ANSI/AAMI/ISO TIR13004:2013(R2016)

Glossary of equivalent standards
Committee representation
Background of AAMI adoption of ISO TS 13004:2013
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
5 Selection and testing of product for substantiating
  and auditing a selected sterilization dose
6 Method VD[max][SD] - Substantiation of a selected
  sterilization dose of 17.5, 20, 22.5, 27.5, 30, 32.5,
  or 35 kGy
7 Maintaining process effectiveness
8 Tables of values for SIP equal to 1.0 VD[max][SD], SIP
  dose reduction factor and augmentation dose
  corresponding to applicable values of average bioburden
  for selected sterilization doses of 17.5, 20, 22.5, 27.5,
  30, 32.5 and 35 kGy
9 Worked examples
Bibliography

Specifies a method for substantiating a selected sterilization dose of 17.5, 20, 22.5, 27.5, 30, 32.5 or 35 kGy that achieves a sterility assurance level (SAL) of 10[-6] or less for radiation sterilization of health care products.