IEC 62366-1:2015

Medical devices - Part 1: Application of usability engineering to medical devices

IEC 62366-1:2015 specifies a process for a manufacturer to analyse, specify, develop and evaluate the usability of a medical device as it relates to safety. This usability engineering (human factors engineering) process permits the manufacturer to assess and mitigate risks 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. This first edition of IEC 62366-1, together with the first edition of IEC 62366-2 (not published yet), cancels and replaces the first edition of IEC 62366 published in 2007 and its Amendment 1:2014. Part 1 has been updated to include contemporary concepts of usability engineering, while also streamlining the process. It strengthens links to ISO 14971:2007 and the related methods of risk management as applied to safety related aspects of medical device user interfaces. Part 2, once published, will contain tutorial information to assist manufactures in complying with Part 1, as well as offering more detailed descriptions of usability engineering methods that can be applied more generally to medical devices that go beyond safety-related aspects of medical device user interfaces. The contents of the corrigendum of July 2016 have been included in this copy.

Dispositifs médicaux - Partie 1: Application de l'ingénierie de l'aptitude à l'utilisation aux dispositifs médicaux

L'IEC 62366-1:2015 spécifie un processus permettant à un fabricant d'analyser, de spécifier, de développer et d'évaluer l'aptitude à l'utilisation d'un dispositif médical, concernant la sécurité. Ce processus d'ingénierie de l'aptitude à l'utilisation (ingénierie des facteurs humains) permet au fabricant d'évaluer et de réduire les risques associés à une utilisation correcte et à des erreurs d'utilisation, c'est-à-dire une utilisation normale. Il peut être utilisé pour identifier les risques associés à une utilisation anormale mais ne les évalue pas et ne les réduit pas. La première édition de l'IEC 62366-1, ainsi que la première édition de l'IEC 62366-2 (à paraître), annulent et remplacent la première édition de l'IEC 62366 parue en 2007 et son Amendement 1:2014. La Partie 1 a été mise à jour afin d'inclure des concepts contemporains d'ingénierie de l'aptitude à l'utilisation, tout en rationalisant le processus. Elle renforce aussi les liens avec l'ISO 14971:2007 et les méthodes connexes de gestion des risques appliquées aux aspects relatifs à la sécurité des interfaces utilisateur des dispositifs médicaux. A sa parution, la Partie 2 contiendra des informations didactiques pour aider les fabricants à se conformer à la Partie 1 et fournira des descriptions plus détaillées des méthodes d'ingénierie de l'aptitude à l'utilisation qui peuvent être appliquées d'une façon plus générale aux dispositifs médicaux et qui vont au-delà des aspects relatifs à la sécurité des interfaces utilisateur des dispositifs médicaux. Le contenu du corrigendum de juillet 2016 a été pris en considération dans cet exemplaire.

General Information

• Status: Published
• Publication Date: 16-Jun-2020
• ICS: 01 - GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION
• ICS: 11.040.01 - Medical equipment in general
• Technical Committee: SC 62A - Common aspects of medical equipment, software, and systems
• Drafting Committee: JWG 4 - TC 62/SC 62A/JWG 4
• Current Stage: PPUB - Publication issued
• Start Date: 15-Mar-2015
• Completion Date: 24-Feb-2015

Relations

• Replaces: IEC 62366:2007/AMD1:2014 - Amendment 1 - Medical devices - Application of usability engineering to medical devices
• Effective Date: 05-Sep-2023
• Replaces: IEC 62366:2007 - Medical devices - Application of usability engineering to medical devices
• Effective Date: 05-Sep-2023
• Amended By: IEC 62366-1:2015/AMD1:2020 - Amendment 1 - Medical devices - Part 1: Application of usability engineering to medical devices
• Effective Date: 05-Sep-2023
• Corrected By: IEC 62366-1:2015/COR1:2016 - Corrigendum 1 - Medical devices - Part 1: Application of usability engineering to medical devices
• Effective Date: 05-Sep-2023

