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  • hm243 replied to the topic Discussion Topic: Brand new biomaterial in the forum Pre-clinical Device Development 8 years, 4 months ago

    Determining the biocompatibility is very important in analyzing a new biomaterial for a medical device. The testing done to verify the biocompatibility has to do with the ISO 10993-1 Test Matrix. After determining they type of device being used, the device is evaluated according to various factors, including cytotoxicity, sensitization, irritation or intracutaneous reactivity, genotoxicity, and implantation, and more. All these aspects are vital in ensuring that the device can be used in clinical trials, and eventually in the market. The two main factors that are mandatory to be tested in all types of medical devices are cytotoxicity and sensitization. The rest of the evaluations are dependent on the type of body contact there is with the medical device being used, surface, external communicating, or implant, and from there the location of the device, and then the duration the device will be used.