聚丙烯纤维药液过滤膜微粒脱落的试验方法研究.PDFVIP

Chinese Journal of Medical Instrumentation 2011 年35 卷第6 期 监 管 与 测 试 文章编号 1671-7104(2011)06-0446-03 ： 聚丙烯纤维药液过滤膜微粒脱落的试验方法研究 宋金子1 1 2 3 3 【作 者】 ，贾 飞 ，柴玉莲 ，孙丙诚 ，李海心 彧 1 国家食品药品监督管理局济南医疗器械质量监督检验中心， 山东省医疗器械生物学评价重点试验室，山东，济南，250101 2 西藏自治区药检所，西藏，拉萨，850000 3 山东恒信检测技术开发中心，山东，济南，250101 【摘 要】通过五组试验(圆、方、方 不晃、烧边、滤器)的对比，讨论了不同的边缘截取和试验方法等对聚丙烯纤维药液过滤膜微粒 脱落试验的影响。结果表明，聚丙烯双面药液过滤膜的边缘微粒脱落现象显著，在考核其微粒污染时必须排除边缘微粒脱 落对试验结果的影响。 【关 键 词】滤膜；微粒脱落；聚丙烯滤膜 【中图分类号】TH789 【文献标志码】B doi:10.3969/j .issn.1671-7104.2011.06.014 Research for the Test method of Polypropylene Fiber Liquid Filtration Membrane Particles Shedding 【Writers 】 1 1 2 3 3 Song Jinzi , Jia Yufei , Chai Yulian , Sun Bingcheng , Li Haixin 1 SFDA Jinan quality supervision and inspection center for medical devices, Shandong provincial key laboratory of biological evaluation of medical devices, Jinan, Shandong, 250101 2 Tibet Autonomous Region Institute for Drug Control, Lasa, Xizang, 850000 3 Hanson Detection Technology Development Center in Shandong, Jinan, Shandong, 250101 【Abstract 】Through five experiments, such as Circle, square, side that does not shake, burning edge, filter, this paper discussed the effect of different experimental methods of polypropylene fiber liquid filtration membrane particles shedding. The results show that: the particles falling off the edge of the polypropylene fiber Double-sided liquid filtration membrane are very important and must be considered off the evaluation of particle pollution. 【 】 Key words filtration membrane,particles shedding, polypropylene filtration membrane 静脉输液是临床