IEC 60601-1-6:2010
(Main)Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
IEC 60601-1-6:2010 specifies a process for a manufacturer to analyse, specify, design, verify and validate usability, as it relates to basic safety and essential performance of medical electrical equipment. This usability engineering process assesses and mitigates risks caused by usability problems associated with correct use and use errors, i.e., normal use. It can be used to identify but does not assess or mitigate risks associated with abnormal use. If the usability engineering process detailed in this collateral standard has been complied with and the acceptance criteria documented in the usability validation plan have been met (see 5.9 of IEC 62366:2007), then the residual risks, as defined in ISO 14971, associated with usability of me equipment are presumed to be acceptable, unless there is objective evidence to the contrary (see 4.1.2 of IEC 62366:2007). The object of this collateral standard is to specify general requirements that are in addition to those of the general standard and to serve as the basis for particular standards. This document cancels and replaces the second edition of IEC 60601-1-6 which has been technically revised. It was revised to align with the usability engineering process in IEC 62366. To allow for equipment manufacturers and testing organizations to make products and to equip themselves for conducting revised tests in accordance with this third edition, it is recommended by SC 62A that the content of this document not be adopted for mandatory implementation 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.
Appareils électromédicaux - Partie 1-6: Exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale: Aptitude à l'utilisation
La CEI 60601-1-6:2010 spécifie un processus destiné à un fabricant pour analyser, spécifier, concevoir, vérifier et valider l'aptitude à l'utilisation, ayant trait à la sécurité de base et aux performances essentielles des appareils électromédicaux. Ce processus d'ingénierie d'aptitude à l'utilisation évalue et réduit les risques provoqués par les problèmes d'aptitude à l'utilsation associés à une utilisation correcte et à des erreurs d'utilisation, c'est-à-dire une utilisation normale. Il peut être utilisé pour identifier mais n'évalue pas et ne réduit pas les risques associés à une utilisation anormale. Si le processus d'ingénierie de l'aptitude à l'utilisation détaillé dans la présente norme collatérale a été satisfait et si les critères d'acceptation documentés dans le plan de validation de l'aptitude à l'utilisation ont été satisfaits (voir le 5.9 de la CEI 62366:2007), les risques résiduels définis dans l'ISO 14971 associés à l'aptitude à l'utilisation d'un appareil em sont alors présumés acceptables, sauf s'il existe une preuve tangible du contraire (voir le 4.1.2 de la CEI 62366:2007). La présente norme collatérale est destinée à spécifier des exigences générales qui viennent compléter celles de la norme générale et à servir de base pour les normes particulières. Ce document annule et remplace la deuxième édition de la CEI 60601-1-6, et constitue une révision technique. La présente édition de la CEI 60601-1-6 a été révisée pour être mise en conformité avec le processus d'ingénierie de l'aptitude à l'utilisation de la CEI 62366. De manière à permettre aux fabricants d'appareils et aux organismes d'essai de réaliser les produits et de s'équiper afin d'effectuer les essais révisés conformément à cette troisième édition, le SC 62A recommande que le contenu de ce document ne soit adopté, et que son application ne devienne obligatoire avant 3 ans après la date de publication, pour les appareils nouvellement conçus, et avant 5 ans après la date de publication pour les appareils déjà en production.
