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对624件医用一次性输液器的初始污染数据做了统计学分析,做出了初始污染的正态分布图,展示输液器内壁与外壁初始污染的关系,并以实验数据说明了灭菌前输液器中初始污染的变化情况。按伽玛辐射灭菌剂量的确定方法实验测得平均初始污染量为7 CFU/件(CFU为菌落形成单位),灭菌保证水平(SAL)为10~6,取样比例(SIP)为1,算得灭菌剂量为17.2 kGy。
The initial pollution data of 624 disposable medical transfusion devices were statistically analyzed and the normal distribution of initial pollution was established to show the relationship between the initial contamination of the inner wall of the infusion set and the outer wall. The experimental data showed that the infusion before sterilization Changes in the initial pollution of the device. According to the method of determining the radiation dose of gamma irradiation, the average initial contamination was 7 CFU / CFU (colony forming units), the SAL was 10-6, the sampling ratio (SIP) was 1, The calculated sterilization dose was 17.2 kGy.