A practical guide to

Machinery Safety
Your guide to machinery safety,
covering legislation, risk assessments
and machinery safety solutions from
Machinery Safety Experts, TÜV SÜD
Product Service.

Edition 5

TÜV SÜD Product Service

Machinery Safety is one of the

most significant issues facing every

manufacturing company in Europe

today. It’s just as important as

productivity and is essential for the

well being of everyone involved.

Welcome 1

section
Legislative Framework

TÜV SÜD has put together this practical guide to provide an insight into

2
the field of machinery safety, basing it around common hazards and

section
issues that they come across on a regular basis. Risk Assessment

TÜV SÜD is a leading international expert in providing testing,

3
certification, training and knowledge services to a range of industries.

section
The Machinery Safety Division provides a range of machinery audits and Four Steps to CE marking
inspections, CE marking services, risk assessments and training solutions,
to help ensure the safety and compliance of machinery.

section
EMC Solutions

5
section
PUWER

Pre-Purchase Audit
6
section

7
section

Appendices
DISCLAIMER
The aim of this Practical Guide to Machinery Safety is to provide general information on Machinery Safety and is not
an exhaustive treatment of the subject. Accordingly, the information in the Practical Guide is not intended to and shall
not constitute consulting or professional advice or services. If you are seeking specific advice on any matters relating to
information in this document, you should – where appropriate – contact us directly with your specific query.

Copyright
The copyright for this Practical Guide to Machinery Safety belongs to TÜV SÜD Product Service. The information
contained may not be copied, quoted or referred to in any other publication or materials without the prior written
consent of TÜV SÜD Product Service.
All rights reserved © 2015 TÜV SÜD Product Service.

3
Introduction to
Machinery Safety
This training course provides an introduction to your
legal responsibilities and requirements and the role that
new technologies are having on the machinery safety
lifecycle, along with practical mechanical and electrical
solutions.

Course includes:
■ CE requirements when building and purchasing machines
■ Creating complex assemblies and modifying machinery
■ Functional safety
■ PUWER assessments

Find out more:

www.tuv-sud.co.uk/
machinery-safety

4
 1

section
Legislative Framework
Section 1 - Legislative Framework
To enable the European Union to trade successfully Section Contents
across boundaries, the European Commission
embarked on a policy of harmonisation. Initially the
Commission proposed Directives, which would identify ■ Framework
a unified approach to the production and trade of
products and goods across Europe. However these ■ Machinery Directive
Directives were prescriptive and it was felt that this
was having a detrimental effect on innovation and ■ EMC Directive
invention. To counter this the Commission introduced
the New Approach Directives (CE marking Directives). ■ Low Voltage Directive

These Directives are not prescriptive and lay down ■ Pressure Equipment Directive
minimum criteria for compliance. The New Approach
Directives are similar in format for ease of reference ■ ATEX Directive
and use. Perhaps the most significant aspect of
the new legislation is the conformity assessment ■ Work Equipment Directive
procedure (the means by which the compliance is
ensured). The Directives offer a flexible approach. ■ EN Standards

Significant Directives: ■ SEMI Assessments

Machinery Directive 2006/42/EC ■ Maritime Specifics

EMC Directive 2004/108/EC
Low Voltage Directive 2006/95/EC

5
 1
section
Legislative Framework

Machinery Directive which is not necessary in order for the machinery to

function, or for which normal components may be
All machines supplied in the European Economic Area substituted in order for the machinery to function.
(EEA) from January 1st 1995, must comply with the
Machinery Directive and be safe. There are few The New Approach Directives lay down minimum
exclusions to the Directive making this one of the most criteria for compliance. These criteria are called The
significant of all the New Approach Directives. Essential Health and Safety Requirements (EHSR).

The scope of the Machinery Directive defines a machine The preferred way to comply with EHSRs is by Risk
as the following: Assessment and the application of harmonised EN
standards, which are replacing the national standards of
1. An assembly fitted with or intended to be fitted member states.
with a drive system other than directly applied
manual or animal effort, consisting of linked parts or
components , at least one of which moves, and which EMC Directive
are joined together for a specific application.
2. Machinery referred to in 1 missing only the The EMC Directive states that most electrical and
components to connect it on site or to sources of electronic products made or sold in Europe must:
energy and motion.
3. Lifting apparatus whose only power source is directly Be so constructed that they do not cause excessive
applied manual effort. electromagnetic interference and are not duly
4. An assembly of machines and / or partly completed affected by electromagnetic interference,
machinery which, in order to achieve the same end Carry CE marking - if your product is sold, used by
are arranged and controlled to function as an integral yourself, given away or used in anyway, it must
whole. comply with the Essential Protection Requirements as
5. Interchangeable equipment means a device which, laid down in the Directive. Ignorance of the legislation
after placing into service with machinery or tractor is no excuse and a punitive penalty structure is
is assembled with that machinery or tractor by the documented.
operator himself in order to change its function.
The requirements under the EMC Directive are:
Safety components for machinery, described as:
That the product must not interfere with any other
which serves to fulfil a safety function, product in any way.
which is independently placed on the market, The product must meet certain standards in that it
the failure and/or malfunction of which endangers must not suffer interference from any other product.
the safety of persons, and

6
 1

section
Legislative Framework
Low Voltage Directive The PED impacts upon design, production, final inspection/
test, marking and labelling and instructions for use/
The Low Voltage Directive states that: maintenance. Therefore, in most affected companies no
single person will be able to resolve all issues particularly
 Only electrical equipment which does not jeopardise when choosing to apply a quality assurance module.
the safety of people, domestic animals and property
shall be placed onto the market. The PED requires that each affected item of pressure
 Equipment operating at voltage between 50v & 1000v equipment be categorised according to specific criteria.
AC and 75v &1500v DC should comply. If you are not fully conversant with the directive this
process can be time consuming and can result in costly
The requirements under the Low Voltage Directive are: errors. The Directive provides many options and routes
to conformity (modules), inappropriate choice can lead
 That the product is electrically safe to significant third party inspection costs.
The product has been constructed in accordance
with accepted good engineering practice and is safe
 The product has been designed and constructed in ATEX Directive
accordance with the Principal Elements of the Safety
Objectives of the Directive. The “ATEX” Directive 94/9/EC is a so-called “New
Approach” Directive which provides the technical
Electrical equipment shall be designed and constructed requirements to be applied to equipment intended for
to ensure that it is safe when connected to the use in potentially explosive atmospheres. It is named
electricity supply, by providing a level of protection after the French “ATmosphere EXplosible”.
against electric shock.
The Directive covers a surprisingly large range of
equipment, potentially including equipment used on
Pressure Equipment Directive fixed offshore platforms, in petro-chemical plants,
mines, flour mills and other areas where a potentially
The Pressure Equipment Directive (PED) 97/23/EC which explosive atmosphere may be present.
affects equipment operating at a pressure greater than
0.5 bar, entered into force on 29th November 1999 and is In very broad terms, there are three pre-conditions for
mandatory from 29th May 2002.PED is generally considered the Directive to apply:
one of, if not the most complex and difficult to understand
of the new approach directives. Many organisations,  The equipment must have its own source of ignition
particularly small and medium sized companies with limited  Be intended for use in a potentially explosive
resource to allocate specifically to the task of conformance, atmosphere (air mixtures)
are reporting difficulties in interpretation and application.  Be under normal atmospheric conditions.

