This document specifies a process for a manufacturer to analyze, specify, develop and evaluate the usability of a medical device as it relates to safety. This usability engineering (human factors engineering) process permits the manufacturer to assess and mitigates risks 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.<\/p>\n
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| 1<\/td>\n | ANSI\/AAMI\/IEC 62366-1:2015, Medical devices \u2013 Part 1: Application of usability engineering to medical devices <\/td>\n<\/tr>\n | ||||||
| 2<\/td>\n | Objectives and uses of AAMI standards and recommended practices <\/td>\n<\/tr>\n | ||||||
| 3<\/td>\n | Title page <\/td>\n<\/tr>\n | ||||||
| 4<\/td>\n | Copyright information <\/td>\n<\/tr>\n | ||||||
| 5<\/td>\n | Contents <\/td>\n<\/tr>\n | ||||||
| 6<\/td>\n | Glossary of equivalent standards <\/td>\n<\/tr>\n | ||||||
| 7<\/td>\n | Committee representation <\/td>\n<\/tr>\n | ||||||
| 9<\/td>\n | Background of ANSI\/AAMI adoption of IEC 62366-1:2015 <\/td>\n<\/tr>\n | ||||||
| 10<\/td>\n | Foreword <\/td>\n<\/tr>\n | ||||||
| 12<\/td>\n | Introduction <\/td>\n<\/tr>\n | ||||||
| 13<\/td>\n | 1 * Scope 2 Normative references 3 Terms and definitions <\/td>\n<\/tr>\n | ||||||
| 14<\/td>\n | Figure 1 \u2013 Relationship of the types of use <\/td>\n<\/tr>\n | ||||||
| 18<\/td>\n | 4 Principles 4.1 General requirements 4.1.1 * Usability engineering process 4.1.2 * Risk control as it relates to user interface design <\/td>\n<\/tr>\n | ||||||
| 19<\/td>\n | 4.1.3 Information for safety as it relates to usability 4.2 * Usability engineering file 4.3 Tailoring of the usability engineering effort 5 * Usability engineering process 5.1 * Prepare use specification <\/td>\n<\/tr>\n | ||||||
| 20<\/td>\n | 5.2 * Identify user interface characteristics related to safety and potential use errors 5.3 * Identify known or foreseeable hazards and hazardous situations 5.4 * Identify and describe hazard-related use scenarios <\/td>\n<\/tr>\n | ||||||
| 21<\/td>\n | 5.5 * Select the hazard-related use scenarios for summative evaluation 5.6 * Establish user interface specification 5.7 * Establish user interface evaluation plan 5.7.1 General <\/td>\n<\/tr>\n | ||||||
| 22<\/td>\n | 5.7.2 * Formative evaluation planning 5.7.3 * Summative evaluation planning <\/td>\n<\/tr>\n | ||||||
| 23<\/td>\n | 5.8 * Perform user interface design, implementation and formative evaluation 5.9 * Perform summative evaluation of the usability of the user interface <\/td>\n<\/tr>\n | ||||||
| 24<\/td>\n | 5.10 User interface of unknown provenance <\/td>\n<\/tr>\n | ||||||
| 25<\/td>\n | Annex A: General guidance and rationale A.1 General guidance A.2 Rationale for requirements in particular clauses and subclauses <\/td>\n<\/tr>\n | ||||||
| 29<\/td>\n | Figure A.1 \u2013 Model of USER-MEDICAL DEVICE interaction <\/td>\n<\/tr>\n | ||||||
| 30<\/td>\n | Figure A.2 \u2013 Relationship of TASKS and functions within a USE SCENARIO <\/td>\n<\/tr>\n | ||||||
| 31<\/td>\n | Figure A.3 \u2013 Relationship of TASKS and functions and USE ERROR within a HAZARD-RELATED USE SCENARIO <\/td>\n<\/tr>\n | ||||||
| 36<\/td>\n | Figure A.4 \u2013 The relationship between the RISK MANAGEMENT PROCESS (ISO 14971:2007)and the USABILITY ENGINEERING PROCESS (IEC 62366-1) <\/td>\n<\/tr>\n | ||||||
| 41<\/td>\n | Annex B: Examples of possible hazardous situations related to usability Table B.1 \u2013 Glossary of relevant RISK MANAGEMENT terms Table B.2 \u2013 Examples of HARM due to RISK caused by USE ERROR(S) or poor USABILITY <\/td>\n<\/tr>\n | ||||||
| 44<\/td>\n | Annex C: Evaluation of a user interface of unknown provenance (uoup) C.1 General C.2 Usability engineering process for user interface of unknown provenance C.2.1 * Use specification C.2.2 * Review of post-production information <\/td>\n<\/tr>\n | ||||||
| 45<\/td>\n | C.2.3 Hazards and hazardous situations related to usability C.2.4 Risk control C.2.5 Residual risk evaluation <\/td>\n<\/tr>\n | ||||||
| 46<\/td>\n | Annex D: Types of medical device use, with examples <\/td>\n<\/tr>\n | ||||||
| 47<\/td>\n | Figure D.1 \u2013 Interrelationships between the different types of MEDICAL DEVICE use, with examples <\/td>\n<\/tr>\n | ||||||
| 48<\/td>\n | Annex E: Reference to the essential principles Table E.1 \u2013 Correspondence between this document and the essential principles <\/td>\n<\/tr>\n | ||||||
| 49<\/td>\n | Bibliography <\/td>\n<\/tr>\n | ||||||
| 51<\/td>\n | Index of defined terms <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" ANSI\/AAMI\/IEC 62366-1:2015 – Medical Devices Part 1: Application of Usability Engineering to Medical Devices<\/b><\/p>\n |