Standards Content (Sample)

IEC 62366-1
Edition 1.0 2015-02
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical devices –
Part 1: Application of usability engineering to medical devices

Dispositifs médicaux –
Partie 1: Application de l'ingénierie de l'aptitude à l'utilisation aux dispositifs
médicaux
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form
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IEC 62366-1
Edition 1.0 2015-02
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical devices –
Part 1: Application of usability engineering to medical devices

Dispositifs médicaux –
Partie 1: Application de l'ingénierie de l'aptitude à l'utilisation aux dispositifs

médicaux
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040 ISBN 978-2-8322-2281-2

– 2 – IEC 62366-1:2015  IEC 2015
CONTENTS
FOREWORD . 4
INTRODUCTION . 6
1 * Scope . 7
2 Normative references . 7
3 Terms and definitions . 7
4 Principles . 12
4.1 General requirements . 12
4.1.1 * USABILITY ENGINEERING PROCESS . 12
4.1.2 * RISK CONTROL as it relates to USER INTERFACE design . 13
4.1.3 Information for SAFETY as it relates to USABILITY . 13
4.2 * USABILITY ENGINEERING FILE . 14
4.3 Tailoring of the USABILITY ENGINEERING effort . 14
5 * USABILITY ENGINEERING PROCESS . 14
5.1 * Prepare USE SPECIFICATION . 14
5.2 * Identify USER INTERFACE characteristics related to SAFETY and potential USE
ERRORS . 15
5.3 * Identify known or foreseeable HAZARDS and HAZARDOUS SITUATIONS . 15
5.4 * Identify and describe HAZARD-RELATED USE SCENARIOS . 15
5.5 * Select the HAZARD-RELATED USE SCENARIOS for SUMMATIVE EVALUATION . 16
5.6 * Establish USER INTERFACE SPECIFICATION . 16
5.7 * Establish USER INTERFACE EVALUATION plan . 16
5.7.1 General . 16
5.7.2 * FORMATIVE EVALUATION planning . 17
5.7.3 * SUMMATIVE EVALUATION planning . 17
5.8 * Perform USER INTERFACE design, implementation and FORMATIVE
EVALUATION . 18
5.9 * Perform SUMMATIVE EVALUATION of the USABILITY of the USER INTERFACE . 19
5.10 USER INTERFACE OF UNKNOWN PROVENANCE . 19
Annex A (informative) General guidance and rationale . 20
A.1 General guidance . 20
A.2 Rationale for requirements in particular clauses and subclauses . 20
ANNEX B (informative) Examples of possible HAZARDOUS SITUATIONS related to
USABILITY . 38
Annex C (normative) Evaluation of a USER INTERFACE OF UNKNOWN PROVENANCE (UOUP) . 41
C.1 General . 41
C.2 USABILITY ENGINEERING PROCESS for USER INTERFACE OF UNKNOWN
PROVENANCE . 41
C.2.1 * USE SPECIFICATION . 41
C.2.2 * Review of POST-PRODUCTION information . 42
C.2.3 HAZARDS and HAZARDOUS SITUATIONS related to USABILITY. 42
C.2.4 RISK CONTROL . 42
C.2.5 RESIDUAL RISK evaluation . 42
Annex D (informative) Types of MEDICAL DEVICE use, with examples . 43
Annex E (informative) Reference to the essential principles . 45
Bibliography . 46
Index of defined terms . 49

Figure 1 – Relationship of the types of use . 8
Figure A.1 – Model of USER-MEDICAL DEVICE interaction . 24
Figure A.2 – Relationship of TASKS and functions within a USE SCENARIO . 25
Figure A.3 – Relationship of TASKS and functions and USE ERROR within a HAZARD-
RELATED USE SCENARIO . 26
Figure A.4 – The relationship between the RISK MANAGEMENT PROCESS
(ISO 14971:2007) and the USABILITY ENGINEERING PROCESS (IEC 62366-1) . 32
Figure D.1 – Interrelationships between the different types of MEDICAL DEVICE use, with
examples . 44

Table B.1 – Glossary of relevant RISK MANAGEMENT terms . 38
Table B.2 – Examples of HARM due to RISK caused by USE ERROR(S) or poor USABILITY
(1 of 3) . 38
Table E.1 – Correspondence between this document and the essential principles . 45

– 4 – IEC 62366-1:2015 © IEC 2015
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL DEVICES –
Part 1: Application of usability engineering to medical devices

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
Co
...

