[Safety assessment of DEHP from PVC medical devices].
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.


CONCLUSIONS
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.
The Center for Medical Device Evaluation, SFDA, Beijing 100044. yangxd@cmde.org.cn
Xiaodong
X
Yang
D004051:Diethylhexyl Phthalate / Q000009:adverse effects*; D004869:Equipment Safety; D010968:Plasticizers / Q000009:adverse effects*; D011143:Polyvinyl Chloride / Q000009:adverse effects*
D010968:Plasticizers; D011143:Polyvinyl Chloride; D004051:Diethylhexyl Phthalate