{"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

PDF Catalog<\/h4>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
1<\/td>\nANSI\/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>\nTitle page <\/td>\n<\/tr>\n
4<\/td>\nAAMI Standard
Copyright information <\/td>\n<\/tr>\n
5<\/td>\nContents <\/td>\n<\/tr>\n
6<\/td>\nCommittee representation <\/td>\n<\/tr>\n
9<\/td>\nBackground of ANSI\/AAMI adoption of IEC 62366-1:2015 and IEC 62366-1:2015\/A1:2020 <\/td>\n<\/tr>\n
10<\/td>\nForeword <\/td>\n<\/tr>\n
12<\/td>\nIntroduction
INTRODUCTION to Amendment 1 <\/td>\n<\/tr>\n
13<\/td>\n1 * Scope
2 Normative references
3 Terms and definitions <\/td>\n<\/tr>\n
14<\/td>\nFigure 1 \u2013 Relationship of the types of use <\/td>\n<\/tr>\n
18<\/td>\n4 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>\n4.1.3 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>\n5.2 * 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>\n5.5 * 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>\n5.7.2 * Formative evaluation planning
5.7.3 * Summative evaluation planning <\/td>\n<\/tr>\n
23<\/td>\n5.8 * 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>\n5.10 User interface of unknown provenance <\/td>\n<\/tr>\n
25<\/td>\nAnnex 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>\nFigure A.1 \u2013 Model of USER-MEDICAL DEVICE interaction <\/td>\n<\/tr>\n
29<\/td>\nFigure A.2 \u2013 Relationship of TASKS and functions within a USE SCENARIO <\/td>\n<\/tr>\n
30<\/td>\nFigure A.3 \u2013 Relationship of TASKS and functions and USE ERROR within a HAZARD-RELATED USE SCENARIO <\/td>\n<\/tr>\n
32<\/td>\nFigure 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>\nFigure 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>\nAnnex 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>\nAnnex 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>\nC.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>\nAnnex D (informative) Types of medical device use, with examples <\/td>\n<\/tr>\n
47<\/td>\nFigure D.1 \u2013 Interrelationships between the different types of MEDICAL DEVICE use, with examples <\/td>\n<\/tr>\n
48<\/td>\nAnnex 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>\nTable E.2 \u2013 Correspondence between this document and the essential principles <\/td>\n<\/tr>\n
50<\/td>\nBibliography <\/td>\n<\/tr>\n
53<\/td>\nIndex 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\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
AAMI<\/b><\/a><\/td>\n2020<\/td>\n54<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":374199,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-374189","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-aami","8":"first","9":"instock","10":"sold-individually","11":"shipping-taxable","12":"purchasable","13":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/374189","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media\/374199"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=374189"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=374189"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=374189"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}