摘要
目前医疗器械最常用的灭菌法是环氧乙烷灭菌。灭菌后的残留物与接触医疗器械的人员健康息息相关。该研究团队主要针对医疗器械经过环氧乙烷灭菌后的可能的残留物进行分析。结论为建议通过对医疗器械生产环节、环氧乙烷生产工艺、灭菌过程、灭菌环境、检测方法等环节进行综合考虑灭菌后残留物的产生情况,进而有针对性地对环氧乙烷、2-氯乙醇、乙二醇开展评价。
At present,the most commonly used sterilization method for medical devices is ethylene oxide sterilization.The residue after sterilization is closely related to the health of the people who contacted with the medical devices.The study team analyzed the possible residues of medical devices after sterilization with ethyleneoxide.It is suggested that ethylene oxide,2-chloroethanol and ethylene glycol should be evaluated comprehensively through the analysis of factors such as production links of medical devices,production process of ethylene oxide,sterilization process,sterilization environment and detection method.
作者
刘柏东
贺伟罡
陈敏
LIU Bodong;HE Weigang;CHEN Min(Center for Medical Device Evaluation,NMPA,Beijing,100081)
出处
《中国医疗器械杂志》
2020年第5期443-447,共5页
Chinese Journal of Medical Instrumentation
作者简介
刘柏东,E-mail:253561424@qq.com。
