ISO 11137-2:2013
Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
ISO 11137-2:2013 specifies methods for determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the sterilization dose to achieve a sterility assurance level, SAL, of 10−6. ISO 11137-2:2013 also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose.
ISO 11137-2:2013 defines product families for sterilization dose establishment and sterilization dose audit.
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Section sec_1
Section sec_2
Section sec_3
Section sec_3.1
Section sec_3.1.1
Section sec_3.1.2
Section sec_3.1.3
Section sec_3.1.4
Section sec_3.1.5
Section sec_3.1.6
Section sec_3.1.7
Section sec_3.1.8
Section sec_3.1.9
Section sec_3.1.10
Section sec_3.1.11
Section sec_3.1.12
Section sec_3.1.13
Section sec_3.1.14
Section sec_3.1.15
Section sec_3.2
Section sec_3.2.1
Section sec_3.2.2
Section sec_3.2.3
Section sec_3.2.4
Section sec_3.2.5
Section sec_3.2.6
Section sec_3.2.7
Section sec_3.2.8
Section sec_3.2.9
Section sec_3.2.10
Section sec_3.2.11
Section sec_3.2.12
Section sec_3.2.13
Section sec_4
Section sec_4.1
Section sec_4.2
Section sec_4.2.1
Section sec_4.2.2
Section sec_4.2.3
Section sec_4.2.4
Section sec_4.3
Section sec_4.3.1
Section sec_4.3.1.1
Section sec_4.3.1.2
Section sec_4.3.1.3
Section sec_4.3.2
Section sec_4.3.3
Section sec_4.3.4
Section sec_4.4
Section sec_4.4.1
Section sec_4.4.2
Section sec_4.4.3
Section sec_4.5
Section sec_5
Section sec_5.1
Section sec_5.1.1
Table tab_1
Section sec_5.1.2
Section sec_5.2
Section sec_5.2.1
Section sec_5.2.2
Section sec_5.2.3
Table tab_2
Section sec_5.2.4
Section sec_5.2.5
Section sec_5.2.6
Section sec_5.3
Section sec_5.3.1
Section sec_5.3.2
Section sec_5.4
Section sec_5.4.1
Section sec_5.4.2
Section sec_5.5
Section sec_5.5.1
Section sec_5.5.2
Section sec_5.5.3
Section sec_6
Section sec_6.1
Section sec_6.2
Section sec_6.3
Section sec_7
Section sec_7.1
Table tab_3
Table tab_4
Section sec_7.2
Section sec_7.2.1
Section sec_7.2.2
Section sec_7.2.2.1
Section sec_7.2.2.2
Section sec_7.2.3
Section sec_7.2.3.1
Section sec_7.2.3.2
Section sec_7.2.3.3
Section sec_7.2.4
Section sec_7.2.5
Section sec_7.2.5.1
Section sec_7.2.5.2
Section sec_7.2.5.3
Section sec_7.2.6
Section sec_7.2.6.1
Section sec_7.2.6.2
Section sec_7.2.7
Section sec_7.2.7.1
Section sec_7.2.7.2
Table tab_5
Table tab_5___1
Table tab_5___2
Table tab_5___3
Section sec_7.3
Section sec_7.3.1
Section sec_7.3.2
Section sec_7.3.3
Section sec_7.3.3.1
Section sec_7.3.3.2
Section sec_7.3.4
Section sec_7.3.4.1
Section sec_7.3.4.2
Section sec_7.3.5
Section sec_7.3.6
Section sec_7.3.6.1
Section sec_7.3.6.2
Section sec_7.3.6.3
Section sec_7.3.7
Section sec_7.3.7.1
Section sec_7.3.7.2
Section sec_7.3.8
Section sec_7.3.8.1
Section sec_7.3.8.2
Section sec_7.4
Table tab_6
Section sec_8
Section sec_8.1
Section sec_8.2
Section sec_8.2.1
Section sec_8.2.2
Section sec_8.2.2.1
Section sec_8.2.2.2
Section sec_8.2.3
Section sec_8.2.3.1
Section sec_8.2.3.1.1
Section sec_8.2.3.1.2
Section sec_8.2.3.1.3
Section sec_8.2.3.2
Section sec_8.2.3.2.1
Section sec_8.2.3.2.2
Table tab_7
