INTERNATIONAL ISO

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STANDARD 80601-2-12

First edition
2011-04-15

Medical electrical equipment —

Part 2-12:
Particular requirements for basic safety
and essential performance of critical care
ventilators
Appareils électromédicaux —
Partie 2-12: Exigences particulières relatives à la sécurité de base et
aux performances essentielles des ventilateurs pulmonaires pour
utilisation en soins intensifs

Reference number
ISO 80601-2-12:2011(E)

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Contents Page

Foreword ............................................................................................................................................................ vi
Introduction ...................................................................................................................................................... viii
201.1 Scope, object and related standards................................................................................................... 1
201.1. 1 Scope ..................................................................................................................................................... 1
201.1. 2 Object .................................................................................................................................................... 2
201.1. 3 Collateral standards ............................................................................................................................. 2
201.1. 4 Particular standards ............................................................................................................................. 2
201.2 Normative references ............................................................................................................................ 3
201.3 Terms and definitions ........................................................................................................................... 6
201.4 General requirements ........................................................................................................................... 9
201.4. 3 ESSENTIAL PERFORMANCE ....................................................................................................................... 9
201.4. 3.101 * Additional requirements for ESSENTIAL PERFORMANCE .............................................................. 9
201.4. 6 * ME EQUIPMENT or ME SYSTEM parts that contact the PATIENT ............................................................ 9
201.4. 11.101 * Additional requirements for pressurized gas input .............................................................. 9
201.4. 11.101.1 Overpressure requirement ...................................................................................................... 9
201.4. 11.101.2 Compatibility requirement ..................................................................................................... 10
201.5 General requirements for testing of ME EQUIPMENT ........................................................................... 10
201.5. 101 * Additional requirements for general requirements for testing of ME EQUIPMENT ................... 10
201.5. 101.1 VENTILATOR test conditions ......................................................................................................... 10
201.5. 101.2 * Gas flowrate and leakage specifications................................................................................ 11
201.5. 101.3 * VENTILATOR testing errors ......................................................................................................... 11
201.6 Classification of ME EQUIPMENT and ME SYSTEMS................................................................................ 11
201.7 ME EQUIPMENT identification, marking and documents ..................................................................... 11
201.7. 2.3 * Consult ACCOMPANYING DOCUMENTS .............................................................................................. 11
201.7. 2.101 Additional requirements for marking on the outside of ME EQUIPMENT or ME EQUIPMENT
parts ...................................................................................................................................................... 11
201.7. 2.4.101 Additional requirements for ACCESSORIES .............................................................................. 12
201.7. 2.13.101 Additional requirements for physiological effects ............................................................. 12
201.7. 2.17.101 Additional requirements for protective packaging ............................................................. 13
201.7. 4.3 * Unit of measure ............................................................................................................................. 13
201.7. 9.1 Additional general requirements ................................................................................................... 13
201.7. 9.2.1.101 Additional general requirements ......................................................................................... 14
201.7. 9.2.2.101 * Additional requirements for warnings and safety notices ............................................. 14
201.7. 9.2.8.101 * Additional requirements for start-up procedure.............................................................. 15
201.7. 9.2.9.101 * Additional requirements for operating instructions ....................................................... 15
201.7. 9.2.12 Cleaning, disinfection, and sterilization .................................................................................. 16
201.7. 9.2.14.101 * Additional requirements for ACCESSORIES, supplementary equipment, used
material ................................................................................................................................................. 16
201.7. 9.2.16.101 * Additional requirements for reference to the technical description ........................... 16
201.7. 9.3.1.101 * Additional general requirements ....................................................................................... 16
201.7. 9.3.101 Additional requirements for the technical description ........................................................ 17
201.8 Protection against electrical HAZARDS from ME EQUIPMENT ............................................................... 17
201.9 Protection against mechanical HAZARDS of ME EQUIPMENT and ME SYSTEMS .................................... 17
201.9. 6.2.1.101 Additional requirements for audible acoustic energy ....................................................... 17
201.9. 101 * Additional requirements for suction procedures ..................................................................... 18
201.10 Protection against unwanted and excessive radiation HAZARDS .................................................... 20

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201.11 Protection against excessive temperatures and other HAZARDS .....................................................20

