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