Abstract:NiTi shape memory alloy (SMA) stent with film are the long-term implanted medical devices which could be used in human's organ, such as esophagus, bile duct, urethra-prostate and blood vessel, by intervene therapy. It is very important to have a good biocompatibility for implanted device. According to standard ISO 10993, we completed biocompatibility evaluation of NiTi stent that included following tests: cytotoxicity, sensitization, genotoxicity, hemolysis and acute systemic toxicity, The results of tests qualify the NiTi stent, and provide an optimistic conclusion for the eventual use of NiTi stent as implanted medical devices.
