经皮肾穿刺套件检测代表性产品研究分析  

Study and Analysis on the Test of Representative Products for Percutaneous Renal Puncture Device

作　　者：蒋鲁杰 郑忠伟 JIANG Lujie;ZHENG Zhongwei(Center for Certification & Evaluation,SHFDA,Shanghai,200020;Innovex Medical Co. Ltd,Shanghai,201210)

机构地区：[1]上海市食品药品监督管理局认证审评中心,上海市200020 [2]上海英诺伟医疗器械有限公司,上海市201210

出　　处：《中国医疗器械杂志》2019年第3期214-216,共3页Chinese Journal of Medical Instrumentation

摘　　要：经皮肾穿刺套件有非常重要的临床使用价值。经皮穿刺肾套件的检测合格是评价其安全有效性的重要方式之一,也是该产品能够在国内上市的重要前提。当生产企业进行产品检测时,代表性产品的选择建议从性能指标、结构组成、材料、生产工艺等方面综合考虑。Percutaneous renal puncture device has very important clinical value.Qualified percutaneous renal puncture device is one of the important ways to evaluate its safety and efficacy,and it is also an important prerequisite for the device to be marketed in China.When manufactuers test the product,the selection of representative products is suggested from the aspects of performance parameter,structure,material and production process.

关 键 词：经皮穿刺肾造瘘术 医疗器械 扩张器 肾造瘘球囊导管 法规 

分 类 号：R197.39[医药卫生—卫生事业管理]