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ANSI/AAMI/ISO 11737-2:2019 - Sterilization of medical devices-Microbiological methods-Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process >
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ANSI/AAMI/ISO 11737-2:2019 - Sterilization of medical devices-Microbiological methods-Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process, 2019
- ANSI/AAMI/ISO 11737-2:2019; Sterilization of medical devices—Microbiological methods—Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
- Title page
- AAMI Standard
- Copyright information
- Contents
- Committee representation
- Background of ANSI/AAMI adoption of ISO 11737-2:2019
- Foreword
- Introduction
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 4 General
- 5 Selection of product [Go to Page]
- 6 Methods for performing tests of sterility
- 7 Assessment of the method for performing tests of sterility
- 8 Maintenance of the method for performing tests of sterility
- Annex A (informative) Guidance on tests of sterility performed in validation and maintenance of a sterilization process [Go to Page]
- Annex B (informative) Typical assignment of responsibilities [Go to Page]
- Bibliography [Go to Page]
