SN EN 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 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
Annex ZA (informative) Relationship between this European
         Standard and the Essential Requirements of EU
         Directive 90/385/EEC, 93/42/EEC and 98/79/EEC
Bibliography

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