IEC 62366:2007

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.

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 .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
...