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

This document describes methods that can be used to determine the minimum dose necessary to achieve the specified requirement for sterility, including methods to substantiate 25 kGy as the sterilization dose.