Section sec_8.2.3.2.3
Section sec_8.2.3.3
Section sec_8.2.3.3.1
Section sec_8.2.3.3.2
Section sec_8.2.3.3.3
Section sec_8.2.3.4
Section sec_8.2.4
Section sec_8.2.4.1
Section sec_8.2.4.2
Section sec_8.2.5
Section sec_8.2.6
Section sec_8.2.6.1
Section sec_8.2.6.2
Section sec_8.2.6.3
Section sec_8.3
Section sec_8.3.1
Section sec_8.3.1.1
Section sec_8.3.1.2
Section sec_8.3.2
Section sec_8.3.2.1
Section sec_8.3.2.2
Section sec_8.3.3
Section sec_8.3.3.1
Section sec_8.3.3.1.1
Section sec_8.3.3.1.2
Section sec_8.3.3.1.3
Section sec_8.3.3.2
Section sec_8.3.3.2.1
Section sec_8.3.3.2.2
Table tab_8
Section sec_8.3.3.2.3
Section sec_8.3.3.3
Section sec_8.3.3.3.1
Section sec_8.3.3.3.2
Section sec_8.3.3.3.3
Section sec_8.3.3.4
Section sec_8.3.4
Section sec_8.3.4.1
Section sec_8.3.4.2
Section sec_8.3.5
Section sec_8.3.6
Section sec_8.3.6.1
Section sec_8.3.6.2
Section sec_8.3.6.3
Section sec_9
Section sec_9.1
Section sec_9.2
Section sec_9.2.1
Section sec_9.2.1.1
Section sec_9.2.1.2
Section sec_9.2.1.3
Section sec_9.2.2
Section sec_9.2.3
Section sec_9.2.3.1
Section sec_9.2.3.2
Section sec_9.2.3.3
Section sec_9.2.4
Table tab_9
Table tab_9___1
Section sec_9.2.5
Section sec_9.2.5.1
Section sec_9.2.5.2
Section sec_9.2.5.3
Section sec_9.2.6
Section sec_9.2.6.1
Section sec_9.2.6.2
Section sec_9.2.6.3
Section sec_9.2.7
Section sec_9.2.7.1
Section sec_9.2.7.2
Section sec_9.2.7.3
Section sec_9.2.7.3.1
Section sec_9.2.7.3.2
Section sec_9.2.7.4
Section sec_9.2.7.4.1
Section sec_9.2.7.4.2
Section sec_9.3
Section sec_9.3.1
Section sec_9.3.2
Section sec_9.3.2.1
Section sec_9.3.2.2
Section sec_9.3.2.3
Section sec_9.3.3
Section sec_9.3.4
Section sec_9.3.4.1
Section sec_9.3.4.2
Section sec_9.3.5
Section sec_9.3.6
Section sec_9.3.6.1
Section sec_9.3.6.2
Section sec_9.3.6.3
Section sec_9.3.7
Section sec_9.3.7.1
Section sec_9.3.7.2
Section sec_9.3.7.3
Section sec_9.3.8
Section sec_9.3.8.1
Section sec_9.3.8.2
Section sec_9.3.8.3
Section sec_9.3.8.3.1
Section sec_9.3.8.3.2
Section sec_9.3.8.4
Section sec_9.3.8.4.1
Section sec_9.3.8.4.2
Section sec_9.4
Section sec_9.4.1
Section sec_9.4.1.1
Section sec_9.4.1.2
Section sec_9.4.1.3
Section sec_9.4.2
Section sec_9.4.3
Section sec_9.4.3.1
Section sec_9.4.3.2
Section sec_9.4.3.3
Section sec_9.4.4
Table tab_10
Section sec_9.4.5
Section sec_9.4.5.1
Section sec_9.4.5.2
Section sec_9.4.5.3
Section sec_9.4.6
Section sec_9.4.6.1
Section sec_9.4.6.2
Section sec_9.4.6.3
Section sec_9.4.7
Section sec_9.4.7.1
Section sec_9.4.7.2
Section sec_9.4.7.3
Section sec_9.4.7.3.1
Section sec_9.4.7.3.2
Section sec_9.4.7.4
Section sec_9.4.7.4.1
Section sec_9.4.7.4.2
Section sec_9.5
Section sec_9.5.1
Section sec_9.5.2
Section sec_9.5.2.1
Section sec_9.5.2.2
Section sec_9.5.2.3
Section sec_9.5.3
Section sec_9.5.4
Section sec_9.5.4.1
Section sec_9.5.4.2
Section sec_9.5.5
Section sec_9.5.6
Section sec_9.5.6.1
Section sec_9.5.6.2
Section sec_9.5.6.3
Section sec_9.5.7
Section sec_9.5.7.1
Section sec_9.5.7.2
Section sec_9.5.7.3
Section sec_9.5.8
Section sec_9.5.8.1
Section sec_9.5.8.2
Section sec_9.5.8.3
Section sec_9.5.8.3.1
Section sec_9.5.8.3.2
