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) 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
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 (informative) Relationship between this European Standard
         and the Essential Requirements of EU Directive 90/385/EEC
         on Active Implantable Medical Devices
Annex ZB (informative) Relationship between this European Standard
         and the Essential Requirements of EU Directive 93/42/EEC
         on Medical Devices
Annex ZC (informative) Relationship between this European Standard
         and the Essential Requirements of EU Directive 98/79/EC
         on in vitro diagnostic medical devices
Bibliography