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目的观察辐照灭菌后的中心静脉导管血液相容性,为辐射灭菌医疗产品安全应用提供依据。方法采用ISO11137标准规定的方法,对辐射灭菌的静脉导管影响凝血功能和溶血率进行了测定。结果经辐照灭菌后的中心静脉导管,用于健康人全血流过前后凝血及血小板功能指标没有影响;溶血率为1.38%,小于5%,符合医疗器械溶血实验要求。结论经设定剂量辐照灭菌后的中心静脉导管血液相容性良好,辐照灭菌后的静脉导管等医疗器械使用安全。
Objective To observe the hemocompatibility of central venous catheters after radiation sterilization and provide the basis for the safe application of radiation sterilization medical products. Methods The method of ISO11137 was used to determine the coagulation function and hemolysis rate of radiation-sterilized intravenous catheter. Results The central venous catheter after irradiation sterilization had no effect on coagulation and platelet function before and after whole blood flow in the healthy people. The rate of hemolysis was 1.38% and less than 5%, which accorded with the requirements of hemolysis test in medical devices. Conclusion The blood compatibility of central venous catheters sterilized by radiation dose setting is good, and the safe use of medical instruments such as intravenous catheters irradiated by irradiation is safe.