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按照ISO11737标准 ,检测了 7类医疗产品的初始污染菌 ,范围 10CFU/件—972 71CFU/件 ;回收率 5 4.6 %— 10 0 % ;校正因子 1.0— 1.83。并以ISO11137标准方法 1完成了辐照灭菌剂量的设定。验证剂量范围为 5 .1— 17.6kGy。取样品 10 0件 ,按各验证剂量辐照 ,以无菌检查法评估 ,阳性样品数均未超过 2件。所需灭菌剂量则从ISO11137标准方法附录B中表B·1外推选定
According to the ISO11737 standard, seven kinds of medical products were tested for initial contamination, ranging from 10 CFU / piece to -972 71 CFU / piece; the recovery rate was from 5 4.6% to 10%; and the correction factor was from 1.0 to 1.83. And to ISO11137 standard method 1 to complete the radiation sterilization dose setting. Validation doses ranged from 5.1-1.7.6 kGy. A total of 10 samples were taken and irradiated according to the verification dose. The results of the aseptic test showed that the number of positive samples did not exceed 2. The required sterilizing dose is extrapolated from Table B.1 in Appendix B of the ISO11137 standard method