7
 1
section
Legislative Framework

The Directive also covers components essential for the The regulations make it an offence to allow work
safe use and safety devices directly contributing to the equipment to leave an employer’s undertaking, or if
safe use of the equipment in scope. These latter devices obtained from another undertaking, be used, unless
may be outside the potentially explosive environment. it is accompanied by physical evidence that the last
inspection has been carried out.

Work Equipment Directive

EN Standards
The Provision and Use of Work Equipment Regulations
1998 (PUWER) requires users of work equipment to By definition a standard is “A document established
carry out risk assessment and provide work equipment by consensus and approved by a recognised body,
that is suitable for its intended task and can be used that provides, for common and repeated use, rules,
without putting persons at risk. guidelines or characteristics for activities or their
results aimed at the achievement of the optimum degree
The Regulations cover any machinery, appliance, of order in a given context” (ISO/IEC guide 2 (1986).
apparatus, tool or installation for use at work (whether
exclusively or not) - effectively it is anything used at Three organisations are mandated by the European
work. The 1998 regulations (updating the original 1992 Commission to produce standards, with each
Regulations) introduce requirements to ensure that, for organisation being responsible for specific standards.
reasons of health and safety, inspections are carried out:
Once a standard has been produced through the
 After installation and before being put into service process as detailed by CEN and CENELEC they become
for the first time; or after assembly at a new site or known as transposed harmonised standards. European
in a new location to ensure that it has been installed member states will then remove any existing national
correctly and is safe to operate. standards which conflict with the new standard and add
 After work equipment has been exposed to any the relevant country prefix.
conditions causing deterioration, which is liable to
cause a dangerous situation. For example, EN designates that the standard is a full,
 At suitable intervals; and harmonised standard. The process of transposition adds
 Each time that exceptional circumstances have the country prefix hence a standard will become BS EN
occurred that are liable to jeopardise the safety of in the UK. A DIN EN standard in Germany will be exactly
work equipment. The results of these inspections the same.
have to be documented and kept.

8
 1

section
Legislative Framework
SEMI revoked). In September 2006, a new maritime version
of PUWER was published. The Merchant Shipping &
Semiconductor Equipment and Materials International Fishing Vessels (Provision & Use of Work Equipment)
(SEMI) is a global industry association for members of the Regulations 2006 impose the minimum health and
semiconductor and related industries. The Environmental safety requirements for the provision and use of work
Health and Safety (EHS) Committee within SEMI’s equipment by workers at work.
International Standards Division develops industry
standards and guidelines that are globally accepted as The regulations require that employers shall ensure that
ensuring the highest level of safety and quality. the work equipment made available to workers on board
a ship, is suitable for the work being carried out and safe
SEMI standards focus on lowering manufacturing to use.
costs, developing new industries and guaranteeing the
existence of open markets. SEMI S2 is the foundation Alongside the maritime PUWER regulations is a
guideline in SEMI’s fleet of safety documents maritime version of LOLER (Lifting operations, Lifting
which defines the minimum safety requirements Equipment Regulations), which applies LOLER to ships in
for semiconductor products. Conforming to SEMI S2 the same manner that PUWER has now been applied.
contributes to business efficiency and profitability whilst
increasing the marketability of products.
Linkspans and Passenger Walkways
Why Use Standards? These, in simple terms, are the bridging between ship
and port that allows for tidal movements. They have
The use of standards is not mandatory, however, if a always been considered machinery due to the latent
standard is applied correctly, conformance with the energy in the hydraulic systems that balance them. At
relevant EHSRs of a directive may be presumed, hence a recent meeting of Notified Bodies for the Machinery
they represent the surest way to compliance. The user Directive, it was discussed whether linkspans should
though, must still ensure that the equipment complies actually fall under Annex IV of the Machinery Directive
with the Directive and is in fact safe. as they effectively lift people, and devices for the
lifting of people are Annex IV machines. The discussion
concluded that linkspans should be considered as Annex
Maritime specifics IV machinery and so maritime architects and builders
will now have to use a Notified Body when building
November 2006 saw a major change with PUWER. Up to linkspans in ports.
this date, work equipment on ships was outside of the
scope of PUWER because there were other maritime
regulations that took precedence (these have now been

9
Functional Safety
Functional Safety is the part of the overall safety of a
system or piece of equipment that depends on the system
or equipment operating correctly in response to its
inputs, including the safe management of likely operator
errors, hardware and software failure and environmental
changes.

TÜV SÜD provide a broad range of functional safety

services from assessments to our industry-recognised
‘Functional Safety Certified Professional’ training course.

Find out more:

www.tuv-sud.co.uk/
functional-safety
 2

section
Risk Assessment
Section 2 - Risk Assessment
Guidance on carrying out risk assessment can be Section Contents
found in many places. EN ISO 12100 is the main
standard for risk assessment for machinery as it sets
down the principles for the process. ■ Hazard Identification

Risk assessment is fundamental to any health and ■ Risk Assessment Objectives

safety process and in particular machinery safety.
Because of this, anyone involved in dealing with ■ Safety Related Control Systems
machinery safety issues should be competent in risk
assessment and be well aware of the types of hazards ■ EN ISO 13849-1 vs EN IEC 62061
that may occur across their working environment.
■ Common Hazards
Risk Assessment is subjective therefore the
information in this section gives help and advice on
risk assessment. It has to be stressed that it is only
a guide and the onus remains firmly with the person
carrying out the assessment to comply with all the
relevant regulations.

11
 2
section
Risk Assessment

Issues to consider when assessing machinery:

Emergency Stops Electrical Enclosure CE marking Environment Guarding

■ Are they fitted ■ Is the enclosure ■ Does the machinery fall ■ Is there adequate ■ Is guarding fitted?
correctly? locked? under the Machinery lighting? ■ Is it adequate?
■ Do they all work ■ Are all enclosures fitted Directive? ■ Is the floor area free ■ Are interlocks fitted
correctly? with electrical warning ■ Have all the Directives from slip and trip where required and are
■ Are they accessible? signs? been considered i.e. hazards? they positively acting?
■ Are they correct type? ■ Are they free from EMC, LVD, ATEX and ■ Do fixed guards require
debris and foreign PED? tools for their removal?
objects? ■ If so, has it been CE
marked?
■ Has it been altered in
a way that could affect
the original CE marking?

12
 2

section
Risk Assessment
Hazard Identification Risk Assessment Objective
A hazard is: To achieve adequate safety according to the state of the
Anything that has the potential to do harm, a source of art and technical and economic requirements. There are
possible injury or damage to health. numerous ways of assessing risk involved with a hazard,
one of which is the hazard rating number system (HRN).
A risk is: The risk assessment method that is used by TÜV SÜD is
The likelihood of someone coming into contact with a Preliminary Hazard Analysis, which uses the HRN system.
hazard and the degree of injury or damage to health that
could be caused should contact occur. A sample risk assessment form can be found in the
appendices at the end of this guide.
A hazardous situation is:
A situation where people are exposed to hazards. Numerical values are assigned to descriptive phrases
relating to:
Examples:
A moving belt on a conveyor would be a hazard. The risk The likelihood of occurrence (LO)
would be the likelihood of someone coming into contact  The frequency of exposure (FE)
with an in-running nip or being drawn along the belt by a  The degree of possible harm (OPH)
protrusion and the severity of injury or damage to health  The number of persons at risk (NP)
that could be caused. An electrical enclosure containing
voltages above 50v AC and 75v DC that has uncovered The hazard description is vital in understanding those risk
terminations is a hazard even though the enclosure may assessments, unless otherwise stated, the risk assessment
be kept locked and strict key control enforced. The reason relates to the hazards in the normal operation of the
for this is that if an electrician had to carry out diagnostic machine. Where a specific risk is associated with that
testing on a live enclosure they could inadvertently touch equipment, a separate risk assessment will be provided.
an adjacent terminal with a tool etc. The risk would be the
likelihood of that happening and the severity of injury or Where there is no control over the frequency of exposure,
damage to health that could be caused. a worst-case scenario must be assumed, and a constant
frequency is assigned.