IEC 62366-1
Edition 1.1 2020-06
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical devices –
Part 1: Application of usability engineering to medical devices

Dispositifs médicaux –
Partie 1: Application de l'ingénierie de l'aptitude à l'utilisation aux dispositifs
médicaux
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form
or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from
either IEC or IEC's member National Committee in the country of the requester. If you have any questions about IEC
copyright or have an enquiry about obtaining additional rights to this publication, please contact the address below or
your local IEC member National Committee for further information.

Droits de reproduction réservés. Sauf indication contraire, aucune partie de cette publication ne peut être reproduite
ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique, y compris la photocopie
et les microfilms, sans l'accord écrit de l'IEC ou du Comité national de l'IEC du pays du demandeur. Si vous avez des
questions sur le copyright de l'IEC ou si vous désirez obtenir des droits supplémentaires sur cette publication, utilisez
les coordonnées ci-après ou contactez le Comité national de l'IEC de votre pays de résidence.

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3, rue de Varembé [e-mail]
CH-1211 Geneva 20 www.iec.ch
Switzerland
About the IEC
The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes
International Standards for all electrical, electronic and related technologies.

About IEC publications
The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the
latest edition, a corrigendum or an amendment might have been published.

IEC publications search - webstore.iec.ch/advsearchform Electropedia - www.electropedia.org
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variety of criteria (reference number, text, technical containing more than 22 000 terminological entries in English
committee,…). It also gives information on projects, replaced and French, with equivalent terms in 16 additional languages.
and withdrawn publications. Also known as the International Electrotechnical Vocabulary

(IEV) online.
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IEC publications issued between 2002 and 2015. Some
IEC Customer Service Centre - webstore.iec.ch/csc entries have been collected from earlier publications of IEC
If you wish to give us your feedback on this publication or TC 37, 77, 86 and CISPR.

need further assistance, please contact the Customer Service

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A propos de l'IEC
La Commission Electrotechnique Internationale (IEC) est la première organisation mondiale qui élabore et publie des
Normes internationales pour tout ce qui a trait à l'électricité, à l'électronique et aux technologies apparentées.

A propos des publications IEC
Le contenu technique des publications IEC est constamment revu. Veuillez vous assurer que vous possédez l’édition la
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en utilisant différents critères (numéro de référence, texte, anglais et en français, ainsi que les termes équivalents dans
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IEC 62366-1
Edition 1.1 2020-06
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical devices –
Part 1: Application of usability engineering to medical devices

Dispositifs médicaux –
Partie 1: Application de l'ingénierie de l'aptitude à l'utilisation aux dispositifs

médicaux
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.01 ISBN 978-2-8322-8551-0

IEC 62366-1
Edition 1.1 2020-06
REDLINE VERSION
VERSION REDLINE
colour
inside
Medical devices –
Part 1: Application of usability engineering to medical devices

