SIST EN 60601-1-6:2010

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

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.

Medizinische elektrische Geräte - Teil 1-6: Allgemeine Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale - Ergänzungsnorm: Gebrauchstauglichkeit (IEC 60601-1-6:2010)

Appareils électromédicaux - Partie 1-6: Exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale: Aptitude à l’utilisation (CEI 60601-1-6:2010)

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.

Medicinska električna oprema - 1-6. del: Splošne zahteve za osnovno varnost in bistvene tehnične lastnosti - Spremljevalni standard: Uporabnost (IEC 60601-1-6:2010)

Ta mednarodni standard opredeljuje POSTOPEK za PROIZVAJALCA, da analizira, opredeli, načrtuje, POTRDI in VERIFICIRA UPORABNOST, saj se nanaša na OSNOVNO VARNOST IN BISTVENE TEHNIČNE LASTNOSTI MEDICINSKE ELEKTRIČNE OPREME, v nadaljevanju ME OPREMA. Ta POSTOPEK INŽENIRINGA UPORABNOSTI ocenjuje in ublaži TVEGANJA, ki jih povzročajo problemi glede UPORABNOSTI, povezanimi s PRAVILNO UPORABO in UPORABNIŠKIMI NAPAKAMI, t.j. OBIČAJNA UPORABA. Uporablja se lahko za prepoznavanje, vendar TVEGANJ, povezanih z NEOBIČAJNO UPORABO, ne ocenjuje in ne ublaži. Če je bil POSTOPEK INŽENIRINGA UPORABNOSTI, ki je podrobno opisan v tem spremljevalnem standardu, izvršen in so bila izpolnjeni sprejemni kriteriji, dokumentirani v načrtu VALIDACIJE UPORABNOSTI (glej točko 5.9. IEC 62366:2007), potem se PREOSTALA TVEGANJA, kot so opredeljena v ISO 14971 in povezana z UPORABNOSTJO ME OPREME, štejejo za sprejemljiva, razen v primeru OBJEKTIVNIH DOKAZOV o nasprotnem (glej točko 4.1.2 IEC 62366:2007).

General Information

• Status: Published
• Publication Date: 03-May-2010
• ICS: 11.040.01 - Medical equipment in general
• Technical Committee: IEMO - Electrical equipment in medical practice
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 13-Apr-2010
• Due Date: 18-Jun-2010
• Completion Date: 04-May-2010
• Directive: 90/385/EEC - Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: EN 60601-1-6:2010 - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability

Relations

• Replaces: SIST EN 60601-1-6:2008 - Medical electrical equipment -- Part 1-6: General requirements for basic safety and essential performance - Collateral Standard: Usability
• Effective Date: 28-Jan-2023
• Amended By: SIST EN 60601-1-6:2010/A2:2021 - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability (IEC 60601-1-6:2010/A2:2020)
• Effective Date: 29-Aug-2017
• Amended By: SIST EN 60601-1-6:2010/A1:2015 - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
• Effective Date: 01-Sep-2015
• Revised: SIST EN 60601-1-6:2008 - Medical electrical equipment -- Part 1-6: General requirements for basic safety and essential performance - Collateral Standard: Usability
• Effective Date: 02-Apr-2013

Standards Content (Sample)

SLOVENSKI STANDARD
01-junij-2010
1DGRPHãþD
SIST EN 60601-1-6:2008
0HGLFLQVNDHOHNWULþQDRSUHPDGHO6SORãQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHWHKQLþQHODVWQRVWL6SUHPOMHYDOQLVWDQGDUG8SRUDEQRVW,(&

Medical electrical equipment - Part 1-6: General requirements for basic safety and
essential performance - Collateral standard: Usability (IEC 60601-1-6:2010)
Medizinische elektrische Geräte - Teil 1-6: Allgemeine Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale - Ergänzungsnorm:
Gebrauchstauglichkeit (IEC 60601-1-6:2010)
Appareils électromédicaux - Partie 1-6: Exigences générales pour la sécurité de base et
les performances essentielles - Norme collatérale: Aptitude à l’utilisation (CEI 60601-1-
6:2010)
Ta slovenski standard je istoveten z: EN 60601-1-6:2010
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN 60601-1-6
NORME EUROPÉENNE
April 2010
EUROPÄISCHE NORM
ICS 11.040 Supersedes EN 60601-1-6:2007

