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

    Before biomaterials can be used for testing during clinical trials, the product must undergo specific testing verification such as using the toxicity table to ensure that the product checks off requirements based on the designated application. The toxicity table helps one know how toxic the product is based on biological effects such as cytotoxicity, genotoxicity, sensitization, irritation, systemic toxicity, hemocompatibility, carcinogenicity, and biodegradation, etc. These devices are broken into three tiers, surface devices, external communication devices, and implant devices. All three of these devices must undergo the checklist to ensure it does not pose a harm to it’s patients. This toxicity table was put into place to have companies follow strict protocols to ensure the safety of the general public. In fact, implant devices is more sensitive compared to surface device but this should not be overlooked so easily, in fact surface devices can be dangerous because of irritation, allergic reaction and body rejection.