This standard provides the chemical analysis methods for release of plasticizer DEHP after medical device which takes PVC as raw material is contacting with liquid of clinical use, under simulation of actual conditions of use.
Basic Data
Standard ID
YY/T 0927-2014 (YY/T0927-2014)
Description (Translated English)
Guidance of determination for di(2-ethylhexyl)phthalate (DEHP) released from PVC medical devices
Sector / Industry
Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard
C31
Classification of International Standard
11.040.30
Word Count Estimation
9,941
Date of Issue
6/17/2014
Date of Implementation
7/1/2015
Quoted Standard
GB/T 6682
Regulation (derived from)
China Food and Drug Administration in 2014 Bulletin No. 30
Issuing agency(ies)
State Food and Drug Administration
Summary
This Standard applies to medical DEHP plasticizer of PVC medical devices in the determination of the use of DEHP leaching. This Standard specifies the post under simulated realistic conditions, polyvinyl chloride (PVC) as raw materials for medical devices
