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.

Medizinische elektrische Geräte - Teil 1-6: Allgemeine Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale - Ergänzungsnorm: Gebrauchstauglichkeit

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.

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
15-Apr-2010
Current Stage
6060 - Document made available
Due Date
16-Apr-2010
Completion Date
16-Apr-2010

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SLOVENSKI STANDARD
SIST EN 60601-1-6:2010
01-junij-2010
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SIST EN 60601-1-6:2008
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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.

---------------------- Page: 1 ----------------------
SIST EN 60601-1-6:2010
---------------------- Page: 2 ----------------------
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
---------------------- Page: 3 ----------------------
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).
---------------------- Page: 4 ----------------------
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
---------------------- Page: 5 ----------------------
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.
---------------------- Page: 6 ----------------------
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
CODE PRIX
ICS 11.040 ISBN 2-8318-1077-4
® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale
---------------------- Page: 7 ----------------------
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

---------------------- Page: 8 ----------------------
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.
---------------------- Page: 9 ----------------------
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 (*).
---------------------- Page: 10 ----------------------
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.
---------------------- Page: 11 ----------------------
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.
---------------------- Page: 12 ----------------------
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
– 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.
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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
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