EN ISO 10993-14:2009
Current
The latest, up-to-date edition.
Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001)
29-04-2009
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Test procedures
4.1 Principle
4.2 Testing of dental devices
4.3 General testing techniques
4.4 Extreme solution test
4.5 Simulation solution test
5 Analysis of filtrate
5.1 General
5.2 Choice of chemicals or elements to be analysed
5.3 Sensitivity of the analysis method
6 Test report
Bibliography
Annex ZA (informative) - Relationship between this European
Standard and the Essential Requirements of
EU Directive 93/42/EEC on Medical Devices
Defines two methods of obtaining solutions of degradation products from ceramics (including glasses) for the purposes of quantification.
| Committee |
CEN/TC 206
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Current
|
| Standards | Relationship |
| NF EN ISO 10993-14 : 2009 | Identical |
| DIN EN ISO 10993-14:2009-08 | Identical |
| I.S. EN ISO 10993-14:2009 | Identical |
| NS EN ISO 10993-14 : 2009 | Identical |
| NBN EN ISO 10993-14 : 2009 | Identical |
| BS EN ISO 10993-14:2009 | Identical |
| NEN EN ISO 10993-14 : 2009 | Identical |
| ISO 10993-14:2001 | Identical |
| UNE-EN ISO 10993-14:2009 | Identical |