AAMI TIR10993 19 2006
$80.17
AAMI/ISO TIR10993-19:2006 [HISTORICAL] Biological evaluation of medical devices—Part 19: Physico-chemical, morphological, and topographical characterization of materials
| Published By | Publication Date | Number of Pages |
| AAMI | 2006 | 29 |
Provides a compilation of parameters and test methods that can be useful for the identification and evaluation of the physico-chemical, morphological, and topographical (PMT) properties of materials in finished medical devices.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI/ISO TIR10993-19:2006, Biological evaluation of medical devices – Part 19: Physico-chemical, morphological and topographical characterization of materials |
| 3 | Copyright information |
| 4 | AAMI Technical Information Report ANSI Technical Report |
| 5 | Contents |
| 6 | Glossary of equivalent standards |
| 8 | Committee representation |
| 10 | Background of AAMI adoption of ISO/TS 10993-19:2006 |
| 11 | Foreword |
| 13 | Introduction |
| 14 | 1 Scope 2 Normative references 3 Terms and definitions |
| 15 | 4 Symbols and abbreviated terms |
| 16 | 5 General principles |
| 17 | 6 Characterization procedure 6.1 General 6.2 Qualitative information 6.3 Material equivalence |
| 18 | 6.4 Quantitative information 6.5 Quantitative assessment 7 Characterization parameters and methods |
| 22 | 8 Reporting of data obtained |
| 23 | Annex A Principles for judging material equivalency |
| 24 | Annex B Nanoparticles — Special consideration in judging material equivalency and biological evaluation |
| 25 | Bibliography |
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