Risk Assessment Definition

Risk Assessment Example
A comprehensive estimation of the probability and degree
of possible injury or damage to health in a hazardous Injury due to access to dangerous parts of machinery.
situation in order to select appropriate safety measures. The present guarding, partially fitted, allows access to the
moving parts.

13
 2
section
Risk Assessment

LO FE DPH NP=H.R.N. As mentioned at the start of this section, EN ISO 12100

2 X 5 X 4 X 1=40 is the main standard for risk assessment for machines
Degree of risk: = Significant and is harmonised to the Machinery Directive. It lays
down principles for risk assessment, hazard analysis and
From this example we can see that the existing guarding, documentation requirements.
whilst offering a certain amount of protection, is not
adequate and the degree of risk can be reduced further Also included within the standard is a table giving
by fitting a guard that completely prevents contact with examples of hazards, hazardous situations and hazardous
the hazard but does not affect the production. events. This table gives detail as to the kind of hazards or
hazardous situations that can occur. Anyone involved in a
Control Measure: risk assessment project for machinery should refer to this
Fit a tunnel guard that prevents all access to the moving list as matter of course unless they are totally confident in
parts in accordance with EN 953 and EN ISO 13857. their knowledge and ability to carry out the assessment.
After control measures fitted:

LO FE DPH NP=H.R.N. Safety Related Control Systems

0.1 X 0.1 X 4 X 1=0.04
Degree of risk: = Negligible A control system responds to input signals from the
machine or from the operator and generates output
The control measure has detailed the machinery needs signals. These make the machine operate in a desired
additional guarding, and has detailed the Standards to manner. So if for example, an operator presses a start
which you should construct that guard in accordance with. button then the control system may respond by closing a
EN Standards will be used for the correct control measure contactor and energising a motor. Control systems can be
where those Standards exist. The control measure is implemented in a range of technologies, but this guidance
deliberately left non-specific in its description in order to is mostly concerned with electro technical systems
allow the designer of that guard some scope of flexibility employing electrical, electronic and programmable
in his approach. If we detail an exact specification to a electronic technologies. Electro technical control systems
guard or control measure, we effectively tie your hands. can range from simple electromechanical relay based
Our assessments are one method of compliance and systems to complex programmable systems with multiple
should you find an alternative way to achieve compliance, analogue and digital inputs and outputs.
then we would welcome your suggestions. Our engineers
are available to give specific advice to you outside of What is a safety related control system?
these assessments should you require it. A control system in a machine should be regarded as
being safety-related if it contributes to reducing the
occurrence of a hazardous situation or if it is required

14
 2

section
Risk Assessment
to function correctly to maintain or achieve safety. The From a users point of view if you are implementing safety
functions carried out by a safety-related control system related controls using electrical/electronic/programmable
are termed safety functions. Generally safety functions electronic systems (E/E/PES) there is no clear distinction
either prevent the initiation of a hazard or detect the onset as to which of the standards should be used for any
of a hazard. Safety-related control systems should be particular application (EN ISO 13849-1 is not “technology
designed and configured to be reliable enough (bearing in specific” and can be used as guidance for non-electrical
mind the consequences of any failure) and to perform the technologies). The choice will be influenced by quite a
necessary functions to achieve or maintain a safe state or number of factors, however whichever of the standards
mitigate the consequences of a hazard. you choose the main steps to follow, and the outcomes,
are pretty much the same.
To assist a designer or assessor in deciding which of the
two main standards to use: BS EN ISO 13849 or EN (IEC) The Choice
62061, a distinction is drawn between those electro technical In the UK there was a considerable body of opinion that
safety related systems that use programmable technologies the use of BS EN ISO 13849-1 should be restricted to low
and those that use electromechanical components. complexity safety systems, and that BS EN 62061 should
be chosen for systems that used “Safety PLCs”, indeed
EN ISO 13849-1 and EN (IEC) 62061 the national foreword to the original BS editions of the
These are standards for safety related control systems that standards almost said as much. However the choices as far
are published in the UK as BS EN ISO 13849-1 and BS EN as the standards themselves are concerned is not that clear.
62061. They are both harmonised to the Machinery Directive Either standard can be used as guidance for both hardware
and this has left many people confused about which and application software for systems up to the highest
standard should be applied in any particular application. integrity or performance identified in them. So how does a
user make the decision? As already mentioned if the safety-
EN ISO 13849-1 (Safety of machinery, Safety related parts related controls use technologies other than E/E/PES then
of control systems, General principles for design) is the EN ISO 13849-1 is the only choice, but for the vast majority of
standard that replaced, EN 954-1 (Safety of machinery, systems several factors will influence the choice.
Safety related parts of control systems, General principles
for design), EN 954-1 was completely withdrawn at the It is becoming clear that more use is being made of EN ISO
end of 2011. EN 62061 (Safety of machinery, functional 13849-1, this is probably due to it being the replacement for
safety of safety-related electrical, electronic and EN 954-1 and carrying over a lot of the familiar content, but it
programmable electronic control systems) is also might also be because it is seen as the more straightforward
harmonised to the Machinery Directive. It is a machinery of the two (not necessarily the case!).
sector standard based on the requirements of IEC 61508.

15
 2
section
Risk Assessment

Some considerations that might influence the choice are: possible hazards should be eliminated by design, or fixed
safeguards should be in place to avoid exposing people
 revious knowledge and experience in the design of
P to hazards. EN ISO 12100 gives excellent guidance on
machinery control systems based upon the concept of these vitally important considerations. It is also worth
Categories described in ISO 13849-1:1999 may mean noting that neither EN ISO 13849-1 nor EN 62061 cover the
that the use of ISO 13849-1:2006 is more appropriate; general electrical safety aspects for machinery, this is the
Control systems based upon media other than subject of EN 60204.
electrical may mean that the use of ISO 13849-1 is more
appropriate; So it is only once it has been decided that further risk
Customer requirements to demonstrate the safety reduction is required from safeguards utilising safety
integrity of a machine control system in terms of a related controls that we should consider the guidance
Safety Integrity Level (SIL) may mean that the use of IEC given by either EN ISO 13849-1 or EN 62061.
62061 is more appropriate;
Control systems of machinery used in, for example, the Both standards use the concept of “functional safety”
process industries, where other safety-related systems which means specifying the safety requirements in terms
(such as safety instrumented systems in accordance of the functional requirements (for example: “When the
with IEC 61511) are characterised in terms of SILs may guard is opened hazardous movement must be stopped”),
mean that the use of IEC 62061 is more appropriate. and the amount of risk reduction required. EN 62061
(Source ISO/DTR 23849) uses Safety Integrity Levels (SIL), EN ISO 13849-1 uses
Performance Levels (PL). Both standards require the user
Main steps to follow essentially the same series of steps:
Machinery safety starts at the very beginning with the
design and development of the machine itself. Wherever

EN ISO 13849-1 Average probability of a dangerous EN 62061

Performance Level (PL) failure per hour [1/h] Safety Integrity Level (SIL)
a ≥ 10-5 to < 10-4 no special safety requirements
b ≥ 3 x 10 to < 10
-6 -5
1
c ≥ 10 to < 3 x 10
-6 -6
1
d ≥ 10 to < 10
-7 -6
2
e ≥ 10 to < 10
-8 -7
3
SIL 3 is directly equivalent to PLe, SIL 2 is directly equivalent to PLd, SIL 1 is equivalent to PLb – PLc
Verification according to hardware reliability. In order to verify that a target SIL or PL has been achieved it is necessary to consider a number of
things, these include the hardware architectures of the safety related controls (e.g. single channel or dual channel), the reliability of the components
used, the amount of Diagnostic Coverage (DC), and the susceptibility to Common Cause Failures (CCF). These are considered to be the quantifiable
aspects.

