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