English version
Medical electrical equipment -
Part 1-6: General requirements for basic safety
and essential performance -
Collateral standard: Usability
(IEC 60601-1-6:2010)
Appareils électromédicaux -  Medizinische elektrische Geräte -
Partie 1-6: Exigences générales Teil 1-6: Allgemeine Festlegungen
pour la sécurité de base für die Sicherheit einschließlich
et les performances essentielles - der wesentlichen Leistungsmerkmale -
Norme collatérale: Aptitude à l'utilisation Ergänzungsnorm: Gebrauchstauglichkeit
(CEI 60601-1-6:2010) (IEC 60601-1-6:2010)

This European Standard was approved by CENELEC on 2010-04-01. CENELEC members are bound to comply
with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard
the status of a national standard without any alteration.

Up-to-date lists and bibliographical references concerning such national standards may be obtained on
application to the Central Secretariat or to any CENELEC member.

This European Standard exists in three official versions (English, French, German). A version in any other
language made by translation under the responsibility of a CENELEC member into its own language and notified
to the Central Secretariat has the same status as the official versions.

CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus,
the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,
Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia,
Spain, Sweden, Switzerland and the United Kingdom.

CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung

Central Secretariat: Avenue Marnix 17, B - 1000 Brussels

© 2010 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 60601-1-6:2010 E
Foreword
The text of document 62A/682/FDIS, future edition 3 of IEC 60601-1-6, prepared by SC 62A, Common
aspects of electrical equipment used in medical practice, of IEC TC 62, Electrical equipment in medical
practice, was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC as
EN 60601-1-6 on 2010-04-01.
This standard supersedes EN 60601-1-6:2007.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN and CENELEC shall not be held responsible for identifying any or all such patent
rights.
The following dates were fixed:
– latest date by which the EN has to be implemented
at national level by publication of an identical
(dop) 2011-01-01
national standard or by endorsement
– latest date by which the national standards conflicting
(dow) 2013-04-01
with the EN have to be withdrawn
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association and covers essential requirements of
EC Directives 93/42/EEC and 90/385/EEC. See Annex ZZ.
Annexes ZA and ZZ have been added by CENELEC.
__________
Endorsement notice
The text of the International Standard IEC 60601-1-6:2010 was approved by CENELEC as a European
Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standards indicated:
[1]  ISO 9241-2:1992 NOTE  Harmonized as EN 29241:1993 (not modified).
[2]  ISO 9241-11:1998 NOTE  Harmonized as EN ISO 9241-11:1998 (not modified).
[3]  ISO 9241-20:2008 NOTE  Harmonized as EN ISO 9241-20:2009 (not modified).
[4]  ISO 9241-110:2006 NOTE  Harmonized as EN ISO 9241-110:2006 (not modified).
[5]  ISO 9241-171:2008 NOTE  Harmonized as EN ISO 9241-171:2008 (not modified).
[7]  ISO 9241-300:2008 NOTE  Harmonized as EN ISO 9241-300:2008 (not modified).
[8]  ISO 9241-302:2008 NOTE  Harmonized as EN ISO 9241-302:2008 (not modified).
[9]  ISO 9241-303:2008 NOTE  Harmonized as EN ISO 9241-303:2008 (not modified).
[10] ISO 9241-304:2008 NOTE  Harmonized as EN ISO 9241-304:2008 (not modified).
[11] ISO 9241-305:2008 NOTE  Harmonized as EN ISO 9241-305:2008 (not modified).
[12] ISO 9241-307:2008 NOTE  Harmonized as EN ISO 9241-307:2008 (not modified).
[13] ISO 9241-400:2007 NOTE  Harmonized as EN ISO 9241-400:2007 (not modified).
[14] ISO 9241-410:2008 NOTE  Harmonized as EN ISO 9241-410:2008 (not modified).
[16] ISO 13407:1999 NOTE  Harmonized as EN ISO 13407:1999 (not modified).

