Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality management system elements
5 Sterilizing agent characterization
6 Process and equipment characterization
7 Product definition
8 Process definition
9 Validation
10 Routine monitoring and control
11 Product release from sterilization
12 Maintaining process effectiveness
Annex A (normative) Process definition based on inactivation of reference microorganisms and knowledge of bioburden on product items to be sterilized
Annex B (normative) Process definition based on inactivation of reference microorganisms
Annex C (informative) Guidance on application of this document
Annex D (informative) Environmental aspects regarding development, validation and routine control of low temperature steam and formaldehyde processes
Bibliography