201.11. 6.4 Leakage...........................................................................................................................................20
201.11. 6.5.101 * Additional requirements for ingress of water or particulate matter
into ME EQUIPMENT or ME SYSTEM ..........................................................................................................21
201.11. 6.6 * Cleaning and disinfection of ME EQUIPMENT or ME SYSTEM........................................................21
201.11. 6.7 Sterilization of ME EQUIPMENT or ME SYSTEM..................................................................................21
201.11. 8.101 Additional requirements for interruption of the power supply/SUPPLY MAINS
to ME EQUIPMENT ....................................................................................................................................22
201.11. 8.101.1 TECHNICAL ALARM CONDITION for power supply failure ..........................................................22
201.11. 8.101.2 INTERNAL ELECTRICAL POWER SOURCE or external reserve electrical power source ............22
201.12 Accuracy of controls and instruments and protection against hazardous outputs.....................23
201.12. 1 * Accuracy of controls and instruments ........................................................................................23
201.12. 1.101 Volume-controlled breath type .................................................................................................23
201.12. 1.102 Pressure-controlled breath type ..............................................................................................26
201.12. 1.103 * DELIVERED VOLUME MONITORING.................................................................................................29
201.12. 1.104 * Response of the VENTILATOR to an increase in O2 concentration ......................................29
201.12. 4 Protection against hazardous output .............................................................................................31
201.12. 4.101 Oxygen monitor .........................................................................................................................31
201.12. 4.102 * Measurement of AIRWAY PRESSURE .........................................................................................31
201.12. 4.103 * Measurement of expired volume and low-volume ALARM CONDITIONS ................................32
201.12. 4.103.1 VENTILATORS intended to provide a DELIVERED VOLUME > 50 ml ...........................................32
201.12. 4.103.2 VENTILATORS intended to provide a DELIVERED VOLUME u 50 ml ...........................................32
201.12. 4.104 * MAXIMUM LIMITED PRESSURE PROTECTION DEVICE .......................................................................33
201.12. 4.105 High-pressure ALARM CONDITION and PROTECTION DEVICE .........................................................33
201.12. 4.106 PEEP ALARM CONDITIONS...............................................................................................................33
201.12. 4.107 * Obstruction ALARM CONDITION..................................................................................................33
201.12. 4.108 * Partial-occlusion ALARM CONDITION .........................................................................................34
201.12. 101 * Protection against accidental adjustments .............................................................................34
201.13 HAZARDOUS SITUATIONS and fault conditions ......................................................................................34
201.13. 2.101 * Additional specific SINGLE FAULT CONDITIONS .........................................................................34
201.13. 102 * Failure of one gas supply to a VENTILATOR ...............................................................................35
201.13. 103 * Independence of ventilation control function and related RISK CONTROL measures ............35
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) ..........................................................................35
201.14. 101 Software life cycle ........................................................................................................................35
201.15 Construction of ME EQUIPMENT.............................................................................................................35
201.15. 3.5.101 Additional requirements for rough handling .......................................................................35
201.15. 3.5.101.1 * Shock and vibration ..........................................................................................................35
201.15. 3.5.101.2 * Shock and vibration for a MOBILE VENTILATOR .................................................................36
201.15. 101 Mode of operation.........................................................................................................................37
201.15. 102 Delivered Oxygen concentration ................................................................................................38
201.15. 103 ACCESSORY self-check ..................................................................................................................38
201.16 ME SYSTEMS ...........................................................................................................................................38
201.16. 1.101 Additional general requirements for ME SYSTEMS ...................................................................38
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS ....................................................38
201.17. 101 Additional requirements for electromagnetic compatibility of ME EQUIPMENT and
ME SYSTEMS ............................................................................................................................................38

201.101 Gas connections .................................................................................................................................38

201.101. 1 * Protection against reverse gas leakage.....................................................................................38
201.101. 2 Connection to the MEDICAL GAS PIPELINE SYSTEM ...........................................................................39
201.101. 3 VBS connectors ...............................................................................................................................39
201.101. 3.1 * General .......................................................................................................................................39
201.101. 3.2 Other named ports.......................................................................................................................39
201.101. 3.2.1 PATIENT-CONNECTION PORT..........................................................................................................39
201.101. 3.2.2 GAS OUTPUT PORT and GAS RETURN PORT ...................................................................................39
201.101. 3.2.3 MANUAL ventilation port ............................................................................................................39
201.101. 3.2.4 EMERGENCY INTAKE PORT ............................................................................................................40