- 3 - EN 60601-1-6:2010
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications

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  When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HD
applies.
Publication Year Title EN/HD Year

IEC 60601-1 2005 Medical electrical equipment - EN 60601-1 2006
Part 1: General requirements for basic
safety and essential performance

IEC 60601-1-8 2006 Medical electrical equipment - EN 60601-1-8 2007
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 62366 2007 Medical devices - Application of usability EN 62366 2008
engineering to medical devices

ISO 14971 2007 Medical devices - Application of risk EN ISO 14971 2009
management to medical devices
Annex ZZ
(informative)
Coverage of Essential Requirements of EC Directives
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association and within its scope the standard covers all
relevant essential requirements as given in Annex I of the EC Directive 93/42/EEC as well as Annex I of
the EC Directive 90/385/EEC.
Compliance with this standard provides one means of conformity with the specified essential
requirements of the Directive(s) concerned.
WARNING: Other requirements and other EC Directives may be applicable to the products falling within
the scope of this standard.
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 2-8318-1077-4
– 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. References to subclauses within this standard are by number only.
In this 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 standard conform to usage described in Annex H of the ISO/IEC
Directives, Part 2. For the purposes of this 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.
Clauses, subclauses and definitions for which a rationale is provided in informative A n nex A
are marked with an asterisk (*).

60601-1-6 © IEC:2010 – 5 –
To assist the user of this collateral standard in migrating from IEC 60601-1-6:2006 to
IEC 62366:2007, Table B.1 has been developed. This table maps the clauses and subclause
of IEC 60601-1-6:2006 to the comparable clauses and subclauses in IEC 62366:2007. To
further assist the user of this collateral standard, Table C.1 relates certain elements of
IEC 62366 to other standards, such as parts of the ISO 9241 series, which might be useful in
meeting the requirements of IEC 62366.
A list of all parts of the IEC 60601 series, under the general title: Medical electrical
equipment, can be found on the IEC website.
The committee has decided that the contents of this publication will remain unchanged until
the maintenance result date indicated on the IEC web site under "http://webstore.iec.ch" in
the data related to the specific publication. At this date, the publication will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
– 6 – 60601-1-6 © IEC:2010
INTRODUCTION
Medical practice is increasingly using MEDICAL ELECTRICAL EQUIPMENT for observation and
treatment of PATIENTS. USE ERRORS caused by inadequate MEDICAL ELECTRICAL EQUIPMENT
USABILITY have become an increasing cause for concern. Much of ME EQUIPMENT developed
without applying a USABILITY ENGINEERING PROCESS are non-intuitive, difficult to learn and to
use. As healthcare evolves, less skilled OPERATORS including PATIENTS themselves are now
using MEDICAL ELECTRICAL EQUIPMENT while the MEDICAL ELECTRICAL EQUIPMENT itself is
becoming more complicated. In simpler times, the OPERATOR of the MEDICAL ELECTRICAL
EQUIPMENT might be able to cope with an ambiguous, difficult-to-use OPERATOR-EQUIPMENT
INTERFACE. The design of usable MEDICAL ELECTRICAL EQUIPMENT is a challenging endeavour.
The design of the OPERATOR-EQUIPMENT INTERFACE to achieve adequate (safe) USABILITY
requires a very different skill set than that of the technical implementation of that interface.
The USABILITY ENGINEERING PROCESS is intended to achieve reasonable USABILITY, which in
turn is intended to minimise USE ERRORS and to minimise use-associated RISKS. Some, but not
all, forms of incorrect use are amenable to be controlled by the MANUFACTURER. The
relationship of the USABILITY ENGINEERING PROCESS to the RISK MANAGEMENT PROCESS is
described in Figure A.1 of IEC 62366:2007.
The first and second editions of this collateral standard described a USABILITY ENGINEERING
PROCESS that was tailored to the needs of MANUFACTURERS of MEDICAL ELECTRICAL EQUIPMENT.
They provided guidance on how to implement and execute the PROCESS to improve the safety
of MEDICAL ELECTRICAL EQUIPMENT.
Subclause 1.3 of IEC 60601-1:2005 states that, “Applicable collateral standards become
normative at the date of their publication and shall apply together with this standard.”
Consequently, the second edition of this collateral standard was developed specifically to
align with IEC 60601-1:2005 and published in 2006. All other relevant collateral standards
within the jurisdiction of IEC Subcommittee 62A also were updated and republished between
2006 and 2007 except for IEC 60601-1-1 and IEC 60601-1-4. These collateral standards were
not revised because their requirements were integrated into IEC 60601-1:2005.
After the second edition of this collateral standard was published, IEC Subcommittee 62A, in
partnership with ISO Technical Committee 210, developed and published a general usability
engineering standard applicable to all MEDICAL DEVICES—IEC 62366:2007. IEC 62366 is based
on IEC 60601-1-6, but was refined using the experience gained with applying the first edition
of IEC 60601-1-6. Although the processes described in IEC 60601-1-6:2006 and
IEC 62366:2007 are very similar, they are not identical.
At its Auckland meeting in 2008, IEC Technical Committee 62 approved a project to revise
IEC 60601-1-6 so that it would reduce or eliminate duplication with IEC 62366 and also create
a bridge between IEC 60601-1 and IEC 62366. This third edition of IEC 60601-1-6 creates
MANUFACTURER to conform to the requirements in IEC 60601-
that bridge and will enable a
1:2005 that make normative reference to IEC 60601-1-6 by employing a USABILITY
ENGINEERING PROCESS complying with IEC 62366:2007. At a point in the future, that bridge can
be eliminated by revising or amending IEC 60601-1 to include a direct reference to IEC 62366
and, as necessary, adding any additional requirements that are specific to medical electrical
equipment, such as those contained in Clauses 4 and 5 of this collateral standard, to
IEC 60601-1 or as a normative annex to IEC 62366.
This collateral standard is intended to be useful not only for MANUFACTURER(S) of MEDICAL
ELECTRICAL EQUIPMENT, but also for technical committees responsible for the preparation of
particular MEDICAL ELECTRICAL EQUIPMENT standards. It should be noted that clinical
investigations conducted according to ISO 14155-1 and usability testing for verification or
validation according to this standard are two fundamentally different activities and should not
be confused.
60601-1-6 © IEC:2010 – 7 –
MEDICAL ELECTRICAL EQUIPMENT –

