AAMI ISO 10993-14 : 2001
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
Hardcopy , PDF
30-08-2021
English
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
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