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 |
| I.S. EN ISO 7198:2017 | CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR PROSTHESES - TUBULAR VASCULAR GRAFTS AND VASCULAR PATCHES (ISO 7198:2016) |
| BS EN ISO 25539-1:2017 | Cardiovascular implants. Endovascular devices Endovascular prostheses |
| I.S. EN ISO 25539-1:2017 | CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017) |
| EN ISO 7198:2017 | Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches (ISO 7198:2016) |
| BS EN ISO 7198:2017 | Cardiovascular implants and extracorporeal systems. Vascular prostheses. Tubular vascular grafts and vascular patches |
| UNE-EN ISO 7198:2017 | Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches (ISO 7198:2016) |
| ISO 5017:2013 | Dense shaped refractory products — Determination of bulk density, apparent porosity and true porosity |
| ISO 10993-16:2017 | Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables |
| ISO 3310-1:2016 | Test sieves — Technical requirements and testing — Part 1: Test sieves of metal wire cloth |
| ISO 6872:2015 | Dentistry — Ceramic materials |
| ISO 10993-12:2012 | Biological evaluation of medical devices — Part 12: Sample preparation and reference materials |
| ISO 9693:1999 | Metal-ceramic dental restorative systems |
| ISO 10993-17:2002 | Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances |
| ISO 10993-1:2009 | Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process |
| ISO 6474:1994 | Implants for surgery — Ceramic materials based on high purity alumina |
| ISO 10993-9:2009 | Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products |
| ISO 3696:1987 | Water for analytical laboratory use — Specification and test methods |
| ASTM C 92 : 1995 | TEST METHODS FOR SIEVE ANALYSIS AND WATER CONTENT OF REFRACTORY MATERIALS |