中心静脉导管辐射灭菌后血液相容性和热源评价试验观察

EVALUATION TEST OF BLOOD COMPATIBILITY AND PYRETOGEN OF RADIATION STERILIZED CENTRAL VEIN CATHETERIZATION

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 blood compatibility of central vein catheterization after radiation sterilization,so as to provide the basis for safe use of radiation sterilization medical product.Method The coagulation function affected by radiation sterilized central vein catheterization and the hemolytic rate were tested by ISO11137 method.Results After the health people＇s whole blood flowed by the radiation sterilized central vein catheterization,the coagulation function and platelet function did not change.The hemolytic rate was 1.38%（which below 5%）,according to the demand of medical equipment hemolytic test.Conclusion The blood compatibility of central vein catheterization by certain dosage radiation sterilized was good,and the medical equipment by radiation sterilization is safe to use.