{"id":508234,"date":"2024-11-05T14:02:50","date_gmt":"2024-11-05T14:02:50","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/sa-tr-iso-249712020\/"},"modified":"2024-11-05T14:02:50","modified_gmt":"2024-11-05T14:02:50","slug":"sa-tr-iso-249712020","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/as\/sa-tr-iso-249712020\/","title":{"rendered":"SA TR ISO 24971:2020"},"content":{"rendered":"
This Standard adopts ISO\/TR 24971:2020, which provides guidance on the development, implementation and maintenance of a risk management system for medical devices according to AS ISO 14971:2020. <\/p>\n
Scope<\/b><\/p>\n
This document provides guidance on the development, implementation and maintenance of a risk management system for medical devices according to ISO 14971:2019.
The risk management process can be part of a quality management system, for example one that is based on ISO 13485:2016[24], but this is not required by ISO 14971:2019. Some requirements in ISO 13485:2016 (Clause 7 on product realization and 8.2.1 on feedback during monitoring and measurement) are related to risk management and can be fulfilled by applying ISO 14971:2019. See also the ISO Handbook: ISO 13485:2016 \u2014 Medical devices \u2014 A practical guide[25].<\/p>\n","protected":false},"excerpt":{"rendered":"
Medical devices – Guidance on the application of AS ISO 14971<\/b><\/p>\n\n\n
\n Published By<\/td>\n Publication Date<\/td>\n Number of Pages<\/td>\n<\/tr>\n \n AS<\/b><\/a><\/td>\n 2020-08-28<\/td>\n 101<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":508241,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2633],"product_tag":[],"class_list":{"0":"post-508234","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-as","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\/508234","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\/508241"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=508234"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=508234"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=508234"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}