{"id":424621,"date":"2024-10-20T06:52:37","date_gmt":"2024-10-20T06:52:37","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-tir40-2018-r2022\/"},"modified":"2024-10-26T12:55:58","modified_gmt":"2024-10-26T12:55:58","slug":"aami-tir40-2018-r2022","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-tir40-2018-r2022\/","title":{"rendered":"AAMI TIR40 2018 R2022"},"content":{"rendered":"

This technical information report describes the approach for establishing a sterilization dose utilizing a modification of the fraction positive, incremental dosing method defined in Method 2 of ANSI\/AAMI\/ISO 11137-2.<\/p>\n

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PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
1<\/td>\nAAMI TIR40:2018\/(R)2022; Sterilization of health care products\u2014Radiation\u2014Guidance on dose setting utilizing a Modified Method 2 <\/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
7<\/td>\nCommittee representation <\/td>\n<\/tr>\n
10<\/td>\nForeword <\/td>\n<\/tr>\n
11<\/td>\n1 Scope
1.1 Inclusions
1.2 Exclusions
2 Normative References
3 Abbreviations, terms, and definitions <\/td>\n<\/tr>\n
14<\/td>\n4 Modified Method 2\u2014Application for method
5 Modified Method 2: Dose setting using fraction positive information from incremental dosing to determine an extrapolation factor <\/td>\n<\/tr>\n
15<\/td>\n6 Procedure for Modified Method 2A
6.1 General
6.2 Stage 1: Select SAL and obtain samples of product <\/td>\n<\/tr>\n
16<\/td>\n6.3 Stage 2: Perform incremental dose experiment
6.3.1 General
6.3.2 A and FFP
Table 1\u2014Values of A for different numbers of positive tests of sterility at median ffp (ModifiedMethod 2A) <\/td>\n<\/tr>\n
17<\/td>\n6.3.3 D*
6.3.4 CD* batch
6.4 Stage 3: Perform verification dose experiment <\/td>\n<\/tr>\n
18<\/td>\n6.5 Stage 4: Consideration of results
6.6 Stage 5: Establish sterilization dose <\/td>\n<\/tr>\n
19<\/td>\n7 Procedure for Modified Method 2B
7.1 General
7.2 Stage 1: Select SAL and obtain samples of product
7.3 Stage 2: Perform incremental dose experiment
7.3.1 General <\/td>\n<\/tr>\n
20<\/td>\n7.3.2 A and FFP
Table 2\u2014Values of A for different numbers of positive tests of sterility at median ffp (ModifiedMethod 2B) <\/td>\n<\/tr>\n
21<\/td>\n7.3.3 D*
7.3.4 CD* batch
7.4 Stage 3: Perform verification dose experiment <\/td>\n<\/tr>\n
22<\/td>\n7.5 Stage 4: Consideration of results
7.6 Stage 5: Establish sterilization dose
8 Auditing sterilization dose <\/td>\n<\/tr>\n
23<\/td>\n9 Worked examples
9.1 General
9.2 Worked example for Modified Method 2A
9.2.1 Stage 2: Incremental dose experiment <\/td>\n<\/tr>\n
24<\/td>\nTable 3\u2014Stage 2\u2014Results of incremental dose sterility tests <\/td>\n<\/tr>\n
25<\/td>\nTable 4\u2014Stage 2 calculations
9.2.2 Stage 3: Verification dose experiment <\/td>\n<\/tr>\n
26<\/td>\nTable 5\u2014Stage 3\u2014Verification dose experiment
9.2.3 Stage 5: Calculation of sterilization dose
9.3 Worked example for Modified Method 2B
9.3.1 Stage 2: Incremental dose experiment <\/td>\n<\/tr>\n
27<\/td>\nTable 6\u2014Stage 2\u2014Results of incremental dose sterility tests <\/td>\n<\/tr>\n
28<\/td>\nTable 7\u2014Stage 2 calculations
9.3.2 Stage 3: Verification dose experiment <\/td>\n<\/tr>\n
29<\/td>\nTable 8\u2014Stage 3\u2014Verification dose experiment
9.3.3 Stage 5: Calculation of sterilization dose
9.4 Worked example for Modified Method 2A with additional dose required
9.4.1 Stage 2: Incremental dose experiment <\/td>\n<\/tr>\n
30<\/td>\nTable 9\u2014Stage 2\u2014Results of incremental dose sterility tests
Table 10\u2014Stage 2 calculations <\/td>\n<\/tr>\n
31<\/td>\nTable 11\u2014Stage 2\u2014Results of incremental dose sterility tests <\/td>\n<\/tr>\n
32<\/td>\nTable 12\u2014Stage 2 Calculations
9.4.2 Stage 3: Verification dose experiment <\/td>\n<\/tr>\n
33<\/td>\nTable 13\u2014Stage 3\u2014Verification dose experiment
9.4.3 Stage 5: Calculation of sterilization dose
9.5 Worked example for Modified Method 2A with SIP of less than 1
9.5.1 Stage 2: Incremental dose experiment <\/td>\n<\/tr>\n
34<\/td>\nTable 14\u2014Stage 2\u2014Results of incremental dose sterility tests <\/td>\n<\/tr>\n
35<\/td>\nTable 15\u2014Stage 2 calculations
9.5.2 Stage 3: Verification dose experiment <\/td>\n<\/tr>\n
36<\/td>\nTable 16\u2014Stage 3\u2014Verification dose experiment
9.5.3 Stage 5: Calculation of sterilization dose <\/td>\n<\/tr>\n
37<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

AAMI TIR40:2018\/(R)2022, Sterilization of health care products\u2014Radiation\u2014Guidance on dose setting utilizing a Modified Method 2<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
AAMI<\/b><\/a><\/td>\n2018<\/td>\n37<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":424629,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-424621","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\/424621","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\/424629"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=424621"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=424621"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=424621"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}