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201.101. 3.2.5 FLOW-DIRECTION-sensitive components .................................................................................. 40

201.101. 3.2.6 ACCESSORY port ......................................................................................................................... 40
201.101. 3.2.7 Monitoring probe port .............................................................................................................. 40
201.101. 3.2.8 Gas EXHAUST PORT ..................................................................................................................... 40
201.102 Requirements for the VBS and ACCESSORIES ..................................................................................... 40
201.102. 1 * General .......................................................................................................................................... 40
201.102. 2 Labelling .......................................................................................................................................... 40
201.102. 3 Breathing tubes .............................................................................................................................. 41
201.102. 4 * Water management ...................................................................................................................... 41
201.102. 4.1 Humidification system ................................................................................................................ 41
201.102. 4.2 HEAT AND MOISTURE EXCHANGER (HME) .......................................................................................... 41
201.102. 5 Gas mixers ...................................................................................................................................... 41
201.102. 6 BREATHING SYSTEM FILTERS .............................................................................................................. 41
201.102. 7 VENTILATOR BREATHING SYSTEMS ...................................................................................................... 41
201.102. 7.1 Leakage from complete VBS ....................................................................................................... 41
201.102. 7.2 * Non-invasive ventilation........................................................................................................... 42
201.103 * Spontaneous breathing during loss of power supply.................................................................. 42
201.104 * Training ............................................................................................................................................. 43
201.105 * Indication of duration of operation ................................................................................................ 43
201.106 SIGNAL INPUT/OUTPUT PART ................................................................................................................... 43
201.106. 1 General ............................................................................................................................................ 43
201.106. 2 * Connection to an electronic health record................................................................................ 43
201.106. 3 * Connection to a DISTRIBUTED ALARM SYSTEM ............................................................................... 43
201.106. 4 * Connection for remote control ................................................................................................... 43
201.107 Display loops ...................................................................................................................................... 43
201.107. 1 Pressure-volume loops .................................................................................................................. 43
201.107. 2 Flow-volume loops ......................................................................................................................... 44
201.108 * Timed ventilatory pause .................................................................................................................. 44
201.108. 1 Expiratory pause ............................................................................................................................ 44
201.108. 2 Inspiratory pause............................................................................................................................ 44
202 Medical electrical equipment – Part 1-2: General requirements for basic safety and
essential performance – Collateral standard: Electromagnetic compatibility –
Requirements and tests ...................................................................................................................... 45
202.6.2.1.10 * Compliance criteria ................................................................................................................... 45
206 Medical electrical equipment – Part 1-6: General requirements for basic safety and
essential performance – Collateral Standard: Usability .................................................................. 46
208 Medical electrical equipment – Part 1-8: General requirements for basic safety and
essential performance – Collateral Standard: General requirements, tests and guidance
for alarm systems in medical electrical equipment and medical electrical systems ................... 47
208.6.3.3.2.101 * Additional requirements for characteristics of ALARM CONDITION logging ...................... 47
208.6.8.3.101 Additional requirements for global indefinite ALARM SIGNAL inactivation states................. 47
208.6.8.4.101 * Additional requirements for termination of ALARM SIGNAL inactivation ............................. 47
Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT and
ME SYSTEMS ............................................................................................................................................ 48

Annex D (informative) Symbols on marking .................................................................................................. 53

Annex AA (informative) Particular guidance and rationale .......................................................................... 55
Annex BB (informative) Reference to the Essential Principles .................................................................... 72
Bibliography ...................................................................................................................................................... 74
Alphabetized index of defined terms used in this particular standard ....................................................... 77

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Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.

International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.

The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.

ISO 80601-2-12 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment,
Subcommittee SC 3, Lung ventilators and related equipment, and Technical Committee IEC/TC 62, Electrical
equipment in medical practice, Subcommittee SC D, Electrical equipment. The draft was circulated for voting
to the national bodies of both ISO and IEC.

