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目的 :设定国产聚氨酯女用避孕套 6 0 Co- γ射线辐射灭菌的适合吸收剂量。方法 :采用公式剂量设定法 ,设定产品的电离辐射灭菌吸收剂量并进行产品消毒试验的测定。结果 :经检测 ,7.5 k Gy的 6 0 Co- γ射线吸收剂量可以将国产聚氨酯女用避孕套初始污染菌数从 (1.42× 10 4) cfu/ g降至 <1cfu/ g;5 .5 k Gy吸收剂量可以将大肠杆菌、金黄色葡萄球菌、白色念球菌菌片上的试验菌全部杀灭 ;使用公式剂量设定法确定的产品灭菌辐射吸收剂量合适范围为 (9.94～ 11.47) k Gy。结论 :按公式剂量设定法设定的吸收剂量对聚氨酯女用避孕套辐射灭菌能达到预期灭菌效果。
Objective: To set the suitable absorbed dose of domestic polyurethane female condom 60Co γ radiation sterilization. Methods: Using the formula dose setting method, set the product dose of ionizing radiation sterilization and determination of product disinfection test. Results: It was found that the initial contamination of domestic polyurethane female condom by 7.6 kCo γ-ray absorbed dose can be reduced from (1.42 × 10 4) cfu / g to <1 cfu / g and 5.5 k Gy absorbed dose can be E. coli, Staphylococcus aureus, Candida albicans test bacteria kill all; the use of formula dose setting method to determine the appropriate range of product sterilization radiation absorbed dose (9.94 ~ 11.47) k Gy. CONCLUSION: Radiation sterilization of female polyurethane condom can achieve the expected sterilization effect according to the dosage set by the formula dose setting method.