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gsharma replied to the topic Discussion Topic: Brand new biomaterial in the forum Pre-clinical Device Development 6 years, 7 months ago
As mentioned before, biocompatibility testing must be performed in accordance to ISO 10993 and other FDA relevant standards. The type of testing depends on the type of device: surface, external or implant device. The biocompatibility testing will also depend on the type of contact with the device and the biological effects due to the device contact and the contact duration. For a medical device, there could be a number of different test required depending on the category a device falls.