【摘要】 目的　采用微生物信息探讨医疗产品辐射灭菌剂量设定的方法。方法　依据ISO11737标准方法检测初始污染菌、回收率、校正因子 ;以ISO11137标准方法 1完成剂量设定。结果　 15种医疗产品初始污染菌范围 8.6～ 972 71.2CFU/件 ,回收率 5 4.6 %～ 10 0 % ,校正因子 1.0～ 1.83,D10 分布 1.4～ 2 .92 ,验证剂量 (SAL 10 -2 )范围5 .1～ 17.6kGy ,最低灭菌剂量 (SAL 10 -6)范围 17.5～ 32 .5kGy。结论　取各产品 10 0件 ,按验证剂量辐照 ,以无菌检查评估 ,阳性数均未超过 2件。提示统计学验证通过。更多还原

【Abstract】 Objectire To establish the radiation sterilization dose for medical devices using data of bioburden on the medical device.Methods Firstly determination of recovery ratio and correction co-efficient of the microbiological test method was used according to ISO11737 standard, then determination of bioburden on the products, finally the dose setting was completed based on the Method 1 in ISO11137 standard.Results Fifteen kinds of medical devices were tested. Bioburden range was from 8.6～97 271.2 CFU/device, recovery ration range 54.6%～100%, correction co-efficiency range 1.00～1.83, D 10 distribution from 1.40 to 2.82 kGy, verification dose (dose at SAL=10 -2 ) range 5.1～17.6 kGy and sterilization dose (dose at SAL=10 -6 ) range 17.5～32.5 kGy.Conclusion One hundred samples of each kind of product were exposed to the pre-determined verification dose and then the sterility test was pereformed. Each sterility test showed positive number was not greater than two. This indicated that the sterilization dose established for each kind of product was statistically acceptable.更多还原