{"id":430112,"date":"2024-10-20T07:21:42","date_gmt":"2024-10-20T07:21:42","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-tir39-2009-r2022\/"},"modified":"2024-10-26T14:00:34","modified_gmt":"2024-10-26T14:00:34","slug":"aami-tir39-2009-r2022","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-tir39-2009-r2022\/","title":{"rendered":"AAMI TIR39 2009 R2022"},"content":{"rendered":"

This technical information report provides guidance on selecting the appropriate form of microbial challenge to use in a validation process and the appropriate inoculation sites for that microbial challenge. The objective of this TIR is to provide medical device manufacturers information on the appropriate microbial challenge to use in sterilization validation processes, the selection of appropriate inoculation sites for that challenge, and the means to qualify a method for liquid inoculation.<\/p>\n

PDF Catalog<\/h4>\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 TIR39:2009\/(R)2022; Guidance on selecting a microbial challenge and inoculation sites for sterilization validation of medical devices <\/td>\n<\/tr>\n
3<\/td>\nTitle page <\/td>\n<\/tr>\n
4<\/td>\nAAMI Technical Information Report
Copyright information <\/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
11<\/td>\nForeword <\/td>\n<\/tr>\n
12<\/td>\nIntroduction <\/td>\n<\/tr>\n
13<\/td>\n1 Scope
1.1 General
1.2 Exclusions
2 Normative references
3 Terms and definitions <\/td>\n<\/tr>\n
15<\/td>\n4 Microbial challenge types and criteria for selection <\/td>\n<\/tr>\n
16<\/td>\n5 Selection of product, inoculation site, and process for inoculation
5.1 Selection of product for inoculation
5.2 Selection of product inoculation site <\/td>\n<\/tr>\n
17<\/td>\n5.3 Process for inoculation
5.3.1 General
5.3.2 Considerations for use of inoculated carriers
6 Testing and assessment of inoculated product
6.1 Testing of inoculated product <\/td>\n<\/tr>\n
18<\/td>\n6.2 Assessment of inoculated product test results
7 Considerations for the use of liquid inoculum
7.1 Use of liquid inoculum
7.2 Testing of inoculated product <\/td>\n<\/tr>\n
19<\/td>\n7.3 Testing considerations <\/td>\n<\/tr>\n
20<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

AAMI TIR39:2009\/(R)2022: Guidance on selecting a microbial challenge and inoculation sites for sterilization validation of medical devices<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
AAMI<\/b><\/a><\/td>\n2009<\/td>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":430119,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-430112","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\/430112","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\/430119"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=430112"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=430112"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=430112"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}