, 2006.
NOTE: This publication has been replaced by INRS guide ED-6122 [44].
[35] CSA, “Safety code for elevators,” CSA B44-00, 2003.
[36] ISO, “Safety of machinery: Guards: General requirements for the design and construction of fixed and movable
guards,” ISO 14120, 2007.
[37] Lupien, T., “Action on machinery: The right trimmer,” Joint Sectoral Association of Occupational Health and
Safety, Printing Sector and Related Activities", Québec, Canada, 2010.
[38] AFNOR, “Safety of packaging machines. Part 8, Strapping machines,” EN 415-8, 2008.
[39] ISO, “Ergonomics of the thermal environment. Method for the assessment of human responses to contact with
surfaces. Part 1, Hot surfaces,” ISO 13732-1, 2008.
[40] Institute for Foreign Relations (IFA), “BG/BGIA risk assessment recommendations according to machinery
directive: design of workplaces with collaborative robots,” German Statuatory Accident Insurance, 2011.
[41] AFNOR, “Safety of packaging machines. Part 10, General requirements,”, EN 415-10, 2014.
[42] CEN, “Safety of machinery: Safety-related parts of control systems. Part 1, General principles for design,” EN
954-1, 1996.
[43] ISO, “Safety of machinery - Safety-related parts of control systems. Part 1, General principles for design,” ISO
13849-1, 1999.
[44] Blaise, J.-C., Lefèvre, B.-D., Lupin, H., Marsot, J., Wélitz, G., “Safety of work equipment: Prevention of
mechanical risks,” French National Research and Safety Institute for the Prevention of Occupational Accidents
and Diseases, France, Guide ED-6122, 2012.
[45] AFNOR, “Safety of packaging machines. Part 7, Group and secondary packaging machines,” EN 415-7, 2008.

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Annex S — Informative References


The following informative references may or may not be specifically cited within this standard, but the ANSI
B11.0 writing Subcommittee considers them as being potentially useful additional sources of information to
the reader. Dated editions of the publications listed below were up-to-date at the time of publication of this
American National Standard. The reader is advised to evaluate the availability (and suitability) of using a
newer revision.
ANSI B11.1—2009 (R2020) Safety Requirements for Mechanical Power Presses
ANSI B11.2—2013 (R2020) Safety Requirements for Hydraulic and Pneumatic Power Presses
ANSI B11.3—2022 Safety Requirements for Power Press Brakes
ANSI B11.4—2003 (R2020) Safety Requirements for Shears
ANSI B11.5—1998 (R2020) Iron Workers – Safety Requirements for Construction, Care and Use
ANSI B11.6—2022 Safety Requirements for Manual Turning Machines
ANSI B11.7—2020 Safety Requirements for Cold Headers and Cold Formers
ANSI B11.8—2022 Safety Requirements for Manual Milling, Drilling, and Boring Machines
ANSI B11.9—2010 (R2020) Safety Requirements for Grinding Machines
ANSI B11.10––2003 (R2020) Safety Requirements for Metal Sawing Machines
ANSI B11.12––2005 (R2020) Safety Requirements for Roll Forming and Roll Bending Machines
ANSI B11.13––2020 Safety Requirements for Single/Multiple Spindle Automatic Bar & Chucking Machines
ANSI B11.15––2022 Safety Requirements for Pipe, Tube and Shape Bending Machines
ANSI B11.16––2014 (MPIF #47)(R2020) Safety Requirements for Metal Powder Compacting Presses
ANSI B11.17––2023 Safety Requirements for Horizontal Hydraulic Extrusion Presses
ANSI B11.18––2006 (R2020) Safety Requirements for Machines Processing or Slitting Coiled or Non-
Coiled Metal (this standard includes the requirements from B11.14-1996, which has been withdrawn)
ANSI B11.20––2017 Safety Requirements for Integrated of Machinery into a System
ANSI B11.21––2006 (R2020) Safety Requirements for Machine Tools Using a Laser for Processing
Materials
ANSI B11.22––2002 (R2020) Safety Requirements for Numerically Controlled Turning Machines
ANSI B11.23––2002 (R2020) Safety Requirements for Machining Centers
ANSI B11.24––2002 (R2020) Safety Requirements for Transfer Machines
ANSI B11.25––2022 Safety Requirements for Large Machines
ANSI B11.26––2018 Functional Safety for Equipment (Electrical/Fluid Power Control Systems) –
Application of ISO 13849 - General Principles for Design
ANSI B11.27––2020 Safety Requirements for Electro Discharge Machines
(ANSI) B11.TR1––2016 Ergonomic Guidelines for the Design, Installation and Use of Machine Tools
(ANSI) B11.TR2––2017 Mist Control Considerations for the Design, Installation and Use of Machine Tools
Using Metalworking Fluids
(ANSI) B11.TR4––2004 (R2015) Selection of Programmable Electronic Systems (PES/PLC) for Machine
Tools
(ANSI) B11.TR5––2006 (R2017) Sound Level Measurement Guidelines: A Guide for Measuring,
Evaluating and Documenting Sound Levels Emitted by Machinery
(ANSI) B11.TR7––2007 (R2017) Designing for Safety and Lean Manufacturing — A guide on integrating
safety and lean manufacturing principles in the use of machinery
(ANSI) B11.TR8––2022 Guide to Inspection of Risk Reduction Measures
(ANSI) B11.TR9––2019 Guidance to Machinery Manufacturers for Consideration of Related IT-Security
(Cyber Security) Aspects
(ANSI) B11.TR10––2022 Functional Safety of Artificial Intelligence for Machinery Applications

