ISO 13004:2022
Sterilization of health care products — Radiation — Substantiation of selected sterilization dose: Method VDmaxSD
This document describes a method for substantiating a selected sterilization dose of 17,5 kGy, 20 kGy, 22,5 kGy, 27,5 kGy, 30 kGy, 32,5 kGy or 35 kGy that achieves a sterility assurance level (SAL) of 10−6 or less for radiation sterilization of health care products. This document also specifies a method of sterilization dose audit used to demonstrate the continued effectiveness of the substantiated sterilization dose.
NOTE 1 Selection and substantiation of the sterilization dose is used to meet the requirements for establishing the sterilization dose within process definition in ISO 11137‑1.
This document does not apply to other sterilization doses than the 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. The method is not used for the substantiation of a selected sterilization dose if the average bioburden of the entire product item exceeds the limit specified for the selected sterilization dose (see Table 3).
NOTE 2 The methods for substantiation of selected sterilization doses of 25 kGy and 15 kGy are not included in this document. They are described in ISO 11137‑2.
If the decision is made to use this method of sterilization dose establishment, the method is intended to be followed in accordance with the requirements (shall) and guidance (should) stipulated herein.
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Definition and maintenance of product families for sterilization dose substantiation and sterilization dose auditing
4.1 General
4.2 Defining product families
4.3 Designation of product to represent a product family
4.3.1 Product to represent a product family
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
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
5.2 Sample item portion (SIP)
5.3 Manner of sampling
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
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
6.2.4 Stage 3: Obtain the selected sterilization dose
6.2.5 Stage 4: Obtain 
6.2.6 Stage 5: Perform verification dose experiment
6.2.7 Stage 6: Interpretation of results
6.2.8 Confirmatory verification dose experiment
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
6.3.5 Stage 3: Obtain the selected sterilization dose
6.3.6 Stage 4: Obtain VDmaxSD
6.3.7 Stage 5: Perform verification dose experiment
6.3.8 Stage 6: Interpretation of results
6.3.9 Confirmatory verification dose experiment
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
7.3.3 Procedure for auditing a sterilization dose substantiated using Method VDmaxSD
7.3.4 Failure of a sterilization dose audit
8 Tables of values for SIP
9 Worked examples
9.1 Substantiation of a selected sterilization dose of 17,5 kGy (SIP less than 1,0)
9.2 Substantiation of a selected sterilization dose of 30 kGy (SIP equal to 1,0)
9.3 Sterilization dose audit for a sterilization dose substantiated using
9.4 Method VDmax22,5
Bibliography
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AS/NZS ISO 11137.1:2006
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Definition and maintenance of product families for sterilization dose substantiation and sterilization dose auditing
4.1 General
4.2 Defining product families
4.3 Designation of product to represent a product family
4.3.1 Product to represent a product family
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
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
5.2 Sample item portion (SIP)
5.3 Manner of sampling
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
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
6.2.4 Stage 3: Obtain the selected sterilization dose
6.2.5 Stage 4: Obtain 
6.2.6 Stage 5: Perform verification dose experiment
6.2.7 Stage 6: Interpretation of results
6.2.8 Confirmatory verification dose experiment
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
6.3.5 Stage 3: Obtain the selected sterilization dose
6.3.6 Stage 4: Obtain VDmaxSD
6.3.7 Stage 5: Perform verification dose experiment
6.3.8 Stage 6: Interpretation of results
6.3.9 Confirmatory verification dose experiment
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
7.3.3 Procedure for auditing a sterilization dose substantiated using Method VDmaxSD
7.3.4 Failure of a sterilization dose audit
8 Tables of values for SIP
9 Worked examples
9.1 Substantiation of a selected sterilization dose of 17,5 kGy (SIP less than 1,0)
9.2 Substantiation of a selected sterilization dose of 30 kGy (SIP equal to 1,0)
9.3 Sterilization dose audit for a sterilization dose substantiated using
9.4 Method VDmax22,5
Bibliography