IEC 62366:2007
(Main)Medical devices - Application of usability engineering to medical devices
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.
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.
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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
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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.96
Index of defined terms .98
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 .76
Table J.1 – Correspondence between this document and the essential principles .95
– 4 – 62366 © IEC:2007
INTERNATIONAL ELECTROTECHNICAL COMMISSION
______________
MEDICAL DEVICES –
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 internat
...
IEC 62366
Edition 1.1 2014-01
CONSOLIDATED
VERSION
VERSION
CONSOLIDÉE
colour
inside
Medical devices – Application of usability engineering to medical devices
Dispositifs médicaux – 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.
IEC Central Office Tel.: +41 22 919 02 11
3, rue de Varembé Fax: +41 22 919 03 00
CH-1211 Geneva 20 info@iec.ch
Switzerland www.iec.ch
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 corrigenda or an amendment might have been published.
IEC Catalogue - webstore.iec.ch/catalogue Electropedia - www.electropedia.org
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77, 86 and CISPR.
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Normes internationales pour tout ce qui a trait à l'électricité, à l'électronique et aux technologies apparentées.
A propos des publications IEC
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IEC 62366
Edition 1.1 2014-01
CONSOLIDATED
VERSION
VERSION
CONSOLIDÉE
colour
inside
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
INTERNATIONALE
ICS 11.040 ISBN 978-2-8322-1371-1
IEC 62366
Edition 1.1 2014-01
REDLINE VERSION
VERSION REDLINE
colour
inside
Medical devices – Application of usability engineering to medical devices
Dispositifs médicaux – Application de l'ingénierie de l'aptitude à l'utilisation aux
dispositifs médicaux
– 2 – 62366 IEC:2007+A1:2014
CONTENTS
FOREWORD . 4
INTRODUCTION . 6
INTRODUCTION TO THE AMENDMENT . 7
1 * Scope . 8
2 Normative references . 8
3 Terms and definitions . 8
4 * Principles . 12
4.1 General requirements . 12
4.1.1 * USABILITY ENGINEERING PROCESS . 12
4.1.2 RESIDUAL RISK . 12
4.1.3 Information for SAFETY . 13
4.2 * USABILITY ENGINEERING FILE . 13
4.3 Scaling of the USABILITY ENGINEERING effort . 13
5 * USABILITY ENGINEERING PROCESS . 14
5.1 * Application specification. 14
5.2 * Frequently used functions . 14
5.3 Identification of HAZARDS and HAZARDOUS SITUATIONS related to USABILITY . 14
5.3.1 Identification of characteristics related to SAFETY . 14
5.3.2 * Identification of known or foreseeable HAZARDS and HAZARDOUS
SITUATIONS . 15
5.4 PRIMARY OPERATING FUNCTIONS . 15
5.5 * USABILITY SPECIFICATION . 16
5.6 USABILITY VALIDATION plan . 16
5.7 * USER INTERFACE design and implementation . 17
5.8 * USABILITY VERIFICATION . 17
5.9 * USABILITY VALIDATION . 18
5.10 * USER INTERFACE OF UNKNOWN PROVENANCE (UOUP) . 18
6 * ACCOMPANYING DOCUMENT . 18
7 * Training and materials for training . 19
Annex A (informative) General guidance and rationale . 20
Annex B (informative) Categories of USER action. 32
Annex C (informative) Examples of USE ERRORS, ABNORMAL USE and possible causes . 34
Annex D (informative) Guidance on the USABILITY ENGINEERING PROCESS . 37
ANNEX E (informative) Questions that can be used to identify MEDICAL DEVICE
characteristics associated with USABILITY that could impact on SAFETY . 61
ANNEX F (informative) Examples of possible USABILITY related HAZARDOUS SITUATIONS . 65
Annex G (informative) USABILITY goals: Illustrative example for a home parenteral
infusion pump . 68
ANNEX H (informative) Sample USABILITY SPECIFICATION and its inputs . 78
Annex I (informative) Recommended reading list . 88
Annex J (informative) Reference to the essential principles . 96
Annex K (normative) Evaluation of a USER INTERFACE OF UNKNOWN PROVENANCE (UOUP) . 97
62366 IEC:2007+A1:2014 – 3 –
Bibliography . 99
Index of defined terms . 101
Figure A.1 – A comparison of the RISK MANAGEMENT PROCESS (ISO 14971:2007) and the
USABILITY ENGINEERING PROCESS (IEC 62366) . 25
Figure B.1 – Categories of foreseeable USER action . 33
Figure D.1 – A USER INTERFACE design cycle . 40
Figure D.2 – Bubble diagram of the conceptual model of a physiological monitor . 53
Figure F.1 – Pictorial representation of the relationship of HAZARD, sequence of events,
HAZARDOUS SITUATION and HARM . 66
Table D.1 – Sample of design flaws and associated USE ERRORS . 38
Table D.2 – Mapping of Figure D.1 to the subclauses of this International Standard . 40
Table D.3 – Examples of USER INTERFACE requirements . 43
Table D.4 – Typical deliverables . 48
Table D.5 – Examples of objective USABILITY goals . 51
Table D.6 – Examples of subjective USABILITY goals . 51
Table D.7 – Examples of USER INTERFACE modelling techniques . 54
Table D.8 – Characteristics of a typical USABILITY testing effort . 54
Table F.1 – Glossary of relevant RISK MANAGEMENT terms . 65
Table F.2 – Examples of HARM due to USABILITY related HAZARDS . 66
Table G.1 – Power on/off . 71
Table G.2 – Program pump . 71
Table G.3 – Start/stop infusion. 72
Table G.4 – Monitor infusion status . 73
Table G.5 – Install and change set . 73
Table G.6 – Priming . 74
a
Table G.7 – Respond to and inactivate ALARM SIGNALS .
...
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