16
 2

section
Risk Assessment
 ssess the Risks
A incorrectly fitted, the mains isn’t terminated at the isolator.
Allocate the Safety measures Image B is a corrected version of A.
Design Architecture
Verify/Validate that the requirements have been met Multiple Earths/ terminations

Both standards have a recommended method to help

establish the amount of risk reduction that is required
from each safety function, although the methods are
quite different the outcomes should be the same (or very
similar) for any given function. In IEC 62061 the requirement Another common electrical fault is that of multiple
is a Safety Integrity Level (SIL), in ISO 13849-1 it is a terminations, in particular with earthing, onto one point.
Performance Level (PL). Both SILs and PLs are defined in
terms of the average probability of a dangerous failure per Guarding
hour, and there is a correspondence between them.

The future?
The standards organisations are working to produce a
single standard that will combine the contents of IEC 62061
and ISO 13849, this standard will be published as IEC/ISO Guarding is one of the more visual issues for machinery
17305. Publication is not expected until about 2018. safety. The examples used below are extreme but the
issues concerned are, is there guarding on the machine
and is it adequate.
Common Hazards
Hydraulics and Pneumatics
These common faults and hazards are examples taken
from our experience and are illustrated using the TÜV
SÜD virtual reality training model.

Isolators
Where you find hydraulics and pneumatics on machinery,
safety issues include the state of the pipework, whether
the pipes are correctly labelled and whether they have
lockable isolators or not.

Common faults that are found are that there isn’t an

isolator fitted, the isolator is of the wrong type or is

17
Take your training to a
higher level
Make sure you keep up-to-date with the latest machinery
safety Standards. TÜV SÜD provide a range of Machinery
Safety training courses from a half day ‘refresher course’
on machinery safety through to a five day University-
backed course on the European Machinery Safety
Requirements.

Find out more:

www.tuv-sud.co.uk/
training
 3

section
Four steps to CE marking
Section 3 - Four steps to CE marking for the
Machinery Directive
The machinery directive is one of the widest ranging Section Contents
directives due to the definitions of what is machinery.
According to machinery Directive 2006/42/EC, ■ Essential Health & Safety Requirements
machinery is:
■ Technical Construction Files
 n assembly, fitted with or intended to be fitted with
A
a drive system other than directly applied human or ■ Declaration of Conformity
animal effort, consisting of linked parts or components,
at least one of which moves, and which are joined ■ Affix the CE mark
together for a specific application
A n assembly referred to in the first indent, missing only ■ Project Management
the components to connect it on site or to sources of
energy and motion
A ssemblies of machinery or partly completed
machinery which, in order to achieve the same end,
are arranged and controlled so that they function as an
integral whole

It also states that a manufacturer is:

 ny natural or legal person who designs and/or

A
manufactures machinery covered by this Directive
and is responsible for the conformity of the machinery
with this Directive with a view to its being placed on
the market, under his own name or trademark or for his
own use.

So whether you are designing, manufacturing or

importing machinery, you need to know what your legal
duties and responsibilities are.

19
 3
section
Four steps to CE marking

Step 1: The Essential Health and 6. EHSRs to offset hazards due to the lifting of moving of
persons
Safety Requirements (EHSRs)
The 2006/42/EC Directive made changes to a number of
In order to comply with the Supply of Machinery (Safety) the EHSRs. Some of the more significant changes are as
Regulations, the machinery must be able to satisfy the follows:
EHSRs for any corresponding hazard which may apply
to it. Typical examples of Essential Health and Safety E HSR 1.1.7 The operating position must be designed to
Requirements are the requirements to provide adequate avoid any risk due to exhaust gases/ lack of oxygen
warning marks where there are moving parts that might EHSR 1.1.8 work stations that are an integral part of
trap parts of the body of personnel using the machine. the machine must be designed for the installation of
Another item would be the requirement to provide seating
safety guards to machine tools. EHSR 1.2.2 Manual controls must be clearly visible and
identifiable; the use of pictograms is recommended
The requirements are wide ranging, taking into account EHSR 1.4.2.1 Fixed guards. Fixing systems must remain
potential dangers to operators and other persons who may attached to the guards when removed
be at risk. The Essential Health and Safety Requirements EHSR 1.1.2 requires risk assessment to be carried out
are mandatory. However, taking into account the state of
art, it may not be possible to meet all the objectives set by Risk assessment is the fundamental starting point for
them. With this in mind, the machinery must be designed designers of machinery under the Machinery (Safety)
and constructed with the purpose of approaching Regulations as well as for operators of existing
these objectives. Within the Supply of Machinery machinery under the Provision and Use of Work
(Safety) Regulations, the Essential Health and Safety Equipment Regulations 98.
Requirements are divided into six sections:
The standard EN ISO 12100 entitled “Safety of
1. EHSRs applicable to all machinery Machinery –Risk Assessment” defines risk assessment
2. EHSRs for Certain categories of machinery including as “a series of logical steps to enable, in a systematic
Foodstuffs machinery, machinery for cosmetics or way, the analysis and evaluation of the risks associated
pharmaceutical products, hand-held and/or hand- with machinery.”
guided machinery, portable fixing and other impact
machinery, machinery for working wood and material EN ISO 12100 goes on; “Risk assessment is followed,
with similar physical characteristics whenever necessary, by risk reduction. Iteration of this
3. EHSRs to offset hazards due to the mobility of process can be necessary to eliminate hazards as far
machinery as practicable and to adequately reduce risks by the
4. EHSRs to offset hazards due to a lifting operation implementation of protective measures.”
5. EHSRs for machinery intended for underground work

20
 3

section
Four steps to CE marking
To assist manufacturers comply with the Directives BS EN 414
A Type Standards
and to harmonise standards throughout the EEA the BS EN 12100
European Commission charged CEN (Commission for B1 B2
B Type Standards BS EN 60204 BS EN 13850
European Normalisation) to prepare standards which BS EN 1088
will provide a European wide scope. These Standards
BS EN 12417
provide two important statements: BS EN 415
C Type Standards BS EN 693
BS EN 474
1. The level of safety attained in a member state must BS EN ISO 10218-1
not be lowered.
2. Products or machinery manufactured in conformity
with a specified published European Standard will be Step 2: Technical Construction File
presumed to comply with the Essential Health and
Safety Requirements covered by those standards. Under the Supply of Machinery (Safety) Regulations,
any manufacturer wishing to supply machinery
Construction of Standards within the European Economic Area (EEA) must be
A Type Standards apply to all machinery and are able to assemble a file, often known as the “product
essential reading to designers and builders. file”, containing technical information relative to the
machinery. The file must remain available for inspection
B Type Standards, these are laterally interlinked and are by a competent national authority, such as the UK
generally divided into B1 and B2 standards. Health and Safety Executive, for a period of ten years.
The file, however, does not have to include detailed
B1 Standards apply to all machinery and are designed to information such as the sub-assemblies of the machine,
promote the essential factors of safety. unless a knowledge of them is essential for verification
and compliance with the Essential Health and Safety
B2 Standards apply when used i.e. if a particular safety Requirements. For machinery it is considered this
device is used it must be manufactured to the relevant information is essential and should be provided.
standard.
The file should contain the following:
C Type Standards, these will inform designers, manufacturers T he Directives applicable for design, manufacture,
and users of specific safety precautions to be taken, and installation etc and with which compliance is claimed
devices which are required to be used in particular A ny other national standards/guidance/technical
specification as applicable
All standards which have been harmonised for A n overall drawing of the machinery
Machinery Directive 98/37/EC will need to be at least A list of the Essential Health and Safety Requirements
rewritten if not fully updated to ensure compliance with
the 2006/42/EC Directive.

