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.

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PDF Pages	PDF Title
5	English CONTENTS
7	INTRODUCTION
8	1 Scope 2 Normative references 3 Terms and definitions
12	4 Principles 4.1 General requirements
13	4.2 Usability engineering file 4.3 Scaling of the usability engineering effort 5 Usability engineering process 5.1 Application specification
14	5.2 Frequently used functions 5.3 Identification of hazards and hazardous situations related to usability
15	5.4 Primary operating functions
16	5.5 Usability specification 5.6 Usability validation plan
17	5.7 User interface design and implementation 5.8 Usability verification
18	5.9 Usability validation 6 Accompanying document
19	7 Training and materials for training
20	Annex A (informative) General guidance and rationale
25	Figure A.1 – A comparison of the risk management process (ISO 14971:2007) and the usability engineering process (IEC 62366)
32	Annex B (informative) Categories of user action
33	Figure B.1 – Categories of foreseeable user action
34	Annex C (informative) Examples of use errors, abnormal use and possible causes
37	Annex D (informative) Guidance on the usability engineering process
38	Tables Table D.1 – Sample of design flaws and associated use errors
40	Figure D.1 – A user interface design cycle Table D.2 – Mapping of Figure D.1 to the subclauses of this International Standard
43	Table D.3 – Examples of user interface requirements
48	Table D.4 – Typical deliverables
51	Table D.5 – Examples of objective usability goals Table D.6 – Examples of subjective usability goals
53	Figure D.2 – Bubble diagram of the conceptual model of a physiological monitor
54	Table D.7 – Examples of user interface modelling techniques Table D.8 – Characteristics of a typical usability testing effort
61	Annex E (informative) Questions that can be used to identify medical device characteristics associated with usability that could impact on safety
65	Annex F (informative) Examples of possible usability related hazardous situations Table F.1 – Glossary of relevant risk management terms
66	Figure F.1 – Pictorial representation of the relationship of hazard, sequence of events, hazardous situation and harm Table F.2 – Examples of harm due to usability related hazards
68	Annex G (informative) Usability goals: Illustrative example for a home parenteral infusion pump
71	Table G.1 – Power on/off Table G.2 – Program pump
72	Table G.3 – Start/stop infusion
73	Table G.4 – Monitor infusion status Table G.5 – Install and change set
74	Table G.6 – Priming Table G.7 – Respond to and inactivate alarm signals a
75	Table G.8 – Lockouts Table G.9 – Power management
76	Table G.10 – Preventative and routine maintenance
77	Table G.11 – Basic operation Table G.12 – Advanced functions
78	Annex H (informative) Sample usability specification and its inputs
88	Annex I (informative) Recommended reading list
96	Annex J (informative) Reference to the essential principles Table J.1 – Correspondence between this document and the essential principles
97	Bibliography
99	Index of defined terms

Published By	Publication Date	Number of Pages
BSI	2008	104


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Status	Withdrawn
Title	Medical devices. Application of usability engineering to medical devices
Publisher	BSI
Committee	CH/62/1
Pages	104
Publication Date	2008-04-30
Withdrawn Date	2018-07-17
Replaced By	BS EN 62366:2008+A1:2015
ISBN	978 0 580 54371 5
Standard Number	BS EN 62366:2008
Identical National Standard Of	EN 62366:2008, IEC 62366:2007
Descriptors	Medical technology, Instructions for use, Medical equipment, Equipment safety, Hazards, Medical instruments, Design, Ergonomics
ICS Codes	11.040.01 - Medical equipment in general

BS EN 62366:2008

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BS EN 62366:2008+A1:2015