Part 1-6: General requirements for basic safety
and essential performance –
Collateral standard: Usability

1 Scope, object and related standards
1.1 * Scope
This International Standard 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, hereafter referred to as ME 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).
1.2 Object
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.
1.3 Related standards
1.3.1 IEC 60601-1
For ME EQUIPMENT, this collateral standard complements IEC 60601-1.
When referring to IEC 60601-1 or to this collateral standard, either individually or in
combination, the following conventions are used:
• "the general standard" designates IEC 60601-1 alone;
• "this collateral standard" designates IEC 60601-1-6 alone;
• "this standard" designates the combination of the general standard and this collateral
standard.
1.3.2 Particular standards
A requirement in a particular standard takes priority over the corresponding requirement in
this collateral standard.
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.

– 8 – 60601-1-6 © IEC:2010
NOTE The way in which these referenced documents are cited determines the extent (in whole or in part) to
which they apply.
IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic
safety and essential performance
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 62366:2007, Medical devices – Application of usability engineering to medical devices
ISO 14971:2007, Medical devices – Application of risk management to medical devices
3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005,
IEC 60601-1-8:2006, IEC 62366:2007 and the following definitions apply.
NOTE An index of defined terms used with this collateral standard is found beginning on page 24.
3.1
* OPERATOR-EQUIPMENT INTERFACE
means by which the OPERATOR and the ME EQUIPMENT communicate
[ANSI/AAMI HE 74:2001, definition 3.24 modified]
NOTE The ACCOMPANYING DOCUMENTS are considered part of the ME EQUIPMENT and the OPERATOR-EQUIPMENT
INTERFACE.
3.2
OPERATOR PROFILE
summary of the mental, physical and demographic traits of the intended OPERATOR population,
as well as any special characteristics that can have a bearing on design decisions, such as
occupational skills and job requirements
4 General requirements
4.1 * Conditions for application to ME EQUIPMENT
The ME EQUIPMENT shall provide adequate USABILITY such that the RISKS resulting from NORMAL
USE and USE ERROR are acceptable. See also 7.1.1 and 12.2 of the general standard.
Compliance with this subclause is considered to exist when compliance with 4.2 and other
clauses and subclauses of this collateral standard is demonstrated.
4.2 * USABILITY ENGINEERING PROCESS for ME EQUIPMENT
A USABILITY ENGINEERING PROCESS complying with IEC 62366 shall be performed.
In applying IEC 62366, the terms in this collateral standard and those in IEC 60601-1:2005
shall be used as follows:
• The term “MEDICAL DEVICE” shall assume the same meaning as ME EQUIPMENT.
• The term “USER” shall assume the same meaning as OPERATOR.
• The term “PATIENT” shall include animals.

