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AAMI TIR56:2013/(R)2024 Guidance for the development, validation and routine control of an ethylene oxide sterilization process utilizing flexible bag systems for the sterilization of medical devices >
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AAMI TIR56:2013/(R)2024 Guidance for the development, validation and routine control of an ethylene oxide sterilization process utilizing flexible bag systems for the sterilization of medical devices, 2013
- AAMI TIR56:2013/(R)2024, Guidance for the development, validation and routine control of an ethylene oxide sterilization process utilizing flexible bag systems for the sterilization of medical devices
- Title page
- AAMI Technical Information Report
- Copyright information
- Contents
- Glossary of equivalent standards
- Committee representation
- Foreword
- Introduction
- 1 Scope
- 2 Terms and definitions
- 3 Process descriptions [Go to Page]
- 4 Quality management systems
- 5 Sterilizing agent characterization [Go to Page]
- 6 Process and Equipment Characterization [Go to Page]
- 7 Product definition [Go to Page]
- 8 Process definition
- 9 Validation [Go to Page]
- 10 Routine Monitoring and Control
- 11 Product Release from Sterilization
- 12 Maintaining Process Effectiveness [Go to Page]
- Annex A: Microbial Validation Using an Augmented Overkill Approach
- Annex B: Microbial Validation Using Reduced EO Concentration
- Bibliography
- Blank Page [Go to Page]