摘要
阐述国际上对PVC医疗器械释放DEHP[邻苯二甲酸二(2-乙基)己酯]安全性评价的思路以及我国对医疗器械释放DEHP的限量要求。选取市面上输血器作为样品,采用模拟浸提和极限浸提的方式进行浸提,分析浸提液中DEHP的含量,对样品释放DEHP的安全性进行评价。
This work states the safety evaluation of DEHP( di( 2-ethylhexyl) phthalate) released from PVC medical devices and the limited requirement of DEHP released from medical devices. The transfusion sets from market as samples were leached in simulated and extreme way. The safety of the samples were evaluated by analysis of the concentration of DEHP in the leaching solutions.
出处
《化学试剂》
CAS
北大核心
2016年第2期145-148,168,共5页
Chemical Reagents