EN 62366:2008

Medical devices - Application of usability engineering to medical devices

Specifies a process for a manufacturer to analyse, specify, design, verify and validate usability, as it relates to safety of a medical device. 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 International Standard has been complied with and the acceptance criteria documented in the usability validation plan have been met, then the residual risks, as defined in ISO 14971, associated with usability of a medical device are presumed to be acceptable, unless there is objective evidence to the contrary. This International Standard does not apply to clinical decision-making relating to the use of a medical device.

Medizinprodukte - Anwendung der Gebrauchstauglichkeit auf Medizinprodukte

Dispositifs médicaux - Application de l'ingénierie de l'aptitude à l'utilisation aux dispositifs médicaux

Spécifie un processus permettant à un fabricant d'analyser, de spécifier, de concevoir, de vérifier et de valider l'aptitude à l'utilisation concernant la sécurité d'un dispositif médical. Ce processus d'ingénierie de l'aptitude à l'utilisation évalue et réduit les risques provoqués par les problèmes d'aptitude à l'utilisation 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 internationale a été satisfait et si les critères d'acceptation documentés dans le plan de validation de l'aptitude à l'utilisation ont été satisfaits, les risques résiduels définis dans l'ISO 14971 associés à l'aptitude à l'utilisation d'un dispositif médical sont alors présumés acceptables, sauf s'il existe une preuve tangible du contraire. La présente Norme internationale ne s'applique pas à la prise de décision clinique relative à l'utilisation d'un dispositif médical.

Medicinske naprave - Uporaba inženirstva uporabljivosti pri medicinskih napravah (IEC 62366:2007)

General Information

• Status: Withdrawn
• Publication Date: 24-Jan-2008
• Withdrawal Date: 30-Nov-2010
• 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: 31-Mar-2018
• Completion Date: 31-Mar-2018
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Directive: 98/79/EC - Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic 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 62366:2008 - Medical devices - Application of usability engineering to medical devices

Relations

• Replaced By: EN 62366-1:2015 - Medical devices - Part 1: Application of usability engineering to medical devices
• Effective Date: 29-Jan-2023
• Amended By: EN 62366:2008/A1:2015 - Medical devices - Application of usability engineering to medical devices
• Effective Date: 28-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
01-april-2008
Medicinske naprave - Uporaba inženirstva uporabljivosti pri medicinskih napravah
(IEC 62366:2007)
Medical devices - Application of usability engineering to medical devices (IEC
62366:2007)
Medizinprodukte - Anwendung der Ergonomie auf Medizinprodukte (IEC 62366:2007)
Dispositifs médicaux - Application de l'ingénierie de l'aptitude a l'utilisation aux dispositifs
médicaux (CEI 62366:2007)
Ta slovenski standard je istoveten z: EN 62366:2008
ICS:
11.040.01
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN 62366
NORME EUROPÉENNE
January 2008
EUROPÄISCHE NORM
ICS 11.040
English version
Medical devices -
Application of usability engineering to medical devices
(IEC 62366:2007)
Dispositifs médicaux -  Medizinprodukte -
Application de l'ingénierie de l'aptitude Anwendung der Gebrauchstauglichkeit
à l'utilisation aux dispositifs médicaux auf Medizinprodukte
(CEI 62366:2007) (IEC 62366:2007)

This European Standard was approved by CENELEC on 2007-12-01. 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

© 2008 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 62366:2008 E
Foreword
The text of document 62A/574/FDIS, future edition 1 of IEC 62366, prepared by a joint working group of
subcommittee 62A: Common aspects of electrical medical equipment used in medical practice, of
IEC TC 62, Electrical equipment in medical practice and ISO/TC 210, Quality management and
corresponding general aspects for medical devices, was submitted to the IEC-CENELEC parallel vote
and was approved by CENELEC as EN 62366 on 2007-12-01.
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) 2008-09-01
– latest date by which the national standards conflicting
with the EN have to be withdrawn (dow) 2010-12-01
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 MDD (93/42/EEC) and IVD (98/79/EC). See Annex ZZ.
In this standard, the following print types are used:
– Requirements and definitions: roman type.
– Means to assess compliance: 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 OR AS NOTED: SMALL CAPITALS.
Annexes ZA and ZZ have been added by CENELEC.
__________
Endorsement notice
The text of the International Standard IEC 62366:2007 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:
IEC 60601-1 NOTE  Harmonized as EN 60601-1:2006 (not modified).
IEC 60601-1-8 NOTE  Harmonized as EN 60601-1-8:2007 (not modified).
ISO 9000 NOTE  Harmonized as EN ISO 9000:2005 (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).
__________
- 3 - EN 62366:2008
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

