{"id":198303,"date":"2024-10-19T12:37:26","date_gmt":"2024-10-19T12:37:26","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-11137-2-2013-ra-2019\/"},"modified":"2024-10-25T05:10:32","modified_gmt":"2024-10-25T05:10:32","slug":"aami-11137-2-2013-ra-2019","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-11137-2-2013-ra-2019\/","title":{"rendered":"AAMI 11137 2 2013 RA 2019"},"content":{"rendered":"

Describes methods that can be used to determine the minimum dose necessary to achieve the specified requirement for sterility, including methods to substantiate 25 kGy as the sterilization dose.<\/p>\n

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1<\/td>\nANSI\/AAMI\/ISO 11137-2:2013\/(R)2019, Sterilization of health care products \u2014 Radiation \u2014Part 2: Establishing the sterilization dose <\/td>\n<\/tr>\n
3<\/td>\nTitle page <\/td>\n<\/tr>\n
4<\/td>\nAAMI Standard
Copyright information
\n <\/td>\n<\/tr>\n
5<\/td>\nContents <\/td>\n<\/tr>\n
7<\/td>\nGlossary of equivalent standards <\/td>\n<\/tr>\n
8<\/td>\nCommittee representation <\/td>\n<\/tr>\n
11<\/td>\nBackground of ANSI\/AAMI adoption of ISO 11137-2:2013 <\/td>\n<\/tr>\n
12<\/td>\nForeword <\/td>\n<\/tr>\n
13<\/td>\nIntroduction <\/td>\n<\/tr>\n
15<\/td>\n1 Scope
2 Normative references
3 Terms, definitions and abbreviated terms
3.1 Terms and definitions <\/td>\n<\/tr>\n
17<\/td>\n3.2 Abbreviated terms <\/td>\n<\/tr>\n
18<\/td>\n4 Definition and maintenance of product families for dose setting, dose substantiation and sterilization dose auditing
4.1 General <\/td>\n<\/tr>\n
19<\/td>\n4.2 Defining product families <\/td>\n<\/tr>\n
20<\/td>\n4.3 Designation of product to represent a product family for performance of a verification dose experiment or sterilization dose audit
4.3.1 Product to represent a product family
4.3.2 Master product
4.3.3 Equivalent product <\/td>\n<\/tr>\n
21<\/td>\n4.3.4 Simulated product
4.4 Maintaining product families
4.4.1 Periodic review
4.4.2 Modification to product and\/or manufacturing process
4.4.3 Records
4.5 Effect of failure of establishment of sterilization dose or of a sterilization dose audit on a product family <\/td>\n<\/tr>\n
22<\/td>\n5 Selection and testing of product for establishing the sterilization dose
5.1 Nature of product <\/td>\n<\/tr>\n
23<\/td>\n5.2 Sample item portion (SIP) <\/td>\n<\/tr>\n
24<\/td>\n5.3 Manner of sampling
5.4 Microbiological testing
5.5 Irradiation <\/td>\n<\/tr>\n
25<\/td>\n6 Methods of dose establishment
7 Method 1: dose setting using bioburden information
7.1 Rationale <\/td>\n<\/tr>\n
26<\/td>\n7.2 Procedure for Method 1 for product with an average bioburden greater than or equal to 1.0 for multiple production batches
7.2.1 General <\/td>\n<\/tr>\n
27<\/td>\n7.2.2 Stage 1: Select SAL and obtain samples of product
7.2.3 Stage 2: Determine average bioburden
7.2.4 Stage 3: Obtain verification dose <\/td>\n<\/tr>\n
28<\/td>\n7.2.5 Stage 4: Perform verification dose experiment
7.2.6 Stage 5: Interpretation of results
7.2.7 Stage 6: Establish sterilization dose <\/td>\n<\/tr>\n
32<\/td>\n7.3 Procedure for Method 1 for product with an average bioburden greater than or equal to 1.0 for a single production batch
7.3.1 Rationale
7.3.2 General
7.3.3 Stage 1: Select SAL and obtain samples of product <\/td>\n<\/tr>\n
33<\/td>\n7.3.4 Stage 2: Determine average bioburden
7.3.5 Stage 3: Obtain verification dose
7.3.6 Stage 4: Perform verification dose experiment <\/td>\n<\/tr>\n
34<\/td>\n7.3.7 Stage 5: Interpretation of results
7.3.8 Stage 6: Establish sterilization dose
7.4 Procedure for Method 1 for product with an average bioburden in the range 0.1 to 0.9 for multiple or single production batches <\/td>\n<\/tr>\n
35<\/td>\n8 Method 2: Dose setting using fraction positive information from incremental dosing to determine an extrapolation factor
