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hruship101 replied to the topic Discussion Topic: Brand new biomaterial in the forum Pre-clinical Device Development 7 years, 6 months ago
There are multiple biocompatibility tests that needs to be carried out on the product prior to clinical trials. These tests must comply with the ISO 10993-1, Biological evaluation of medical devices. As per the ISO 10993 standard, biocompatibility tests include cytotoxicity, sensitization, hemocompatibility, pyrogenicity, genotoxicity, and implantation. These tests will help determine if the device possess any foreign object or micro-organisms that can potentially harm the patient if implanted. A biomaterial or medical implant that is a sterile device and in contact with lymphatic system requires the pyrogenicity test. On the other hand, for biomaterial or medical devices having direct contact with circulating blood requires the hemocompatibility test. All in all, there are multiple tests for various applications that is required prior to clinical trials and all the test must comply to ISO 10993-1 and the applicable ASTM standard.