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IEC 60601-1-6 ®
Edition 3.0 2010-01
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 1-6: General requirements for basic safety and essential performance –
Collateral standard: Usability
Appareils électromédicaux –
Partie 1-6: Exigences générales pour la sécurité de base et les performances
essentielles – Norme collatérale: Aptitude à l'utilisation
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by
any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either IEC or
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IEC 60601-1-6 ®
Edition 3.0 2010-01
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 1-6: General requirements for basic safety and essential performance –
Collateral standard: Usability
Appareils électromédicaux –
Partie 1-6: Exigences générales pour la sécurité de base et les performances
essentielles – Norme collatérale: Aptitude à l'utilisation
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
U
CODE PRIX
ICS 11.040 ISBN 978-2-88910-211-2
– 2 – 60601-1-6 © IEC:2010
CONTENTS
FOREWORD.3
INTRODUCTION.6
1 Scope, object and related standards.7
1.1 * Scope .7
1.2 Object .7
1.3 Related standards .7
1.3.1 IEC 60601-1 .7
1.3.2 Particular standards .7
2 Normative references .7
3 Terms and definitions .8
4 General requirements .8
4.1 * Conditions for application to ME EQUIPMENT .8
4.2 * USABILITY ENGINEERING PROCESS for ME EQUIPMENT.8
5 * Replacement of requirements given in IEC 62366 .9
Annex A (informative) General guidance and rationale.10
Annex B (informative) Mapping between the elements of IEC 60601-1-6:2006 and the
related elements in IEC 62366:2007 .12
Annex C (informative) References to items of USABILITY provided in IEC 62366:2007
and their use in other standards.19
Bibliography.22
Index of defined terms used with this collateral standard .24
Table B.1 – Mapping between the elements of IEC 60601-1-6:2006 and the related
elements in IEC 62366:2007 .12
Table C.1 – References to items of USABILITY in IEC 62366 and their use in other
standards.19
60601-1-6 © IEC:2010 – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
Part 1-6: General requirements for basic safety
and essential performance –
Collateral standard: Usability
FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested
in the subject dealt with may participate in this preparatory work. International, governmental and non-
governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely
with the International Organization for Standardization (ISO) in accordance with conditions determined by
agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence
between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
the latter.
5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
services carried out by independent certification bodies.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
International Standard IEC 60601-1-6 has been prepared by subcommittee 62A: Common
aspects of electrical equipment used in medical practice, of IEC technical committee 62:
Electrical equipment in medical practice.
This third edition constitutes a collateral standard to IEC 60601-1: Medical electrical
equipment – Part 1: General requirements for basic safety and essential performance
hereafter referred to as the general standard.
This document cancels and replaces the second edition of IEC 60601-1-6 which has been
technically revised. To allow for equipment manufacturers and testing organizations to make
products and to equip themselves for conducting revised tests in accordance with this third
edition, it is recommended by SC 62A that the content of this document not be adopted for
mandatory implementation 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.
– 4 – 60601-1-6 © IEC:2010
This edition of IEC 60601-1-6 was revised to align with the USABILITY ENGINEERING PROCESS in
IEC 62366.
The text of this standard is based on the following documents:
FDIS Report on voting
62A/682/FDIS 62A/689/RVD
Full information on the voting for the approval of this standard can be found in the report on
voting indicated in the above table.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
In the IEC 60601 series of publications, collateral standards specify general requirements for
safety applicable to:
– a subgroup of MEDICAL ELECTRICAL EQUIPMENT (e.g. radiological equipment); or
– a specific characteristic of all MEDICAL ELECTRICAL EQUIPMENT, not fully addressed in the
general standard (e.g. alarm systems).
In this collateral standard, the following print types are used:
– Requirements and definitions: roman type.
– Test specifications or instructions to modify requirements in IEC 62366: 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 CLAUSE 3 OF THE GENERAL STANDARD, IN THIS COLLATERAL STANDARD OR AS
NOTED: SMALL CAPITALS.
In referring to the structure of this standard, the term
– “clause” means one of the numbered divisions within the table of contents, inclusive of all
subdivisions (e.g. Clause 4 includes subclauses 4.1, 4.2, etc.);
– “subclause” means a numbered subdivision of a clause (e.g. 4.1 and 4.2 are all
subclauses of Clause 4).
References to clauses within this standard are preceded by the term “Clause” followed by the
clause number. Refere
...
IEC 60601-1-6 ®
Edition 3.1 2013-10
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –
Part 1-6: General requirements for basic safety and essential performance –
Collateral standard: Usability
Appareils électromédicaux –
Partie 1-6: Exigences générales pour la sécurité de base et les performances
essentielles – Norme collatérale: Aptitude à l'utilisation
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form
or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from
either IEC or IEC's member National Committee in the country of the requester. If you have any questions about IEC
copyright or have an enquiry about obtaining additional rights to this publication, please contact the address below or
your local IEC member National Committee for further information.
Droits de reproduction réservés. Sauf indication contraire, aucune partie de cette publication ne peut être reproduite
ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique, y compris la photocopie
et les microfilms, sans l'accord écrit de l'IEC ou du Comité national de l'IEC du pays du demandeur. Si vous avez des
questions sur le copyright de l'IEC ou si vous désirez obtenir des droits supplémentaires sur cette publication, utilisez
les coordonnées ci-après ou contactez le Comité national de l'IEC de votre pays de résidence.
