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  • aja38 replied to the topic Discussion Topic: Brand new biomaterial in the forum Pre-clinical Device Development 7 years, 4 months ago

    To test the biocompatibility of a new material device you go through the ISO 10993­1 Test Matrix check list. There are several tests that needs to be preformed on the new material device. For example: cytotoxicity, carcinogenicity, genotoxicity, irritation and more. The new material must go through some of the tests, it will depend on what the new material is going to be used for. Is it going to be for skin, bone replacement, heart valve replacement…? The reason being is that the location in our body requires different stress, elasticity, durability, etc. because it go under different biological environments which the material must withstand. Testing toxicity is required for all material because the device that we are creating are intended to improve and help, not to cause harm or kill.