60601-1-6 © IEC:2010 – 9 –
• The term "SAFETY” shall assume the same meaning as BASIC SAFETY and ESSENTIAL
PERFORMANCE.
• The term “USER INTERFACE” shall assume the same meaning as OPERATOR-EQUIPMENT
INTERFACE.
• The term “USER PROFILE” shall assume the same meaning as OPERATOR PROFILE.
Compliance is checked by inspection of the USABILITY ENGINEERING FILE. Evidence of
compliance with this clause and all requirements of this standard referring to inspection of the
USABILITY ENGINEERING FILE are satisfied if the MANUFACTURER has:
– established a USABILITY ENGINEERING PROCESS;
– established acceptance criteria for USABILITY; and
– demonstrated that the acceptance criteria for USABILITY have been met.
5 * Replacement of requirements given in IEC 62366
In addition to requirements of IEC 62366 the following replacements shall apply:
Replace the first two paragraphs including NOTES 1 and 2 of Clause 6 of IEC 62366:2007 by:
The instructions for use shall include a brief description of the ME EQUIPMENT, its physical
operating principles and significant physical and performance characteristics relevant to its
USABILITY. The same information shall also be included in the technical description, if this is
provided as a separate document.
NOTE An important purpose of this description is to help the OPERATOR to develop a correct mental model of the
ME EQUIPMENT.
The instructions for use shall contain a summary of the application specification.

– 10 – 60601-1-6 © IEC:2010
Annex A
(informative)
General guidance and rationale

A.1 General guidance
This annex provides a concise rationale for the important requirements of this collateral
standard. Its purpose is to promote effective application of the collateral standard by
explaining the reasons for the requirements and provide additional guidance where
appropriate.
A.2 Rationale for particular clauses and subclauses
The following are rationales for specific clauses and subclauses in this collateral standard,
with clause and subclause numbers parallel to those in the body of the document.
Subclause 1.1 – Scope
This collateral standard focuses on the USABILITY of the OPERATOR-EQUIPMENT INTERFACE of
ME EQUIPMENT. USABILITY, in general, includes attributes such as OPERATOR satisfaction and
EFFICIENCY. These attributes might be related to the BASIC SAFETY or ESSENTIAL PERFORMANCE
of the ME EQUIPMENT. A degradation of these attributes can increase the probability of USE
ERROR. Examples of attributes that are not considered could include the aesthetics of the
ME EQUIPMENT or the amount of supplies consumed.
Definition 3.1 – OPERATOR-EQUIPMENT INTERFACE
The OPERATOR-EQUIPMENT INTERFACE includes all means of communication between the
ME EQUIPMENT to the OPERATOR and the OPERATOR to the ME EQUIPMENT. These means include,
but are not limited to:
– markings and ACCOMPANYING DOCUMENTS;
– lights;
– video displays;
– push buttons;
– touch screens;
– auditory and visual INFORMATION SIGNALS;
– ALARM SIGNALS;
– vibratory signals;
– keyboard and mouse; and
– haptic controls.
Subclause 4.1 – Conditions for application to ME EQUIPMENT
This collateral standard specifies requirements addressing particular RISKS associated with
USABILITY. When these requirements are complied with, the RESIDUAL RISKS associated with
USABILITY are presumed to be acceptable unless there is OBJECTIVE EVIDENCE to the contrary.
This follows from 4.2 of the general standard, which states “Where this standard or any of its
collateral or particular standards specify verifiable requirements addressing particular RISKS,
and these requirements are complied with, the RESIDUAL RISKS addressed by these