8.1 Rationale <\/td>\n<\/tr>\n
36<\/td>\n8.2 Procedure for Method 2A
8.2.1 General
8.2.2 Stage 1: Select SAL and obtain samples of product
8.2.3 Stage 2: Perform incremental dose experiment
8.2.3.1 General <\/td>\n<\/tr>\n
37<\/td>\n8.2.3.2 A and FFP
8.2.3.3 D* <\/td>\n<\/tr>\n
38<\/td>\n8.2.3.4 CD* batch
8.2.4 Stage 3: Perform verification dose experiment <\/td>\n<\/tr>\n
39<\/td>\n8.2.5 Stage 4: Interpretation of results
8.2.6 Stage 5: Establish sterilization dose <\/td>\n<\/tr>\n
40<\/td>\n8.3 Procedure for Method 2B
8.3.1 General
8.3.2 Stage 1: Select SAL and obtain samples of product
8.3.3 Stage 2: Perform incremental dose experiment
8.3.3.1 General <\/td>\n<\/tr>\n
41<\/td>\n8.3.3.2 A and FFP
8.3.3.3 D* <\/td>\n<\/tr>\n
42<\/td>\n8.3.3.4 CD* batch
8.3.4 Stage 3: Perform verification dose experiment <\/td>\n<\/tr>\n
43<\/td>\n8.3.5 Stage 4: Interpretation of results
8.3.6 Stage 5: Establish sterilization dose
9 Method VDmax \u2014 Substantiation of 25 kGy or 15 kGy as the sterilization dose
9.1 Rationale <\/td>\n<\/tr>\n
44<\/td>\n9.2 Procedure for Method VDmax25 for multiple production batches
9.2.1 General <\/td>\n<\/tr>\n
45<\/td>\n9.2.2 Stage 1: Obtain samples of product
9.2.3 Stage 2: Determine average bioburden
9.2.4 Stage 3: Obtain VDmax25 <\/td>\n<\/tr>\n
47<\/td>\n9.2.5 Stage 4: Perform verification dose experiment
9.2.6 Stage 5: Interpretation of results <\/td>\n<\/tr>\n
48<\/td>\n9.2.7 Confirmatory verification dose experiment
9.2.7.1 General
9.2.7.2 Stage 1: Obtain samples of product
9.2.7.3 Stage 2: Perform confirmatory verification dose experiment
9.2.7.4 Stage 3: Interpretation of results <\/td>\n<\/tr>\n
49<\/td>\n9.3 Procedure for Method VDmax25 for a single production batch
9.3.1 Rationale
9.3.2 General
9.3.3 Stage 1: Obtain samples of product
9.3.4 Stage 2: Determine average bioburden
9.3.5 Stage 3: Obtain VDmax25 <\/td>\n<\/tr>\n
50<\/td>\n9.3.6 Stage 4: Perform verification dose experiment
9.3.7 Stage 5: Interpretation of results <\/td>\n<\/tr>\n
51<\/td>\n9.3.8 Confirmatory verification dose experiment
9.3.8.1 General
9.3.8.2 Stage 1: Obtain samples of product
9.3.8.3 Stage 2: Perform confirmatory verification dose experiment
9.3.8.4 Stage 3: Interpretation of results <\/td>\n<\/tr>\n
52<\/td>\n9.4 Procedure for Method VDmax15 for multiple production batches
9.4.1 General
9.4.2 Stage 1: Obtain samples of product
9.4.3 Stage 2: Determine average bioburden
9.4.4 Stage 3: Obtain VDmax15 <\/td>\n<\/tr>\n
53<\/td>\n9.4.5 Stage 4: Perform verification dose experiment <\/td>\n<\/tr>\n
54<\/td>\n9.4.6 Stage 5: Interpretation of results
9.4.7 Confirmatory verification dose experiment
9.4.7.1 General
9.4.7.2 Stage 1: Obtain samples of product
9.4.7.3 Stage 2: Perform confirmatory verification dose experiment <\/td>\n<\/tr>\n
55<\/td>\n9.4.7.4 Stage 3: Interpretation of results
9.5 Procedure for Method VDmax15 for a single production batch
9.5.1 Rationale
9.5.2 General
9.5.3 Stage 1: Obtain samples of product
9.5.4 Stage 2: Determine average bioburden <\/td>\n<\/tr>\n
56<\/td>\n9.5.5 Stage 3: Obtain VDmax15
9.5.6 Stage 4: Perform verification dose experiment
9.5.7 Stage 5: Interpretation of results <\/td>\n<\/tr>\n
57<\/td>\n9.5.8 Confirmatory verification dose experiment
9.5.8.1 General
9.5.8.2 Stage 1: Obtain samples of product
9.5.8.3 Stage 2: Perform confirmatory verification dose experiment
9.5.8.4 Stage 3: Interpretation of results <\/td>\n<\/tr>\n
58<\/td>\n10 Sterilization dose audit
10.1 Purpose and frequency
10.2 Procedure for auditing a sterilization dose established using Method 1, Method 2A or Method 2B
10.2.1 General
10.2.2 Stage 1: Obtain samples of product
10.2.3 Stage 2: Determine average bioburden <\/td>\n<\/tr>\n
59<\/td>\n10.2.4 Stage 3: Perform verification dose experiment
10.2.5 Stage 4: Interpretation of results <\/td>\n<\/tr>\n
