AAMI TIR33 : 2005

Glossary of equivalent standards
Committee representation
Introduction
1 Scope
  1.1 Inclusions
  1.2 Exclusions
2 Normative references
3 Terms and definitions
4 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 Designating of product to represent a product family
      for performance of a verification dose experiment or
      sterilization dose audit
      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 product and manufacturing process
      4.4.3 Records
  4.5 Effect of failure of establishment of sterilization
      dose or of a sterilization dose audit on a product
      family
5 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 Irradiation
6 Method VD[max] - Substantiation of a selected sterilization
  dose
  6.1 Rationale
  6.2 Procedure for Method VD[max] 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: Select sterilization dose
      6.2.5 Stage 4: Obtain VD[max][SD]
      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 VD[max] 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: Selection of a sterilization dose
      6.3.6 Stage 4: Obtain VD[max][SD]
      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 Auditing sterilization dose
  7.1 Purpose and frequency
  7.2 Procedure for auditing a sterilization dose
      substantiated using Method VD[max]
      7.2.1 General
      7.2.2 Stage 1: Obtain samples of product
      7.2.3 Stage 2: Determine average bioburden
      7.2.4 Stage 3: Perform verification dose experiment
      7.2.5 Stage 4: Interpretation of results
      7.2.6 Confirmatory sterilization dose audit
8 Augmentation of a sterilization dose substantiated
  using Method VD[max]
9 Worked examples
  9.1 Substantiation of a selected Dose: SIP < 1.0 and
      SIP = 1.0
  9.2 Dose auditing and augmentation: Worked example
      of a sterilization dose audit for a sterilization dose
      substantiated using Method VD[max][25]
Annex A - VD[max][SD] look-up tables for verification doses,
          SIP dose reduction factors, and dose augmentation
          values
Bibliography

Specifies a method of substantiating a selected dose for a sterility assurance level (SAL) of 10[-6] for radiation sterilization of health care products.