As many have mentioned like @bb254 and @dag56 before testing in clinical trials many tests need to be preformed. The biocompatibility testing needs to be performed in accordance with ISO 10993 including Cytotoxicity, Genotoxicity, Irritation, Systemic Tox, Hemocompatibility, Implantation, Toxikokinetics. A urinary catheter is an example of a mucous membrane Surface Device- This would mean for limited use- Cytotoxicity, Sensation, and Irritation/Intracutaneous reaction. For an orthopedic- is a Tissue/ Bone implant device that’s permanent would require Cytotoxicity, Sensation, Irritation, Systemic Toxicity, Sub-chronic toxicity, genotoxicity, implantation, hemocompatabiltiy, chronic toxicity, and carcinogenicity. For example, a laparoscope would be Tissue/Bone/Dentin communicating External Communicating Device and would require a cytotoxicity, sensation, irritation as standard ISO evaluation tests. Overall, there are different types of tests based on body contact location and body contact duration.