This first edition of ISO 80601-2-12 cancels and replaces the second edition of IEC 60601-2-12:2001. This
edition of ISO 80601-2-12 constitutes a major technical revision of IEC 60601-2-12:2001 and includes an
alignment with the third edition of IEC 60601-1.

The most significant changes are the following modifications:

 extending the scope to include the critical care VENTILATOR and its ACCESSORIES, where the characteristics
of those ACCESSORIES can affect the BASIC SAFETY and ESSENTIAL PERFORMANCE of the VENTILATOR, and
thus not only the critical care VENTILATOR itself;

 identification of ESSENTIAL PERFORMANCE for a critical care VENTILATOR and its ACCESSORIES;

 modification of the obstruction of the expiratory limb (continuing AIRWAY PRESSURE) ALARM CONDITION
requirement;

and the following additions:

 tests for ventilation performance;

 tests for mechanical strength;

 new symbols;

 requirements for a critical care VENTILATOR as a component of an ME SYSTEM;

 tests for enclosure integrity (water ingress);

 tests for closed suction survivability of the VENTILATOR;

 tests for cleaning and disinfection procedures;

 consideration of contamination of the breathing gas delivered to the PATIENT from the gas pathways.

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ISO 80601 consists of the following parts, under the general title Medical electrical equipment:

 Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators

 Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic
workstation

 Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas
monitors

 Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for
body temperature measurement

 Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter
equipment for medical use

IEC 80601 consists of the following parts, under the general title Medical electrical equipment:

 IEC 80601-2-30: Particular requirements for the basic safety and essential performance of automated
non-invasive sphygmomanometers

 IEC 80601-2-35: Particular requirements for the basic safety and essential performance of heating
devices using blankets, pads and mattresses and intended for heating in medical use

 IEC 80601-2-58: Particular requirements for the basic safety and essential performance of lens removal
devices and vitrectomy devices for ophthalmic surgery

 IEC 80601-2-59: Particular requirements for the basic safety and essential performance of screening
thermographs for human febrile temperature screening

 IEC 80601-2-60: Particular requirements for basic safety and essential performance of dental equipment

The ISO and IEC 80601 family of standards are also parts of the IEC 60601 family of standards.

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Introduction
In this International Standard, the following print types are used:

 Requirements and definitions: roman type.

 Test specifications: italic type.

 Informative material appearing outside of tables, such as notes, examples and references: in smaller
type. Normative text of tables is also in a smaller type.

 TERMS DEFINED IN IEC 60601-1:2005, CLAUSE 3, IN THIS PARTICULAR STANDARD OR AS NOTED: SMALL
CAPITALS TYPE.

In referring to the structure of this standard, the term

 “clause” means one of the seventeen numbered divisions within the table of contents, inclusive of all
subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);

 “subclause” means a numbered subdivision of a clause (e.g. 201.7.1, 201.7.2 and 201.7.2.1 are all
subclauses of Clause 201.7).

References to clauses within this International Standard are preceded by the term “Clause” followed by the
clause number. References to subclauses within this particular International Standard are by number only.

In this International Standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
combination of the conditions is true.

The verbal forms used in this International Standard conform to usage described in Annex H of the ISO/IEC
Directives, Part 2. For the purposes of this International Standard, the auxiliary verb:

 “shall” means that compliance with a requirement or a test is mandatory for compliance with this
standard;

 “should” means that compliance with a requirement or a test is recommended but is not mandatory for
compliance with this standard;

 “may” is used to describe a permissible way to achieve compliance with a requirement or test.

An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates that
there is guidance or rationale related to that item in Annex AA.

The attention of Member Bodies and National Committees is drawn to the fact that equipment manufacturers
and testing organizations may need a transitional period following publication of a new, amended or revised
ISO or IEC publication in which to make products in accordance with the new requirements and to equip
themselves for conducting new or revised tests. It is the recommendation of the committee that the content of
this International Standard not be adopted for mandatory implementation nationally earlier than 3 years from
the date of publication for equipment newly designed, and not earlier than 5 years from the date of publication
for equipment already in production.

