BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 14: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM CERAMICS

Available format(s)

Hardcopy

Published date

01-08-2009

Publisher

Swiss Standards

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

Describes two methods of obtaining solutions of degradation products from ceramics (including glasses) for the purpose of qualification. It also provides guidance on the analyses of these solutions in order to identify the degradation products.

Committee	INB/NK 129
DevelopmentNote	Supersedes SN 119800. (06/2006)
DocumentType	Standard
Pages	0
PublisherName	Swiss Standards
Status	Current
Supersedes	SN 119800 : 1990

Standards	Relationship
DIN EN ISO 10993-14:2009-08	Identical
NS EN ISO 10993-14 : 2009	Identical
I.S. 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
UNE-EN ISO 10993-14:2009	Identical
EN ISO 10993-14:2009	Identical
UNI EN ISO 10993-14 : 2009	Identical
NF EN ISO 10993-14 : 2009	Identical
ISO 10993-14:2001	Identical
DIN EN ISO 10993-14 E : 2009	Identical