EN 60601-1-6:2007

Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral Standard: Usability

Specifies requirements for a process to analyse, design, verify and validate the usability, as it relates to basic safety and essential performance of medical electrical equipment. This collateral standard addresses normal use and use errors but excludes abnormal use. The object of this collateral standard is to specify general requirements that are in addition to those of the general standard IEC 60601-1 and to serve as the basis for particular standards.

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

Spécifie les exigences d'un processus destiné à analyser, concevoir, vérifier et valider l'aptitude à l'utilisation ayant trait à la sécurité de base et les performances essentielles des appareils électromédicaux. La présente norme collatérale traite de l'utilisation normale et des erreurs d'utilisation mais exclut l'utilisation anormale. La présente norme collatérale est destinée à spécifier des exigences générales qui viennent compléter celles de la norme générale CEI 60601-1 et à servir de base pour les normes particulières.

Medicinska električna oprema - 1-6. del: Splošne zahteve za osnovno varnost in bistvene tehnične lastnosti - Spremljevalni standard: Uporabnost (IEC 60601-1-6:2006)

General Information

• Status: Withdrawn
• Publication Date: 30-Jul-2007
• Withdrawal Date: 31-May-2012
• 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: 9960 - Withdrawal effective - Withdrawal
• Start Date: 01-Apr-2013
• Completion Date: 01-Apr-2013
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/432 - Standardisation Mandate addressed to CEN and CENELEC within the framework of Directive 2007/47/EC amending Directive 90/385/EEC and Directive 93/42/EEC relating to Medical Devices
• Ref Project: SIST EN 60601-1-6:2008 - Medical electrical equipment -- Part 1-6: General requirements for basic safety and essential performance - Collateral Standard: Usability

Relations

• Replaces: EN 60601-1-6:2004 - Medical electrical equipment - Part 1-6: General requirements for safety - Collateral standard: Usability
• Effective Date: 28-Jan-2023
• Replaced By: EN 60601-1-6:2010 - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
• Effective Date: 28-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
01-januar-2008
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SIST EN 60601-1-6:2005
0HGLFLQVNDHOHNWULþQDRSUHPDGHO6SORãQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHWHKQLþQHODVWQRVWL6SUHPOMHYDOQLVWDQGDUG8SRUDEQRVW,(&

Medical electrical equipment - Part 1-6: General requirements for basic safety and
essential performance - Collateral Standard: Usability (IEC 60601-1-6:2006)
Medizinische elektrische Geräte - Teil 1-6: Allgemeine Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale - Ergänzungsnorm:
Gebrauchstauglichkeit (IEC 60601-1-6:2006)
Appareils électromédicaux - Partie 1-6: Exigences générales pour la sécurité de base et
les performances essentielles - Norme collatérale: Aptitude a l'utilisation (IEC 60601-1-
6:2006)
Ta slovenski standard je istoveten z: EN 60601-1-6:2007
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
July 2007
EUROPÄISCHE NORM
ICS 11.040 Supersedes EN 60601-1-6:2004

English version
Medical electrical equipment -
Part 1-6: General requirements
for basic safety and essential performance -
Collateral Standard: Usability
(IEC 60601-1-6:2006)
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 60601-1-6:2006) (IEC 60601-1-6:2006)

This European Standard was approved by CENELEC on 2007-05-01. 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, 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: rue de Stassart 35, B - 1050 Brussels

