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Fp55 replied to the topic Discussion Topic: Brand new biomaterial in the forum Pre-clinical Device Development 7 years ago
Apart from FDA regulations and ISO 10993, it is equally important to test the material understand the different conditions it will undergo. For example, if an implant is meant to bear load (orthopedic implant), it would be beneficial to know the tolerances and the maximum limit it can handle, as well as extreme cases such as a such twisting motion or low squat position (for hip implants) such considerations will help determine the limitations of the material.