AS/NZS ISO 11137.2:2006

1 Scope2 Normative references3 Abbreviations, terms and definitions 3.1 Abbreviations 3.2 Terms4 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 family5 Selection and testing of product for establishing and verifying 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 Irradiation6 Methods of dose establishment7 Method 1: dose setting using bioburden information 7.1 Rationale 7.2 Procedure for Method 1 for product with an average bioburden >= 1,0 for multiple production batches 7.3 Procedure for Method 1 for product with an average bioburden >= 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 batches8 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 2B9 Method VD[max] - Substantiation of 25 kGy or 15 kGy as the sterilization dose 9.1 Rationale 9.2 Procedure for Method VD[max][25] for multiple production batches 9.3 Procedure for Method VD[max][25] for a single production batch 9.4 Procedure for Method VD[max][15] for multiple production batches 9.5 Procedure for Method VD[max][15] for a single production batch10 Auditing sterilization dose 10.1 Purpose and frequency 10.2 Procedure for auditing a sterilization dose established using Method 1 or Method 2 10.3 Procedure for auditing a sterilization dose substantiated using VD[max]11 Worked examples 11.1 Worked examples for Method 1 11.2 Worked examples for Method 2 11.3 Worked examples for Method VD[max] 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 VD[max][25]Bibliography