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vcf3 replied to the topic Discussion Topic: Brand new biomaterial in the forum Pre-clinical Device Development 7 years, 2 months ago
As others students stated, referencing the Toxicity Table from ISO 10993 should give a general idea of tests needed prior to clinical trial phase. Ultimately the test needed will depend on the expected functionality of the medical devices. For instance, in the case of orthopedic implants, it is important to measure maximal load and stress level the implant can support without being subjected to deformation. It might also be beneficial how the biomaterial will react to other parameters such as variation in heat, twisting motion or pH value. Others bioengineered products might require similar and additional testing. For instance, for a device that interacts permanently with bones should be texted for genotoxicity, carcinogenicity, cytotoxicity, implantation, sensitization, and chronic toxicity, whereas tests for medical devices that interact only with the will probably don’t require carcinogenicity or chronic toxicity.