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BS ISO 13004:2022 Sterilization of health care products — Radiation — Substantiation of selected sterilization dose: Method VDmaxSD, 2022
- National foreword
- 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 [Go to Page]
- 4.1 General
- 4.2 Defining product families
- 4.3 Designation of product to represent a product family [Go to Page]
- 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 [Go to Page]
- 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 [Go to Page]
- 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 [Go to Page]
- 6.1 Rationale
- 6.2 Procedure for Method VDmaxSD for multiple production batches [Go to Page]
- 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 [Go to Page]
- 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 [Go to Page]
- 7.1 General
- 7.2 Frequency of determination of bioburden
- 7.3 Sterilization dose audit [Go to Page]
- 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 [Go to Page]
- 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 [Go to Page]
