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目的观察一次性使用滴定管式输液器辐照灭菌后组织相容性和致畸毒性,为辐射灭菌后的医疗产品安全应用提供依据。方法依据ISO11137标准相关规定,采用细胞毒性试验和动物试验对辐照灭菌后的一次性使用滴定管式输液器进行了组织相容性和致畸毒性评价。结果试验的灭菌剂量为9.4 kGy,辐照灭菌后的一次性使用滴定管式输液器无细胞毒性、不会致敏和引起皮内刺激,无遗传毒性(不会引起染色体畸变),无诱导骨髓多染红细胞微核发生率增高作用。结论经设定剂量辐照灭菌后的一次性使用滴定管式输液器组织相容性良好、无致畸毒性,辐射灭菌作为医疗器械灭菌方法具有较好的安全性。
Objective To observe the histocompatibility and teratogenicity of disposable burette transfusion set after irradiation sterilization and provide the basis for the safe application of medical products after radiation sterilization. Methods According to the relevant regulations of ISO11137 standard, the cytotoxicity test and animal experiment were used to evaluate the histocompatibility and teratogenicity of disposable sterilized disposable burette infusion set. Results The sterilizing dose was 9.4 kGy. The single-use burette irrigated after irradiation was non-cytotoxic, non-sensitized and intradermally stimulated, non-genotoxic (did not cause chromosomal aberrations) and did not induce bone marrow RBC micronuclei increased incidence of role. Conclusion The single-use burette infusion set sterilized by setting dose radiation has good tissue compatibility and no teratogenicity. Radiation sterilization has good safety as a medical device sterilization method.