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  • srg36 replied to the topic Discussion Topic: Brand new biomaterial in the forum Pre-clinical Device Development 7 years, 11 months ago

    As the others have mentioned already, referencing the Toxicity Table from ISO 10993, there are different tests required for different applications. Therefore, if you know what application you are planning to use the biomaterial for, you just reference the corresponding row in the toxicity table to determine what testing will be required. Several questions I have regarding the toxicity table: What exactly is the distinction between initial evaluation tests and supplementary evaluation tests? How do you know whether it is advisable to perform the “additional tests which may be applicable?” If you don’t know the specific application of the biomaterial that you are working on, or if it may be applicable to a variety of devices with different applications, how do you select which biocompatibility tests to run?