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  • merzkrashed replied to the topic Discussion Topic: Brand new biomaterial in the forum Pre-clinical Device Development 8 years, 9 months ago

    When we test the biocompatibility of material especially for medical devices,there are some categories depending on final usages.As mentioned above, cytotoxicity, skin irritation, sensitization, systemic toxicity, and so on.ISO 10993 describes the biocompatibility test for medical devices.However, when you chek the biocompatibility of medical devices, I recommend to start with cytotoxicity. Most of cases, if the cytotoxicity is low, it is more probable to pass the rest of categories. Biocompatibility testing must done to meet current FDA and international standards. Biocompatibility testing requirements comes into effect if a product is scheduled for Pre-Market Approval (PMA) or 510k submissions. Biocompatiblity testing determines the biological reaction of a body to a product/device that comes in contact with it for a defined duration. USP Class VI United States Pharmacopeia (USP) tests Systemic Toxicity Test,intracutaneous test, and implantation test