BS EN 62366:2008
$200.03
Medical devices. Application of usability engineering to medical devices
| Published By | Publication Date | Number of Pages |
| BSI | 2008 | 104 |
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.
PDF Catalog
| 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 |
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BS EN 62366:2008+A1:2015
Medical devices. Application of usability engineering to medical devices Published By Publication Date Number of…
