湖北省输液输血器具中DEHP溶出检测与分析  

Determination and Analysis of Dehp Dissolution in Infusion or Transfusion Apparatus in Hubei Province

作　　者：魏嫣 梅享林 李玲 彭晖 WEI Yan;MEI Xiang-lin;LI Ling;PENG Hui(Hubei Medical Devices Quality Supervision and Test Institute,Hubei Wuhan 430075)

机构地区：[1]湖北省医疗器械质量监督检验研究院,湖北武汉430075

出　　处：《中国医疗器械信息》2021年第3期10-11,31,共3页China Medical Device Information

摘　　要：目的:了解湖北省使用的输液输血器具中DEHP的溶出情况,为医疗器械安全风险监测工作提供数据积累。方法:参考标准YY/T 0927-2014的检验方法,采用气相色谱-质谱联用法测定30个批次输液输血器中DEHP溶出量。结果:通过对30批输注器具进行检测,声称不含有DEHP的一批产品的结果很低,其他29批产品的DEHP溶出量在2.17~9.45mg。其中输血器DEHP溶出量为2.17~6.79mg,输液器DEHP溶出量为2.68~9.45mg。结论:不同生产企业由于材料和工艺不同,DEHP的溶出量存在较大差异,对于成年人而言均在安全范围内,但是对于婴幼儿和儿童等特殊人群的使用存在较大的安全风险。Objective:To understand the dissolution of DEHP in the infusion or transfusion apparatus used in hubei province,and to provide data accumulation for the safety risk monitoring of medical devices.Methods:According to the test method of standard YY/T 0927-2014,the DEHP dissolution in 30 batches of infusion or transfusion apparatus were determined by gas chromatography-mass spectrometry(gc-ms).Results:Through the testing of 30 batches of infusion or transfusion apparatus,the results of the batch that claimed not to contain DEHP were very low,and the DEHP dissolution amount of the other 29 batches was between 2.17-9.45mg.The dissolution of DEHP in the infusion apparatus was 2.17-6.79mg,and that of DEHP in the infusion set was 2.68-9.45mg.Conclusion:Due to different materials and processes in different manufacturers,the amount of DEHP dissolved varies greatly,which is within the safe range for adults.However,there are greater safety risks for infants,children and other special groups.

关 键 词：一次性使用输液器 邻苯二甲酸二乙酯 气相色谱-质谱联用法 

分 类 号：TH789[机械工程—仪器科学与技术]