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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

Publisher

National Standards Authority of Ireland

Preview

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.

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.

DocumentType
Standard
Pages
24
PublisherName
National Standards Authority of Ireland
Status
Current
Supersedes

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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Hardcopy - English
PDF - English
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