Prior to clinical trials biocompatibility testing should be completed in regards to ISO 10993. The types of biocompatible tests needed for a particular device can be determined by using the toxicity table. General biocompatible tests include cytotoxicity, genotoxicity, irritation and implantation. By completing these tests you can determine how poisonous the device is to the cells and genes. It helps determine whether or not the device will destroy blood cells, if it is implantable or if it will irritate skin cells etc. A biomaterial associated with an implant device that interacts with the bone permanently is required to have cytotoxicity, sensitization, genotoxicity, implantation, and chronic toxicity and carcinogenicity tests completed. While a surface device that only interacts with the skin for a limited time only needs to have a toxicity, sensitization, and initiation test completed prior to clinical trials.

Reference: Week Three Lecture Notes