Section sec_9.5.8.4
Section sec_9.5.8.4.1
Section sec_9.5.8.4.2
Section sec_10
Section sec_10.1
Section sec_10.2
Section sec_10.2.1
Section sec_10.2.1.1
Section sec_10.2.1.2
Section sec_10.2.2
Section sec_10.2.3
Section sec_10.2.4
Section sec_10.2.4.1
Section sec_10.2.4.2
Section sec_10.2.5
Section sec_10.2.5.1
Section sec_10.2.5.2
Section sec_10.2.5.3
Section sec_10.2.6
Section sec_10.2.6.1
Section sec_10.2.6.2
Section sec_10.2.6.3
Section sec_10.2.6.4
Section sec_10.2.6.5
Section sec_10.3
Section sec_10.3.1
Section sec_10.3.1.1
Section sec_10.3.1.2
Section sec_10.3.2
Section sec_10.3.3
Section sec_10.3.3.1
Section sec_10.3.3.2
Section sec_10.3.4
Section sec_10.3.4.1
Section sec_10.3.4.2
Section sec_10.3.5
Section sec_10.3.5.1
Section sec_10.3.5.2
Section sec_10.3.5.3
Section sec_10.3.6
Section sec_10.3.6.1
Section sec_10.3.6.1.1
Section sec_10.3.6.1.2
Section sec_10.3.6.2
Section sec_10.3.6.3
Section sec_10.3.6.3.1
Section sec_10.3.6.3.2
Section sec_10.3.6.4
Section sec_10.3.7
Section sec_10.3.7.1
Table tab_11
Table tab_11___1
Section sec_10.3.7.2
Table tab_12
Section sec_10.4
Section sec_11
Section sec_11.1
Table tab_13
Table tab_14
Table tab_15
Section sec_11.2
Section sec_11.2.1
Section sec_11.2.2
Section sec_11.2.2.1
Section sec_11.2.2.1.1
Section sec_11.2.2.1.2
Table tab_16
Section sec_11.2.2.2
Table tab_17
Table tab_18
Section sec_11.2.2.3
Table tab_19
Section sec_11.2.2.4
Table tab_20
Section sec_11.2.3
Section sec_11.2.3.1
Section sec_11.2.3.1.1
Section sec_11.2.3.1.2
Table tab_21
Section sec_11.2.3.2
Table tab_22
Table tab_23
Section sec_11.2.3.3
Table tab_24
Section sec_11.2.3.4
Table tab_25
Section sec_11.2.4
Section sec_11.2.4.1
Section sec_11.2.4.1.1
Section sec_11.2.4.1.2
Table tab_26
Section sec_11.2.4.2
Table tab_27
Table tab_28
Section sec_11.2.4.3
Table tab_29
Section sec_11.2.4.4
Table tab_30
Section sec_11.3
Table tab_31
Table tab_32
Section sec_11.4
Table tab_33
Section sec_11.5
Table tab_34
Section sec_11.6
Table tab_35
Reference ref_1
Reference ref_2
Reference ref_3
Reference ref_4
Reference ref_5
Reference ref_6
Reference ref_7
Reference ref_8
Reference ref_9
Reference ref_10
Reference ref_11
Reference ref_12
Reference ref_13
Reference ref_14
Reference ref_15
Reference ref_16
Reference ref_17
Reference ref_18
Reference ref_19
Reference ref_20
Reference ref_21
Foreword
Introduction
1 Scope
2 Normative references
3 Terms, definitions, and abbreviated terms
3.1 Terms and definitions
3.2 Abbreviated terms
4 Definition and maintenance of product families for dose setting, dose substantiation, and sterilization dose auditing
4.1 General
4.2 Defining product families
4.3 Designation of product to represent a product family for performance of a verification dose experiment or sterilization dose audit
4.4 Maintaining product families
4.5 Effect of failure of establishment of sterilization dose or of a sterilization dose audit on a product family
5 Selection and testing of product for establishing the sterilization dose
5.1 Nature of product
5.2 Sample item portion (SIP)
5.3 Manner of sampling
