AAMI TIR10993 19 2020
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AAMI/ISO TIR10993-19:2020 Biological evaluation of medical devices—Part 19: Physico-chemical, morphological and topographical characterization of materials
| Published By | Publication Date | Number of Pages |
| AAMI | 2020 |
This document provides a compilation of parameters and test methods that can be useful for the identification and evaluation of the physical, i.e. physico?chemical, morphological and topographical (PMT) properties of materials in finished medical devices. Such an assessment is limited to those properties that are relevant to biological evaluation and the medical device’s intended use (clinical application and duration of use) even if such properties overlap with clinical effectiveness.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | AAMI/ISO TIR10993-19:2020; Biological evaluation of medical devices—Part 19: Physico-chemical, morphological and topographical characterization of materials |
| 3 | Title page |
| 5 | Copyright information AAMI Technical Information Report |
| 6 | ANSI Registration Contents |
| 7 | Committee representation |
| 9 | Background of AAMI adoption of ISO/TS 10993-19:2020 |
| 10 | Foreword |
| 11 | Introduction |
| 13 | 1 Scope 2 Normative references 3 Terms and definitions |
| 14 | 4 General principles |
| 15 | 5 Characterization procedure 5.1 General 5.2 Qualitative information 5.3 Material equivalence |
| 16 | 5.4 Quantitative Assessment 6 Characterization parameters and methods |
| 17 | Table 1 — Typical properties assessed for PMT characterization of materials including polymers, metals, alloys, ceramics and natural macromolecules Table 2 — Other properties to consider assessing for PMT characterization, depending on material composition 7 Reporting of data obtained |
| 18 | Annex A (informative) Principles for judging material equivalence |
| 19 | Table A.1 — Methodology abbreviations Table A.2 — Typical properties assessed for PMT characterization and potential methods and references |
| 21 | Table A.3 — Other properties to consider assessing for PMT characterization and potential methods and references |
| 23 | Bibliography |
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