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eLibrary > 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 >

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, 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]
5.1 General
5.2 Sample item portion (SIP)
5.3 Packaging of product and sample item portions
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]
A.1 Scope
A.2 Guidance on normative references
A.3 Guidance on terms and definitions
A.4 General
A.5 Selection of product [Go to Page]
A.5.1 General
A.5.2 Guidance on sample item portion (SIP) [Go to Page]
Table A.1 — Examples for selection of SIP
A.5.3 Packaging of product and sample item portions
A.6 Methods for performing tests of sterility
A.7 Assessment of method for performing tests of sterility
A.8 Maintenance of the method for performing tests of sterility
Annex B (informative) Typical assignment of responsibilities [Go to Page]
Table B.1 — Typical assignment of responsibilities
Bibliography [Go to Page]

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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

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