IEC Secretariat Tel.: +41 22 919 02 11
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Switzerland
About the IEC
The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes
International Standards for all electrical, electronic and related technologies.
About IEC publications
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IEC 60601-1-6 ®
Edition 3.1 2013-10
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –
Part 1-6: General requirements for basic safety and essential performance –
Collateral standard: Usability
Appareils électromédicaux –
Partie 1-6: Exigences générales pour la sécurité de base et les performances
essentielles – Norme collatérale: Aptitude à l'utilisation
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040 ISBN 978-2-8322-1186-1
IEC 60601-1-6 ®
Edition 3.1 2013-10
CONSOLIDATED VERSION
REDLINE VERSION
VERSION REDLINE
colour
inside
Medical electrical equipment –
Part 1-6: General requirements for basic safety and essential performance –
Collateral standard: Usability
Appareils électromédicaux –
Partie 1-6: Exigences générales pour la sécurité de base et les performances
essentielles – Norme collatérale: Aptitude à l'utilisation
– 2 – 60601-1-6 IEC:2010+A1:2013
CONTENTS
FOREWORD . 3
INTRODUCTION . 6
INTRODUCTION TO THE AMENDMENT . 7
1 Scope, object and related standards . 9
1.1 * Scope . 9
1.2 Object . 9
1.3 Related standards . 9
1.3.1 IEC 60601-1 . 9
1.3.2 Particular standards . 9
2 Normative references . 9
3 Terms and definitions . 10
4 General requirements . 10
4.1 * Conditions for application to ME EQUIPMENT . 10
4.2 * USABILITY ENGINEERING PROCESS for ME EQUIPMENT . 11
5 * Replacement of requirements given in IEC 62366 . 11
Annex A (informative) General guidance and rationale . 12
Annex B (informative) Mapping between the elements of IEC 60601-1-6:2006 and the
related elements in IEC 62366:2007 . 14
Annex C (informative) References to items of USABILITY provided in IEC 62366:2007
and their use in other standards . 22
Bibliography . 25
Index of defined terms used with this collateral standard . 27
Table B.1 – Mapping between the elements of IEC 60601-1-6:2006 and the related
4)
elements in IEC 62366:2007+A1— . 14
Table C.1 – References to items of USABILITY in IEC 62366 and their use in other
standards . 22
60601-1-6 IEC:2010+A1:2013 – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
Part 1-6: General requirements for basic safety
and essential performance –
Collateral standard: Usability
FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested
in the subject dealt with may participate in this preparatory work. International, governmental and non-
governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely
with the International Organization for Standardization (ISO) in accordance with conditions determined by
agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence
between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
the latter.
5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
services carried out by independent certification bodies.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
This Consolidated version of IEC 60601-1-6 bears the edition number 3.1. It consists of
the third edition (2010) [documents 62A/682/FDIS and 62A/689/RVD] and its amendment
1 (2013) [documents 62A/890/FDIS and 62A/898/RVD]. The technical content is identical
to the base edition and its amendment.
In this Redline version, a vertical line in the margin shows where the technical content
is modified by amendment 1. Additions and deletions are displayed in red, with
deletions being struck through. A separate Final version with all changes accepted is
available in this publication.
This publication has been prepared for user convenience.
– 4 – 60601-1-6 IEC:2010+A1:2013
International Standard IEC 60601-1-6 has been prepared by subcommittee 62A: Common
aspects of electrical equipment used in medical practice, of IEC technical committee 62:
Electrical equipment in medical practice.
This third edition constitutes a collateral standard to IEC 60601-1: Medical electrical
equipment – Part 1: General requirements for basic safety and essential performance
hereafter referred to as the general standard.
This document cancels and replaces the second edition of IEC 60601-1-6 which has been
technically revised. To allow for equipment manufacturers and testing organizations to make
products and to equip themselves for conducting revised tests in accordance with this third
edition, it is recomme
...
IEC 60601-1-6 ®
Edition 3.2 2020-07
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –
Part 1-6: General requirements for basic safety and essential performance –
Collateral standard: Usability
Appareils électromédicaux –
Partie 1-6: Exigences générales pour la sécurité de base et les performances
essentielles – Norme collatérale: Aptitude à l'utilisation
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form
or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from
either IEC or IEC's member National Committee in the country of the requester. If you have any questions about IEC
copyright or have an enquiry about obtaining additional rights to this publication, please contact the address below or
your local IEC member National Committee for further information.