60<\/td>\n10.2.6 Augmentation of a sterilization dose established using Method 1, Method 2A or Method 2B
10.2.6.1 General
10.2.6.2 Stage 1: Analyse data from the failed sterilization dose audit <\/td>\n<\/tr>\n
61<\/td>\n10.2.6.3 Stage 2: Determine extrapolation factor, E
10.2.6.4 Stage 3: Calculate adjusted dose (the dose to achieve an SAL value of 10\u20132)
10.2.6.5 Stage 4: Calculate augmented sterilization dose
10.3 Procedure for auditing a sterilization dose substantiated using Method VDmax25 or Method VDmax15
10.3.1 General <\/td>\n<\/tr>\n
62<\/td>\n10.3.2 Stage 1: Obtain samples of product
10.3.3 Stage 2: Determine average bioburden
10.3.4 Stage 3: Perform verification dose experiment
10.3.5 Stage 4: Interpretation of results <\/td>\n<\/tr>\n
63<\/td>\n10.3.6 Confirmatory sterilization dose audit
10.3.6.1 General
10.3.6.2 Stage 1: Obtain samples of product
10.3.6.3 Stage 2: Perform confirmatory verification dose experiment <\/td>\n<\/tr>\n
64<\/td>\n10.3.6.4 Stage 3: Interpretation of results
10.3.7 Augmentation of a sterilization dose substantiated using Method VDmax25 or Method VDmax15
10.3.7.1 Method VDmax25 <\/td>\n<\/tr>\n
65<\/td>\n10.3.7.2 Method VDmax15 <\/td>\n<\/tr>\n
66<\/td>\n10.4 Failure of a sterilization dose audit
11 Worked examples
11.1 Worked examples for Method 1 <\/td>\n<\/tr>\n
69<\/td>\n11.2 Worked examples for Method 2
11.2.1 General <\/td>\n<\/tr>\n
70<\/td>\n11.2.2 Worked example for Method 2A (SIP equal to 1.0)
11.2.2.1 Stage 1: Select SAL and obtain samples of product
11.2.2.2 Stage 2: Perform incremental dose experiment <\/td>\n<\/tr>\n
72<\/td>\nStage 3: Perform verification dose experiment <\/td>\n<\/tr>\n
73<\/td>\n11.2.2.3 Stages 4 and 5: Interpretation of results and establishment of sterilization dose
11.2.3 Worked example for Method 2A (SIP less than 1.0)
11.2.3.1 Stage 1: Select SAL and obtain samples of product <\/td>\n<\/tr>\n
74<\/td>\n11.2.3.2 Stage 2: Perform incremental dose experiment <\/td>\n<\/tr>\n
76<\/td>\n11.2.3.3 Stage 3: Perform verification dose experiment <\/td>\n<\/tr>\n
77<\/td>\n11.2.3.4 Stages 4 and 5: Interpretation of results and establishment of sterilization dose <\/td>\n<\/tr>\n
78<\/td>\n11.2.4 Worked example for Method 2B
11.2.4.1 Stage 1: Select SAL and obtain samples of product
11.2.4.2 Stage 2: Perform incremental dose experiment <\/td>\n<\/tr>\n
80<\/td>\n11.2.4.3 Stage 3: Perform verification dose experiment <\/td>\n<\/tr>\n
81<\/td>\n11.2.4.4 Stages 4 and 5: Interpretation of results and establishment of sterilization dose
11.3 Worked examples for Method VDmax <\/td>\n<\/tr>\n
83<\/td>\n11.4 Worked example of a sterilization dose audit for a dose established using Method 1, the findings from which necessitated augmentation of the sterilization dose <\/td>\n<\/tr>\n
84<\/td>\n11.5 Worked example of a sterilization dose audit for a dose established using Method 2A, the findings from which necessitated augmentation of the sterilization dose <\/td>\n<\/tr>\n
85<\/td>\n11.6 Worked example of a sterilization dose audit for a sterilization dose substantiated using Method VDmax25 <\/td>\n<\/tr>\n
87<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

ANSI\/AAMI\/ ISO 11137-2: 2013\/(R)2019 – Sterilization of health care products-Radiation-Part 2: Establishing the sterilization dose<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
AAMI<\/b><\/a><\/td>\n2017<\/td>\n92<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":198304,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-198303","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\/198303","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\/198304"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=198303"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=198303"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=198303"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}