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BS ISO 13004:2022

BS ISO 13004:2022

$198.66

Sterilization of health care products. Radiation. Substantiation of selected sterilization dose: Method VDmaxSD

Published By Publication Date Number of Pages
BSI 2022 64
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PDF Catalog

PDF Pages PDF Title
2 National foreword
7 Foreword
8 Introduction
9 1 Scope
2 Normative references
3 Terms and definitions
13 4 Definition and maintenance of product families for sterilization dose substantiation and sterilization dose auditing
4.1 General
4.2 Defining product families
14 4.3 Designation of product to represent a product family
4.3.1 Product to represent a product family
15 4.3.2 Master product
4.3.3 Equivalent product
4.3.4 Simulated product
4.4 Maintaining product families
4.4.1 Periodic review
16 4.4.2 Modification to either product or manufacturing process, or both
4.4.3 Records
4.5 Consequence of failure of sterilization dose substantiation or sterilization dose audit
5 Selection and testing of product for substantiating and auditing a selected sterilization dose
5.1 Nature of product
17 5.2 Sample item portion (SIP)
18 5.3 Manner of sampling
19 5.4 Microbiological testing
5.5 Irradiation
6 Method  — Substantiation of a selected sterilization dose of 17,5 kGy, 20 kGy, 22,5 kGy, 27,5 kGy, 30 kGy, 32,5 kGy or 35 kGy
6.1 Rationale
20 6.2 Procedure for Method VDmaxSD for multiple production batches
6.2.1 General
6.2.2 Stage 1: Obtain samples of product
6.2.3 Stage 2: Determine average bioburden
21 6.2.4 Stage 3: Obtain the selected sterilization dose
22 6.2.5 Stage 4: Obtain 
6.2.6 Stage 5: Perform verification dose experiment
23 6.2.7 Stage 6: Interpretation of results
24 6.2.8 Confirmatory verification dose experiment
25 6.3 Procedure for Method VDmaxSD for a single production batch
6.3.1 Rationale
6.3.2 General
6.3.3 Stage 1: Obtain samples of product
6.3.4 Stage 2: Determine average bioburden
26 6.3.5 Stage 3: Obtain the selected sterilization dose
6.3.6 Stage 4: Obtain VDmaxSD
27 6.3.7 Stage 5: Perform verification dose experiment
6.3.8 Stage 6: Interpretation of results
28 6.3.9 Confirmatory verification dose experiment
29 7 Maintaining process effectiveness
7.1 General
7.2 Frequency of determination of bioburden
7.3 Sterilization dose audit
7.3.1 Frequency
7.3.2 Outcome
30 7.3.3 Procedure for auditing a sterilization dose substantiated using Method VDmaxSD
33 7.3.4 Failure of a sterilization dose audit
34 8 Tables of values for SIP
58 9 Worked examples
9.1 Substantiation of a selected sterilization dose of 17,5 kGy (SIP less than 1,0)
59 9.2 Substantiation of a selected sterilization dose of 30 kGy (SIP equal to 1,0)
60 9.3 Sterilization dose audit for a sterilization dose substantiated using
9.4 Method VDmax22,5
62 Bibliography

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BS ISO 13004:2022
$198.66