{"id":197970,"date":"2024-10-19T12:36:15","date_gmt":"2024-10-19T12:36:15","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-22442-2-2016\/"},"modified":"2024-10-25T05:09:32","modified_gmt":"2024-10-25T05:09:32","slug":"aami-22442-2-2016","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-22442-2-2016\/","title":{"rendered":"AAMI 22442 2 2016"},"content":{"rendered":"

Specifies requirements for controls on the sourcing, collection and handling (which includes storage and transport) of animals and tissues for the manufacture of medical devices utilizing materials of animal origin, other than in vitro diagnostic 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
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
1<\/td>\nANSI\/AAMI\/ISO 22442-2:2016; Medical devices utilizing animal tissues and their derivatives\u2014Part 2: Controls on sourcing, collection and handling <\/td>\n<\/tr>\n
2<\/td>\nObjectives and uses of AAMI standards and recommended practices <\/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 Page <\/td>\n<\/tr>\n
6<\/td>\nGlossary of equivalent standards <\/td>\n<\/tr>\n
7<\/td>\nCommittee representation <\/td>\n<\/tr>\n
8<\/td>\nBackground of ANSI\/AAMI adoption of ISO 22442-2:2016 <\/td>\n<\/tr>\n
9<\/td>\nForeword <\/td>\n<\/tr>\n
10<\/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
4.1 General
4.2 Quality system elements <\/td>\n<\/tr>\n
13<\/td>\n4.3 Procedures
4.4 Personnel
4.5 Current regulatory requirements and guidance <\/td>\n<\/tr>\n
14<\/td>\n5 Sourcing
5.1 General
5.2 Species and strain
5.3 Geography
5.4 Inspection <\/td>\n<\/tr>\n
15<\/td>\n5.5 Certification
5.6 Traceability
6 Collection
7 Handling <\/td>\n<\/tr>\n
16<\/td>\n8 Storage and transport <\/td>\n<\/tr>\n
17<\/td>\nAnnex A (normative) Additional requirements relating to the application of this part of ISO 22442 to bovine-sourced materials
A.1 General
A.2 General aspects
A.3 The likelihood of infectivity in the source animals
A.3.1 General <\/td>\n<\/tr>\n
18<\/td>\nA.3.2 The BSE status of the countries or regions of origin
A.3.2.1 General
A.3.2.2 Negligible BSE risk <\/td>\n<\/tr>\n
19<\/td>\nA.3.2.3 Controlled BSE risk
A.3.2.4 Undetermined BSE risk
A.3.2.5 Particular circumstances <\/td>\n<\/tr>\n
20<\/td>\nA.3.3 Sourcing from closed\/low risk herds
A.3.4 The age of the donor animals
A.3.5 The feeding history of the donor animals
A.4 The infectivity of the source tissue
A.5 Measures to prevent cross-contamination <\/td>\n<\/tr>\n
22<\/td>\nAnnex B (informative) Certification and attestation
B.1 Example of a certificate to be issued <\/td>\n<\/tr>\n
23<\/td>\nB.2 Example of a health attestation to be issued by a veterinarian <\/td>\n<\/tr>\n
24<\/td>\nAnnex C (informative) Veterinary services <\/td>\n<\/tr>\n
25<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

ANSI\/AAMI\/ISO 22442-2:2016 – Medical devices utilizing animal tissues and their derivatives-Part 2: Controls on sourcing, collection and handling.<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
AAMI<\/b><\/a><\/td>\n2016<\/td>\n25<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":197974,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-197970","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\/197970","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\/197974"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=197970"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=197970"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=197970"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}