{"id":463879,"date":"2024-10-20T10:31:16","date_gmt":"2024-10-20T10:31:16","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-tir34971-2023\/"},"modified":"2024-10-26T19:23:56","modified_gmt":"2024-10-26T19:23:56","slug":"aami-tir34971-2023","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-tir34971-2023\/","title":{"rendered":"AAMI TIR34971 2023"},"content":{"rendered":"

This document provides guidance and intends to serve as a companion to ANSI\/AAMI\/ISO 14971:2019 for those performing risk management for machine learning (ML) or artificial intelligence (AI) incorporating medical devices.<\/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
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
1<\/td>\nAAMI TIR34971:2023; Application of ISO 14971 to machine learning in artificial intelligence\u2014Guide <\/td>\n<\/tr>\n
3<\/td>\nTitle page <\/td>\n<\/tr>\n
4<\/td>\nAAMI Technical Information Report
Copyright information <\/td>\n<\/tr>\n
5<\/td>\nContents Page <\/td>\n<\/tr>\n
6<\/td>\nCommittee representation <\/td>\n<\/tr>\n
7<\/td>\nForeword <\/td>\n<\/tr>\n
8<\/td>\nBSI British Standard <\/td>\n<\/tr>\n
9<\/td>\nIntroduction <\/td>\n<\/tr>\n
11<\/td>\n1 Scope
2 Normative references
3 Terms and definitions <\/td>\n<\/tr>\n
12<\/td>\n4 General requirements for risk management system
4.1 Risk management process <\/td>\n<\/tr>\n
13<\/td>\n4.2 Management responsibilities
4.3 Competence of personnel
4.4 Risk management plan <\/td>\n<\/tr>\n
14<\/td>\n4.5 Risk management file
5 Risk analysis
5.1 Risk analysis process
5.2 Intended use and reasonably foreseeable misuse <\/td>\n<\/tr>\n
15<\/td>\n5.3 Identification of characteristics related to safety
5.3.1 General
5.3.2 Data management <\/td>\n<\/tr>\n
16<\/td>\n5.3.3 Bias <\/td>\n<\/tr>\n
18<\/td>\n5.3.4 Data storage\/security\/privacy <\/td>\n<\/tr>\n
19<\/td>\n5.3.5 Overtrust
5.3.6 Adaptive systems <\/td>\n<\/tr>\n
20<\/td>\n5.3.7 Other safety considerations <\/td>\n<\/tr>\n
21<\/td>\n5.4 Identification of hazards and hazardous situations
5.5 Risk estimation <\/td>\n<\/tr>\n
22<\/td>\n6 Risk evaluation
7 Risk control <\/td>\n<\/tr>\n
23<\/td>\n8 Evaluation of overall residual risk
9 Risk management review
10 Production and post-production activities <\/td>\n<\/tr>\n
24<\/td>\nAnnex A (informative) Risk management process overview
Figure A.1\u2014A schematic representation of the risk management process <\/td>\n<\/tr>\n
25<\/td>\nFigure A.2\u2014Relationship between hazard, hazardous situation, and harm <\/td>\n<\/tr>\n
26<\/td>\nAnnex B (informative) Risk management examples
Table B.1\u2014Examples of ML-related hazards <\/td>\n<\/tr>\n
27<\/td>\nTable B.2\u2014Examples of events and circumstances <\/td>\n<\/tr>\n
28<\/td>\nTable B.3\u2014Examples of relationships between hazards, foreseeable sequences of events, hazardous situations, harm, and potential risk control measures <\/td>\n<\/tr>\n
29<\/td>\nAnnex C (informative) Personnel qualifications <\/td>\n<\/tr>\n
30<\/td>\nAnnex D (informative) Considerations for autonomous systems
Table D.1\u2014IMDRF SaMD Categories <\/td>\n<\/tr>\n
31<\/td>\nTable D.2\u2014Possible adaptation of SaMD Categories to autonomous systems <\/td>\n<\/tr>\n
32<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

AAMI TIR34971:2023 Application of ISO 14971 to machine learning in artificial intelligence<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
AAMI<\/b><\/a><\/td>\n2023<\/td>\n33<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":463884,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-463879","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\/463879","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\/463884"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=463879"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=463879"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=463879"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}