As mentioned above in the week 3 lectures as well as from bb254, biocompatibility testing should be completed in strict accordance to ISO 10993. The table dictates, in relation to its intended application and criticality to the body (ex. tooth filling vs heart valve) the number and type of testing that should be performed to ensure the product is deemed “safe”. After all, nothing is 100% biocompatible.

Also in regards to srg36 question about selecting biocompatibility test to run when unsure of the use of the product, I believe that, when in doubt, all tests in question should be performed if reasonable judgement cannot be applied. This is to say that it is always safer to error on the side of caution when designing/ implementing medical devices and take some extra time (days to months) rather than face a massive unexpected recall of the product that will both cost the parent company a significant amount of money and no doubt tarnish their reputation as a medical device supplier.