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 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
• Withdrawal Date: 31-Mar-2013
• ICS: 11.040 - Medical equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62A - IEC_SC_62A
• Parallel Committee: IEC/SC 62A - IEC_SC_62A
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 16-Apr-2010
• Completion Date: 16-Apr-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: 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)

Relations

• Replaces: EN 60601-1-6:2007 - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral Standard: Usability
• Effective Date: 28-Jan-2023
• Amended By: 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: EN 60601-1-6:2010/A2:2021 - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
• Effective Date: 27-Jan-2023

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
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