AAMI TIR22456 2022
$102.21
AAMI/ISO TIR22456:2022, Sterilization of health care products—Microbiological methods—Guidance on conducting bioburden determinations and tests of sterility for biologics and tissue-based products
| Published By | Publication Date | Number of Pages |
| AAMI | 2022 |
Provides guidance for bioburden testing and tests of sterility for biologics and tissue-based products, where this testing is in relation to product sterilization.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | AAMI/ISO TIR22456:2022; Sterilization of health care products—Microbiological methods—Guidance on conducting bioburden determinations and tests of sterility for biologics and tissue-based products |
| 3 | Title page |
| 4 | Copyright information |
| 5 | AAMI Technical Information Report |
| 6 | Contents Page |
| 7 | Committee representation |
| 11 | Background of AAMI adoption of ISO/TS 22456:2021 |
| 12 | Foreword |
| 13 | Introduction |
| 15 | 1 Scope 1.1 Inclusions 1.2 Exclusions 2 Normative references |
| 16 | 3 Terms and definitions |
| 17 | 4 Definition and maintenance of product families 5 Selection and testing of product for bioburden and tests of sterility 5.1 General |
| 18 | 5.2 Nature of product 5.3 Sample Item Portion (SIP) 5.4 Sampling conditions 5.4.1 General 5.4.2 Considerations for human tissue donor batches in sterilization 5.4.3 Use of multiple batches |
| 19 | 5.4.4 Considerations for packaging 5.5 Microbiological testing 5.5.1 Bioburden test considerations for biologics/tissues 5.5.1.1 General |
| 20 | 5.5.1.2 Extraction fluid 5.5.1.3 Extraction methods 5.5.1.4 Membrane filter selection 5.5.1.5 Filtration considerations 5.5.1.6 Most Probable Number (MPN) |
| 21 | 5.5.1.7 Media for incubation 5.5.1.8 Culture conditions 5.5.1.9 Enumeration and characterization |
| 22 | 5.5.1.10 Interpretation of data 5.5.2 Test of sterility considerations for biologics/tissues 5.5.2.1 General 5.5.2.2 Performance of test of sterility 5.5.2.3 Culture conditions |
| 23 | 5.5.2.4 Membrane filtration of eluate 5.5.2.5 Examination of growth medium 5.5.3 Verification of microbiological methods 5.5.3.1 Method suitability |
| 24 | 5.5.3.2 Bioburden test verification (recovery efficiency test) 5.5.3.3 Method suitability for test of sterility (bacteriostasis/fungistasis test) 5.5.4 Rapid microbiology tests |
| 25 | Bibliography |
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