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.<\/p>\n
| PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
|---|---|---|---|---|---|---|---|
| 5<\/td>\n | English CONTENTS <\/td>\n<\/tr>\n | ||||||
| 7<\/td>\n | INTRODUCTION <\/td>\n<\/tr>\n | ||||||
| 8<\/td>\n | 1 Scope 2 Normative references 3 Terms and definitions <\/td>\n<\/tr>\n | ||||||
| 12<\/td>\n | 4 Principles 4.1 General requirements <\/td>\n<\/tr>\n | ||||||
| 13<\/td>\n | 4.2 Usability engineering file 4.3 Scaling of the usability engineering effort 5 Usability engineering process 5.1 Application specification <\/td>\n<\/tr>\n | ||||||
| 14<\/td>\n | 5.2 Frequently used functions 5.3 Identification of hazards and hazardous situations related to usability <\/td>\n<\/tr>\n | ||||||
| 15<\/td>\n | 5.4 Primary operating functions <\/td>\n<\/tr>\n | ||||||
| 16<\/td>\n | 5.5 Usability specification 5.6 Usability validation plan <\/td>\n<\/tr>\n | ||||||
| 17<\/td>\n | 5.7 User interface design and implementation 5.8 Usability verification <\/td>\n<\/tr>\n | ||||||
| 18<\/td>\n | 5.9 Usability validation 6 Accompanying document <\/td>\n<\/tr>\n | ||||||
| 19<\/td>\n | 7 Training and materials for training <\/td>\n<\/tr>\n | ||||||
| 20<\/td>\n | Annex A (informative) General guidance and rationale <\/td>\n<\/tr>\n | ||||||
| 25<\/td>\n | Figure\u00a0A.1 \u2013 A comparison of the risk management process (ISO\u00a014971:2007) and the usability engineering process (IEC\u00a062366) <\/td>\n<\/tr>\n | ||||||
| 32<\/td>\n | Annex B (informative) Categories of user action <\/td>\n<\/tr>\n | ||||||
| 33<\/td>\n | Figure\u00a0B.1 \u2013 Categories of foreseeable user action <\/td>\n<\/tr>\n | ||||||
| 34<\/td>\n | Annex C (informative) Examples of use errors, abnormal use and possible causes <\/td>\n<\/tr>\n | ||||||
| 37<\/td>\n | Annex D (informative) Guidance on the usability engineering process <\/td>\n<\/tr>\n | ||||||
| 38<\/td>\n | Tables Table\u00a0D.1 \u2013 Sample of design flaws and associated use errors <\/td>\n<\/tr>\n | ||||||
| 40<\/td>\n | Figure\u00a0D.1 \u2013 A user interface design cycle Table\u00a0D.2 \u2013 Mapping of Figure\u00a0D.1 to the subclauses of this International Standard <\/td>\n<\/tr>\n | ||||||
| 43<\/td>\n | Table\u00a0D.3 \u2013 Examples of user interface requirements <\/td>\n<\/tr>\n | ||||||
| 48<\/td>\n | Table\u00a0D.4 \u2013 Typical deliverables <\/td>\n<\/tr>\n | ||||||
| 51<\/td>\n | Table\u00a0D.5 \u2013 Examples of objective usability goals Table\u00a0D.6 \u2013 Examples of subjective usability goals <\/td>\n<\/tr>\n | ||||||
| 53<\/td>\n | Figure\u00a0D.2 \u2013 Bubble diagram of the conceptual model of a physiological monitor <\/td>\n<\/tr>\n | ||||||
| 54<\/td>\n | Table\u00a0D.7 \u2013 Examples of user interface modelling techniques Table\u00a0D.8 \u2013 Characteristics of a typical usability testing effort <\/td>\n<\/tr>\n | ||||||
| 61<\/td>\n | Annex E (informative) Questions that can be used to identify medical device characteristics associated with usability that could impact on safety <\/td>\n<\/tr>\n | ||||||
| 65<\/td>\n | Annex F (informative) Examples of possible usability related hazardous situations Table\u00a0F.1 \u2013 Glossary of relevant risk management terms <\/td>\n<\/tr>\n | ||||||
| 66<\/td>\n | Figure\u00a0F.1 \u2013 Pictorial representation of the relationship of hazard, sequence of events, hazardous situation and harm Table\u00a0F.2 \u2013 Examples of harm due to usability related hazards <\/td>\n<\/tr>\n | ||||||
| 68<\/td>\n | Annex G (informative) Usability goals: Illustrative example for a home parenteral infusion pump <\/td>\n<\/tr>\n | ||||||
| 71<\/td>\n | Table\u00a0G.1 \u2013 Power on\/off Table\u00a0G.2 \u2013 Program pump <\/td>\n<\/tr>\n | ||||||
| 72<\/td>\n | Table\u00a0G.3 \u2013 Start\/stop infusion <\/td>\n<\/tr>\n | ||||||
| 73<\/td>\n | Table\u00a0G.4 \u2013 Monitor infusion status Table\u00a0G.5 \u2013 Install and change set <\/td>\n<\/tr>\n | ||||||
| 74<\/td>\n | Table\u00a0G.6 \u2013 Priming Table\u00a0G.7 \u2013 Respond to and inactivate alarm signals\u00a0a <\/td>\n<\/tr>\n | ||||||
| 75<\/td>\n | Table\u00a0G.8 \u2013 Lockouts Table\u00a0G.9 \u2013 Power management <\/td>\n<\/tr>\n | ||||||
| 76<\/td>\n | Table\u00a0G.10 \u2013 Preventative and routine maintenance <\/td>\n<\/tr>\n | ||||||
| 77<\/td>\n | Table\u00a0G.11 \u2013 Basic operation Table\u00a0G.12 \u2013 Advanced functions <\/td>\n<\/tr>\n | ||||||
| 78<\/td>\n | Annex H (informative) Sample usability specification and its inputs <\/td>\n<\/tr>\n | ||||||
| 88<\/td>\n | Annex I (informative) Recommended reading list <\/td>\n<\/tr>\n | ||||||
| 96<\/td>\n | Annex J (informative) Reference to the essential principles Table J.1 \u2013 Correspondence between this document and the essential principles <\/td>\n<\/tr>\n | ||||||
| 97<\/td>\n | Bibliography <\/td>\n<\/tr>\n | ||||||
| 99<\/td>\n | Index of defined terms <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" Medical devices. Application of usability engineering to medical devices<\/b><\/p>\n |