EN 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, 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 contains 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.

Medizinprodukte - Teil 1: Anwendung der Gebrauchstauglichkeit auf Medizinprodukte

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 A l'UTILISATION d'un DISPOSITIF MEDICAL, concernant la SECURITE. Ce PROCESSUS D'INGENIERIE DE L'APTITUDE A L'UTILISATION (INGENIERIE 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, annule et remplace 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'INGENIERIE DE L'APTITUDE A 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 MEDICAUX. La Partie 2 contient des informations didactiques pour aider les fabricants à se conformer à la Partie 1 et fournit des descriptions plus détaillées des méthodes d'INGENIERIE DE L'APTITUDE A L'UTILISATION QUI PEUVENT ETRE APPLIQUEES D'UNE FAÇON PLUS GENERALE AUX DISPOSITIFS MEDICAUX et qui vont au-delà des aspects relatifs à la sécurité des INTERFACES UTILISATEUR des DISPOSITIFS MEDICAUX.

Medicinske naprave - 1. del: Izvedba tehnik uporabe pri medicinskih napravah

Ta del standarda IEC 62366 določa POSTOPEK, s pomočjo katerega PROIZVAJALEC analizira, določi, razvije in oceni UPORABNOST MEDICINSKE NAPRAVE, saj se nanaša na VARNOST. Ta POSTOPEK IZVEDBE TEHNIK UPORABE (NAČRTOVANJE ČLOVEŠKIH DEJAVNIKOV) omogoča PROIZVAJALCU, da oceni in blaži TVEGANJA, povezana z NEPRAVILNO UPORABO IN NAPAKAMI PRI UPORABI, tj. pri NORMALNI UPORABI. Uporablja se lahko za opredelitev, vendar ne ocenjuje ali blaži TVEGANJ, povezanih z NENORMALNO UPORABO.
OPOMBA 1: VARNOST je svoboda pred nesprejemljivim TVEGANJEM. Nesprejemljivo TVEGANJE lahko izhaja iz NAPAKE PRI UPORABI, kar lahko vodi v izpostavljenost neposrednim fizičnim NEVARNOSTIM ali izgubo ali degradacijo klinične uporabnosti.
OPOMBA 2: Navodila za izvedbo TEHNIK UPORABE za MEDICINSKE NAPRAVE so na voljo v standardu IEC 62366-22, ki ne obravnava samo VARNOSTI, ampak tudi vidike UPORABNOSTI, ki se ne nanašajo na VARNOST. Če je bil upoštevan POSTOPEK IZVEDBE TEHNIK UPORABE v tem mednarodnem standardu, se UPORABNOST MEDICINSKE NAPRAVE v zvezi z VARNOSTJO šteje za sprejemljivo, če ni OBJEKTIVNIH DOKAZOV o nasprotnem.
OPOMBA 3: Taki OBJEKTIVNI DOKAZI lahko posledično izvirajo iz POPROIZVODNEGA nadzora.

General Information

• Status: Published
• Publication Date: 23-Apr-2015
• Withdrawal Date: 30-Mar-2018
• ICS: 11.040 - Medical equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62A - IEC_SC_62A
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 24-Apr-2015
• Completion Date: 24-Apr-2015
• 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 62366-1:2015 - Medical devices - Part 1: Application of usability engineering to medical devices

Relations

• Replaces: EN 62366:2008 - Medical devices - Application of usability engineering to medical devices
• Effective Date: 29-Jan-2023
• Replaces: EN 62366:2008/A1:2015 - Medical devices - Application of usability engineering to medical devices
• Effective Date: 28-Jan-2023
• Amended By: EN 62366-1:2015/A1:2020 - Medical devices - Part 1: Application of usability engineering to medical devices
• Effective Date: 26-Jan-2023
• Corrected By: EN 62366-1:2015/AC:2015 - Medical devices - Part 1: Application of usability engineering to medical devices
• Effective Date: 30-Jun-2015

Standards Content (Sample)

SLOVENSKI STANDARD
01-september-2015
1DGRPHãþD
SIST EN 62366:2008
SIST EN 62366:2008/A1:2015
Medicinske naprave - 1. del: Izvedba tehnik uporabe pri medicinskih napravah
Medical devices - Part 1: Application of usability engineering to medical devices
Medizinprodukte - Anwendung der Gebrauchstauglichkeit auf Medizinprodukte
Dispositifs médicaux - Partie 1: Application de l'ingénierie de l'aptitude à l'utilisation aux
dispositifs médicaux
Ta slovenski standard je istoveten z: EN 62366-1:2015
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 62366-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2015
ICS 11.040
English Version
Medical devices - Part 1: Application of usability engineering to
medical devices
(IEC 62366-1:2015)
Dispositifs médicaux - Partie 1: Application de l'ingénierie Medizinprodukte - Anwendung der Gebrauchstauglichkeit
de l'aptitude à l'utilisation aux dispositifs médicaux auf Medizinprodukte
(IEC 62366-1:2015) (IEC 62366-1:2015)
This European Standard was approved by CENELEC on 2015-03-31. 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 CEN-CENELEC
Management Centre 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 CEN-CENELEC Management Centre 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.

European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2015 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN 62366-1:2015 E
Foreword
The text of document 62A/977/FDIS, future edition 1 of IEC 62366-1, 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 approved by CENELEC as EN 62366-
1:2015.
The following dates are fixed:
• latest date by which the document has (dop) 2015-12-31
to be implemented at national level by
publication of an identical national
standard or by endorsement
(dow) 2018-03-31
• latest date by which the national
standards conflicting with the

document have to be withdrawn
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC [and/or CEN] shall not be held responsible for identifying any or all such patent
rights.
Endorsement notice
The text of the International Standard IEC 62366-1:2015 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 60601-1:2005 NOTE Harmonized as EN 60601-1:2006.
IEC 60601-1:2005/A1:2012 NOTE Harmonized as EN 60601-1:2006/A1:2013.
IEC 60601-1-6:2010 NOTE Harmonized as EN 60601-1-6:2010.
IEC 60601-1-6:2010/A1:2013 NOTE Harmonized as EN 60601-1-6:2010/A1:2013.
IEC 60601-1-8:2006 NOTE Harmonized as EN 60601-1-8:2007.
IEC 60601-1-8:2006/A1:2012 NOTE Harmonized as EN 60601-1-8:2007/A1:2013.
IEC 60601-1-11 NOTE Harmonized as EN 60601-1-11.
ISO 7010:2011 NOTE Harmonized as EN ISO 7010:2012.
ISO 9000:2005 NOTE Harmonized as EN ISO 9000:2005.
ISO 9001:2008 NOTE Harmonized as EN ISO 9001:2008.
ISO 9241-11:1998 NOTE Harmonized as EN ISO 9241-11:1998.
ISO 13485:2003 NOTE Harmonized as EN ISO 13485:2012.

- 3 - EN 62366-1:2015
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
NOTE 1 When an International Publication has been modified by common modifications, indicated by (mod), the relevant EN/HD

applies.
NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is available here:
www.cenelec.eu.
Publication Year Title EN/HD Year

ISO 14971 2007 Medical devices - Application of risk EN ISO 14971 2012
management to medical devices
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

IEC 62366-1:2015  IEC 2015 – 3 –

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
...