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INTERNATIONAL STANDARD ISO 80601-2-12:2011(E)

Medical electrical equipment —

Part 2-12:
Particular requirements for basic safety and essential
performance of critical care ventilators

201.1 Scope, object and related standards

IEC 60601-1:2005, Clause 1 applies, except as follows:

201.1.1 Scope

Subclause 1.1 of IEC 60601-1:2005, Clause 1 is replaced by:

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of a VENTILATOR in
combination with its ACCESSORIES, hereafter referred to as ME EQUIPMENT:

 intended to be attended by a professional OPERATOR for those PATIENTS who are dependent on
mechanical ventilation; and

NOTE 1 Such VENTILATORS are considered a LIFE-SUPPORTING ME EQUIPMENT OR ME SYSTEM.

 intended for use in critical care environments in a professional healthcare facility or intended for use in
transport within a professional healthcare facility.

NOTE 2 A critical care VENTILATOR intended for use in transport within a professional healthcare facility is not
considered an emergency and transport ventilator.

This International Standard is also applicable to those ACCESSORIES intended by their MANUFACTURER to be
connected to a BREATHING SYSTEM, or to a VENTILATOR, where the characteristics of those ACCESSORIES can
affect the BASIC SAFETY or ESSENTIAL PERFORMANCE of the VENTILATOR.

This International Standard is not applicable to ME EQUIPMENT or an ME SYSTEM operating in ventilation modes
intended for patients who are not dependent on mechanical ventilation.

NOTE 3 A critical care VENTILATOR, when operating in such a mode, is not considered LIFE-SUPPORTING ME EQUIPMENT OR
ME SYSTEM.

If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only,

the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause
applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.

HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of
this standard are not covered by specific requirements in this standard except in IEC 60601-1:2005, 7.2.13
and 8.4.1.

NOTE 4 Additional information can be found in IEC 60601-1:2005, 4.2.

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This International Standard is not applicable to continuous positive airway pressure (CPAP) ME EQUIPMENT,
sleep apnoea therapy ME EQUIPMENT, HOME HEALTHCARE ENVIRONMENT VENTILATORS, ventilatory support
ME EQUIPMENT, emergency and transport ventilators, anaesthetic ventilators, high-frequency jet ventilators
(HFJVs) and high-frequency oscillatory ventilators (HFOVs).[26] This International Standard does not specify
the requirements for ME EQUIPMENT that is intended solely to augment the ventilation of spontaneously
breathing PATIENTS within a professional healthcare facility.

This International Standard does not specify the requirements for VENTILATORS or ACCESSORIES intended for
anaesthetic applications which are given in ISO 80601-2-13.

This International Standard does not specify the requirements for VENTILATORS or ACCESSORIES intended for
home care ventilators for ventilator-dependent PATIENTS which are given in ISO 10651-2 1).

This International Standard does not specify the requirements for VENTILATORS or ACCESSORIES intended for
emergency and transport which are given in ISO 10651-3 2).

This International Standard does not specify the requirements for VENTILATORS or ACCESSORIES intended for
home-care ventilatory support devices which are given in ISO 10651-6 3).

201.1.2 Object

Subclause 1.2 of IEC 60601-1:2005 is replaced by:

The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE
requirements for a VENTILATOR, as defined in 201.3.222, and its ACCESSORIES.

NOTE ACCESSORIES are included because the combination of the VENTILATOR and the ACCESSORIES needs to be
adequately safe. ACCESSORIES can have a significant impact on the BASIC SAFETY or ESSENTIAL PERFORMANCE of a
VENTILATOR.

201.1.3 Collateral standards

Subclause 1.3 of IEC 60601-1:2005 applies with the following addition:

This particular standard refers to those applicable collateral standards that are listed in IEC 60601-1:2005,
Clause 2 as well as 201.2 of this particular standard.

IEC 60601-1-3:2008 and IEC 60601-1-11:2010 do not apply.

201.1.4 Particular standards

Subclause 1.4 of IEC 60601-1:2005 is replaced by:

In the IEC 60601 series, particular standards may modify, replace or delete requirements contained in the
general standard, including the collateral standards, as appropriate for the particular ME EQUIPMENT under
consideration, and may add other BASIC SAFETY or ESSENTIAL PERFORMANCE requirements.

