Provisional standard<\/p>\n
| PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
|---|---|---|---|---|---|---|---|
| 1<\/td>\n | AAMI HIT1000-4 (PS):2020; Safety and effectiveness of health IT software and systems\u2014Part 4: Application of human factors engineering <\/td>\n<\/tr>\n | ||||||
| 3<\/td>\n | Title page <\/td>\n<\/tr>\n | ||||||
| 4<\/td>\n | Provisional AAMI\/American National Standard Copyright language <\/td>\n<\/tr>\n | ||||||
| 5<\/td>\n | Contents <\/td>\n<\/tr>\n | ||||||
| 6<\/td>\n | Committee representation <\/td>\n<\/tr>\n | ||||||
| 8<\/td>\n | Foreword <\/td>\n<\/tr>\n | ||||||
| 9<\/td>\n | Introduction <\/td>\n<\/tr>\n | ||||||
| 11<\/td>\n | 1 Scope 2 Normative References 3 Terms and definitions <\/td>\n<\/tr>\n | ||||||
| 13<\/td>\n | 4 Context and concepts <\/td>\n<\/tr>\n | ||||||
| 15<\/td>\n | Table 1 \u2013 Lifecycle roles and responsibilities <\/td>\n<\/tr>\n | ||||||
| 16<\/td>\n | Figure 1 – Health IT software lifecycle stages within a HIT system (with integration and recursion possible on all paths) <\/td>\n<\/tr>\n | ||||||
| 17<\/td>\n | Table 2 \u2013 Health IT software lifecycle stages, roles, and activities involved in HFE <\/td>\n<\/tr>\n | ||||||
| 23<\/td>\n | 5 Development stage human factors engineering 5.1 General Development stage human factors engineering process <\/td>\n<\/tr>\n | ||||||
| 24<\/td>\n | Figure 2 \u2013 An illustration of a sample implementation of a user-centered design process <\/td>\n<\/tr>\n | ||||||
| 25<\/td>\n | 5.2 Development stage optimizing the user experience through user-centered design and evaluation methods <\/td>\n<\/tr>\n | ||||||
| 26<\/td>\n | Table 3 \u2013 Examples of User interface characteristics that can promote or degrade usability <\/td>\n<\/tr>\n | ||||||
| 27<\/td>\n | 5.3 Development stage conducting user research <\/td>\n<\/tr>\n | ||||||
| 35<\/td>\n | Table 4 \u2013 Measurable usability goals <\/td>\n<\/tr>\n | ||||||
| 36<\/td>\n | Table 5 \u2013 Sample objective and subjective usability goals 5.4 Development stage managing use-related risk <\/td>\n<\/tr>\n | ||||||
| 37<\/td>\n | Table 6 \u2013 Sample use errors and hazardous situations leading to possible harm <\/td>\n<\/tr>\n | ||||||
| 40<\/td>\n | Figure 3 \u2013 FDA Design Control Guidance for Medical Device Manufacturers <\/td>\n<\/tr>\n | ||||||
| 41<\/td>\n | Table 7 \u2013 Examples of use-safety benefit <\/td>\n<\/tr>\n | ||||||
| 42<\/td>\n | 5.5 Development stage designing the user interface <\/td>\n<\/tr>\n | ||||||
| 43<\/td>\n | 5.6 Development stage evaluating the user interface <\/td>\n<\/tr>\n | ||||||
| 49<\/td>\n | 6 Acquisition stage human factors engineering 6.1 Procurement <\/td>\n<\/tr>\n | ||||||
| 50<\/td>\n | 6.2 Guidance and good practice for procurement <\/td>\n<\/tr>\n | ||||||
| 51<\/td>\n | 7 Integration stage human factors engineering 7.1 General Integration stage human factors engineering 7.2 Integration stage of human factors engineering process <\/td>\n<\/tr>\n | ||||||
| 52<\/td>\n | 7.3 Guidance and good practice for integration stage of human factors engineering process <\/td>\n<\/tr>\n | ||||||
| 53<\/td>\n | 8 Implementation stage human factors engineering 8.1 General Implementation stage – human factors engineering 8.2 Implementation stage – human factors engineering process <\/td>\n<\/tr>\n | ||||||
| 54<\/td>\n | 8.3 Guidance and good practice for implementation stage – human factors engineering process <\/td>\n<\/tr>\n | ||||||
| 55<\/td>\n | 9 Operational use in the clinical setting stage – human factors engineering 9.1 General operational use in the clinical setting stage – human factors engineering 9.2 Operational use in the clinical setting stage – human factors engineering process <\/td>\n<\/tr>\n | ||||||
| 56<\/td>\n | 9.3 Guidance and good practice for Operational stage – human factors engineering process <\/td>\n<\/tr>\n | ||||||
| 57<\/td>\n | 10 Decommissioning stage – human factors engineering 10.1 General decommissioning stage – human factors engineering <\/td>\n<\/tr>\n | ||||||
| 58<\/td>\n | 10.2 Decommissioning stage – human factors engineering process 10.3 Guidance and good practice for Decommissioning stage – human factors engineering process <\/td>\n<\/tr>\n | ||||||
| 59<\/td>\n | Annex A Summary of Requirements Table 8 \u2013 Summary of Requirements <\/td>\n<\/tr>\n | ||||||
| 64<\/td>\n | Annex B Considerations for conducting validation usability tests B.1 Overview of validation usability tests <\/td>\n<\/tr>\n | ||||||
| 65<\/td>\n | Figure 4 \u2013 An illustration of the risk analysis and mitigation process (Johnathan Kendler, Curiolis) B.2 Recommendations for conducting successful validation usability tests (See IEC 62366-1 and IEC 62366-2) <\/td>\n<\/tr>\n | ||||||
| 68<\/td>\n | B.3 Additional considerations for usability testing B.3.1 Selecting usability test participants <\/td>\n<\/tr>\n | ||||||
| 69<\/td>\n | B.3.2 Specifying usability test tasks B.3.3 Conducting root cause analysis <\/td>\n<\/tr>\n | ||||||
| 70<\/td>\n | B.3.4 Documenting user interaction problems <\/td>\n<\/tr>\n | ||||||
| 72<\/td>\n | Annex C Sample expert review findings C.1 Sample Finding (Opportunity for Improvement): Placement of referral function Figure 5 \u2013 Referral function located under Demographics C.2 Sample Finding (Opportunity for improvement): Use of ellipses <\/td>\n<\/tr>\n | ||||||
| 73<\/td>\n | Figure 6 \u2013 Indication of allergies is subtle Figure 7 \u2013 Clicking on \u201c\u2026\u201d leads to list of allergies or none C.3 Sample Finding (Strength): Allergy Alerts Figure 8 \u2013 Clinical Reminders <\/td>\n<\/tr>\n | ||||||
| 74<\/td>\n | Bibliography and cited references <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" AAMI HIT1000-4 (PS):2020 Safety and effectiveness of health IT software and systems-Part 4: Application of human factors engineering<\/b><\/p>\n |