{"id":424619,"date":"2024-10-20T06:52:37","date_gmt":"2024-10-20T06:52:37","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-tir22456-2022\/"},"modified":"2024-10-26T12:55:58","modified_gmt":"2024-10-26T12:55:58","slug":"aami-tir22456-2022","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-tir22456-2022\/","title":{"rendered":"AAMI TIR22456 2022"},"content":{"rendered":"

Provides guidance for bioburden testing and tests of sterility for biologics and tissue-based products, where this testing is in relation to product sterilization.<\/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
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
1<\/td>\nAAMI\/ISO TIR22456:2022; Sterilization of health care products\u2014Microbiological methods\u2014Guidance on conducting bioburden determinations and tests of sterility for biologics and tissue-based products <\/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 <\/td>\n<\/tr>\n
6<\/td>\nContents Page <\/td>\n<\/tr>\n
7<\/td>\nCommittee representation <\/td>\n<\/tr>\n
11<\/td>\nBackground of AAMI adoption of ISO\/TS 22456:2021 <\/td>\n<\/tr>\n
12<\/td>\nForeword <\/td>\n<\/tr>\n
13<\/td>\nIntroduction <\/td>\n<\/tr>\n
15<\/td>\n1 Scope
1.1 Inclusions
1.2 Exclusions
2 Normative references <\/td>\n<\/tr>\n
16<\/td>\n3 Terms and definitions <\/td>\n<\/tr>\n
17<\/td>\n4 Definition and maintenance of product families
5 Selection and testing of product for bioburden and tests of sterility
5.1 General <\/td>\n<\/tr>\n
18<\/td>\n5.2 Nature of product
5.3 Sample Item Portion (SIP)
5.4 Sampling conditions
5.4.1 General
5.4.2 Considerations for human tissue donor batches in sterilization
5.4.3 Use of multiple batches <\/td>\n<\/tr>\n
19<\/td>\n5.4.4 Considerations for packaging
5.5 Microbiological testing
5.5.1 Bioburden test considerations for biologics\/tissues
5.5.1.1 General <\/td>\n<\/tr>\n
20<\/td>\n5.5.1.2 Extraction fluid
5.5.1.3 Extraction methods
5.5.1.4 Membrane filter selection
5.5.1.5 Filtration considerations
5.5.1.6 Most Probable Number (MPN) <\/td>\n<\/tr>\n
21<\/td>\n5.5.1.7 Media for incubation
5.5.1.8 Culture conditions
5.5.1.9 Enumeration and characterization <\/td>\n<\/tr>\n
22<\/td>\n5.5.1.10 Interpretation of data
5.5.2 Test of sterility considerations for biologics\/tissues
5.5.2.1 General
5.5.2.2 Performance of test of sterility
5.5.2.3 Culture conditions <\/td>\n<\/tr>\n
23<\/td>\n5.5.2.4 Membrane filtration of eluate
5.5.2.5 Examination of growth medium
5.5.3 Verification of microbiological methods
5.5.3.1 Method suitability <\/td>\n<\/tr>\n
24<\/td>\n5.5.3.2 Bioburden test verification (recovery efficiency test)
5.5.3.3 Method suitability for test of sterility (bacteriostasis\/fungistasis test)
5.5.4 Rapid microbiology tests <\/td>\n<\/tr>\n
25<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

AAMI\/ISO TIR22456:2022, Sterilization of health care products\u2014Microbiological methods\u2014Guidance on conducting bioburden determinations and tests of sterility for biologics and tissue-based products<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
AAMI<\/b><\/a><\/td>\n2022<\/td>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":424624,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-424619","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\/424619","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\/424624"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=424619"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=424619"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=424619"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}