{"id":198062,"date":"2024-10-19T12:36:34","date_gmt":"2024-10-19T12:36:34","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-22442-3-2007-ra-2016\/"},"modified":"2024-10-25T05:09:47","modified_gmt":"2024-10-25T05:09:47","slug":"aami-22442-3-2007-ra-2016","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-22442-3-2007-ra-2016\/","title":{"rendered":"AAMI 22442 3 2007 RA 2016"},"content":{"rendered":"

Specifies requirements for the validation of the elimination and\/or inactivation of viruses and TSE agents during the manufacture of medical devices (excluding in-vitro diagnostic medical devices) utilizing animal tissue or products derived from animal tissue, which are non-viable or have been rendered non-viable. Does not cover other transmissible and non-transmissible agents.<\/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
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
1<\/td>\nANSI\/AAMI\/ISO 22442-3:2007\/(R)2016, Medical devices utilizing animal tissues and their derivatives\u2014Part 3: Validation of the elimination and\/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents <\/td>\n<\/tr>\n
2<\/td>\nObjectives and uses of AAMI standards andrecommended practices <\/td>\n<\/tr>\n
3<\/td>\nTitle Page
\n <\/td>\n<\/tr>\n
4<\/td>\nAAMI Standard
Copyright information
\n <\/td>\n<\/tr>\n
5<\/td>\nContents <\/td>\n<\/tr>\n
6<\/td>\nGlossary of equivalent standards <\/td>\n<\/tr>\n
8<\/td>\nCommittee representation <\/td>\n<\/tr>\n
9<\/td>\nBackground of AAMI Adoption of ISO 22442-3:2007 <\/td>\n<\/tr>\n
11<\/td>\nForeword <\/td>\n<\/tr>\n
12<\/td>\nIntroduction <\/td>\n<\/tr>\n
13<\/td>\n1 Scope
2 Normative references <\/td>\n<\/tr>\n
14<\/td>\n3 Terms and definitions <\/td>\n<\/tr>\n
15<\/td>\n4 General requirements
4.1 Risk management
4.2 Sourcing and manufacturing process
4.3 General requirements related to validation
4.3.1 Documented procedures
4.3.2 Personnel <\/td>\n<\/tr>\n
16<\/td>\n4.3.3 Calibration
4.3.4 Equipment
4.3.5 Experimental systems
5 Literature review
5.1 Conduct of the literature review
5.2 Application of literature review output
5.3 Viruses <\/td>\n<\/tr>\n
17<\/td>\n5.4 TSE agents
6 Elimination and\/or inactivation study of viruses and TSE agents
6.1 General
6.2 Protocol <\/td>\n<\/tr>\n
18<\/td>\n6.3 Conduct of the study
6.4 Interpretation of data
7 Final report <\/td>\n<\/tr>\n
19<\/td>\n8 Review of final report
9 Routine monitoring and control of critical process parameters <\/td>\n<\/tr>\n
20<\/td>\nAnnex A
\nRequirements related to literature review
A.1 General
A.1.1 Methodology
A.1.1.1 General
A.1.1.2 Objective <\/td>\n<\/tr>\n
21<\/td>\nA.1.1.3 Identification of data
A.1.1.4 Relevance of data <\/td>\n<\/tr>\n
22<\/td>\nA.1.1.5 Assessment
A.1.2 Critical evaluation <\/td>\n<\/tr>\n
23<\/td>\nA.2 Conclusions
A.3 Report <\/td>\n<\/tr>\n
24<\/td>\nAnnex B
\nGuidance on the elimination and\/or inactivation study for viruses
B.1 General
B.2 Selection of viruses <\/td>\n<\/tr>\n
25<\/td>\nB.3 Design and implications of elimination and\/or inactivation studies
B.3.1 General
B.3.2 Design of the study <\/td>\n<\/tr>\n
26<\/td>\nB.3.3 Culturing model viruses
B.3.4 Conduct of cell culture tests
B.3.5 Reduction factors <\/td>\n<\/tr>\n
27<\/td>\nB.4 Elimination and\/or inactivation study limitations <\/td>\n<\/tr>\n
29<\/td>\nAnnex C
\nGuidance on the elimination and\/or inactivation study for TSE agents
C.1 General
C.2 TSE agents surviving inactivation steps <\/td>\n<\/tr>\n
31<\/td>\nAnnex D
\nGuidance on scaling down <\/td>\n<\/tr>\n
32<\/td>\nAnnex E
\nStatistical evaluation of virus titres and reduction factors andassessment of their validity <\/td>\n<\/tr>\n
33<\/td>\nAnnex F
\nCalculation of reduction factors <\/td>\n<\/tr>\n
34<\/td>\nAnnex G
\nProbability of detection of agents at low concentrations <\/td>\n<\/tr>\n
35<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

ANSI\/AAMI\/ISO 22442-3:2007\/(R)2016 – Medical devices utilizing animal tissues and their derivatives-Part 3: Validation of the elimination and\/or inactivation of viruses and transimissible spongiform encephalopathy (TSE) agents<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
AAMI<\/b><\/a><\/td>\n2007<\/td>\n36<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":198064,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-198062","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\/198062","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\/198064"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=198062"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=198062"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=198062"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}