21
 3
section
Four steps to CE marking

 omplete detailed drawings, calculation notes and

C Declaration of Incorporation
test results etc, deemed necessary to endorse the Partly completed machinery means an assembly
conformity of the machinery, with the EHSRs which is almost machinery but which cannot in itself
A n account of the techniques used to reduce or perform a specific application. It is only intended to be
eliminate hazards posed by the machinery/product. incorporated into or assembled with other machinery or
Drawings of the operating system/control circuitry partly completed machinery. The manufacturer of partly
with details outlining how it works completed machinery should draw up a declaration of
T he standards used and any reports/test results incorporation which should accompany the assembly
required by these standards instructions and the partly completed machinery when
A copy of all works and site testing and commissioning it is placed on the market. The declaration and assembly
reports instructions will then form part of the technical file for
If so desired a certificate or technical report obtained the final machinery.
from a competent body in support of standards
conformity
A copy of the operator’s instructions and maintenance Step 4: CE mark
manual
Affix the CE mark to machines which are issued with
Non-European manufacturers must appoint someone a Declaration of Conformity only. CE marking must be
within Europe to hold their Technical Files and this affixed in the immediate vicinity of the name of the
person’s name and address must be included in the manufacturer or Authorised Representative and applied
Declaration. using the same technique.

Step 3: Declaration Project Management

The Declaration of Conformity is a certificate, which must When building machines or when combining machines
accompany every machine placed on what is termed “the to produce a ‘complex assembly’ of machines it is easy
market” (unless a Declaration of Incorporation is issued to get things wrong and end up with a project that
instead). The manufacturer of a machine automatically requires a lot of rework and ends up going over budget
places the machine on “the market”. The Declaration or overtime. To this end, ensure that the CE marking is
is the manufacturer’s assurance to the customer that considered from the start.
the product complies with the applicable directives.
The Declaration carries relevant product information Frequently what happens is that equipment is designed
and is signed by a responsible person on behalf of the and installed with no thought as to what happens either
manufacturer or importer. upstream or downstream, or who takes

22
 3

section
Four steps to CE marking
the responsibility for which parts, and who takes Make sure they all understand which EN Standards to
responsibility for the final assembly. follow, and make sure they have copies of the Standards.
Ask for sample Declarations before deciding on suppliers,
This can be exacerbated when equipment is sourced and check to see if they have all the information on them,
from outside the European Economic Area, or existing and the correct numbers for example.
equipment is linked to new equipment.
Issue Purchase Orders, and ensure there is a clause
Common problems that occur when CE marking about CE marking, and whose responsibility it is.
is not considered from the start include: If building a complex assembly, decide how EMC
E quipment being installed before a final layout is issues are to be tackled if testing is to be carried out,
agreed - leads to machines being moved and rework all suppliers should be aware of potential failures,
being required. especially if using Inverter Drives. Check that these are
Consideration not given to a Safety related control installed using the manufacturers guidelines.
system at the start, leading to a number of problems
when linking different machines of different Before accepting and paying for any machines, check
performance level the machine under EN ISO 13849. that they meet the requirements of the order and also
Consideration not being given to control system that they conform to the Machinery Directive. If there is
functionality with feed conveyors not being stopped any doubt, it should be resolved before final payment.
when a process is stopped, leading to damaged
product at best, and injury at worst.
Machinery not being inspected before installation, and
then when non compliances are found, disagreements
about who pays to put it right, the supplier, the
contractor or the user.
Control colours not being agreed, with different
suppliers using different colours, leading to confusion.
The European Standard allows for Green, White, Black
or Grey for Start, and Red, White, Black or Grey for
Stop! Even by complying with the Standard, errors can
occur.

When starting a project, decide who is going to take

the responsibility for the CE marking, and lay down
the ground rules. Decide what Performance Level
the machine will come under, using EN ISO 13849 and
ensure all suppliers are aware of what is required.

23
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 4

section
EMC Solution
Section 4 - EMC Solutions
The main objectives of the EMC Directive, introduced in Section Contents
1992 and a mandatory requirement from 1996, are:

T o harmonise technical rules and requirements for ■ EMC Directive

controlling interference emitted by equipment and the
control of immunity of equipment to electromagnetic ■ Mains Filters
noise.
■ Cables

25
 4
section
EMC Solution

EMC Solutions electromagnetic compatibility. If, for example,

the control system of a machine is disturbed by
The EMC Directive, 2004/108/EC is due to be superseded electromagnetic interference it may randomly
by the EMC Directive 2014/30/EU in April 2016. In the malfunction, creating a potentially dangerous situation.
UK the Directive is implemented by the Electromagnetic Conversely, if the electrical and electronic systems
Compatibility (EMC) Regulations 2006. fitted to a machine generate a high level of interference,
they may cause other nearby equipment to malfunction.
The EMC Directive is concerned with the protection of
the radio spectrum to ensure that broadcast radio, TV,
communication and telecommunication systems can Higher Immunity
operate without interference. The immunity requirement
ensures that equipment operates without unacceptable The machinery sector Functional Safety standard EN
degradation. What is less well realised is that the EMC 62061, based on EN 61508, requires higher levels of
Directive is not a safety Directive and does not address immunity to interference for safety related electronic
EMC and its impact on Functional Safety. equipment. EN ISO 13849-1 requires compliance with
appropriate EMC standards. EMC immunity testing
The requirement for equipment to remain safe in relation is one of the verification techniques but as IEC/TS
to EMC and Functional Safety falls under the Machinery 61000-1-2 states, EMC and Functional Safety cannot
Directive 2006/42/EC itself, specifically under clause be achieved by testing alone due to the difficulty of
1.5.11; External radiation - Machinery must be designed testing all combinations and permutations of equipment
and constructed in such a way that external radiation and environment, operating conditions and modes
does not interfere with its operation. of operation. Conversely testing at higher immunity
levels can find failures that could not be predicted by
However demonstrating EMC and Functional Safety reviewing the design and therefore has a verification
under the Machinery Directive requires compliance with role to assess the ‘common’ EMC failure mechanisms.
the EMC Directive as a first step but with the addition of A new draft standard has been issued that provides
a risk assessment of the design for EMC and Functional more specific guidance on the higher immunity levels
Safety and the achievement of higher immunity required; EN 61000-6-7 Electromagnetic compatibility
performance for safety related elements. (EMC) - Part 6-7: Generic standards - Immunity
requirements for equipment intended to perform
Electromagnetic compatibility (EMC) is an issue that functions in a safety-related system (functional safety)
many machine builders find complex and confusing, in industrial locations.
but that doesn’t mean that they can ignore their
legal obligation to ensure their products meet the
requirements of the EMC and Machinery Directive.
There can be no doubt about the need for

