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Investigations of chemical characterization according to DIN EN ISO 10993-18 can be used for a range of important applications:
– assessment of the overall biological safety of a medical device
– measurement of the level of a leachable substances in a medical device
– judging equivalence of a final device to a prototype device
– screening of potential new materials for suitability in a medical device for a proposed clinical application
The following methods are available:
- physicochemical tests – polymers
- extractable organic substances in polymers
- quantitative determination of extractable metallic ions
- corrosion test
- mechanical tests
- morphological characterization
- thermal analyses |
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