孔径为15μm药液过滤器的过滤性能评价  

Evaluation of Iltration Performance of Fluid Filter with a Pore Size of 15 μm

作　　者：聂佳祺[1] 姚秀军[1] 郭伟 徐志洲 夏杰[1] 王常斌 万敏[1] NIE Jiaqi;YAO Xiujun;GUO Wei;XU Zhizhou;XIA Jie;WANG Changbin;WAN Min(Physicial Room,Shandong Quality Inspection Center for Medical Devices,Jinan Shandong 250101,China)

机构地区：[1]山东省医疗器械产品质量检验中心物理室,山东济南250101

出　　处：《中国医疗设备》2018年第11期59-61,共3页China Medical Devices

摘　　要：GB8368-2005《一次性使用输液器重力输液式》对标称孔径15μm药液过滤器的过滤性能给出了评价方法,即用直径为(20±1)μm的胶乳粒子悬浮液作为试验液进行滤除率试验,同时在ISO8536-4:2004给出的显微镜法的基础上增加了微粒计数器法。由于微粒计数器法,可设置明确的粒径计数范围,则在试验液的选择上可以有更大的自由度。考虑到用20μm的标准物质评价15μm药液过滤器的局限性,本文选择了均值粒径分别为16、18、20、21μm的乳胶微粒标准物质制备试验液进行对比试验,检测结果表明选用16μm的标准物质试验所得的滤除率结果更有助于差别化地反映药液过滤器的过滤性能。In GB8368-2005 Infusion sets for single use,gravity feed,an evaluation method for the filtration performance of fluid filter with a nominal pore size of 15μm was recommended.An aqueous suspension of latex particle with a diameter of(20±1)μm could be used as a test liquid in the test for efficiency of the fluid filter.The efficiency of the fluid filter was added to the particle counter method based on the microscopy method given in ISO8536-4:2004.Due to the particle counter method,a clear particle size counting range could be set,and there was a greater degree of freedom in the selection of the test liquid.Considering the limitation of evaluating the 15μm fluid filter with 20μm standard substance,we selected the test preparation of latex particle standard substance with average particle size of 16,18,20 and 21μm for comparison test.The test results showed that the results of the filtration efficiency obtained by using the 16μm standard substance were more helpful to differentially reflect the filtration performance of the fluid filter.

关 键 词：药液过滤器 滤除率 微粒计数器法 标准物质 

分 类 号：R331[医药卫生—人体生理学]