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ANSI-ISO 12100:2012 (ISO 12100:2010 IDT) Safety of Machinery — General principles for design, risk
assessment and risk reduction
ANSI Z590.3 – 2011 (R2016) Prevention through Design - Guidelines for Addressing Occupational Hazards
and Risks in Design and Redesign Processes
ANSI / RIA R15.06 – 2012 Safety Requirements for Industrial Robots and Robot Systems
ANSI / PMMI B155.1 – 2016 Safety Requirements for Packaging and Processing Machinery
ANSI / ASSP A1264.1 – 2017 Safety Requirements for Industrial Fixed Stairs, Floor and Wall Openings,
and Industrial Railings and Toe Boards
ANSI / ASSP A1264.2 – 2012 Standard for the Provision of Slip Resistance on Walking/Working Surfaces
ANSI ASC A14.3-2008 (R2018) American National Standard for Safety Requirements for Fixed Ladders
ANSI / ASC O1.1-2013 Woodworking Machinery – Safety Requirements
ANSI / ASME B20.1 – 2021 Safety Standards for Conveyors and Related Equipment
ANSI Z136.1 – 2022 Standard for Safe Use of Lasers
ANSI Z136.9-2013 American National Standard for Safe Use of Lasers in Manufacturing Environments
ANSI / ASSP Z490.1– 2016 Criteria for Accepted Practices in Safety, Health and Environment Training
ASME Boiler And Pressure Vessel Code (BPVC) 2017 Section VIII, Division I
MIL STD 882E: 2012 Systems Safety Program Requirements
NFPA (National Fluid Power Association) / T2.6.1 R2 – 2001 (R19) Fluid power components – method for verifying
the fatigue and establishing the burst pressure ratings of the pressure containing envelope of a metal
fluid power component
IEC 60204-1:2016 Safety of machinery — Electrical equipment of machines — Part 1: General requirements
IEC 60825-1:2014 Safety of laser products — Part 1: Equipment classification, requirements and user's
guide
IEC 61000-6-4:2018 Electromagnetic compatibility (EMC) - Part 6-4: Generic standards - Emission
standard for industrial environments
IEC 61496-1:2020 Safety of machinery — Electro-sensitive protective equipment — Part 1: General
requirements and test
IEC 61496-2:2020 Safety of machinery — Electro-sensitive protective equipment - Part 2: Particular
requirements for equipment using active opto-electronic protective devices (AOPDs)
IEC 61508-1:2010 Functional safety of electrical/electronic/programmable electronic safety-related
systems — Part 1: General requirements
IEC 61508-3:2010 Functional safety of electrical/electronic/programmable electronic safety-related
systems — Part 3: Software requirements
IEC 62061:2021 Safety of machinery — Functional safety of safety-related electrical, electronic and
programmable electronic control systems
ISO 3864:2011 Graphical Symbols Series (includes ISO 3864-1, ISO 3864-2, ISO 3864-3 and ISO 3864-4)
ISO 13732-1:2006 Ergonomics of the thermal environment — Methods for the assessment of human
responses to contact with surfaces — Part 1: Hot surfaces
ISO 13732-3:2005 Ergonomics of the thermal environment — Methods for the assessment of human
responses to contact with surfaces – Part 3: Cold surfaces
ISO 13849-1:2023 Safety of machinery — Safety-related parts of control systems — Part 1: General
principles for design
ISO TR 13849-100:2000 Safety of machinery — Safety-related parts of control systems — Part 100:
Guidelines for the use and application of ISO 13849
ISO 13849-2:2012 Safety of machinery — Safety-related parts of control systems — Part 2: Validation
ISO 13850:2015 Safety of machinery — Emergency stop -- Principles for design
ISO 13857:2019 Safety of machinery — Safety distances to prevent hazard zones being reached by upper
and lower limbs

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ISO TR 14121-2:2012 Safety of machinery — Risk assessment, Part 2: Practical guidance and examples
of methods
ISO 14159:2002 Safety of machinery — Hygiene requirements for the design of machinery
ISO 20607:2019 Safety of machinery - Instruction handbook - General drafting principles
ISO 21469:2006 Safety of machinery — Lubricants with incidental product contact — Hygiene
requirements
ISO 13855:2010 Safety of machinery — Positioning of protective equipment with respect to the approach
speeds of parts of the human body
ISO 13856-1:2013 Safety of machinery — Pressure-sensitive protective devices -- Part 1: General
principles for design and testing of pressure-sensitive mats and pressure-sensitive floors
ISO 14118:2017 Safety of machinery — Prevention of unexpected start-up
ISO 14119:2013 Safety of machinery — Interlocking devices associated with guards — Principles for
design and selection
ISO 14120:2015 Safety of machinery — Guards -- General requirements for the design and construction
of fixed and movable guards

© 2023 B11 Standards, Inc. Page 135

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