60601-1-6 © IEC:2010 – 11 –
requirements shall be presumed to be acceptable unless there is OBJECTIVE EVIDENCE to the
contrary.”
The criteria for judging RISK acceptability are established by the USABILITY VALIDATION plan,
which specifies the criteria for determining successful VALIDATION of the USABILITY of the
PRIMARY OPERATING FUNCTIONS.
Subclause 4.2 – USABILITY ENGINEERING PROCESS for ME EQUIPMENT
The first edition of this collateral standard was published in 2004, and introduced a USABILITY
ENGINEERING PROCESS tailored to ME EQUIPMENT. The second edition was published in 2006
and was intended to align the collateral standard with the third edition of IEC 60601-1 —
principally the inclusion in IEC 60601-1:2005 of the requirement to conduct a RISK
MANAGEMENT PROCESS following ISO 14971. The USABILITY ENGINEERING PROCESS described in
the second edition of IEC 60601-1-6 was little altered from that in the first edition.
Shortly after the publication of the 2004 edition of IEC 60601-1-6, IEC Subcommittee 62A
formed a joint project with ISO Technical Committee 210 to develop a general USABILITY
ENGINEERING PROCESS standard applicable to all MEDICAL DEVICES as defined in the ISO quality
system standard, ISO 13485:2003. This project was similar in scope to the effort that took the
RISK MANAGEMENT PROCESS described in IEC 60601-1-4 and generalized it to produce
ISO 14971. The result of the joint IEC/SC 62A – ISO/TC 210 USABILITY standard project was
IEC 62366:2007.
While the USABILITY ENGINEERING PROCESS described in IEC 62366 is more mature and refined
than the PROCESS in the second edition of IEC 60601-1-6, it is fundamentally the same
PROCESS involving the same elements.
As with the RISK MANAGEMENT PROCESS before it, the existence of a generalized standard for
USABILITY ENGINEERING eliminates the need for much, but not all, of the content in the second
edition of IEC 60601-1-6. For example, IEC 62366 defines the USER as the “person using, i.e.
operating or handling, the MEDICAL DEVICE”. This definition includes those who clean, maintain
or install the MEDICAL DEVICE. In IEC 60601-1:2005, persons performing those functions are
described as SERVICE PERSONNEL. This subclause bridges between the general PROCESS
requirement in IEC 62366 and the specific application to ME EQUIPMENT.
Clause 5 – Replacement of requirements given in IEC 62366
Clause 6 of IEC 62366:2007 specifies the general requirements for the material to be included
in the ACCOMPANYING DOCUMENT, if such a document is provided. The ACCOMPANYING
DOCUMENT is required to include a summary of the application specification (see 5.1 of
IEC 62366). This replacement paragraph clarifies that for ME EQUIPMENT the summary is
described in the same terms used in subclause 7.9.2.5 of IEC 60601-1:2005 to specify the
ME EQUIPMENT description.
In IEC 60601-1, the ACCOMPANYING DOCUMENTS consist of the instructions for use and the
technical description. IEC 62366, on the other hand, discusses the ACCOMPANYING DOCUMENT
without specifically identifying any sub-parts. IEC 60601-1 anticipates that the instructions for
use and the technical description can be provided as separate physical documents. If they
are, then the summary of the application specification is required to appear in both
documents.
– 12 – 60601-1-6 © IEC:2010
Annex B
(informative)
Mapping between the elements of IEC 60601-1-6:2006 and
the related elements in IEC 62366:2007

