{"id":374189,"date":"2024-10-20T02:37:24","date_gmt":"2024-10-20T02:37:24","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-iec62366-1-2015-amd1-2020\/"},"modified":"2024-10-26T04:35:03","modified_gmt":"2024-10-26T04:35:03","slug":"aami-iec62366-1-2015-amd1-2020","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-iec62366-1-2015-amd1-2020\/","title":{"rendered":"AAMI\/IEC62366 1 2015 AMD1 2020"},"content":{"rendered":"
The first edition of IEC 62366-1 was published in 2015. Since its publication, experts working in the field have identified several inaccuracies that warrant correction.<\/p>\n
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1<\/td>\n | ANSI\/AAMI\/IEC 62366-1:2015+AMD1:2020; Medical devices\u2014Part 1: Application of usability engineering to medical devices\u2014Amendment 1 (Consolidated Text) \n <\/td>\n<\/tr>\n | ||||||
3<\/td>\n | Title page <\/td>\n<\/tr>\n | ||||||
4<\/td>\n | AAMI Standard Copyright information <\/td>\n<\/tr>\n | ||||||
5<\/td>\n | Contents <\/td>\n<\/tr>\n | ||||||
6<\/td>\n | Committee representation <\/td>\n<\/tr>\n | ||||||
9<\/td>\n | Background of ANSI\/AAMI adoption of IEC 62366-1:2015 and IEC 62366-1:2015\/A1:2020 <\/td>\n<\/tr>\n | ||||||
10<\/td>\n | Foreword <\/td>\n<\/tr>\n | ||||||
12<\/td>\n | Introduction INTRODUCTION to Amendment 1 <\/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 (informative) General guidance and rationale A.1 General guidance A.2 Rationale for requirements in particular clauses and subclauses <\/td>\n<\/tr>\n | ||||||
28<\/td>\n | Figure A.1 \u2013 Model of USER-MEDICAL DEVICE interaction <\/td>\n<\/tr>\n | ||||||
29<\/td>\n | Figure A.2 \u2013 Relationship of TASKS and functions within a USE SCENARIO <\/td>\n<\/tr>\n | ||||||
30<\/td>\n | Figure A.3 \u2013 Relationship of TASKS and functions and USE ERROR within a HAZARD-RELATED USE SCENARIO <\/td>\n<\/tr>\n | ||||||
32<\/td>\n | Figure A.4 \u2013 Types of use as described in this document and their relationship to the concept of \u201creasonably foreseeable misuse\u201d in ISO 14971 <\/td>\n<\/tr>\n | ||||||
34<\/td>\n | Figure A.5 \u2013 The relationship between the RISK MANAGEMENT PROCESS (ISO 14971:2019) and the USABILITY ENGINEERING PROCESS (IEC 62366-1) <\/td>\n<\/tr>\n | ||||||
41<\/td>\n | Annex B (informative) 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 caused by USE ERROR(S) or poor USABILITY <\/td>\n<\/tr>\n | ||||||
44<\/td>\n | Annex C (normative) 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 <\/td>\n<\/tr>\n | ||||||
45<\/td>\n | C.2.2 * Review of post-production information 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 (informative) 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 (informative) Reference to the essential principles E.1\u2003Non-IVD medical devices Table E.1 \u2013 Correspondence between this document and the essential principles E.2\u2003IVD medical devices <\/td>\n<\/tr>\n | ||||||
49<\/td>\n | Table E.2 \u2013 Correspondence between this document and the essential principles <\/td>\n<\/tr>\n | ||||||
50<\/td>\n | Bibliography <\/td>\n<\/tr>\n | ||||||
53<\/td>\n | Index of defined terms <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" ANSI\/AAMI\/IEC 62366-1: 2015+AMD1:2020 (Consolidated Text), Medical devices-Part 1: Application of usability engineering to medical devices, including Amendment 1<\/b><\/p>\n |