• Shopping Cart
    There are no items in your cart

I.S. 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)

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2009

€53.00
Excluding VAT
Summarise this standard

For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.


Dates of withdrawal of national standards are available from NSAI.

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. It also gives guidance on the analysis of these solutions in order to identify the degradation products.

Committee
ISO/TC 194
DocumentType
Standard
Pages
24
PublisherName
National Standards Authority of Ireland
Status
Current
Supersedes

€53.00
Excluding VAT