Standard No.:	YY/T 0927-2014
English Name:	Guidance of determination for di(2-ethylhexyl) phthalate(DEHP) released from PVC medical devices
Chinese Name:	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
Chinese Classification:	C31    General and microsurgical devices
Professional Classification:	YY    Professional Standard - Pharmaceutics
ICS Classification:	11.040.30 11.040.30    Surgical instruments and materials 11.040.30
Issued by:	China Food and Drug Adminstration
Issued on:	2014-06-17
Implemented on:	2015-7-1
Status:	valid
Language:	English
File Format:	PDF
Word Count:	5500 words
Price(USD):	140.00
Delivery:	via email in 1~3 business day

本标准适用于DEHP为增塑剂的医用聚氯乙烯制造的医疗器械在使用中DEHP溶出量的测定。
本标准规定了在模拟实际使用条件下，以聚氯乙烯（PVC）为原料制成的医疗器械与临床使用液体接触后，增塑剂DEHP溶出量测定的化学分析方法。