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eLibrary > ANSI/AAMI/ISO 13004:2022 Sterilization of health care products—Radiation—Substantiation of selected sterilization dose: Method VDmaxSD >

ANSI/AAMI/ISO 13004:2022 Sterilization of health care products—Radiation—Substantiation of selected sterilization dose: Method VDmaxSD, 2022

ANSI/AAMI/ISO 13004:2022; Sterilization of health care products—Radiation—Substantiation of selected sterilization dose: Method VDmaxSD
Title page
AAMI Standard
Copyright information
Committee representation
Background of ANSI/AAMI adoption of ISO 13004:2022
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 [Go to Page]
Table 1 — Nature of product items for sterilization dose substantiation and for sterilization dose auditing
5.2 Sample item portion (SIP) [Go to Page]
Table 2 — Examples for calculation of SIP
5.3 Manner of sampling
5.4 Microbiological testing
5.5 Irradiation
6 Method VDmaxSD—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 [Go to Page]
Table 3 — Upper limit of average bioburden for selection of a given sterilization dose
6.2.5 Stage 4: Obtain VDmaxSD [Go to Page]
Table 4 — Table in Clause 8 corresponding to the selected sterilization dose
6.2.6 Stage 5: Perform verification dose experiment
6.2.7 Stage 6: Interpretation of results
6.2.8 Confirmatory verification dose experiment [Go to Page]
6.2.8.1 General
6.2.8.2 Stage 1: Obtain samples of product
6.2.8.3 Stage 2: Perform confirmatory verification dose experiment
6.2.8.4 Stage 3: Interpretation of results
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 [Go to Page]
6.3.9.1 General
6.3.9.2 Stage 1: Obtain samples of product
6.3.9.3 Stage 2: Perform confirmatory verification dose experiment
6.3.9.4 Stage 3: Interpretation of results
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 [Go to Page]
7.3.3.1 General
7.3.3.2 Stage 1: Obtain samples of product
7.3.3.3 Stage 2: Determine average bioburden
7.3.3.4 Stage 3: Perform verification dose experiment
7.3.3.5 Stage 4: Interpretation of results
7.3.3.6 Confirmatory sterilization dose audit [Go to Page]
7.3.3.6.1 General
7.3.3.6.2 Stage 1: Obtain samples of product
7.3.3.6.3 Stage 2: Perform confirmatory verification dose experiment
7.3.3.6.4 Stage 3: Interpretation of results
7.3.3.7 Augmentation of a sterilization dose substantiated using Method VDmaxSD
7.3.4 Failure of a sterilization dose audit
8 Tables of values for SIP [Go to Page]
Table 5 — 17,5 kGy selected sterilization dose for which the upper limit of average bioburden is 9,0
Table 6 — 20 kGy selected sterilization dose for which the upper limit of average bioburden is 45
Table 7 — 22,5 kGy selected sterilization dose for which the upper limit of average bioburden is 220
Table 8 — 27,5 kGy selected sterilization dose for which the upper limit of average bioburden is 5 000
Table 9 — 30 kGy selected sterilization dose for which the upper limit of average bioburden is 23 000
Table 10 — 32,5 kGy selected sterilization dose for which the upper limit of average bioburden is 100 000
Table 11 — 35 kGy selected sterilization dose for which the upper limit of average bioburden is 440 000
9 Worked examples [Go to Page]
9.1 Substantiation of a selected sterilization dose of 17,5 kGy (SIP less than 1,0) [Go to Page]
Table 12 — Method VDmax17,5 substantiation (SIP less than 1,0)
9.2 Substantiation of a selected sterilization dose of 30 kGy (SIP equal to 1,0) [Go to Page]
Table 13 — Method VDmax30 substantiation (SIP equal to 1,0)
9.3 Sterilization dose audit for a sterilization dose substantiated using
9.4 Method VDmax22,5 [Go to Page]
Table 14 — Sterilization dose audit following which augmentation of the sterilization dose was required (selected sterilization dose substantiated using Method VDmax22,5)
Bibliography [Go to Page]

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