BS PD 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

Explains 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.