医用聚丙烯雾度性能的不确定度评价  

Uncertainty Evaluation of Medical Polypropylene Haze Performance

作　　者：肖娟[1] 刘佳[1] 李冰[1] 鲁志龙 陈皓楠 徐昕荣[1] XIAO Juan;LIU Jia;LI Bing;LU Zhi-long;CHEN Hao-nan;XU Xin-rong(Medical Devices Research&Testing Center,South China University of Technology,Guangdong Guangzhou 510006,China)

机构地区：[1]华南理工大学,医疗器械研究检验中心,广东广州510006

出　　处：《广州化工》2022年第20期128-131,共4页GuangZhou Chemical Industry

基　　金：机械制造系统工程国家重点实验基金项目(sklms2020023);广东省药品监督管理局科技创新项目(2021YDZ04)。

摘　　要：以注射器具用聚丙烯专用料为研究对象,探讨标准YY/T 0242-2007《医用输液、输血、注射器具用聚丙烯专用料》中雾度性能的不确定度评定方法。采用GB/T 2546.2及GB/T 17037.3中规定的实验方法,制备D1型方片试样用于检测,并分析了操作重复性、样品均匀性、测量准确性、仪器分辨力等参数对雾度测量不确定度实验结果的影响。发现影响医用聚丙烯雾度测量的主要因素为仪器测量准性和操作重复性,测量不确定度的评定对聚丙烯雾度方法的实施与评价具有重要意义。Taking polypropylene special materials for injection equipments as the research object,the uncertainty evaluation method of haze performance of standard YY/T 0242-2007 Polypropylene Material for Manufacture of Infusion,Blood Transfusion and Injection Equipments for Medical Use was discussed.D1 square specimen was prepared by the experimental method specified in GB/T 2546.2 and GB/T 17037.3.Then,the effects of operating repeatability,sample uniformity,measurement accuracy,instrument resolution and other parameters on the experimental results of measurement uncertainty were analyzed.It was found that the main factors affecting the measurement of medical polypropylene haze were the instrument measurement accuracy and the operating repeatability.The evaluation of measurement uncertainty is of great significance to the implementation and evaluation of polypropylene haze method.

关 键 词：医用聚丙烯 雾度 不确定度评价 

分 类 号：TQ323.9[化学工程—合成树脂塑料工业]