ISO 14971 2007 Medical devices - Application of risk EN ISO 14971 2007
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 Directives 93/42/EEC and 98/79/EC.
Compliance with this standard provides one means of conformity with the specified essential
requirements of the Directives concerned.
WARNING: Other requirements and other EC Directives may be applicable to the products falling within
the scope of this standard.
__________
IEC 62366
Edition 1.0 2007-10
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical devices – Application of usability engineering to medical devices

Dispositifs médicaux – Application de l'ingénierie de l'aptitude à l'utilisation aux
dispositifs médicaux
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
XD
CODE PRIX
ICS 11.040 ISBN 2-8318-9313-5
– 2 – 62366 © IEC:2007
CONTENTS
FOREWORD.4
INTRODUCTION.6

1 * Scope .7
2 Normative references .7
3 Terms and definitions .7
4 * Principles.11
4.1 General requirements.11
4.1.1 * USABILITY ENGINEERING PROCESS .11
4.1.2 RESIDUAL RISK .11
4.1.3 Information for SAFETY .12
4.2 * USABILITY ENGINEERING FILE .12
4.3 Scaling of the USABILITY ENGINEERING effort.12
5 * USABILITY ENGINEERING PROCESS.12
5.1 * Application specification.12
5.2 * Frequently used functions .13
5.3 Identification of HAZARDS and HAZARDOUS SITUATIONS related to USABILITY .13
5.3.1 Identification of characteristics related to SAFETY .13
5.3.2 * Identification of known or foreseeable HAZARDS and HAZARDOUS
SITUATIONS.14
5.4 PRIMARY OPERATING FUNCTIONS .14
5.5 * USABILITY SPECIFICATION .15
5.6 USABILITY VALIDATION plan.15
5.7 * USER INTERFACE design and implementation .16
5.8 * USABILITY VERIFICATION.16
5.9 * USABILITY VALIDATION.17
6 * ACCOMPANYING DOCUMENT .17
7 * Training and materials for training.18

Annex A (informative) General guidance and rationale.19
Annex B (informative) Categories of USER action.31
Annex C (informative) Examples of USE ERRORS, ABNORMAL USE and possible causes.33
Annex D (informative) Guidance on the USABILITY ENGINEERING PROCESS.36
ANNEX E (informative) Questions that can be used to identify MEDICAL DEVICE
characteristics associated with USABILITY that could impact on SAFETY.60
ANNEX F (informative) Examples of possible USABILITY related HAZARDOUS SITUATIONS.64
Annex G (informative) USABILITY goals: Illustrative example for a home parenteral
infusion pump .67
ANNEX H (informative) Sample USABILITY SPECIFICATION and its inputs .77
Annex I (informative) Recommended reading list .87
Annex J (informative) Reference to the essential principles .95

Bibliography.

Index of defined terms .

62366 © IEC:2007 – 3 –
Figure A.1 – A comparison of the RISK MANAGEMENT PROCESS (ISO 14971:2007) and the
USABILITY ENGINEERING PROCESS (IEC 62366) .24
Figure B.1 – Categories of foreseeable USER action.32
Figure D.1 – A USER INTERFACE design cycle .39
Figure D.2 – Bubble diagram of the conceptual model of a physiological monitor.52
Figure F.1 – Pictorial representation of the relationship of HAZARD, sequence of events,
HAZARDOUS SITUATION and HARM .65

Table D.1 – Sample of design flaws and associated USE ERRORS .37
Table D.2 – Mapping of Figure D.1 to the subclauses of this International Standard .39
Table D.3 – Examples of USER INTERFACE requirements .42
Table D.4 – Typical deliverables .47
Table D.5 – Examples of objective USABILITY goals .50
Table D.6 – Examples of subjective USABILITY goals.50
Table D.7 – Examples of USER INTERFACE modelling techniques .53
Table D.8 – Characteristics of a typical USABILITY testing effort .53
Table F.1 – Glossary of relevant RISK MANAGEMENT terms .64
Table F.2 – Examples of HARM due to USABILITY related HAZARDS.65
Table G.1 – Power on/off .70
Table G.2 – Program pump.70
Table G.3 – Start/stop infusion.71
Table G.4 – Monitor infusion status.72
Table G.5 – Install and change set.72
Table G.6 – Priming.73
a
Table G.7 – Respond to and inactivate ALARM SIGNALS .73
Table G.8 – Lockouts.74
Table G.9 – Power management.74
Table G.10 – Preventative and routine maintenance .75
Table G.11 – Basic operation.76
Table G.12 – Advanced functions .
...