PREN ISO 11135 : DRAFT 2011

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality management systems
5 Sterilizing agent characterization
6 Process and equipment characterization
7 Product definition
8 Process definition
9 Validation
10 Routine monitoring and control
11 Product Release from sterilization
12 Maintaining process effectiveness
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) - Temperature sensors, RH
        sensors and biological indicator numbers
Annex D (informative) - Guidance on the application
        of the normative requirements
Annex E (normative) - Release of clinical trial or
        research and development product
Bibliography

Gives requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices in both the industrial and health care facility settings, and it acknowledges the similarities and differences between the two applications.