5.4 Microbiological testing
5.5 Irradiation
6 Methods of dose establishment
7 Method 1: dose setting using bioburden information
7.1 Rationale
7.2 Procedure for Method 1 for product with an average bioburden greater than or equal to 1,0 for multiple production batches
7.3 Procedure for Method 1 for product with an average bioburden greater than or equal to 1,0 for a single production batch
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
8 Method 2: Dose setting using fraction positive information from incremental dosing to determine an extrapolation factor
8.1 Rationale
8.2 Procedure for Method 2A
8.3 Procedure for Method 2B
9 Method VDmax — Substantiation of 25 kGy or 15 kGy as the sterilization dose
9.1 Rationale
9.2 Procedure for Method VDmax25 for multiple production batches
9.3 Procedure for Method VDmax25 for a single production batch
9.4 Procedure for Method VDmax15 for multiple production batches
9.5 Procedure for Method VDmax15 for a single production batch
10 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
10.3 Procedure for auditing a sterilization dose substantiated using Method VDmax25 or Method VDmax15
10.4 Failure of a sterilization dose audit
11 Worked examples
11.1 Worked examples for Method 1
11.2 Worked examples for Method 2
11.3 Worked examples for Method VDmax
11.4 Worked example of a sterilization dose audit for a dose established using Method 1, the findings from which necessitated augmentation of the sterilization dose
11.5 Worked example of a sterilization dose audit for a dose established using Method 2A, the findings from which necessitated augmentation of the sterilization dose
11.6 Worked example of a sterilization dose audit for a sterilization dose substantiated using Method VDmax25
Bibliography
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Section sec_1
Section sec_2
Section sec_3
Section sec_3.1
Section sec_3.1.1
Section sec_3.1.2
Section sec_3.1.3
Section sec_3.1.4
Section sec_3.1.5
Section sec_3.1.6
Section sec_3.1.7
Section sec_3.1.8
Section sec_3.1.9
Section sec_3.1.10
Section sec_3.1.11
Section sec_3.1.12
Section sec_3.1.13
Section sec_3.1.14
Section sec_3.1.15
Section sec_3.2
Section sec_3.2.1
Section sec_3.2.2
Section sec_3.2.3
Section sec_3.2.4
Section sec_3.2.5
Section sec_3.2.6
Section sec_3.2.7
Section sec_3.2.8
Section sec_3.2.9
Section sec_3.2.10
Section sec_3.2.11
Section sec_3.2.12
Section sec_3.2.13
Section sec_4
Section sec_4.1
Section sec_4.2
Section sec_4.2.1
Section sec_4.2.2
Section sec_4.2.3
Section sec_4.2.4
Section sec_4.3
Section sec_4.3.1
Section sec_4.3.1.1
Section sec_4.3.1.2
Section sec_4.3.1.3
Section sec_4.3.2
Section sec_4.3.3
Section sec_4.3.4
Section sec_4.4
Section sec_4.4.1
Section sec_4.4.2
Section sec_4.4.3
Section sec_4.5
Section sec_5
Section sec_5.1
Section sec_5.1.1
Table tab_1
Section sec_5.1.2
Section sec_5.2
Section sec_5.2.1
Section sec_5.2.2
Section sec_5.2.3
Table tab_2
Section sec_5.2.4
Section sec_5.2.5
Section sec_5.2.6
Section sec_5.3
Section sec_5.3.1
Section sec_5.3.2
Section sec_5.4
Section sec_5.4.1
Section sec_5.4.2
Section sec_5.5
Section sec_5.5.1
Section sec_5.5.2
Section sec_5.5.3
Section sec_6
Section sec_6.1
Section sec_6.2
Section sec_6.3
Section sec_7
Section sec_7.1
Table tab_3
Table tab_4
Section sec_7.2
Section sec_7.2.1
Section sec_7.2.2
Section sec_7.2.2.1
Section sec_7.2.2.2
Section sec_7.2.3
Section sec_7.2.3.1
Section sec_7.2.3.2
Section sec_7.2.3.3
Section sec_7.2.4
Section sec_7.2.5
Section sec_7.2.5.1
Section sec_7.2.5.2
Section sec_7.2.5.3
Section sec_7.2.6
Section sec_7.2.6.1
Section sec_7.2.6.2
Section sec_7.2.7
Section sec_7.2.7.1
Section sec_7.2.7.2
Table tab_5
Table tab_5___1
Table tab_5___2
Table tab_5___3
Section sec_7.3
Section sec_7.3.1
Section sec_7.3.2
Section sec_7.3.3
Section sec_7.3.3.1
Section sec_7.3.3.2
Section sec_7.3.4
Section sec_7.3.4.1
Section sec_7.3.4.2
Section sec_7.3.5
Section sec_7.3.6
Section sec_7.3.6.1
Section sec_7.3.6.2
Section sec_7.3.6.3
Section sec_7.3.7
Section sec_7.3.7.1
Section sec_7.3.7.2
Section sec_7.3.8
Section sec_7.3.8.1
Section sec_7.3.8.2
Section sec_7.4
Table tab_6
Section sec_8
Section sec_8.1
Section sec_8.2
Section sec_8.2.1
Section sec_8.2.2
Section sec_8.2.2.1
Section sec_8.2.2.2
Section sec_8.2.3
Section sec_8.2.3.1
Section sec_8.2.3.1.1
Section sec_8.2.3.1.2
Section sec_8.2.3.1.3
Section sec_8.2.3.2
Section sec_8.2.3.2.1
Section sec_8.2.3.2.2
Table tab_7
Section sec_8.2.3.2.3
Section sec_8.2.3.3
Section sec_8.2.3.3.1
Section sec_8.2.3.3.2
Section sec_8.2.3.3.3
Section sec_8.2.3.4
Section sec_8.2.4
Section sec_8.2.4.1
Section sec_8.2.4.2
Section sec_8.2.5
Section sec_8.2.6
Section sec_8.2.6.1
Section sec_8.2.6.2
Section sec_8.2.6.3
Section sec_8.3
Section sec_8.3.1
Section sec_8.3.1.1
Section sec_8.3.1.2
Section sec_8.3.2
Section sec_8.3.2.1
Section sec_8.3.2.2
Section sec_8.3.3
Section sec_8.3.3.1
Section sec_8.3.3.1.1
Section sec_8.3.3.1.2
Section sec_8.3.3.1.3
Section sec_8.3.3.2
Section sec_8.3.3.2.1
Section sec_8.3.3.2.2
Table tab_8
Section sec_8.3.3.2.3
Section sec_8.3.3.3
Section sec_8.3.3.3.1
Section sec_8.3.3.3.2
Section sec_8.3.3.3.3
Section sec_8.3.3.4
Section sec_8.3.4
Section sec_8.3.4.1
Section sec_8.3.4.2
Section sec_8.3.5
Section sec_8.3.6
Section sec_8.3.6.1
Section sec_8.3.6.2
Section sec_8.3.6.3
Section sec_9
Section sec_9.1
Section sec_9.2
Section sec_9.2.1
Section sec_9.2.1.1
Section sec_9.2.1.2
Section sec_9.2.1.3
Section sec_9.2.2
Section sec_9.2.3
Section sec_9.2.3.1
Section sec_9.2.3.2
Section sec_9.2.3.3
Section sec_9.2.4
Table tab_9
Table tab_9___1
Section sec_9.2.5
Section sec_9.2.5.1
Section sec_9.2.5.2
Section sec_9.2.5.3
Section sec_9.2.6
Section sec_9.2.6.1
Section sec_9.2.6.2
Section sec_9.2.6.3
Section sec_9.2.7
Section sec_9.2.7.1
Section sec_9.2.7.2
Section sec_9.2.7.3
Section sec_9.2.7.3.1
Section sec_9.2.7.3.2
Section sec_9.2.7.4
Section sec_9.2.7.4.1
Section sec_9.2.7.4.2
Section sec_9.3
Section sec_9.3.1
Section sec_9.3.2
Section sec_9.3.2.1
Section sec_9.3.2.2
Section sec_9.3.2.3
Section sec_9.3.3
Section sec_9.3.4
Section sec_9.3.4.1
Section sec_9.3.4.2
Section sec_9.3.5
Section sec_9.3.6
Section sec_9.3.6.1
Section sec_9.3.6.2
