Glossary of equivalent standards
Committee representation
Background of ANSI/AAMI adoption
of ISO 11737-2:2009
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality management system elements
5 Selection of product
6 Methods for performing tests of sterility
7 Assessment of method for performing tests of sterility
8 Maintenance of the method for performing tests of sterility
Annex A (informative) - Guidance on tests of sterility
performed in validation and maintenance
of a sterilization process
Bibliography