EN 60601-1-6:2004

Medical electrical equipment - Part 1-6: General requirements for safety - Collateral standard: Usability

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. 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 control by the manufacturer. The usability engineering process is part of the process of risk control. This Collateral Standard describes a usability engineering process, and provides guidance on how to implement and execute the process to provide medical electrical equipment safety. It addresses normal use and use errors but excludes abnormal use.

Medizinische elektrische Geräte - Teil 1-6: Allgemeine Festlegungen für die Sicherheit - Ergänzungsnorm: Gebrauchstauglichkeit

Appareils électromédicaux - Partie 1-6: Règles générales de sécurité - Norme collatérale: Aptitude à l'utilisation

Les appareils électromédicaux sont de plus en plus utilisés en pratique médicale pour l'observation et le traitement des patients. Les erreurs d'utilisation dues à une aptitude à l'utilisation inadéquate des appareils électromédicaux sont devenues une préoccupation majeure. Le processus d'ingénierie de l'aptitude à l'utilisation est destiné à obtenir une aptitude à l'utilisation raisonnable qui, a son tour, est destinée à minimiser les erreurs d'utilisation et à minimiser les risques associés à l'utilisation. Certaines formes d'utilisation incorrecte, mais pas toutes, sont maîtrisables par le constructeur. Le processus d'ingénierie de l'aptitude à l'utilisation fait partie du processus de maîtrise du risque. La présente norme collatérale décrit un processus d'ingénierie de l'aptitude à l'utilisation et fournit des lignes directrices pour la mise en oeuvre et l'exécution de ce processus pour contribuer à la sécurité des appareils électromédicaux. Elle traite de l'utilisation normale et des erreurs d'utilisation mais exclut l'utilisation anormale.

Medicinska električna oprema – 1-6. del: Splošne varnostne zahteve – Kolateralni standard: Uporabnost

General Information

• Status: Withdrawn
• Publication Date: 04-Nov-2004
• Withdrawal Date: 31-Aug-2007
• 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-Jun-2012
• Completion Date: 01-Jun-2012
• 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 60601-1-6:2005 - Medical electrical equipment -- Part 1-6: General requirements for safety - Collateral standard: Usability

Relations

• Replaced By: 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

Standards Content (Sample)

EUROPEAN STANDARD EN 60601-1-6
NORME EUROPÉENNE
EUROPÄISCHE NORM November 2004

ICS 11.040
English version
Medical electrical equipment
Part 1-6: General requirements for safety –
Collateral standard: Usability
(IEC 60601-1-6:2004)
Appareils électromédicaux Medizinische elektrische Geräte
Partie 1-6: Règles générales de sécurité - Teil 1-6: Allgemeine Festlegungen
Norme collatérale: Aptitude à l'utilisation für die Sicherheit –
(CEI 60601-1-6:2004) Ergänzungsnorm: Gebrauchstauglichkeit
(IEC 60601-1-6:2004)
This European Standard was approved by CENELEC on 2004-09-01. 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, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden,
Switzerland and 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

© 2004 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.

Ref. No. EN 60601-1-6:2004 E
Foreword
The text of document 62A/452/FDIS, future edition 1 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 2004-09-01.
The following dates were 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) 2005-06-01
– latest date by which the national standards conflicting
with the EN have to be withdrawn (dow) 2007-09-01
This European Standard is a collateral standard to EN 60601-1:1990, hereinafter referred to as the
general standard.
In the 60601 series of publications, collateral standards specify general requirements for safety
applicable to
– a group 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. electromagnetic compatibility).
The numbering of sections, clauses and subclauses of this collateral standard corresponds with that of
the general standard.
Clauses, subclauses, tables and figures which are additional to those of the general standard are
numbered starting from 201; additional annexes are lettered AAA, BBB, etc., and additional items
aaa), bbb), etc.
In this collateral standard, the following print types are used:
– requirements and definitions: roman type;
– notes, examples, explanations, advice, introductions, general statements and references: smaller roman type;
– test specifications: italic type;
– TERMS DEFINED IN CLAUSE 2 OF THE GENERAL STANDARD, IN THIS COLLATERAL STANDARD OR AS NOTED
IN THE INDEX OF DEFINED TERMS: SMALL CAPITALS.
The requirements are followed by specifications for the relevant tests.
Clauses and subclauses for which a rationale is provided in the informative Annex AAA are marked
with an asterisk (*).
Annex ZA has been added by CENELEC.
__________
Endorsement notice
The text of the International Standard IEC 60601-1-6:2004 was approved by CENELEC as a
European Standard without any modification.

