S.R. CEN ISO TS 11135-2:2008

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality management systems
   4.1 Documentation
   4.2 Management responsibility
   4.3 Product realization
   4.4 Measurement, analysis and improvement - Control
        of non-conforming product
5 Sterilizing agent characterization
   5.1 Sterilizing agent
   5.2 Microbicidal effectiveness
   5.3 Materials effects
   5.4 Environmental considerations
6 Process and equipment characterization
   6.1 Process characterization
   6.2 Equipment characterization
7 Product definition
   7.1 General
   7.2 Product safety and performance
   7.3 Microbiological quality
   7.4 Documentation
8 Process definition
9 Validation
   9.1 Installation qualification
   9.2 Operational qualification
   9.3 Performance qualification
   9.4 Varying load configurations
   9.5 Review and approval of validation
10 Routine monitoring and control
   10.1 General
   10.2 Parametric release
11 Product release from sterilization
12 Maintaining process effectiveness
   12.1 General
   12.2 Maintenance of equipment
   12.3 Requalification
   12.4 Assessment of change
Annex A (informative) Guidance on ISO 11135-1:2007 Annex
                      A Determination of process lethality
                      - Biological indicator/bombardon approach
Annex B (informative) Guidance on ISO 11135-1:2007 Annex B
                      Conservative determination of lethal rate
                      of the sterilization process - Overkill
                      approach
Bibliography

Presents guidance for the requirements in ISO 11135-1:2007. It does not repeat the requirements and is not intended to be used in isolation.