26
 4

section
EMC Solution
Risk Assessment for EMC and summarised as saying that equipment must be designed
and manufactured so that the electromagnetic
Functional Safety disturbance it creates is not excessive, and so that it
has a reasonable level of immunity to electromagnetic
The best practice method of achieving EMC and disturbances. In addition, fixed installations – which
Functional Safety is by reference to technical includes the majority of machines - must be installed
specification IEC/TS 61000-1-2; Methodology for the applying good engineering practices and respecting the
achievement of functional safety of electrical and intended use of its components.
electronic systems including equipment with regard to
electromagnetic phenomena. IEC/TS 61000-1-2 can be Then comes a very interesting statement, “There are
considered the ‘EMC annex’ to EN 61508 and EN 62061. no conformity assessment or CE marking requirements
for fixed installations”. Does this mean that builders of
Where possible the design should mitigate the EMC machines categorised as fixed installations have no
immunity hazard by use of e.g. inherently immune need to concern themselves with the EMC performance
technology, diverse technology and other design of their products? Indeed it does not. The machines
measures such as those set out in the IET guide; must still be designed and manufactured so that they
Overview of techniques and measures related to EMC meet the essential requirements mentioned earlier – the
for Functional Safety, available on the IET website. only relaxation of the rules relates to assessment and
Although the tools available for EMC hazard and risk marking, not to performance!
assessment are limited, approaches are available such
as those specified in IEC/TS 61000-1-2 to construct an But how can machine builders be sure that their
EMC matrix to identify and analyse the safety related products really do have satisfactory EMC performance?
elements of a system and their interaction with internal It’s very tempting to think that the answer is to use only
and external sources of interference. The key objective components that are themselves compliant with the
is that even if a safety related element becomes EMC Regulations. Surely, if all of the components used
susceptible, the overall system remains safe. in a machine satisfy the regulations, it’s reasonable to
conclude that the whole machine must also meet the
regulations?
EMC Directive
Unfortunately, that’s not how it works and it’s relatively
Returning to the first step to meet the EMC Directive, easy to see why. Consider, for example, a variable
to understand the implications for machine builders, speed drive that, for the sake of argument, produces
a good starting point is to look at the “Guide to the a level of electromagnetic interference about half of
Electromagnetic Compatibility (EMC) Regulations that acceptable under the regulations. Clearly, there’s
2006”. Section 2 of this guide, which covers essential no problem in stating that this drive complies with the
requirements, includes statements that can be regulations.

27
 4
section
EMC Solution

Now put four of those drives on a machine. Is it For this reason, many machine builders find it preferable
reasonable to assume that the machine complies with to work with a specialist consultant like TÜV SÜD on
the regulations, simply because each of the drives matters relating to EMC. Provided that they are involved
is compliant? Probably not. The machine may be with a project at an early enough stage, a consultant of
compliant, especially if measures to control EMC have this type can provide design guidance that will help to
been incorporated in its design, but the point is that it optimise the EMC performance of the machine, as well
can’t be assumed to be compliant. In fact, since there as giving invaluable advice on compliance and testing.
is no proven way of calculating or modelling the EMC The consultant’s services may also include arranging for
performance of a machine, it is the opinion of TÜV SÜD and supervising the tests.
that the only way compliance with the EMC Directive
can be verified is by testing. This opinion may be The period after testing is often the time when the
considered by some as rather controversial, but when knowledge and ability of the consultant engineer really
the Health & Safety Executive was asked to comment on comes into play. Rather than walk away from a machine
this issue, it provided the following statement: which has issues with EMC and hence has failed some
or all of the tests carried out, TÜV SÜD engineers
“Section 6 of the Health & Safety at Work Act (HSW) will work with the customer to find the source of the
places a duty on manufacturers to carry out or arrange problem and guide the customer to find a solution.
for the carrying out of such testing and examination The following principles can be used to improve the
as may be necessary to ensure that the article is machines EMC performance and help pass the testing.
so designed and constructed that it will, as far as is
reasonably practicable, be safe and without risks to 1. Mains Filters
health. In the context of EMC, in most applications it To reduce the conducted emissions from the machine
is the electromagnetic immunity of equipment that is and improve its immunity to transients, a mains filter is
of interest in relation to Section 6 of the HSW. If it is required. It is important to ensure that all supply cables
reasonably practicable to carry out testing for immunity are filtered, i.e. all live supply cables and Neutral. When
to electromagnetic disturbances, the HSW requires this fitting a mains filter it is important to ensure that it is
to be carried out”. fitted correctly, i.e. it must be mounted at the point
where the mains incoming cable enters the cabinet, the
This statement leaves no room for doubt about the body of the mains filter should be bonded to the metal
necessity for EMC testing of machines in the vast majority work of the electrical cabinet and the bond should be
of cases – there is simply no shortcut to achieving metal to metal. When wiring the rest of the electrical
compliance with the EMC and Machinery Directive cabinet ensure that all cables are routed away from the
Regulations. Unfortunately, there is also no doubt that mains input cables.
EMC testing can be complex and time consuming,
especially for the majority of machine builders that lack
in-house expertise in this specialist area.

28
 4

section
EMC Solution

Electrical
cables be used. The screens of these cables must be
Electrical
Mains
Mains
Filter
Cabinet
Cabinet bonded to their local EMC earth at both ends, and it
Filter
is recommended that this bonding exists around all
360 degrees of the cables (i.e. their entire periphery).
Unscreened cables entering and leaving the cabinet
should be filtered.
Mains
MainsCable
Cable

When installing screened cables the screen should not


be used as a signal return path. For unscreened cables
Electrical
Electrical
Cabinet
Cabinet all signal and return cables should be twisted, i.e. Live &
Neutral, 24v and 0v. It is important not to mix signal and
return cables. When bonding other parts of machinery
such as doors and lids etc. ensure that the earth straps
Mains
Mains
Filter
Filter
have a large cross section. Braids or thick cables are
Mains
MainsCable
Cable
normally used for these purposes. These should be kept
as short as possible.
2. Cables Unscreened cables are filtered
When routing cables within a machine it is important to
consider the types of cables concerned. Mains Mains
These can be broken down into the following broad Filter Filter

areas:
Trunking bonded to
A B
cabinets at both ends

T ype 1: Sensitive analogue cables. (Measuring signals)

Type 2: Ordinary analogue cables and digital cables. Cabinet 1 Cabinet 2

(RS422, RS458, limit switches)

Type 3: Low voltage AC controls and DC power.
(Relays, contactors, solenoids DOL motors) All metal work bonded to earth
Type 4: Very noisy signals. (Inverter input / output
cables, DC motors, RF generators)

It is important not to mix the different types of cable

together, however when contact is unavoidable they
should run perpendicular to each other. When the
machine consists of a number of sub assemblies, which
require interconnection via long lengths of cables,
it is recommended that where possible, screened

29
mCom+ Solution
Helping you manage machinery compliance
mCom + is a bespoke software solution that enables TÜV
SÜD to support you in meeting CE marking and PUWER
obligations, by guiding users through the compliance
process. A simple checklist system ensures that no
vital steps are missed with a final report generating a
prioritised action list for any areas of non-compliance.

