ISO 17665-1 : 2006(R2016)

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 processes
        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
   12.5 Assessment of change
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

This part of ISO 17665 specifies requirements for the development, validation and routine control of a moist heat sterilization process for medical devices.