DIN EN ISO 10993-14 E : 2009
Current
The latest, up-to-date edition.
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 14: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM CERAMICS
Hardcopy , PDF
English
01-01-2009
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
Annex ZB (informative) Relationship between this European
Standard and the Essential Requirements of EU Directive
90/385/EEC on Active Implantable Medical Devices
National Annex NA (informative) Bibliography
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