中文摘要：

聚氯乙烯制成的一次性医疗器械在生产加工过程中,常使用环己酮作为部件粘结剂。由于残留的环己酮可释放到医疗器械管道和储存的溶液中,并可能对病人产生一定的副作用,因此,医疗器械中环己酮的快速检测日显重要。利用自主研制的紫外光电离-离子迁移谱装置对环己酮进行检测,检测限为15ppb,检测线性动态范围达到三个数量级。分别对三个品牌一次性输液器包装中的气体进行迁移谱测量,获得包装内环己酮的平均浓度分别为16.78,17.59和46.69ppm。该方法可以用于一次性医疗器械中环己酮等有机溶剂的快速检测,进行医疗器械产品的质量监控。

英文摘要：

In the manufacture of disposable PVC medical devices,cyclohexanone i s frequently used as an adhesive reagent,which can be released into the tube ai rspace or stored solution and thus may cause some adverse effects on patients in therapy.In this paper,an ultraviolet photoionization ion mobility spectromet ry（ UV-IMS） technique has been developed to detect cyclohexanone through monitoring t h e gas composition within a package of infusion sets.The concentrations of cycl o hexanone were prepared by means of exponential dilution method,and the experim e nts show that the UV-IMS has a limit of detection at 15 ppb and its measurable l inear dynamics range is over three orders of magnitude.The concentrations of c y clohexanone in three brands of infusion sets packages were determined to be 16. 7 8,17.59 and 46.69 ppm respectively.The UV-IMS is proposed as a tool for t he qu ality control of medical devices to monitor illegal uses of chemical solvents li ke cyclohexanone.