Standard Number: YY/T 0927-2014(YY/T0927-2014)
Chinese:聚氯乙烯医疗器械中邻苯二甲酸二(2-乙基己基)酯(DEHP)溶出量测定指南
English:Guidance of determination for Di(2-ethylhexyl)phthalate (DEHP) released from PVC medical devices
Effective Date:2015-07-01
ICS:11.040.30
Standard Applicability:This standard applies to DEHP as a plasticizer for medical devices made of polyvinyl chloride in use in the determination of the amount of DEHP dissolved. This standard specifies the simulation of actual conditions of use, polyvinyl chloride (PVC) as raw materials made of medical devices and clinical use of liquid contact, the plasticizer DEHP dissolution determination of chemical analysis methods.
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