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