Section sec_9.3.6.3
Section sec_9.3.7
Section sec_9.3.7.1
Section sec_9.3.7.2
Section sec_9.3.7.3
Section sec_9.3.8
Section sec_9.3.8.1
Section sec_9.3.8.2
Section sec_9.3.8.3
Section sec_9.3.8.3.1
Section sec_9.3.8.3.2
Section sec_9.3.8.4
Section sec_9.3.8.4.1
Section sec_9.3.8.4.2
Section sec_9.4
Section sec_9.4.1
Section sec_9.4.1.1
Section sec_9.4.1.2
Section sec_9.4.1.3
Section sec_9.4.2
Section sec_9.4.3
Section sec_9.4.3.1
Section sec_9.4.3.2
Section sec_9.4.3.3
Section sec_9.4.4
Table tab_10
Section sec_9.4.5
Section sec_9.4.5.1
Section sec_9.4.5.2
Section sec_9.4.5.3
Section sec_9.4.6
Section sec_9.4.6.1
Section sec_9.4.6.2
Section sec_9.4.6.3
Section sec_9.4.7
Section sec_9.4.7.1
Section sec_9.4.7.2
Section sec_9.4.7.3
Section sec_9.4.7.3.1
Section sec_9.4.7.3.2
Section sec_9.4.7.4
Section sec_9.4.7.4.1
Section sec_9.4.7.4.2
Section sec_9.5
Section sec_9.5.1
Section sec_9.5.2
Section sec_9.5.2.1
Section sec_9.5.2.2
Section sec_9.5.2.3
Section sec_9.5.3
Section sec_9.5.4
Section sec_9.5.4.1
Section sec_9.5.4.2
Section sec_9.5.5
Section sec_9.5.6
Section sec_9.5.6.1
Section sec_9.5.6.2
Section sec_9.5.6.3
Section sec_9.5.7
Section sec_9.5.7.1
Section sec_9.5.7.2
Section sec_9.5.7.3
Section sec_9.5.8
Section sec_9.5.8.1
Section sec_9.5.8.2
Section sec_9.5.8.3
Section sec_9.5.8.3.1
Section sec_9.5.8.3.2
Section sec_9.5.8.4
Section sec_9.5.8.4.1
Section sec_9.5.8.4.2
Section sec_10
Section sec_10.1
Section sec_10.2
Section sec_10.2.1
Section sec_10.2.1.1
Section sec_10.2.1.2
Section sec_10.2.2
Section sec_10.2.3
Section sec_10.2.4
Section sec_10.2.4.1
Section sec_10.2.4.2
Section sec_10.2.5
Section sec_10.2.5.1
Section sec_10.2.5.2
Section sec_10.2.5.3
Section sec_10.2.6
Section sec_10.2.6.1
Section sec_10.2.6.2
Section sec_10.2.6.3
Section sec_10.2.6.4
Section sec_10.2.6.5
Section sec_10.3
Section sec_10.3.1
Section sec_10.3.1.1
Section sec_10.3.1.2
Section sec_10.3.2
Section sec_10.3.3
Section sec_10.3.3.1
Section sec_10.3.3.2
Section sec_10.3.4
Section sec_10.3.4.1
Section sec_10.3.4.2
Section sec_10.3.5
Section sec_10.3.5.1
Section sec_10.3.5.2
Section sec_10.3.5.3
Section sec_10.3.6
Section sec_10.3.6.1
Section sec_10.3.6.1.1
Section sec_10.3.6.1.2
Section sec_10.3.6.2
Section sec_10.3.6.3
Section sec_10.3.6.3.1
Section sec_10.3.6.3.2
Section sec_10.3.6.4
Section sec_10.3.7
Section sec_10.3.7.1
Table tab_11
Table tab_11___1
Section sec_10.3.7.2
Table tab_12
Section sec_10.4
Section sec_11
Section sec_11.1
Table tab_13
Table tab_14
Table tab_15
Section sec_11.2
Section sec_11.2.1
Section sec_11.2.2
Section sec_11.2.2.1
Section sec_11.2.2.1.1
Section sec_11.2.2.1.2
Table tab_16
Section sec_11.2.2.2
Table tab_17
Table tab_18
Section sec_11.2.2.3
Table tab_19
Section sec_11.2.2.4
Table tab_20
Section sec_11.2.3
Section sec_11.2.3.1
Section sec_11.2.3.1.1
Section sec_11.2.3.1.2
Table tab_21
Section sec_11.2.3.2
Table tab_22
Table tab_23
Section sec_11.2.3.3
Table tab_24
Section sec_11.2.3.4
Table tab_25
Section sec_11.2.4
Section sec_11.2.4.1
Section sec_11.2.4.1.1
Section sec_11.2.4.1.2
Table tab_26
Section sec_11.2.4.2
