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AAMI/ISO TIR21387:2023 - Sterilization of health care products—Guidance on the requirements for the validation and routine processing of ethylene oxide sterilization processes using parametric release >
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AAMI/ISO TIR21387:2023 - Sterilization of health care products—Guidance on the requirements for the validation and routine processing of ethylene oxide sterilization processes using parametric release, 2023
- AAMI/ISO TIR21387:2023; Sterilization of health care products—Guidance on the requirements for the validation and routine processing of ethylene oxide sterilization processes using parametric release
- Title page
- Copyright information
- AAMI Technical Information Report
- Contents
- Committee representation
- Background of AAMI adoption of ISO/TS 21387:2020
- Foreword
- Introduction
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 4 Quality management systems
- 5 Sterilization agent characterization
- 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]
- 13 ISO 11135:2014, Annex A
- 14 ISO 11135:2014, Annex B
- Annex A (informative) Establishing specifications for parametric release based on routine processing data [Go to Page]
- Bibliography [Go to Page]