A requirement of a particular standard takes priority over IEC 60601-1:2005 or the collateral standards.

1) In the future, this standard is expected to be harmonized with IEC 60601-1:2005 and IEC 60601-1-11:2010, at which
time it will be replaced by ISO 80601-2-xx.
2) In the future, this standard is expected to be harmonized with IEC 60601-1:2005, at which time it will be replaced by
ISO 80601-2-xx.
3) In the future, this standard is expected to be harmonized with IEC 60601-1:2005 and IEC 60601-1-11:2010, at which
time it will be replaced by ISO 80601-2-xx.

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For brevity, IEC 60601-1:2005 is referred to in this particular standard as the general standard. Collateral
standards are referred to by their document number.

The numbering of clauses and subclauses of this particular standard corresponds to those of the general
standard with the prefix “201” (e.g. 201.1 in this standard addresses the content of Clause 1 of the general
standard) or applicable collateral standard with the prefix “2xx” where xx is the final digits of the collateral
standard document number (e.g. 202.4 in this particular standard addresses the content of Clause 4 of the
IEC 60601-1-2 collateral standard, 208.4 in this particular standard addresses the content of Clause 4 of the
IEC 60601-1-8 collateral standard, etc.). The changes to the text of the general standard are specified by the
use of the following words:

“Replacement” means that the clause or subclause of IEC 60601-1:2005 or the applicable collateral standard
is replaced completely by the text of this particular standard.

“Addition” means that the text of this particular standard is additional to the requirements of IEC 60601-1:2005
or the applicable collateral standard.

“Amendment” means that the clause or subclause of IEC 60601-1:2005 or the applicable collateral standard is
amended as indicated by the text of this particular standard.

Subclauses or figures that are additional to those of the general standard are numbered starting from 201.101,
additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc.

Subclauses or figures that are additional to those of a collateral standard are numbered starting from 20x,
where “x” is the number of the collateral standard, e.g. 202 for IEC 60601-1-2, 203 for IEC 60601-1-3, etc.

The term “this standard” is used to make reference to IEC 60601-1:2005, any applicable collateral standards
and this particular standard taken together.

Where there is no corresponding clause or subclause in this particular standard, the clause or subclause of
IEC 60601-1:2005 or the applicable collateral standard, although possibly not relevant, applies without
modification; where it is intended that any part of IEC 60601-1:2005 or the applicable collateral standard,
although possibly relevant, is not to be applied, a statement to that effect is given in this particular standard.

201.2 Normative references

The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.

NOTE Informative references are listed in the bibliography beginning on page 74.

IEC 60601-1:2005, Clause 2 applies, except as follows:

Replacement:

IEC 60601-1-2:2007, Medical electrical equipment — Part 1-2: General requirements for basic safety and
essential performance — Collateral standard: Electromagnetic compatibility — Requirements and tests

IEC 60601-1-6:2010, Medical electrical equipment — Part 1-6: General requirements for basic safety and
essential performance — Collateral standard: Usability

IEC 60601-1-8:2006, Medical electrical equipment — Part 1-8: General requirements for basic safety and
essential performance — Collateral standard: General requirements, tests and guidance for alarm systems in
medical electrical equipment and medical electrical systems

IEC 61672-1:2002, Electroacoustics — Sound level meters — Part 1: Specifications

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Addition:

ISO 32:1977, Gas cylinders for medical use — Marking for identification of content

ISO 594-1:1986, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical
equipment — Part 1: General requirements

ISO 594-2:1998, Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical
equipment — Part 2: Lock fittings

ISO 3744:2010, Acoustics — Determination of sound power levels and sound energy levels of noise sources
using sound pressure — Engineering methods for an essentially free field over a reflecting plane

ISO 4135:2001, Anaesthetic and respiratory equipment — Vocabulary

ISO 4871:1996, Acoustics — Declaration and verification of noise emission values of machinery and
equipment

ISO 5356-1:2004, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets

ISO 5359:2008, Low-pressure hose assemblies for use with medical gases

ISO 5367:2000, Breathing tubes intended for use with anaesthetic apparatus and ventilators

