Based on ISO11137 and ISO10993, bio-burden of the coronary artery stents and the sterilizing dose were determined. Results indicted that when the average bio-burden was 332.49cfu per device, verification dose was 9.5292kGy (SAL10,-2,) the minimum sterilizing dose was determined to be 23.1kGy (SAL10,-6,). The irradiated samples were inspected their biocompatibility by the cytotoxicity test, sensitization test, local reactions of muscle embedding test, chromosome aberration test of human blood cell in vitro, haemolysis test. It was showed that the coronary artery stents sterilized by irradiation have no cytoxicity, no sensitivity, no mutagencity in chromosome aberration test and no haemolysis. Furthermore, the package kept sterile and no leakage was found. The good biocompatibility of coronary artery stents sterilized by irradiation can be used for further clinic application.