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)

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).

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
• 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/A1:2015 - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
• Effective Date: 29-Jan-2023
• 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
• 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

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 60601-1-6:2010
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
SIST EN 60601-1-6:2010 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 60601-1-6:2010

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SIST EN 60601-1-6:2010

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

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SIST EN 60601-1-6:2010
EN 60601-1-6:2010 - 2 -
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).

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SIST EN 60601-1-6:2010
- 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

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SIST EN 60601-1-6:2010
EN 60601-1-6:2010 - 4 -
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.

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SIST EN 60601-1-6:2010
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
® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale

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SIST EN 60601-1-6:2010
– 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

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SIST EN 60601-1-6:2010
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.

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SIST EN 60601-1-6:2010
– 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 (*).

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SIST EN 60601-1-6:2010
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.

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SIST EN 60601-1-6:2010
– 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.

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SIST EN 60601-1-6:2010
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.

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SIST EN 60601-1-6:2010
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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.

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SIST EN 60601-1-6:2010
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
USAB
...