Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality system elements
   4.1 General
   4.2 Assignment of responsibilities
   4.3 Documentation and records
   4.4 Design control
   4.5 Calibration
5 Sterilizing agent characterization
   5.1 General
   5.2 Sterilizing agent
   5.3 Microbicidal effectiveness
   5.4 Material effects
   5.5 Safety and the environment
6 Process and equipment characterization
   6.1 General
   6.2 Process characterization
   6.3 Equipment characterization
7 Product definition
8 Process definition
9 Validation
   9.1 General
   9.2 Installation qualification
   9.3 Operational qualification
   9.4 Performance qualification
   9.5 Review and approval of validation
10 Routine monitoring and control
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 (normative) Factors to be considered in
         selection of microorganisms for demonstrating
         microbicidal effectiveness
Annex B (normative) Approach 1 - Process definition
         based on inactivation of the microbial
         population in its natural state
Annex C (normative) Approach 2 - Process definition
         based on inactivation of reference
         microorganisms and knowledge of bioburden on
         product items to be sterilized
Annex D (normative) Approach 3 - Conservative process
         definition based on inactivation of reference
         microorganisms
Annex E (informative) Guidance on application of this
         International Standard
Annex ZA Deleted
Bibliography