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一次性射频等离子手术电极灭菌方式的选择与验证

Selection and validation of electrode sterilization methodsfor radiofrequency plasma surgery

作者: 佟笛  王燕  刘志成 
单位:首都医科大学生物医学工程学院(北京100069)
关键词: 一次性射频等离子手术电极;灭菌方法;环氧乙烷灭菌;灭菌环境;有毒气体残留 
分类号:R318.04
出版年·卷·期(页码):2017·36·5(507-512)
摘要:

目的 选择一次性射频等离子手术电极灭菌方式,并对灭菌效果进行验证。方法 综合比较4种常用灭菌方式的特征和环境,基于一次性射频等离子手术电极材料及特性,选择环氧乙烷灭菌法进行灭菌。灭菌完成后确认一次性射频等离子手术电极的性能,并采用生物指示剂对产品微生物及环氧乙烷残留进行测试。结果 采用环氧乙烷灭菌方法对一次性射频等离子手术电极进行灭菌,灭菌器内灭菌参数为:预真空度60kPa±5kPa、灭菌温度50℃±5℃、相对湿度55%RH±20%RH、灭菌压力0~5kPa、保压时间1min、加药计量<895g、灭菌剂作用时间6h、排残真空度-60kPa±5kPa、排残次数3次、每次排残时间为30min、有毒气体解吸时间为14d。结论 环氧乙烷灭菌法是针对包装后一次性射频等离子手术电极可行且有效的灭菌方法。

Objective To select the sterilization mode of disposable radiofrequency plasma electrode,and to verify the sterilization effect. Methods We compared the characteristics and environment of the four commonly used sterilization methods,and chose ethylene oxide sterilization method based on the materials and characteristics of disposable radiofrequency plasma surgical electrodes. After sterilization,the performance of the disposable radiofrequency plasma electrode was confirmed,and biological indicators were used to test the products,microorganisms and ethylene oxide residues. Results We used ethylene oxide sterilization method to sterilize the disposable radiofrequency plasma surgical electrode,the sterilization parameters were determined as follows:pre vacuum 60kPa±5kPa,sterilization temperature 50℃±5℃, relative humidity 55%RH + 20%RH,sterilization pressure 0-5kPa,the holding time 1min,the dosing rate <895g,the sterilizing agent time 6h,the residual vacuum degree -60kPa±5kPa,the number of times of residue removal 3 times,the time of each row 30min,the desorption time of toxic gas14d. Conclusion Ethylene oxide sterilization is a feasible and effective sterilization method for disposable radiofrequency plasma electrode after packaging.

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