摘要
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 study tissue compatibility and teratogenicity of the radiation sterilized disposable burette transfusion apparatus, in order to provide evidence for the safety of radiation sterilized medical devices. Methods According to the ISO11737 standard, cytotoxicity test and animal experiments were used to evaluate the tissue compatibility and the teratogenicity of the radiation sterilized disposable burette transfusion apparatus. Results The sterilizing dosage was at the level of 9.4 kGy. The radiation sterilized sample products showed no cytotoxicity, no sensitization, no intracutaneous irritation, no genotoxicity in chromosome aberration test, and would not increase the micronucleus rate of PCE. Conclusion Disposable burette transfusion apparatus show good tissue compatibility and no teratogenicity after radiation sterilization. Radiation sterilization is a biologically safe method for sterilization of medical devices.
出处
《中国消毒学杂志》
CAS
北大核心
2012年第3期180-182,187,共4页
Chinese Journal of Disinfection
关键词
辐照灭菌
输液器
组织相容性
致畸毒性
radiation sterilization
transfusion apparatus
tissue compatibility
teratogenicity
