CEN ISO/TS 13004:2014

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

ISO/TS 13004:2013 describes 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. ISO/TS 13004:2013 also specifies a method of sterilization dose audit used to demonstrate the continued effectiveness of the substantiated sterilization dose.