Standard Number: YY/T 1854-2022(YY/T1854-2022)
Chinese:聚氯乙烯医疗器械中偏苯三酸三辛酯（TOTM）溶出量测试方法
English:Test method for trioctyl triphthalate (TOTM) released from PVC medical devices
Effective Date:2023-09-01
ICS:11.120.20
Standard Applicability:This document specifies a chemical analysis method for the determination of the amount of plasticizer TOTM dissolved in medical devices made from polyvinyl chloride (PVC) plasticized with trimellitate (TOTM), after contact with clinical infusion fluid under conditions that simulate actual use. This document applies to medical devices made from TOTM plasticized PVC.
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