{"id":198009,"date":"2024-10-19T12:36:24","date_gmt":"2024-10-19T12:36:24","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-tir24971-2013-ra-2016\/"},"modified":"2024-10-25T05:09:39","modified_gmt":"2024-10-25T05:09:39","slug":"aami-tir24971-2013-ra-2016","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-tir24971-2013-ra-2016\/","title":{"rendered":"AAMI TIR24971 2013 RA 2016"},"content":{"rendered":"

Provides guidance that addresses specific areas that are problematic for those implementing a risk management system.<\/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
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
1<\/td>\nAAMI\/ISO TIR24971:2013, Medical devices \u2014 Guidance on the application of ISO 14971 <\/td>\n<\/tr>\n
3<\/td>\nTitle page <\/td>\n<\/tr>\n
4<\/td>\nCopyright information <\/td>\n<\/tr>\n
5<\/td>\nAAMI Technical Information Report
ANSI Technical Report <\/td>\n<\/tr>\n
6<\/td>\nContents <\/td>\n<\/tr>\n
7<\/td>\nGlossary of equivalent standards <\/td>\n<\/tr>\n
8<\/td>\nCommittee representation <\/td>\n<\/tr>\n
10<\/td>\nBackground of ANSI\/AAMI adoption of ISO\/TS 24971:2013 <\/td>\n<\/tr>\n
11<\/td>\nForeword <\/td>\n<\/tr>\n
12<\/td>\nIntroduction <\/td>\n<\/tr>\n
13<\/td>\n1 Scope
2 The role of international product safety and process standards in risk management
2.1 Overview <\/td>\n<\/tr>\n
14<\/td>\n2.2 Use of international product safety standards in risk management <\/td>\n<\/tr>\n
17<\/td>\n2.3 International process standards and ISO 14971 <\/td>\n<\/tr>\n
19<\/td>\n3 Developing the policy for determining the criteria for risk acceptability <\/td>\n<\/tr>\n
20<\/td>\n4 Production and post-production feedback loop
4.1 Overview
4.2 Observation and transmission <\/td>\n<\/tr>\n
23<\/td>\n4.3 Assessment
4.4 Action <\/td>\n<\/tr>\n
24<\/td>\n5 Differentiation of information for safety and disclosure of residual risk
5.1 Difference between \u201cinformation for safety\u201d and \u201cdisclosure of residual risk\u201d
5.2 Information for safety <\/td>\n<\/tr>\n
25<\/td>\n5.3 Disclosure of residual risk
6 Evaluation of overall residual risk
6.1 Overview <\/td>\n<\/tr>\n
26<\/td>\n6.2 Inputs and other considerations for overall residual risk evaluation <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

AAMI\/ISO TIR24971:2013\/(R)2016 – Medical devices-Guidance on the application of ISO 14971<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
AAMI<\/b><\/a><\/td>\n2013<\/td>\n27<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":198014,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-198009","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\/198009","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\/198014"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=198009"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=198009"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=198009"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}