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EN ISO 10993-14:2009

Current

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)

Published date

29-04-2009

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Summarise this standard

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

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