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jlw23 replied to the topic Discussion Topic: Brand new biomaterial in the forum Pre-clinical Device Development 7 years, 6 months ago
As mention, for testing in biocompatibility, the testing should follow ISO 10993. However, depending on the product there are various other testing that needs to be done before the procurement of any material that goes into a process and after the product is completed. This also have to go through the QC department, that will either do additional testing or confirm any testing done before is with in desired integrity. The company that I work with has a product that is a consumable that going into the body. For different product, I think that the testing would differ. I also think the process would also dictate also of the testing. Depending on how much sterility is needed for the process, there may be various testing done to, insure that the product can maintain its efficacy and not do any damage the biological system.
For orthopedics that go into the body also must be considered in the process that would insure the immune response is with in expectation. In most cases with orthopedic implants, the coating is what dictates how the biological system will respond. The is where testing for biocompatibility can focus in on. I think that this will differ depending on the product.