UNI EN ISO 11135-1 : 2008

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality management systems
   4.1 Documentation
   4.2 Management responsibility
   4.3 Product realization
   4.4 Measurement, analysis and improvement - Control
        of nonconforming product
5 Sterilizing agent characterization
   5.1 Sterilizing agent
   5.2 Microbicidal effectiveness
   5.3 Material effects
   5.4 Environmental considerations
6 Process and equipment characterization
   6.1 Process characterization
   6.2 Equipment characterization
7 Product definition
   7.1 General
   7.2 Product safety and performance
   7.3 Microbiological quality
   7.4 Documentation
8 Process definition
9 Validation
   9.1 Installation qualification
   9.2 Operational qualification
   9.3 Performance qualification
   9.4 Varying load configurations
   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 (normative) Determination of lethal rate of the
                    sterilization process - Biological
                    indicator/bioburden approach
Annex B (normative) Conservative determination of lethal
                    rate of the sterilization process -
                    Overkill approach
Annex C (informative) General guidance
Annex ZA (informative) Relationship between this European
                       Standard and the Essential
                       Requirements of EU Directive
                       93/42/EEC Medical devices
Bibliography

Describes requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices.