血液净化治疗滤网的功能特性指标研究  

Study on Functional Characteristic Index of Blood Purification Therapy Filter

作　　者：胡相华 谢妍[1,2] 宁锐剑 Hu Xianghua;Xie Yan;Ning Ruijian(NMPA Key Laboratory for Extracorporeal Circulation Devices,Guangzhou Guangdong 510663,China;Guangzhou Medical Instruments Quality Surveillance and Inspection Center,Guangzhou Guangdong 510663,China)

机构地区：[1]国家药品监督管理局体外循环器械重点实验室,广东广州510663 [2]广东省医疗器械质量监督检验所,广东广州510663

出　　处：《医疗装备》2023年第23期31-33,36,共4页Medical Equipment

基　　金：广东省药品监督管理局科技创新项目(2022ZDZ05)。

摘　　要：血液净化治疗滤网是血液净化治疗耗材中的重要功能组件,但现行标准尚缺少该部件相关统一适用的功能特性指标。针对这一情况,该研究结合血液净化治疗滤网的结构特点及适用的临床功能特性,对与临床功能相关的特性指标开展研究,从宏观及微观方面分别对该组件的匹配性进行分析。实验结果显示,血液净化治疗滤网的适宜安装位置、网孔均匀性、合适孔高范围等结构特性有助于临床预期功能的实现。建议将滤网安装位置及相关网孔结构特性等指标作为完善相关产品行业标准参数的补充参考。Blood purification therapy filter is an important functional component in blood purification therapy,but the current national standard of related products containing this component still lacks a uniform requirement of applicable functional characteristics index.According to this situation,the characteristic index related to clinical function of this component is studied.Combined with the structure characteristics of blood purification therapy filter and applicable clinical function characteristics,the ablicability between the structure characteristics and clinical function of the component was analyzed from macro and micro aspects.The experimental results show that the blood purification therapy filter contained in the test can achieve the expected clinical function appropriate installation position and the design of the pore structure.The relevant functional and characteristic index can be used as the improvement and useful supplementary reference of the industry standard parameters of related products.

关 键 词：血液净化治疗滤网 功能特性 指标研究 

分 类 号：R459.5[医药卫生—治疗学]