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akshayakirithy replied to the topic Discussion Topic: Brand new biomaterial in the forum Pre-clinical Device Development 7 years, 10 months ago
Biomaterials should be tested for biocompatibility in regards to ISO 10993 before any clinical trials. Biomaterials are classified into different categories based on their usage like surface biomaterials, implants etc. ISO 10993 has set standard tests for these Biomaterials according to their category. These tests shoe that how safe the biomaterial is for the surrounding body tissues. Biomaterials should not interact with the internal body tissues in case of implants and also in case of surface biomaterials they should not interact with external environment along with internal body tissues. Tests like genotoxicity, carcinogenicity, sensitization, cytoxicity, hemocompatility etc ensure the biomaterials biocompatibility.