一次性使用输液器环氧乙烷残留量检测的应用研究  

Application Study on Determination of Ethylene Oxide Residue in Disposable Infusion Set

作　　者：刘路 张莺莺 梁国东 胡红刚 LIU Lu;ZHANG Ying-ying;LIANG Guo-dong;HU Hong-gang(Jiangxi Province Medical Equipment Testing Center,Jiangxi Nanchang 330000)

机构地区：[1]江西省医疗器械检测中心,江西南昌330000

出　　处：《中国医疗器械信息》2023年第7期33-35,125,共4页China Medical Device Information

摘　　要：采用顶空气相色谱法对一次性使用输液器环氧乙烷进行检测,通过实验测定输液器环氧乙烷残留量,比较不同的取样方式得到浸提液对检测结果的影响,并通过实验数据对比输液器不同材料部件的环氧乙烷残留量并分析原因。结果表明,采用多组件取样的极限浸提制备浸提液的方式最为合理。此外,发现输液器中丙烯腈-丁二烯-苯乙烯材质制成的组件对环氧乙烷的吸附较强,该实验对实际样品的检测及生产具有参考意义。By used Headspace gas chromatography to detecting ethylene oxide in disposable infusion set.the residual amount of ethylene oxide in infusion set was measured experimentally.The influence of different sampling methods on the test results was obtained by comparing the influence of extracts on the test results,and the residual amount of ethylene oxide in different material components of infusion set was compared and the reasons were analyzed.Results of the experimental results showed that the ultimate extraction method of multi-component sampling was the most reasonable.In addition,the experiment found that the component made of ABS material in the infusion set had strong adsorption of EO.The experiment has reference significance for the actual sample detection and production.

关 键 词：一次性使用输液器 气相色谱法 环氧乙烷残留量 材质 取样方式 

分 类 号：R187.2[医药卫生—流行病学]