[聚氯乙烯医疗设备中邻苯二甲酸二（2-乙基己基）酯的安全性评估]
[Safety assessment of DEHP from PVC medical devices].
作者信息
Yang Xiaodong
机构信息
The Center for Medical Device Evaluation, SFDA, Beijing 100044.
出版信息
Zhongguo Yi Liao Qi Xie Za Zhi. 2012 Mar;36(2):118-20.
OBJECTIVE
To Investigate necessity of safety evaluation, research ideas, evaluation methods of DEHP in PVC medical devices.
METHODS
The ideas of The United States, Japan and the European Union on safety evaluation of DEHP in PVC medical devices was reviewed and sorted, regarding to currently requirements for PVC medical devices in our country, the research ideas and methods of DEHP in PVC medical devices was explored.
RESULTS
DEHP released from High-risk PVC medical devices may exceed human tolerance intake values and thus potentially be harmful to human health. So it is necessary for production enterprise to assess safety of DEHP in PVC medical device. The assessment can be done by material control and detecting release of DEHP from PVC medical devices.
CONCLUSION
In order to assess safety of DEHP in PVC medical device, production enterprise can firstly assess materials according to national standard. Secondly, production enterprise can detect release of DEHP from PVC medical devices simulating clinical application. By comparing release of DEHP from PVC medical devices and TI, safety of DEHP in PVC medical device can be evaluated.
目的
探讨聚氯乙烯（PVC）医疗器械中邻苯二甲酸二（2-乙基己基）酯（DEHP）安全性评价的必要性、研究思路及评价方法。
方法
梳理美国、日本及欧盟对PVC医疗器械中DEHP安全性评价的思路，结合我国目前对PVC医疗器械的要求，探索PVC医疗器械中DEHP的研究思路与方法。
结果
高风险PVC医疗器械释放的DEHP可能超过人体耐受摄入量，从而对人体健康产生潜在危害。因此，生产企业有必要对PVC医疗器械中DEHP的安全性进行评估。该评估可通过材料控制及检测PVC医疗器械中DEHP的释放量来完成。
结论
为评估PVC医疗器械中DEHP的安全性，生产企业可首先依据国家标准对材料进行评估。其次，生产企业可模拟临床应用检测PVC医疗器械中DEHP的释放量。通过比较PVC医疗器械中DEHP的释放量与耐受摄入量（TI），可对PVC医疗器械中DEHP的安全性进行评价。
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