ANSI/AAMI/ ISO 11137-2:2013(R2019)

Glossary of equivalent standards
Committee representation
Background of ANSI/AAMI adoption of ISO 11137-2:2013
Foreword
Introduction
1 Scope
2 Normative references
3 Terms, definitions and abbreviated terms
4 Definition and maintenance of product families
   for dose setting, dose substantiation and
   sterilization dose auditing
5 Selection and testing of product for establishing
   the sterilization dose
6 Methods of dose establishment
7 Method 1: dose setting using bioburden information
8 Method 2: Dose setting using fraction positive
   information from incremental dosing to determine
   an extrapolation factor
9 Method VD[max] - Substantiation of 25 kGy or 15 kGy
   as the sterilization dose
10 Sterilization dose audit
11 Worked examples
Bibliography

Describes methods of determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the sterilization dose to achieve a sterility assurance level, SAL, of 10[-6].