一次性使用输液器初始污染的调查及灭菌剂量的确定
INVESTIGATION OF INITIAL CONTAMINATION FOR DISPOSAL MEDICAL INFUSION ITEMS AND DETERMINATION OF STERILIZATION DOSE
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摘要: 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。Abstract: Statistical analyses on initial contamination of 624 disposal medical infusion items have been made. The normal distribution of the initial contamination, the relation of initial contamination on inner and outer walls of disposal medical infusion items and the changes of initial contamination before irradiation are shown. The sterilizated dose for disposal infusion is determined as 17.2 kGy using bioburden information. The SAL (sterility assurance level) dose is 10~6. The SIP (device sample item proportion) is 1 and the average initial contamination is 7 CFU/item.