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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Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 14: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM CERAMICS
Available format(s)

Hardcopy , PDF

Superseded date

08-30-2021

Language(s)

English

Published date

01-01-2011

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

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 10993-1:2009 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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