UNI 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
02-07-2009
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
Describes two methods of obtaining solutions of degradation products from ceramics (including glasses) for the purposes of quantification. Also provides guidance on the analysis of these solutions in order to identify the degradation products.
| Committee |
CT 44
|
| DocumentType |
Standard
|
| PublisherName |
Ente Nazionale Italiano di Unificazione (UNI)
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| NF EN ISO 10993-14 : 2009 | Identical |
| SN EN ISO 10993-14:2009 | Identical |
| DIN EN ISO 10993-14:2009-08 | Identical |
| I.S. EN ISO 10993-14:2009 | Identical |
| UNE-EN ISO 10993-14:2009 | Identical |
| 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 |
| 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 |
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