AAMI 10993 14 2001 RA 2011
$65.83
ANSI/AAMI/ISO 10993-14:2001/(R)2011 – Biological evaluation of medical devices-Part 14: Identification and quantification of degradation products from ceramics
| Published By | Publication Date | Number of Pages |
| AAMI | 2001 | 21 |
Specifies two methods for obtaining solutions of degradation products from ceramics (including glasses) for the purposes of quantification.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI/ISO 10993-14:2001/(R)2011, Identification and quantification of degradation products from ceramics |
| 2 | Objectives and Uses of AAMI Standards and Recommended Practices |
| 3 | Title Page |
| 4 | Copyright Page |
| 5 | Contents |
| 7 | Glossary of equivalent standards |
| 9 | Committee representation |
| 10 | Background of AAMI adoption of ISO 10993-14:2001 |
| 11 | Foreword |
| 12 | Introduction |
| 13 | 1 Scope 2 Normative references 3 Terms and definitions |
| 14 | 4 Test procedures 4.1 Principle 4.2 Testing of dental devices 4.2.1 General |
| 15 | 4.2.2 Test methods for dental devices exposed to the oral cavity 4.2.3 Specimen characterization 4.2.4 Analysis 4.3 General testing techniques 4.3.1 Mass determination 4.3.2 Drying techniques 4.4 Extreme solution test 4.4.1 Principle 4.4.2 Application range 4.4.3 Extreme test sample preparation 4.4.3.1 Specimen configuration 4.4.3.2 Granulation 4.4.3.3 Sizing |
| 16 | 4.4.3.4 Specimen preparation 4.4.4 Extreme test sample characterization 4.4.4.1 Surface area characterization 4.4.4.2 Density 4.4.4.3 Solubility characterization 4.4.4.4 Microstructural and X-ray characterization 4.4.5 Test equipment 4.4.5.1 Test container 4.4.5.2 Büchner funnel 4.4.6 Citric acid buffer solution 4.4.7 Test procedure |
| 17 | 4.5 Simulation solution test 4.5.1 Principle 4.5.2 Application range 4.5.3 Simulation test specimen configuration 4.5.3.1 Coated ceramics 4.5.3.1.1 Blank disks 4.5.3.1.2 Coated disks 4.5.3.2 All other ceramics 4.5.4 Simulation test sample characterization 4.5.4.1 General |
| 18 | 4.5.4.2 Density 4.5.4.3 Microstructural and X-ray characterization 4.5.4.4 Surface area characterization 4.5.5 Test equipment 4.5.5.1 Test container 4.5.5.2 Büchner funnel 4.5.6 Buffer solution 4.5.7 Coated disk test procedure 4.5.7.1 General 4.5.7.2 Blank disk test 4.5.7.3 Coated disk test |
| 19 | 4.5.8 Test procedure (all other ceramics) 5 Analysis of filtrate 5.1 General 5.2 Choice of chemicals or elements to be analyzed 5.3 Sensitivity of the analysis method |
| 20 | 6 Test report |
| 21 | Bibliography |
