Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality management systems
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 (informative) - Guidance on ISO 11135-1:2007 Annex
A Determination of process lethality - Biological
indicator/bioburden approach
Annex B (informative) - Guidance on ISO 11135-1:2007 Annex
B Conservative determination of lethal rate of the
sterilization process - Overkill approach
Bibliography