医疗保健产品辐照灭菌剂量设定方法实践应用的研究  

Study and application on establishing the sterilization dose of medical healthcare products

作　　者：李尚知[1] 刘清芳[1] 

机构地区：[1]苏州大学放射医学与公共卫生学院,苏州215123

出　　处：《辐射研究与辐射工艺学报》2008年第4期249-252,共4页Journal of Radiation Research and Radiation Processing

摘　　要：探索辐照灭菌剂量设定方法,为合理选取辐照灭菌剂量提供依据。在实践基础上,对来自全国52个厂家的148种不同种类出口医疗保健产品分别进行初始污染菌检测,并据此进行ISO11137剂量设定。同时以公式法计算辐照吸收剂量。结果发现,在相同初始污染菌条件下,依据ISO11137方法设定的灭菌剂量大于公式法。当初始污染菌小于1000cfu/unit时,两者的剂量均小于VDmax(-1)法设定的剂量。研究认为,对于常规生产的辐射灭菌产品,其灭菌剂量应首选ISO11137方法;对于低污染产品的灭菌,应首选VDmax(-1)法;在中国如应用公式法设定灭菌剂量,其安全性应受到质疑。On the basis of practical application combined with current domestic study, to provide evidences for the selection of appropriate dose setting method. In our test 148 samples collected were from 52 manufacturers all over China. After bioburden estimate, the dose setting was performed with ISO11137 method 1 along with other two method （Ig method and VDmax（-1）method）. The bioburden on product ranges from 7.17 to 1.98×10^5cfu/unit. On the same level of bioburden, the sterilization dose from ISO11137 method 1 is more than that from Ig method. Both of them are less than that from VDmax （-1）. It is thought that the VDmax（-1） method is perfect for product with less contamination, ISO11137 method 1 is perfect for produced regularly. The dose safety of Ig method which used in china is suspicious.

关 键 词：辐射灭菌 初始污染菌 剂量设定 医疗保健产品 

分 类 号：R187[医药卫生—流行病学] R81[医药卫生—公共卫生与预防医学]