This annex contains a mapping of the clauses and subclause of IEC 60601-1-6:2006 to the
comparable clauses and subclauses in IEC 62366:2007. Table B.1 is intended to provide a
tool to assist users of IEC 60601-1-6:2006 to trace requirements between that edition and
their equivalent requirements in IEC 62366:2007.
Table B.1 – Mapping between the elements of IEC 60601-1-6:2006
and the related elements in IEC 62366:2007
Related elements in
IEC 60601-1-6:2006 IEC 62366:2007
Clause Title Clause Title
1 Scope, object and related standards 1 Scope
NOTE IEC 62366:2007 applies to MEDICAL
DEVICES as defined in 3.11. That definition is
identical to that in ISO 13485:2003.
2 Normative references 2 Normative references
3 Terms and definitions 3 Terms and definitions
3.1 ABNORMAL USE 3.1 ABNORMAL USE
IEC 60601-1: ACCOMPANYING DOCUMENT 3.2 ACCOMPANYING DOCUMENT
2005, 3.4
IEC 60601-1-8: ALARM LIMIT 3.3 ALARM LIMIT
2006, 3.3
IEC 60601-1-8: ALARM OFF 3.4 ALARM OFF
2006, 3.4
IEC 60601-1-8: ALARM SIGNAL 3.5 ALARM SIGNAL
2006, 3.9
IEC 60601-1-8: ALARM SYSTEM 3.6 ALARM SYSTEM
2006, 3.11
IEC 60601-1: BASIC SAFETY
SAFETY
2005, 3.10
ISO 14971:
NOTE SAFETY is used as defined term in
2007, 2.24
IEC 60601-1: ESSENTIAL PERFORMANCE
IEC 62366.
2005, 3.27
3.7 CORRECT USE
NOTE This is a new term in IEC 62366, and
is defined as “NORMAL USE without USE ERROR.”
3.2 EFFECTIVENESS 3.8 EFFECTIVENESS
3.3 EFFICIENCY 3.9 EFFICIENCY
NOTE Not a defined term in IEC 62366.
IEC 60601-1: HAND-HELD
2005, 3.37
IEC 60601-1: HARM ISO 14971: HARM
2005, 3.38 2007, 2.2
IEC 60601-1: HAZARD ISO 14971: HAZARD
2005, 3.39 2007, 2.3
IEC 60601-1: HAZARDOUS SITUATION ISO 14971: HAZARDOUS SITUATION
2005, 3.40 2007, 2.4
60601-1-6 © IEC:2010 – 13 –
Table B.1 (continued)
Related elements in
IEC 60601-1-6:2006 IEC 62366:2007
Clause Title Clause Title
IEC 60601-1-8: INFORMATION SIGNAL 3.10 INFORMATION SIGNAL
2006, 3.23
IEC 60601-1: INTENDED USE ISO 14971: INTENDED USE
2005, 3.44 2007, 2.5
IEC 60601-1: MANUFACTURER ISO 14971: MANUFACTURER
2005, 3.55 2007, 2.8
IEC 60601-1: MEDICAL ELECTRICAL EQUIPMENT 3.11 MEDICAL DEVICE
2005, 3.63
IEC 60601-1: NORMAL USE 3.12 NORMAL USE
2005, 3.71
NOTE The phrase, “or in accordance with
generally accepted practice for those MEDICAL
DEVICES provided without instructions for use”
has been added to deal with MEDICAL DEVICES,
such as simple surgical instruments, that are
not accompanied by instructions for use.
IEC 60601-1: OBJECTIVE EVIDENCE ISO 14971: OBJECTIVE EVIDENCE
2005, 3.72 2007, 2.10
IEC 60601-1: OPERATOR 3.23 USER
2005, 3.73
NOTE In IEC 62366, the USER includes but is
not limited to cleaners, maintainers and
installers. In IEC 60601-1:2005, individuals
who install, assemble, maintain or repair
ME EQUIPMENT are described as “SERVICE
PERSONNEL.”
3.4 OPERATOR-EQUIPMENT INTERFACE 3.24 USER INTERFACE
NOTE The word “communicate” was replaced
by “interact”.
3.5 OPERATOR PROFILE 3.25 USER PROFILE
IEC 60601-1: PATIENT 3.13 PATIENT
2005, 3.76
NOTE “Animal” has been deleted from the
IEC 60601-1 definition.
3.6 PRIMARY OPERATING FUNCTION 3.14 PRIMARY OPERATING FUNCTION
IEC 60601-1: PROCESS ISO 14971: PROCESS
2005, 3.89 2007, 2.13
NOTE Not a defined term in IEC 62366.
3.7 REASONABLY FORESEEABLE MISUSE
IEC 60601-1- REMINDER SIGNAL 3.15 REMINDER SIGNAL
8:2006, 3.34
IEC 60601-1: RESIDUAL RISK ISO 14971: RESIDUAL RISK
2005, 3.100 2007, 2.15
IEC 60601-1: RESPONSIBLE ORGANIZATION 3.16 RESPONSIBLE ORGANIZATION
2005, 3.101
IEC 60601-1: RISK ISO 14971: RISK
2005, 3.102 2007, 2.16
IEC 60601-1: RISK ANALYSIS ISO 14971: RISK ANALYSIS
2005, 3.103 2007, 2.17
IEC 60601-1: RISK CONTROL ISO 14971: RISK CONTROL
2005, 3.105 2007, 2.19
IEC 60601-1: RISK EVALUATION ISO 14971: RISK EVALUATION
2005, 3.106 2007, 2.21
IEC 60601-1: RISK MANAGEMENT ISO 14971: RISK MANAGEMENT
2005, 3.107 2007, 2.22
– 14 – 60601-1-6 © IEC:2010
Table B.1 (continued)
Related elements in
IEC 60601-1-6:2006 IEC 62366:2007
Clause Title Clause Title
IEC 60601-1: RISK MANAGEMENT FILE ISO 14971: RISK MANAGEMENT FILE
2005, 3.108 2007, 2.23
IEC 60601-1, SEVERITY ISO 14971: SEVERITY
2005, 3.114 2007, 2.25
NOTE Not a defined term in IEC 62366.
3.8 TRAINING
3.9 USE ERROR 3.21 USE ERROR
3.10 USE SCENARIO 3.22 USE SCENARIO
NOTE The phrase “used to specify and test
the USABILITY of the ME EQUIPMENT” is replaced
by “as performed by a specified USER in a
specified environment” to make the definition
more general.
3.11 USABILITY 3.17 USABILITY
NOTE 1 The phrase “of the USER INTERFACE”
has been inserted into the definition.
NOTE 2 Impaired EFFICIENCY can also lead to
USE ERRORS. The OPERATOR might be induced
to take inappropriate short cuts if the
ME EQUIPMENT does not meet their
expectations.
3.12 USABILITY ENGINEERING 3.18 USABILITY ENGINEERING
3.13 USABILITY ENGINEERING FILE 3.19 USABILITY ENGINEERING FILE
3.14 USABILITY SPECIFICATION 3.20 USABILITY SPECIFICATION
3.15 VALIDATION 3.26 VALIDATION
IEC 60601-1: VERIFICATION ISO 14971: VERIFICATION
2005, 3.138 2007, 2.28
4 General requirements 4 Principles
4.1 Conditions for application to 4.1.2 RESIDUAL RISK
ME EQUIPMENT
This requirement is covered in 4.1 of this
collateral standard as well as in 4.1.2 of
IEC 62366.
NOTE This subclause in IEC 62366 mimics
the statement in the fourth bullet of 4.2 of
IEC 60601-1:2005 and closes the loop with
respect to the acceptability of RESIDUAL RISKS
associated with USABILITY when the process
described in IEC 62366 has been complied
with and the acceptance criteria document in
the USABILITY VALIDATION plan have been met.