Droits de reproduction réservés. Sauf indication contraire, aucune partie de cette publication ne peut être reproduite
ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique, y compris la photocopie
et les microfilms, sans l'accord écrit de l'IEC ou du Comité national de l'IEC du pays du demandeur. Si vous avez des
questions sur le copyright de l'IEC ou si vous désirez obtenir des droits supplémentaires sur cette publication, utilisez
les coordonnées ci-après ou contactez le Comité national de l'IEC de votre pays de résidence.
IEC Central Office Tel.: +41 22 919 02 11
3, rue de Varembé info@iec.ch
CH-1211 Geneva 20 www.iec.ch
Switzerland
About the IEC
The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes
International Standards for all electrical, electronic and related technologies.
About IEC publications
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IEC 60601-1-6 ®
Edition 3.2 2020-07
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –
Part 1-6: General requirements for basic safety and essential performance –
Collateral standard: Usability
Appareils électromédicaux –
Partie 1-6: Exigences générales pour la sécurité de base et les performances
essentielles – Norme collatérale: Aptitude à l'utilisation
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.01 ISBN 978-2-8322-8706-4
IEC 60601-1-6 ®
Edition 3.2 2020-07
REDLINE VERSION
VERSION REDLINE
colour
inside
Medical electrical equipment –
Part 1-6: General requirements for basic safety and essential performance –
Collateral standard: Usability
Appareils électromédicaux –
Partie 1-6: Exigences générales pour la sécurité de base et les performances
essentielles – Norme collatérale: Aptitude à l'utilisation
– 2 – IEC 60601-1-6:2010+AMD1:2013
+AMD2:2020 CSV IEC 2020
CONTENTS
FOREWORD . 3
INTRODUCTION . 6
INTRODUCTION to Amendment 1 . 7
INTRODUCTION to Amendment 2 . 7
1 Scope, object and related standards . 9
1.1 * Scope . 9
1.2 Object . 9
1.3 Related standards . 9
1.3.1 IEC 60601-1 . 9
1.3.2 Particular standards . 10
2 Normative references . 10
3 Terms and definitions . 10
4 General requirements . 11
4.1 * Conditions for application to ME EQUIPMENT . 11
4.2 * USABILITY ENGINEERING PROCESS for ME EQUIPMENT . 11
5 * Replacement of requirements given in IEC 62366 ME EQUIPMENT ACCOMPANYING
DOCUMENTS . 12
Annex A (informative) General guidance and rationale . 14
Annex B (informative) Mapping between the elements of IEC 60601-1-6:2006 and the
related elements in IEC 62366:2007 .
Annex C (informative) References to items of USABILITY provided in IEC 62366:2007
and their use in other standards .
Bibliography . 28
Index of defined terms used with this collateral standard . 30
Table B.1 – Mapping between the elements of IEC 60601-1-6:2006 and the related
4)
elements in IEC 62366:2007+A1— .
Table C.1 – References to items of USABILITY in IEC 62366 and their use in other
standards .
+AMD2:2020 CSV IEC 2020
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
Part 1-6: General requirements for basic safety
and essential performance –
Collateral standard: Usability
FOREWORD
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This consolidated version of the official IEC Standard and its amendment has been
prepared for user convenience.
IEC 60601-1-6 edition 3.2 contains the third edition (2010-01) [documents 62A/682/FDIS
and 62A/689/RVD], its amendment 1 (2013-10) [documents 62A/890/FDIS and
62A/898/RVD] and its amendment 2 (2020-07) [documents 62A/1391/FDIS and
62A/1406/RVD].
In this Redline version, a vertical line in the margin shows where the technical content
is modified by amendments 1 and 2. Additions are in green text, deletions are in
strikethrough red text. A separate Final version with all changes accepted is available
in this publication.
– 4 – IEC 60601-1-6:2010+AMD1:2013
+AMD2:2020 CSV IEC 2020
International Standard IEC 60601-1-6 has been prepared by subcommittee 62A: Common
aspects of electrical equipment used in medical practice, of IEC technical committee 62:
Electrical equipment in medical practice.
This third edition constitutes a collateral standard to
...
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