Safety assessment of DEHP from PVC medical devices / 中国医疗器械杂志
Chinese Journal of Medical Instrumentation
;
(6): 118-120, 2012.
Article
in Chinese
| WPRIM
| ID: wpr-325916
ABSTRACT
<p><b>OBJECTIVE</b>To Investigate necessity of safety evaluation, research ideas, evaluation methods of DEHP in PVC medical devices.</p><p><b>METHODS</b>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.</p><p><b>RESULTS</b>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.</p><p><b>CONCLUSION</b>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.</p>
Full text:
Available
Index:
WPRIM (Western Pacific)
Main subject:
Plasticizers
/
Polyvinyl Chloride
/
Diethylhexyl Phthalate
/
Equipment Safety
Language:
Chinese
Journal:
Chinese Journal of Medical Instrumentation
Year:
2012
Type:
Article
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