医疗产品辐照灭菌剂量设定的研究

RESEARCH ON DOSE SETTING FOR RADIATION STERILIZATION OF MEDICAL DEVICE

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。

Bioburdens on seven kinds of medical products were determined in accordance with ISO 11737. Different data were obtained for different products. The bioburden changed from 10 cfu/device to 97271 cfu/device the recovery ratio from 54.6% to 100%,and the correcting coefficiency from 1.0 to 1.8. Based on such bioburden and method 1 of ISO 11137, the verification dose was set up for each kind of products, from 5.1 kGy to 17.6 kGy. 100 samples were taken respectively from each kind of products and exposed to the pre-defermined verificction dose. The sterility test showed the positive number was not more than 2. Thus the sterilication dose was determined according to Table B.1 of ISO11137.