© 2007 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 60601-1-6:2007 E
Foreword
The text of document 62A/550/FDIS, future edition 2 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 2007-05-01.
The following date was fixed:
– latest date by which the EN has to be implemented
at national level by publication of an identical
national standard or by endorsement (dop) 2008-02-01
This European Standard supersedes EN 60601-1-6:2004. However, EN 60601-1-6:2004 remains valid
until all the parts 2 that are used in conjunction with it have been withdrawn. No date of withdrawal of
conflicting national standards (dow) has therefore been fixed. However, when Part 1-6 is used for
appliances not covered by a part 2, EN 60601-1-6:2004 is not to be used after 2009-09-12.
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 Directive 93/42/EEC. See Annex ZZ.
This European Standard constitutes a collateral standard to EN 60601-1:2006, hereafter referred to as
the general standard.
This EN 60601-1-6 was revised to structurally align it with EN 60601-1:2006 and to implement the
decision of IEC SC 62A that the clause numbering structure of collateral standards written to
EN 60601-1:2006 would adhere to the form specified in ISO/IEC Directives, Part 2:2004. The principle
technical changes are in Clause 4, which now recognizes that there is a general requirement for a risk
management process in EN 60601-1:2006.
In the 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: in roman type;
− test specifications: in 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 NOTES:
IN SMALL CAPITALS.
In referring to the structure of this standard, the term
– “clause” means one of the six numbered divisions within the table of contents, inclusive of all
subdivisions (e.g. Clause 6 includes Subclauses 6.1, 6.2, etc.);
– “subclause” means a numbered subdivision of a clause (e.g. 6.1, 6.2 and 6.2.1 are all subclauses
of Clause 6).
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.

- 3 - EN 60601-1-6:2007
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 Annex A are
marked with an asterisk (*).
Annexes ZA and ZZ have been added by CENELEC.
__________
Endorsement notice
The text of the International Standard IEC 60601-1-6:2006 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:
NOTE   Harmonized as EN ISO 9000:2000 (not modified).
ISO 9000
ISO 9001 NOTE   Harmonized as EN ISO 9001:2000 (not modified).
ISO 9241-11 NOTE   Harmonized as EN ISO 9241-11:1998 (not modified).
ISO 13485 NOTE   Harmonized as EN ISO 13485:2003 (not modified).
__________
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
ISO/IEC 14971 2000 Medical devices - Application of risk EN ISO 14971 2000
management to medical devices + corr. February 2002

- 5 - EN 60601-1-6:2007
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.
Compliance with this standard provides one means of conformity with the specified essential
requirements of the Directive 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 2.0 2006-12
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
XB
CODE PRIX
ICS 11.040 ISBN 2-8318-8933-2
60601-1-6 © IEC:2006 –– 2 – 3 – 60601-1-6 © IEC:2006
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
2 Normative references .7
3 Terms and definitions .8
4 General requirements .10
4.1 * Conditions for application to ME EQUIPMENT .10
4.2 * RISK MANAGEMENT PROCESS for ME EQUIPMENT.10
5 ME EQUIPMENT identification, marking and documents.10
5.1 * ACCOMPANYING DOCUMENTS.10
5.2 * TRAINING and materials for TRAINING .11
6 * USE ERROR and USABILITY .11
6.1 * Safety for the PATIENT, OPERATOR and other persons .11
6.2 * USABILITY ENGINEERING PROCESS .11

Annex A (informative) General guidance and rationale.15
Annex B (informative) A taxonomy of OPERATOR action .21
Annex C (informative) Examples of USE ERRORS, ABNORMAL USE and design flaws
potentially leading to USE ERRORS .22
Annex D (informative) Guidance on the USABILITY ENGINEERING PROCESS.25
Annex E (informative) Sample USABILITY SPECIFICATION .53
Annex F (informative) Reference documents.62

Bibliography.71

Index of defined terms used in this collateral standard.73

Figure B.1 – Summary of the taxonomy of OPERATOR action.21
Figure D.1 – An OPERATOR-EQUIPMENT INTERFACE design cycle.28
Figure D.2 – Bubble diagram of the conceptual model of a physiological monitor.43
Figure E.1 – Example of a USABILITY SPECIFICATION for a hypothetical device .53

Table D.1 – Sample of design flaws and associated USE ERRORS .27
Table D.2 – Mapping of Figure D.1 to the subclauses of this standard .28
Table D.3 – Examples of OPERATOR-EQUIPMENT INTERFACE requirements .31
Table D.4 – Typical deliverables .37
Table D.5 – Examples of objective and subjective USABILITY goals .41
Table D.6 – Examples of OPERATOR-EQUIPMENT INTERFACE modelling techniques .44
Table D.7 – Characteristics of a typical USABILITY testing effort .44

60601-1-6 © IEC:200660601-1-6 © IEC:2006 –– 3 – 5 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
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MEDICAL ELECTRICAL EQUIPMENT –
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