AAMI BE83 2006 RA 2011
$75.64
ANSI/AAMI BE83:2006/(R)2011 – Biological evaluation of medical devices-Part 18: Chemical characterization of materials
| Published By | Publication Date | Number of Pages |
| AAMI | 2006 | 31 |
Describes a framework for the identification of a material and the identification of a material and the identification and of its chemical constituents.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI BE83:2006, Biological evaluation of medical devices – Part 18: Chemical characterization of materials |
| 2 | Objectives and uses of AAMI standards and recommended practices |
| 3 | Title page |
| 4 | AAMI Standard Copyright Information |
| 5 | Contents |
| 6 | Glossary of equivalent standards |
| 8 | Committee representation |
| 10 | Background of AAMI adoption of ISO 10993-18:2006 and rationa |
| 11 | Major technical deviations from ISO 10993-18:2005 |
| 14 | Foreword |
| 16 | Introduction |
| 17 | 1 Scope 2 Normative references |
| 18 | 3 Terms and definitions |
| 19 | 4 Symbols and abbreviated terms |
| 20 | 5 General principles |
| 21 | 6 Characterization procedure 6.1 General 6.2 Qualitative information |
| 22 | 6.3 Quantitative information 7 Chemical characterization parameters and methods 7.1 General |
| 23 | 7.2 Polymers |
| 24 | 7.3 Metals and alloys 7.4 Ceramics |
| 25 | 7.5 Natural macromolecules |
| 26 | 8 Reporting of data obtained |
| 27 | Annex A Information sources for chemical characterization A.1 General A.2 Generic name of material A.3 Other nomenclatures and chemical descriptions of materials A.3.1 General A.3.2 IUPAC nomenclature and structure formulae of polymeric chemicals A.3.3 CAS Registry number, USAN, and other registry name and/or number |
| 28 | A.4 General information concerning chemical nature of materials A.5 Information from the material supplier A.6 Chemical analyses A.6.1 Non-specific chemical analysis relevant to exposure assessment |
| 29 | A.6.2 Qualitative analysis A.6.3 Quantitative analysis of specific toxic chemicals for exposure assessment A.7 National and international material and/or product standards A.8 Material master file |
| 30 | Bibliography |
