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AAMI TIR40 2018 R2022

AAMI TIR40 2018 R2022

$102.21

AAMI TIR40:2018/(R)2022, Sterilization of health care products—Radiation—Guidance on dose setting utilizing a Modified Method 2

Published By Publication Date Number of Pages
AAMI 2018 37
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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.

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PDF Pages PDF Title
1 AAMI TIR40:2018/(R)2022; Sterilization of health care products—Radiation—Guidance on dose setting utilizing a Modified Method 2
3 Title page
4 AAMI Technical Information Report
Copyright information
5 Contents
6 Glossary of equivalent standards
7 Committee representation
10 Foreword
11 1 Scope
1.1 Inclusions
1.2 Exclusions
2 Normative References
3 Abbreviations, terms, and definitions
14 4 Modified Method 2—Application for method
5 Modified Method 2: Dose setting using fraction positive information from incremental dosing to determine an extrapolation factor
15 6 Procedure for Modified Method 2A
6.1 General
6.2 Stage 1: Select SAL and obtain samples of product
16 6.3 Stage 2: Perform incremental dose experiment
6.3.1 General
6.3.2 A and FFP
Table 1—Values of A for different numbers of positive tests of sterility at median ffp (ModifiedMethod 2A)
17 6.3.3 D*
6.3.4 CD* batch
6.4 Stage 3: Perform verification dose experiment
18 6.5 Stage 4: Consideration of results
6.6 Stage 5: Establish sterilization dose
19 7 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
20 7.3.2 A and FFP
Table 2—Values of A for different numbers of positive tests of sterility at median ffp (ModifiedMethod 2B)
21 7.3.3 D*
7.3.4 CD* batch
7.4 Stage 3: Perform verification dose experiment
22 7.5 Stage 4: Consideration of results
7.6 Stage 5: Establish sterilization dose
8 Auditing sterilization dose
23 9 Worked examples
9.1 General
9.2 Worked example for Modified Method 2A
9.2.1 Stage 2: Incremental dose experiment
24 Table 3—Stage 2—Results of incremental dose sterility tests
25 Table 4—Stage 2 calculations
9.2.2 Stage 3: Verification dose experiment
26 Table 5—Stage 3—Verification 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
27 Table 6—Stage 2—Results of incremental dose sterility tests
28 Table 7—Stage 2 calculations
9.3.2 Stage 3: Verification dose experiment
29 Table 8—Stage 3—Verification 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
30 Table 9—Stage 2—Results of incremental dose sterility tests
Table 10—Stage 2 calculations
31 Table 11—Stage 2—Results of incremental dose sterility tests
32 Table 12—Stage 2 Calculations
9.4.2 Stage 3: Verification dose experiment
33 Table 13—Stage 3—Verification 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
34 Table 14—Stage 2—Results of incremental dose sterility tests
35 Table 15—Stage 2 calculations
9.5.2 Stage 3: Verification dose experiment
36 Table 16—Stage 3—Verification dose experiment
9.5.3 Stage 5: Calculation of sterilization dose
37 Bibliography

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AAMI TIR40 2018 R2022
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