AAMI 11737 2 2019
$93.55
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
| Published By | Publication Date | Number of Pages |
| AAMI | 2019 | 29 |
Specifies the general criteria for tests of sterility on medical devices that have been exposed to a treatment with the sterilizing agent that is a fraction of the specified sterilization process. These tests are intended to be performed when defining, validating or maintaining a sterilization process.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | 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 |
| 3 | Title page |
| 4 | AAMI Standard Copyright information |
| 5 | Contents |
| 6 | Committee representation |
| 9 | Background of ANSI/AAMI adoption of ISO 11737-2:2019 |
| 10 | Foreword |
| 12 | Introduction |
| 13 | 1 Scope 2 Normative references 3 Terms and definitions |
| 16 | 4 General 5 Selection of product 5.1 General |
| 17 | 5.2 Sample item portion (SIP) 5.3 Packaging of product and sample item portions |
| 18 | 6 Methods for performing tests of sterility |
| 19 | 7 Assessment of the method for performing tests of sterility 8 Maintenance of the method for performing tests of sterility |
| 20 | Annex A (informative) Guidance on tests of sterility performed in validation and maintenance of a sterilization process A.1 Scope A.2 Guidance on normative references A.3 Guidance on terms and definitions A.4 General A.5 Selection of product A.5.1 General |
| 21 | A.5.2 Guidance on sample item portion (SIP) Table A.1 — Examples for selection of SIP |
| 22 | A.5.3 Packaging of product and sample item portions A.6 Methods for performing tests of sterility |
| 25 | A.7 Assessment of method for performing tests of sterility |
| 26 | A.8 Maintenance of the method for performing tests of sterility |
| 27 | Annex B (informative) Typical assignment of responsibilities Table B.1 — Typical assignment of responsibilities |
| 28 | Bibliography |
