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目的评价中心静脉导管辐照灭菌后致畸毒性,为一次性使用医疗产品安全应用提供依据。方法采用ISO11137标准规定的方法,对辐射灭菌后的中心静脉导管进行了染色体畸变和致突变等毒性试验观察。结果经钴60辐照灭菌后的中心静脉导管样品,对试验动物无遗传毒性,无诱导骨髓多染红细胞微核发生率增高作用,无致突变作用。结论经设定剂量辐照灭菌后的中心静脉导管具有良好的使用安全性。
Objective To evaluate the teratogenicity and toxicity of central venous catheter after sterilizing and provide the basis for the safe use of medical products for one time use. Methods According to the method of ISO11137, the central venous catheters after radiation sterilization were tested for their chromosomal aberrations and mutagenicity. Results The samples of central venous catheter sterilized by cobalt 60 irradiation showed no genotoxic effects on test animals and no increase in the incidence of micronuclei in erythrocytes induced by bone marrow. Conclusion The central venous catheter sterilized by radiation dose setting has good safety.