Table tab_27
Table tab_28
Section sec_11.2.4.3
Table tab_29
Section sec_11.2.4.4
Table tab_30
Section sec_11.3
Table tab_31
Table tab_32
Section sec_11.4
Table tab_33
Section sec_11.5
Table tab_34
Section sec_11.6
Table tab_35
Reference ref_1
Reference ref_2
Reference ref_3
Reference ref_4
Reference ref_5
Reference ref_6
Reference ref_7
Reference ref_8
Reference ref_9
Reference ref_10
Reference ref_11
Reference ref_12
Reference ref_13
Reference ref_14
Reference ref_15
Reference ref_16
Reference ref_17
Reference ref_18
Reference ref_19
Reference ref_20
Reference ref_21
Foreword
Introduction
1 Scope
2 Normative references
3 Terms, definitions, and abbreviated terms
3.1 Terms and definitions
3.2 Abbreviated terms
4 Definition and maintenance of product families for dose setting, dose substantiation, and sterilization dose auditing
4.1 General
4.2 Defining product families
4.3 Designation of product to represent a product family for performance of a verification dose experiment or sterilization dose audit
4.4 Maintaining product families
4.5 Effect of failure of establishment of sterilization dose or of a sterilization dose audit on a product family
5 Selection and testing of product for establishing the sterilization dose
5.1 Nature of product
5.2 Sample item portion (SIP)
5.3 Manner of sampling
5.4 Microbiological testing
5.5 Irradiation
6 Methods of dose establishment
7 Method 1: dose setting using bioburden information
7.1 Rationale
7.2 Procedure for Method 1 for product with an average bioburden greater than or equal to 1,0 for multiple production batches
7.3 Procedure for Method 1 for product with an average bioburden greater than or equal to 1,0 for a single production batch
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
8 Method 2: Dose setting using fraction positive information from incremental dosing to determine an extrapolation factor
8.1 Rationale
8.2 Procedure for Method 2A
8.3 Procedure for Method 2B
9 Method VDmax — Substantiation of 25 kGy or 15 kGy as the sterilization dose
9.1 Rationale
9.2 Procedure for Method VDmax25 for multiple production batches
9.3 Procedure for Method VDmax25 for a single production batch
9.4 Procedure for Method VDmax15 for multiple production batches
9.5 Procedure for Method VDmax15 for a single production batch
10 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
10.3 Procedure for auditing a sterilization dose substantiated using Method VDmax25 or Method VDmax15
10.4 Failure of a sterilization dose audit
11 Worked examples
11.1 Worked examples for Method 1
11.2 Worked examples for Method 2
11.3 Worked examples for Method VDmax
11.4 Worked example of a sterilization dose audit for a dose established using Method 1, the findings from which necessitated augmentation of the sterilization dose
11.5 Worked example of a sterilization dose audit for a dose established using Method 2A, the findings from which necessitated augmentation of the sterilization dose
11.6 Worked example of a sterilization dose audit for a sterilization dose substantiated using Method VDmax25
Bibliography