Foreword
Introduction
1 Scope
2 Normative references
3 Definitions
4 Quality management system elements
   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 General
   5.2 Sterilizing agent
   5.3 Microbicidal effectiveness
   5.4 Effects on materials
   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
        9.2.1 Equipment
        9.2.2 Installation
   9.3 Operational qualification
   9.4 Performance qualification
        9.4.1 General
        9.4.2 Microbiological performance qualification
        9.4.3 Physical performance qualification
        9.4.4 Aseptic processing 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 (informative) - Guidance on the application of this
        International Standard
   A.1 Scope
   A.2 Normative references
   A.3 Definitions
   A.4 Quality management system elements
        A.4.1 Documentation
        A.4.2 Management responsibility
        A.4.3 Product realization
        A.4.4 Measurement, analysis and improvement - Control
              of non-conforming product
   A.5 Sterilizing agent characterization
   A.6 Process and equipment characterization
   A.7 Product definition
   A.8 Process definition
   A.9 Validation
   A.10 Routine monitoring and control
   A.11 Product release from sterilization
   A.12 Maintaining process effectiveness
Annex B (normative) - Determination of lethal rate of
        the sterilization process (Combined Reference
        Organism/bioburden approach)
   B.1 General
   B.2 Procedure
   B.3 Process lethality determination
        B.3.1 Direct enumeration (Survivor Curve)
        B.3.2 Fraction-negative method using Holcomb-Spearman
              Karber procedure (HSKP)
        B.3.3 Fraction-negative method using Stumbo Murphy
              Cochran procedure (SMCP)
Annex C (normative) - Conservative determination of lethal
        rate of the sterilization process (Halfcycle approach)
   C.1 General
   C.2 Procedure
Annex D (informative) - Flowahart for process definition
        (Clause 8) and Microbiological Performance Qualification
        (9.4.2)
Annex ZA (informative) - Clauses of this International
         Standard addressing essential requirements
         or other provisions of EU Directives
Bibliography