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 5

section
PUWER
Section 5 - PUWER
The Provision and Use of Work Equipment Regulations Section Contents
1998 (PUWER) requires users of work equipment to
carry out risk assessment and provide work equipment
that is suitable for its intended task and can be used ■ PUWER Regulations
without putting persons at risk. The Regulations cover
any machinery, appliance, apparatus, tool or installation ■ Regulation 6
for use at work (whether exclusively or not) - effectively
it is anything used at work. ■ Regulation 10-24

The Regulations introduce requirements to ensure that

health and safety inspections are carried out:

 fter installation and before being put into service

A
for the first time; or after assembly at a new site or
in a new location to ensure that it has been installed
correctly and is safe to operate.
After work equipment has been exposed to any
conditions causing deterioration, which is liable to
cause a dangerous situation.
At suitable intervals; and
Each time that exceptional circumstances have
occurred that are liable to jeopardise the safety of
work equipment. The results of these inspections
have to be documented and kept until the subsequent
inspection is recorded.

The Regulations make it an offense to allow work

equipment to leave an employer’s undertaking, or if
obtained from another undertaking, be used, unless
it is accompanied by physical evidence that the last
inspection has been carried out.

31
 5
section
PUWER

PUWER Regulation 6: Inspection

The primary objective of PUWER is to ensure the Where the safety of work equipment depends on
provision of safe work equipment and its safe use. This installation it must be inspected:
has several components, which are interlinked: (a) After installation and before being put into
service for the first time or
 ork equipment should not give rise to risks to health
W (b) After assembly at a new site or in a new location
and safety, irrespective of its age or place of origin.
T he Regulations implement European Community (EC) Work equipment that is exposed to conditions causing
Directive 89/655/EEC, amended by the non-lifting deterioration liable to result in a dangerous situation
aspects of the Work Equipment Directive (AUWED). must be inspected:
T he Regulations are made under the Health and Safety (a) At suitable intervals, and
at Work, etc Act 1974 (HSW Act), and apply to all users (b) Each time circumstances liable to jeopardise the
and the self employed covered by that Act in Great safety have occurred
Britain except the crews of sea-going ships.
These regulations place a requirement to carry out a Risk The results of any inspection made under this regulation
Assessment on all existing equipment (see section Six). must be recorded and kept until the next inspection.
T he regulations ask that the electrical system, the
guarding and other possible hazards be assessed and Every employer shall ensure that no work equipment:
corrected if required. (a) Leaves their undertaking, or
(b) If obtained from the undertaking of another
The Health And Safety At Work Act 1974 Section 2(2) person, is used in their undertaking unless
Employers must, so far as is reasonably practicable
provide and maintain plant and systems of work that are It is accompanied by physical evidence that the last
safe & without risk to health. required inspection has been carried out:

Risk Assessments are a key part to any PUWER Y ou should ensure that the persons who determine the
assessment and are cross-referenced with the nature of the inspections required and who carry out
appropriate section/question at all times. If a non- the inspections are competent to do so.
compliance does occur and you are asked for your T he competent person should have the necessary
reports you will probably be asked primarily for the knowledge and experience to decide what the
risk assessments carried out against the equipment in inspection should include, how and when it should be
question. In order to fully comply, Risk Assessments carried out.
are carried out and where problems are found they are Every employer must ensure that any work equipment
reported against a particular section/question. complies with any European Directive that applies to it.

32
 5

section
PUWER
Regulations 10-24 Reg 17: Controls
 an the operator see all around the machine from the
C
The following questions highlight the types of hazards operating position
that need to be considered under PUWER: Is there a delayed start and warning system

Reg 10: Conformity with community requirements Reg 18: Control systems
Equipment complies with all applicable Directives I s the control system fail safe
Is it possible to be trapped in a machine
Reg 11: Dangerous parts of machinery
I s there access to dangerous parts of machinery Reg 19: Isolation of energy sources
A re guards positioned correctly and securely held Can all sources of energy be isolated and locked
Can the guarding be bypassed or disabled
Reg 20: Stability
Reg 12: Protection against specified hazards I s the machine stable under its own weight or bolted to
I s there any possibility of fire or explosion the floor
Is there a possibility of a discharge of hazardous material
Reg 21: Lighting
Reg 13: High or very low temperatures I s ambient lighting of adequate intensity
A re there any hot/cold surfaces If not is the machine provided with adequate lighting

Reg 14: Controls for starting or making a Reg 22: Maintenance

significant change in operating conditions  an safe maintenance be carried out
C
I s a start control provided A re safe working procedures in place
Is there a reset facility provided
W ill the machine restart automatically after a stoppage Reg 23: Markings
 re flow directions marked
A
Reg 15: Stop controls A re rotational directions marked
 re normal stop controls provided
A A re pipes and vessels marked
Does the machine stop safely A re permanently live circuits marked

Reg 16: Emergency stops Reg 24: Warnings

 re E -stops located correctly
A  re relevant PPE warnings posted
A
Do they function correctly A re electrical safety warnings posted
A re hot surface warnings posted
Have audible & visual warnings got a checking function

33
Field Labelling - Your
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Service includes:
■ Preliminary Inspection
■ The Field Evaluation Final Inspection
■ The NRTL Field Label

Find out more:

www.tuv-sud.co.uk/
field-labelling
 6

section
Pre-Purchase Audit
Section 6 - Pre-Purchase Audit
The Pre-Purchase Audit is a system designed to assist Section Contents
their clients to purchase machinery and equipment that
is both safe and correct.
■ Background

■ PUWER Assessment

■ Solution

■ What to look at

35
 6
section
Pre-Purchase Audit

Background use to make sure it is safe. This inspection, if carried out

correctly, will highlight any safety issues, which may
When the Provision and Use of Work Equipment have an effect on the CE marking of the equipment. Any
Regulations (PUWER) first came into force in 1992 it issues that appear to relate to the CE marking of the
included a very simplistic view on CE marking: the end equipment should be raised with the manufacturer or
user only has to check that the equipment concerned supplier of the equipment. However, as the equipment
carried a CE Mark. If it did, they were able to presume has been installed it may be more difficult to deal with.
conformity. PUWER was updated in 1998 and one of the
more important, but easily overlooked, changes was
that the onus was now put on the end-user to make sure The Solution
that the equipment complies with all relevant legislation
such as CE marking. These changes were re-enforced A solution to this is to use a User Requirement
with further changes in June 2002. Specification (URS) when purchasing new equipment.
This specification will outline your requirements for the
This point has been further backed up in other guidance equipment supplier. A URS should include statements
from HSE including “INDG 271 - Buying new machinery”. such as:
This document asks the question “Is CE marking a T he machine must comply with all applicable European
guarantee of safety?” The answer given is “No. The and UK legislation. (List all applicable Directives)
manufacturer is claiming that the machinery complies Euro-Norm Standards should be used to achieve
with the law. You still need to check the machine is safe compliance with the Essential Safety Requirements of
before it is used”. A list of items to think about (such as do all applicable Directives
any parts look dangerous, are there guards and are they Documentary evidence demonstrating compliance
in place?) is included along with a brief checklist entitled with all applicable Directives will be required
“What do I do when I have bought new machinery?” The A Declaration of Conformity will be required
key in all of this is that the emphasis is on the purchaser to A CE mark will be applied to the machine, preferably on
check that the machine is safe to use. the makers nameplate
A full operation and maintenance manual that complies
If this is the case, and the end-user should now check with EHSR 1.7.4 of the Machinery Directive will be
more thoroughly regarding the CE marking of new required
equipment, what is the best way to do this?
The above is not a complete list, but is indicative of the
type of information you should be asking for.
PUWER
To ensure compliance with the URS, the equipment may
To fully comply with PUWER, any new equipment should need to be inspected or audited before it is shipped from
be inspected after installation and before it is put into the manufacturer or supplier. But this inspection need not