60601-1-6 © IEC:2010 – 15 –
Table B.1 (continued)
Related elements in
IEC 60601-1-6:2006 IEC 62366:2007
Clause Title Clause Title
5.3.1 Identification of characteristics related to
SAFETY
NOTE In IEC 62366, the list of items to be
considered in that part of the RISK ANALYSIS
specified in ISO 14971:2007, 4.2 has been
reduced to:
– the application specification including the
user profile(s); and
– the frequently used functions.
IEC 62366 explicitly requires the frequently
used functions to be identified as an input to
the RISK ANALYSIS. In IEC 60601-1-6:2006, this
was implicit in the definition of PRIMARY
OPERATING FUNCTION.
RISK MANAGEMENT PROCESS for
4.2
ME EQUIPMENT
5.3.2 Identification of known or foreseeable
HAZARDS and HAZARDOUS SITUATIONS
NOTE In IEC 62366, the list of items to be
considered has been expanded from that in 4.2
of IEC 60601-1-6:2006. The list now includes:
– preliminary USE SCENARIOS; and
– if an incorrect mental model of the operation
of the device can cause a USE ERROR
resulting in a HAZARDOUS SITUATION.
IEC 62366 requires that the SEVERITY of
possible HARMS be recorded in USABILITY
ENGINEERING FILE so that this information is
available in case a RISK/benefit analysis is
required in subclause 5.9 of IEC 62366:2007.
NOTE There is no equivalent heading in
5 ME EQUIPMENT identification, marking
IEC 62366.
and documents
5.1 6
ACCOMPANYING DOCUMENTS ACCOMPANYING DOCUMENT
NOTE IEC 62366 does not distinguish
between the instructions for use and the
technical description. It refers only to the
ACCOMPANYING DOCUMENTS. This requirement to
include a summary of the MEDICAL DEVICE
application specification in the technical
description, if this is provided as a separate
document, is covered in Clause 5 of this
collateral standard
5.2 TRAINING and materials for TRAINING 7 Training and materials for training
NOTE The list of training options in
IEC 62366 has been clarified to indicate that
the MANUFACTURER is required to do at least
one of the following:
– provide the training materials;
– ensure that
...