基于技术审评的电子泌尿系统内窥镜相关问题研究  

Study on Electronic Urinary System Endoscopy Based on Medical Devices Technical Review

作　　者：吴璠 WU Fan(Center for Drug Evaluation and Inspection of Anhui,Anhui Hefei 230000)

机构地区：[1]安徽省药品审评查验中心,安徽合肥230000

出　　处：《中国医疗器械信息》2025年第1期23-25,46,共4页China Medical Device Information

摘　　要：针对电子泌尿系统内窥镜的结构形式和临床使用风险,结合相关行业标准和调研情况,从产品注册技术审评角度对内窥镜的图像质量、机械性能、生物学特性研究、消毒灭菌、产品稳定性、关键生产工艺以及临床评价七个方面进行全面分析,旨在建立一套电子泌尿系统内窥镜质量安全评估的核心指标体系。This paper addresses the structural design and clinical usage risks of electronic endoscopes for the urinary system.By incorporating relevant industry standards and research findings,it comprehensively analyzes seven key aspects from the perspective of product registration and technical review:image quality,mechanical properties,biological characteristics research,disinfection and sterilization,product stability,critical manufacturing processes,and clinical evaluation.The objective is to establish a core set of quality and safety assessment indicators for electronic urological system endoscopes.

关 键 词：电子泌尿系统内窥镜 技术审评 质量安全评估 

分 类 号：TH773[机械工程—仪器科学与技术]