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AAMI ISO 10993-14 : 2001

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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

Available format(s)

PDF

Language(s)

English

Published date

01-01-2011

Superseded date

30-08-2021

Summarise this standard

Glossary of equivalent standards
Committee representation
Background of AAMI adoption of ISO 10993-14:2001
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Test procedures
  4.1 Principle
  4.2 Testing of dental devices
      4.2.1 General
      4.2.2 Test methods for dental devices exposed to the
            oral cavity
      4.2.3 Specimen characterization
      4.2.4 Analysis
  4.3 General testing techniques
      4.3.1 Mass determination
      4.3.2 Drying techniques
  4.4 Extreme solution test
      4.4.1 Principle
      4.4.2 Application range
      4.4.3 Extreme test sample preparation
            4.4.3.1 Specimen configuration
            4.4.3.2 Granulation
            4.4.3.3 Sizing
            4.4.3.4 Specimen preparation
      4.4.4 Extreme test sample characterization
            4.4.4.1 Surface area characterization
            4.4.4.2 Density
            4.4.4.3 Solubility characterization
            4.4.4.4 Microstructural and X-ray characterization
      4.4.5 Test equipment
            4.4.5.1 Test container
            4.4.5.2 Büchner funnel
      4.4.6 Citric acid buffer solution
      4.4.7 Test procedure
  4.5 Simulation solution test
      4.5.1 Principle
      4.5.2 Application range
      4.5.3 Simulation test specimen configuration
            4.5.3.1 Coated ceramics
            4.5.3.2 All other ceramics
      4.5.4 Simulation test sample characterization
            4.5.4.1 General
            4.5.4.2 Density
            4.5.4.3 Microstructural and X-ray characterization
            4.5.4.4 Surface area characterization
      4.5.5 Test equipment
            4.5.5.1 Test container
            4.5.5.2 Büchner funnel
      4.5.6 Buffer solution
      4.5.7 Coated disk test procedure
            4.5.7.1 General
            4.5.7.2 Blank disk test
            4.5.7.3 Coated disk test
      4.5.8 Test procedure (all other ceramics)
5 Analysis of filtrate
  5.1 General
  5.2 Choice of chemicals or elements to be analyzed
  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 purposes of quantification.

Committee
WG 02
DocumentType
Standard
Pages
21
ProductNote
Reconfirmed 2001
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Superseded
SupersededBy

Standards Relationship
ISO 10993-14:2001 Identical

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A newer version of this standard is available.

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