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Bhargav replied to the topic Discussion Topic: Brand new biomaterial in the forum Pre-clinical Device Development 7 years, 9 months ago
The tests to assess the biocompability of the material should follow ISO 10993. The following tests should be done on the biomaterial for verification and validation of the product: Evaluation and testing within a risk management process, tests for genotoxicity, carcinogenicity and reproductive toxicity, tests for in vitro cytotoxicity, tests for irritation and skin sensitization.
Different applications will require different types of testing. The test will depend on the material used and the process that was performed to manufacture the final product.