PVC材料导管类医疗器械DEHP析出的安全评价试验模型研究  

Research on Experimental Model of Security Assessment of DEHP Migration from PVC-Tubes Medical Devices

作　　者：王越 包世勇 沈国理[2] 王军 姜红强 WANG Yue;BAO Shiyong;SHEN Guoli;WANG Jun;JIANG Hongqiang(Center for Medical Device Evaluation in Zhejiang Province, Hangzhou, 3100092;Zhejiang Crops Hospital of CAPF, Hangzhou, 31005)

机构地区：[1]浙江省医疗器械审评中心,杭州市310009 [2]武警浙江省总队医院,杭州市310051

出　　处：《中国医疗器械杂志》2018年第3期222-224,共3页Chinese Journal of Medical Instrumentation

基　　金：浙江省食品药品监管系统科技计划项目(YQ201702)

摘　　要：众所周知,DEHP(邻苯二甲酸二(2-乙基)己酯)对人类有很严重的危害,也因此得到了广泛关注。由于其与PVC的非共价键结合方式,导致DEHP易从PVC医疗器械中析出,继而接触使用者或病患,造成危害。影响DEHP析出的因素很多,为科学评价PVC材料导管类医疗器械DEHP析出的安全性,该文建立了一种试验模型,通过结合临床使用情况,对影响因素进行了较为全面、系统的分析。以输液器为例,应用本试验模型能对其中DEHP析出的安全性进行评价。As we all know, DEHP is seriously harmful to human health and consequently has been acquired critical attention. DEHP is able to migrate from PVC medical devices for the non-chemically bound to PVC, thus contact with user and patient. The DEHP migration is influenced by various parameters. In order to assess the security of PVC-tubes medical devices scientifically of DEHP migration, we develop an experimental model by analyzing the parameters comprehensively and systematically, taking into account the clinical practices. For example, assessing the security of DEHP migration from infusion sets by utilizing this model.

关 键 词：邻苯二甲酸二(2-乙基)己酯 析出因素 试验模型 安全性评价 

分 类 号：R114[医药卫生—卫生毒理学]