- 3 - EN 60601-1-6:2004
In the official version, for Bibliography, the following notes have to be added for the standard indicated:
ISO 9000 NOTE Harmonized as EN ISO 9000:2000 (not modified)
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 Where 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 1988 Medical electrical equipment EN 60601-1 1990
Part 1: General requirements for safety + Corr. Juli 1994
A1 1991 A1 1993
+ Corr. Juli 1994
A2 1995
+ corr. June 1995 A2 1995
A13 1996
IEC 60601-1-8 2003 Medical electrical equipment EN 60601-1-8 2004
Part 1-8: General requirements for safety
- Collateral standard: General
requirements, tests and guidance for
alarm systems in medical electrical
equipment and medical electrical systems

ISO 14971 2000 Medical devices - Application of risk EN ISO 14971 2000
management to medical devices + corr. February 2002
A1 2003 A1 2003
NORME CEI
INTERNATIONALE
IEC
60601-1-6
INTERNATIONAL
Première édition
STANDARD
First edition
2004-06
Appareils électromédicaux –
Partie 1-6:
Règles générales de sécurité –
Norme collatérale: Aptitude à l'utilisation

Medical electrical equipment –
Part 1-6:
General requirements for safety –
Collateral Standard: Usability

 IEC 2004 Droits de reproduction réservés  Copyright - all rights reserved
Aucune partie de cette publication ne peut être reproduite ni No part of this publication may be reproduced or utilized in any
utilisée sous quelque forme que ce soit et par aucun procédé, form or by any means, electronic or mechanical, including
électronique ou mécanique, y compris la photocopie et les photocopying and microfilm, without permission in writing from
microfilms, sans l'accord écrit de l'éditeur. the publisher.
International Electrotechnical Commission, 3, rue de Varembé, PO Box 131, CH-1211 Geneva 20, Switzerland
Telephone: [phone] Telefax: [phone] E-mail: [e-mail] Web: www.iec.ch
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International Electrotechnical Commission
МеждународнаяЭлектротехническаяКомиссия
Pour prix, voir catalogue en vigueur
For price, see current catalogue

60601-1-6  IEC:2004 – 3 –
CONTENTS
FOREWORD.7
INTRODUCTION.11

SECTION ONE – GENERAL
1 Scope and object.13
1.201 Scope.13
1.202 Relationship to other standards.13
1.202.1 IEC 60601-1 .13
1.202.2 Particular Standards .13
1.202.3 Normative references.13
2 Terminology and definitions.15
3 General requirements .19
6 Identification, markings and documents .19
6.8 ACCOMPANYING DOCUMENTS .19
6.8.1 General .19
6.8.2 Instructions for use .19
6.8.201 TRAINING and materials for TRAINING .19

SECTIONS TWO TO SIX – NOT USED

SECTION SEVEN – PROTECTION AGAINST EXCESSIVE TEMPERATURES AND
OTHER SAFETY HAZARDS
46* USE ERROR and USABILITY.21
46.201 SAFETY for the PATIENT, OPERATOR and other persons .21
46.202 USABILITY ENGINEERING PROCESS.21
46.202.1 General.21
46.202.2 Input for the USABILITY ENGINEERING PROCESS.23
46.202.3 USABILITY SPECIFICATION .25
46.202.4 USABILITY VERIFICATION .27
46.202.5 USABILITY VALIDATION plan .27
46.202.6 USABILITY VALIDATION.27

SECTION EIGHT TO TEN – NOT USED

Annex AAA (informative) General guidance and rationale .29
Annex BBB (informative) A Taxonomy of OPERATOR action.41
Annex CCC (informative) Examples of USE ERRORS, ABNORMAL USE and design flaws
potentially leading to USE ERRORS .43
Annex DDD (informative) Guidance on the USABILITY ENGINEERING PROCESS .49
Annex EEE (informative) Sample USABILITY SPECIFICATION.107
Annex FFF (informative) Reference documents .125

60601-1-6  IEC:2004 – 5 –
Bibliography.143
Terminology – Index of defined terms .147
Figure BBB.1 – Summary of the taxonomy of OPERATOR action .41
Figure DDD.1 – An OPERATOR-EQUIPMENT INTERFACE design cycle.55
Figure DDD.2 – Bubble diagram of the conceptual model of a physiological monitor .85
Figure EEE.1 – Example of a USABILITY SPECIFICATION for a hypothetical device .107
Table DDD.1 – Sample of design flaws and associated USE ERRORS .53
Table DDD.2 – Mapping of Figure DDD.1 to the subclauses of this standard .55
Table DDD.3 – Examples of OPERATOR-EQUIPMENT INTERFACE requirements .63
Table DDD.4 – Typical deliverables .75
Table DDD.5 – Examples of objective and subjective USABILITY goals .83
Table DDD.6 – Examples of OPERATOR-EQUIPMENT INTERFACE modelling techniques .87
Table DDD.7 – Characteristics of a typical USABILITY testing effort .87

60601-1-6  IEC:2004 – 7 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
___________
MEDICAL ELECTRICAL EQUIPMENT –

Part 1-6: General requirements for safety –
Collateral Standard: Usability

FOREWORD
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