生物负载回收率对医疗器械辐照灭菌剂量的影响  

Effects of bioburden-recovery on radiation sterilization dose of medical devices

作　　者：张悦[1] ZHANG Yue(Beijing Research Center for Radiation Application,Beijing 100015,China)

机构地区：[1]北京市射线应用研究中心

出　　处：《辐射研究与辐射工艺学报》2019年第6期42-47,共6页Journal of Radiation Research and Radiation Processing

摘　　要：根据不同实验参数测试出的生物负载回收率的差异,评价其对产品辐照灭菌剂量的影响。选取股骨柄、骨蜡和双极球头等3种产品,运用不同的检测标准分别测试每种产品的生物负载回收率,结合ISO11137-2:2013中方法1的原理,得出不同的生物负载结果对应的产品辐照灭菌的最低剂量。产品生物负载回收率的差异,导致了产品生物负载和灭菌剂量的差异,同时也直接对产品的灭菌质量控制造成了影响。The aim is to evaluate the effects of bioburden-recovery on the radiation sterilization dose of various products based on the differences in the bioburden-recovery obtained using different experimental parameters.Three types of products including femoral stem,bone wax,and bipolar ball head were selected and subjected to bioburdenrecovery tests using different testing standards.Further,the minimum irradiation sterilization dose of the products corresponding to different results of bioburden was obtained based on the ISO 11137-2:2013(Method 1)standard.The test results indicate that the different bioburden-recovery of the products lead to a difference in bioburden and sterilization dose,which directly affects the quality control of sterilization.

关 键 词：辐照 灭菌剂量 回收率 生物负载 医疗器械 

分 类 号：R187[医药卫生—流行病学]