36
 6

section
Pre-Purchase Audit
be limited to only safety issues. Often a purchaser may Areas to look at include:
want to inspect his equipment to ensure the product he is  ocumentation, manuals, etc.
D
receiving is indeed the product he believes he is buying. Drawings, electrical pneumatic, hydraulic etc.
These inspections are both engineering and quality Electrical wiring and termination checks
based. Often a company may lack the skill or resources to Hardware checks
carry out an inspection of this type in one visit. Environmental checks
Calibration, machine parameters, control systems
Combining the two inspections into one is a cost Software
effective method of ensuring the machine you receive Safety CE, PUWER as applicable
is both safe and meets your specification. Any potential Safety related control systems, interlocks etc.
issues can be raised with the manufacturer and either Safety, manual handling, COSHH, hazards etc
dealt with before it is shipped or at least be planned Ergonomic Assessments
into the installation process once the equipment has Maintenance and cleaning procedures
been shipped. Retrofitting is the more difficult method of Training requirements
compliance; it is always advisable to deal with safety as
early as possible in the purchasing process, the design It may also be beneficial at this stage to collate all the
stage being preferable. relevant documentation such as manuals, drawings etc
so that a file is in place when the equipment arrives on
So, if as a company, you decide to include such an audit site.
in your equipment purchasing policy, what would you
need to look at and who should carry out the audit?
Dealing with the person first, they should have a good External Assistance
knowledge of the equipment type itself as well as
competent understanding of PUWER and CE marking There may be many reasons why a company feels
legislation and have a sound engineering background that a pre-purchasing audit is not feasible. It may be
to understand the latest developments in machine manpower, time, competence or a mixture of the three.
manufacture. Whilst the auditor may not go through the TÜV SÜD currently carries out this kind of audit for a
EHSRs as in-depth as the manufacturer, the same areas number of major blue chip companies, both in the UK
need to be covered. It may be beneficial for the auditors and abroad. Following the audit, the client will receive
to create a generic checklist that can be used so that all a full report highlighting any problem areas with a
people who are carrying out an audit for the company recommended corrective action. TÜV SÜD can also
are looking at the same points. carry out an inspection to enable compliance with
PUWER.

37
 7
section
Appendices

Machinery Safety
Training
Make sure you keep up-to-date with the latest machinery
safety Standards. TÜV SÜD provide a range of Machinery
Safety training courses from a half day ‘refresher
workshop’ on machinery safety through to a five day
University-backed course on the European Machinery
Safety Requirements.

Find out more:

www.tuv-sud.co.uk/
training

38 38
 7

section
Appendices
Section 7 - Appendices
The following pages consist of forms, charts and Section Contents
checklists that can be used to make-up a machinery
safety inspection. Please feel free to photocopy
before using. ■ Safety Related Control Systems

Please note the use of the checklists does not ■ EN 62061

guarantee compliance, they should be used as aide
memoires as part of an inspection. ■ Risk Assessment Template

■ Technical File Checklist

39
 7
section
Appendices

Safety Related Control Systems

EN ISO 13849-1

Severity of injury
S1 - Slight injury
S2 - Severe injury

Frequency of Exposure
F1 - Less frequent or short duration
F2 - Frequent or long duration

Possibility of Avoidance
P1 - Possible
P2 - Less possible

EN 62061
Frequency, FR Probability of
Class CI Avoidance, Av
Severity (duration > 10 min) Hazard. Event, Pr
Consequences
SE 3-4 5-7 8-10 11-13 14-15
<1 hour 5 Common 5
Death, losing an eye or arm 4 SIL 2 SIL 2 SIL 2 SIL 3 SIL 3
>hr - >1 day 5 Likely 4
Permanent, losing fingers 3 OM SIL 1 SIL 2 SIL 3
>1 day - <2 wks 4 Possible 3 Impossible 5
Reversible, medical attention 2 OM SIL 1 SIL 1
>2 wks - <1yr 3 Rarely 2 Possible 3
Reversible, first aid 1 OM SIL 1
>1 year 2 Negligible 1 Likely 1

Calculate Class first, Cl (Class) = Fr + Pr + Av, then the consequence defines the SIL level.

40
 Risk Assessment

Company: ......................................................................................................................................

Type: .................................................................. Make: ............................................................

Model : ............................................................... Serial Number: ............................................

Location: ........................................................... Power Supply: .............................................

Nature of Hazard:

Risk Assessment:
LO FE DPH NP HRN
Degree of Risk:
Recommended Control Measure:

Risk Assessment:
LO FE DPH NP HRN
Degree of Risk:
Further risk reduction required?
Assessment By:

Date:


41
 FE Frequency of
LO Likelihood of Occurrence
Exposure
0 Impossible cannot happen 0.1 Infrequently
0.1 Almost unlikely possible in extreme circumstances 0.2 Annually
0.5 Highly unlikely though conceivable 1 Monthly
1 Unlikely but could occur 1.5 Weekly
2 Possible but unusual 2.5 Daily
5 Even chance could happen 4 Hourly
8 Probable not surprised 5 Constantly
10 Likely to be expected
15 Certain no doubt

DPH Degree of Possible Harm NP Number of Persons

0.1 Scratch or bruise 1 1-2 persons
0.5 Laceration or mild ill health 2 3-7 persons
1 Break of a minor bone or minor illness (temporary) 4 8-15 persons
2 Break of a major bone or minor illness (permanent) 8 16-50 persons
4 Loss of limb/eye/serious illness of a temporary natury 12 50+ persons
8 Loss of limbs/eyes/serious illness of a permanent nature
15 Fatality

Risk Negligible Very Low Low Significant High Very High Extreme Unacceptable
HRN 0-1 1-5 5-10 10-50 50-100 100-500 500-1000 Over 1000

Comments/Measures Implemented:

Review Dates:


42 42
 Technical File Inclusions

Section One : Risk Assessments Signature

1A Safety related control circuit assessment
1B Risk assessment
1C Support documentation for assessments

Section Two : Essential Requirements

2A Essential health and safety requirements
2B Complete detailed drawings showing conformity with the ESHR
2C Calculation notes, test results showing conformity with EHSR
2D Electrical checklist
2E Pneumatic checklist
2F Hydraulic checklist

Section Three : Standards

3A The Standards used
3B Reports and test results required by the Harmonised Standards

Section Four : Certification and Specifications

4A Any technical specifications
4B Certificates or technical reports obtained from a competent body
supporting conformity (optional)

Section Five : Drawings

5A Overall drawings
5B Drawing of control circuitry
5C Specific drawings

Section Six : Manuals

6A Instruction manual in the language of the country of intended use
6B Maintenance manual
6C Other manuals

Section Seven : Series Manufacture

7A For series manufacture internal measures implemented to ensure
machinery remains in conformity with the Directive

Section Eight : Other Documentation

8A Any other documentation showing support for product

Section Nine : Declarations/Inclusions

9A Declaration of Conformity/Incorporation


43
A practical guide to machinery safety
www.tuv-sud.co.uk/machinery
[email protected]

TÜV SÜD Product Service

2014 © TUV SUD Ltd | UK-MKG/IDP/1.0/en/GB

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