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