AAMI ISO 17665-1 : 2006

Glossary of equivalent standards
Committee representation
Background of AAMI Adoption of ISO 17665-1:2006
Foreword
Introduction
1 Scope
   1.1 Inclusions
   1.2 Exclusions
2 Normative references
3 Terms and 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 Sterilizing agent
   5.2 Microbicidal effectiveness
   5.3 Materials effects
   5.4 Environmental consideration
6 Process and equipment characterization
   6.1 Process
        6.1.1 General
        6.1.2 Saturated steam process
        6.1.3 Contained product processes
   6.2 Equipment
7 Product definition
8 Process definition
9 Validation
   9.1 General
   9.2 Installation qualification (IQ)
        9.2.1 Equipment
        9.2.2 Installation
        9.2.3 Function
   9.3 Operational qualification (OQ)
   9.4 Performance qualification (PQ)
   9.5 Review and approval of validation
10 Routine monitoring and control
11 Product release from sterilization
12 Maintaining process effectiveness
   12.1 Demonstration of continued effectiveness
   12.2 Recalibration
   12.3 Maintenance of equipment
   12.4 Requalification
Annex A (informative) - Guidance
Annex B (informative) - Process definition based on
                        inactivation of the microbial
                        population in its natural state
                        (bioburden-based method)
Annex C (informative) - Process definition based on the
                        inactivation of a reference
                        microorganism and a knowledge of
                        bioburden on product items to be
                        sterilized (combined bioburden/biological
                        indicator based method
Annex D (informative) - Conservative process definition
                        based on inactivation of reference
                        microorganisms (overkill method)
Annex E (informative) - Operating cycles
Bibliography

Describes requirements for the development, validation and routine control of a moist heat sterilization process for medical devices.