Dispositifs médicaux –
Partie 1: Application de l'ingénierie de l'aptitude à l'utilisation aux dispositifs
médicaux
– 2 – IEC 62366-1:2015+AMD1:2020 CSV
 IEC 2020
CONTENTS
FOREWORD . 4
INTRODUCTION . 7
INTRODUCTION to Amendment 1 . 7
1 * Scope . 8
2 Normative references . 8
3 Terms and definitions . 8
4 Principles . 14
4.1 General requirements . 14
4.1.1 * USABILITY ENGINEERING PROCESS . 14
4.1.2 * RISK CONTROL as it relates to USER INTERFACE design . 14
4.1.3 Information for SAFETY as it relates to USABILITY . 15
4.2 * USABILITY ENGINEERING FILE . 15
4.3 Tailoring of the USABILITY ENGINEERING effort . 15
5 * USABILITY ENGINEERING PROCESS . 15
5.1 * Prepare USE SPECIFICATION . 15
5.2 * Identify USER INTERFACE characteristics related to SAFETY and potential USE
ERRORS . 16
5.3 * Identify known or foreseeable HAZARDS and HAZARDOUS SITUATIONS . 16
5.4 * Identify and describe HAZARD-RELATED USE SCENARIOS . 17
5.5 * Select the HAZARD-RELATED USE SCENARIOS for SUMMATIVE EVALUATION . 17
5.6 * Establish USER INTERFACE SPECIFICATION . 17
5.7 * Establish USER INTERFACE EVALUATION plan . 18
5.7.1 General . 18
5.7.2 * FORMATIVE EVALUATION planning . 19
5.7.3 * SUMMATIVE EVALUATION planning . 19
5.8 * Perform USER INTERFACE design, implementation and FORMATIVE
EVALUATION . 20
5.9 * Perform SUMMATIVE EVALUATION of the USABILITY of the USER INTERFACE . 20
5.10 USER INTERFACE OF UNKNOWN PROVENANCE . 21
Annex A (informative) General guidance and rationale . 22
A.1 General guidance . 22
A.2 Rationale for requirements in particular clauses and subclauses . 22
ANNEX B (informative) Examples of possible HAZARDOUS SITUATIONS related to
USABILITY . 44
Annex C (normative) Evaluation of a USER INTERFACE OF UNKNOWN PROVENANCE (UOUP) . 47
C.1 General . 47
C.2 USABILITY ENGINEERING PROCESS for USER INTERFACE OF UNKNOWN
PROVENANCE . 47
C.2.1 * USE SPECIFICATION . 47
C.2.2 * Review of POST-PRODUCTION information . 48
C.2.3 HAZARDS and HAZARDOUS SITUATIONS related to USABILITY. 48
C.2.4 RISK CONTROL . 48
C.2.5 RESIDUAL RISK evaluation . 48
Annex D (informative) Types of MEDICAL DEVICE use, with examples . 49
Annex E (informative) Reference to the essential principles . 52
E.1 Non-IVD MEDICAL DEVICES . 52

 IEC 2020
E.2 IVD medical DEVICES . 53
Bibliography . 55
Index of defined terms . 59

Figure 1 – Relationship of the types of use . 9
Figure A.1 – Model of USER-MEDICAL DEVICE interaction . 26
Figure A.2 – Relationship of TASKS and functions within a USE SCENARIO . 27
Figure A.3 – Relationship of TASKS and functions and USE ERROR within a HAZARD-
RELATED USE SCENARIO . 28
Figure A.4 – The relationship between the RISK MANAGEMENT PROCESS
(ISO 14971:2007) and the USABILITY ENGINEERING PROCESS (IEC 62366-1) .
Figure A.4 – Types of use as described in this document and their relationship to the
concept of “reasonably foreseeable misuse” in ISO 14971 . 34
Figure A.5 – The relationship between the RISK MANAGEMENT PROCESS
(ISO 14971:2019) and the USABILITY ENGINEERING PROCESS (IEC 62366-1) . 37
Figure D.1 – Interrelationships between the different types of MEDICAL DEVICE use, with
examples . 51

Table B.1 – Glossary of relevant RISK MANAGEMENT terms . 44
Table B.2 – Examples of HARM due to RISK caused by USE ERROR(S) or poor USABILITY
(1 of 3) . 44
Table E.1 – Correspondence between this document and the essential principles . 53
Table E.2 – Correspondence between this document and the essential principles . 54

– 4 – IEC 62366-1:2015+AMD1:2020 CSV
 IEC 2020
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL DEVICES –
Part 1: Application of usability engineering to medical devices

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 tec
...