ISO 7000:2004, Graphical symbols for use on equipment — Index and synopsis

ISO 7010:— 4), Graphical symbols — Safety colours and safety signs — Registered safety signs

ISO 7010:2003, Graphical symbols — Safety colours and safety signs — Safety signs used in workplaces and
public areas including (Amendment 1:2006)

ISO 7396-1:2007, Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases
and vacuum

ISO 7396-1:2007, Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases
and vacuum including (Amendment 1:2010)

ISO 7396-1:2007, Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases
and vacuum including (Amendment 2:2010)

ISO 8185:2007, Respiratory tract humidifiers for medical use — Particular requirements for respiratory
humidification systems

ISO 8836:2007, Suction catheters for use in the respiratory tract

ISO 9360-1:2000, Anaesthetic and respiratory equipment — Heat and moisture exchangers (HMEs) for
humidifying respired gases in humans — Part 1: HMEs for use with minimum tidal volumes of 250 ml

ISO 9360-2:2001, Anaesthetic and respiratory equipment — Heat and moisture exchangers (HMEs) for
humidifying respired gases in humans — Part 2: HMEs for use with tracheostomized patients having minimum
tidal volumes of 250 ml

ISO 10079-1:1999, Medical suction equipment — Part 1: Electrically powered suction equipment — Safety
requirements

ISO 10079-3:1999, Medical suction equipment — Part 3: Suction equipment powered from a vacuum or
pressure source

4) To be published. (Revision of ISO 7010:2003)

4 © ISO 2011 – All rights reserved

 This is a preview - click here to buy the full publication ISO 80601-2-12:2011(E)

ISO 10524-1:2006, Pressure regulators for use with medical gases — Part 1: Pressure regulators and
pressure regulators with flow-metering devices

ISO 11195:1995, Gas mixers for medical use — Stand-alone gas mixers

ISO 14937:2009, Sterilization of health care products — General requirements for characterization of a
sterilizing agent and the development, validation and routine control of a sterilization process for medical
devices

ISO 15223-1:2007, Medical devices — Symbols to be used with medical device labels, labelling and
information to be supplied — Part 1: General requirements

ISO 15223-1:2007, Medical devices — Symbols to be used with medical device labels, labelling and
information to be supplied — Part 1: General requirements. Amendment 1:2008

ISO 17664:2004, Sterilization of medical devices — Information to be provided by the manufacturer for the
processing of resterilizable medical devices

ISO 23328-1:2003, Breathing system filters for anaesthetic and respiratory use: — Part 1: Salt test method to
assess filtration performance

ISO 23328-2:2002, Breathing system filters for anaesthetic and respiratory use: — Part 2: Non-filtration
aspects

ISO 80601-2-13:— 5), Medical electrical equipment — Part 2-13: Particular requirements for basic safety and
essential performance of an anaesthetic workstation

ISO 80601-2-55:—5), Medical electrical equipment — Part 2-55: Particular requirements for the basic safety
and essential performance of respiratory gas monitors

IEC 60068-2-27:2008 6), Environmental testing — Part 2-27: Tests — Test Ea and guidance: Shock

IEC 60068-2-31:2008, Environmental testing — Part 2-31: Tests — Test Ec: Rough handling shocks, primarily
for equipment-type specimens

IEC 60068-2-64:2008, Environmental testing — Part 2-64: Tests — Test Fh: Vibration, broadband random
and guidance

ISO 60529:1989, Degrees of protection provided by enclosures (IP Code)

IEC 60601-1:2005, Medical electrical equipment — Part 1: General requirements for basic safety and
essential performance

IEC 60601-1-11:2010, Medical electrical equipment — Part 1-11: General requirements for basic safety and
essential performance — Collateral Standard: Requirements for medical electrical equipment and medical
electrical systems used in the home healthcare environment

IEC 60601-2-2:2009, Medical electrical equipment — Part 2-2: Particular requirements for the basic safety
and essential performance of high frequency surgical equipment and high frequency surgical accessories

IEC 62304:2006, Medical device software — Software life cycle processes

IEC 62366:2007, Medical devices — Application of usability engineering to medical devices

5) To be published.
6) Cancels and replaces ISO 60068-2-29:1987.

© ISO 2011 – All rights reserved 5