{"id":465653,"date":"2024-10-20T10:41:46","date_gmt":"2024-10-20T10:41:46","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-11607-2-2019-a1-2023\/"},"modified":"2024-10-26T19:43:05","modified_gmt":"2024-10-26T19:43:05","slug":"aami-11607-2-2019-a1-2023","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-11607-2-2019-a1-2023\/","title":{"rendered":"AAMI 11607 2 2019 A1 2023"},"content":{"rendered":"

This amendment adds Annex B on risk management and related modifications to the text.<\/p>\n

PDF Catalog<\/h4>\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\/ISO 11607-2:2019\/A1:2023; Packaging for terminally sterilized medical devices\u2014Part 2: Validation requirements for forming, sealing and assembly processes\u2014Amendment 1: Application of risk management <\/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
11<\/td>\nBackground of ANSI\/AAMI adoption of ISO 11607-2:2019\/Amd 1:2023 <\/td>\n<\/tr>\n
12<\/td>\nForeword <\/td>\n<\/tr>\n
13<\/td>\nAMENDMENT 1: Application of risk management <\/td>\n<\/tr>\n
15<\/td>\nAnnex A (normative) Risk management
A.1 General
A.2 Application of the risk management process <\/td>\n<\/tr>\n
16<\/td>\nA.3 Risk management plan
A.3.1 General
A.3.2 Criteria for risk acceptability <\/td>\n<\/tr>\n
17<\/td>\nA.4 Specific hazards and hazardous situations to be addressed
Table B.1 \u2014 Hazards and contributing factors
A.5 Risk estimation
A.6 Risk evaluation
A.7 Risk control <\/td>\n<\/tr>\n
18<\/td>\nA.8 Monitoring effectiveness of risk control measures <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

ANSI\/AAMI\/ISO 11607-2:2019\/A1:2023 Packaging for terminally sterilized medical devices\u2014Part 2: Validation requirements for forming, sealing and assembly processes Amendment 1: Application of risk management<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
AAMI<\/b><\/a><\/td>\n2019<\/td>\n18<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":465660,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-465653","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\/465653","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\/465660"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=465653"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=465653"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=465653"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}