一次性使用测温硅胶导尿管检测  

Detection of Disposable Temperature Measuring Silicone Catheter

作　　者：吴碧君 胡旭君 WU Bi-jun;HU Xu-jun(Guangdong Medical Device Quality Supervision and Inspection Institute,Guangdong Guangzhou 510663;Industrial Analysis and Testing Center,Guangdong Academy of Sciences,Guangdong Guangzhou 510400)

机构地区：[1]广东省医疗器械质量监督检验所,广东广州510663 [2]广东省科学院工业分析检测中心,广东广州510400

出　　处：《中国医疗器械信息》2023年第9期16-19,159,共5页China Medical Device Information

摘　　要：介绍一次性使用测温硅胶导尿管(以下简称导尿管)的工作原理,并结合工作原理及医药行业标准YY 0325-2016《一次性使用无菌导尿管》对导尿管的几个重要性能指标进行分析,项目包括:耐弯曲性、流量、测温精度、环氧乙烷残留量,并对每个项目的关键点和注意事项加以总结。以期规范相关性能测试实验的步骤,为导尿管的生产企业的研发人员、测试工程师、出厂检验员等相关人员及第三方检测实验室的测试工程师在性能指标测试中提供参考意见。Introduces the working principle of testing temperature urethral catheter for single use(hereinafter referred to as urethral catheter),analyzes several important performance indicators of urethral catheter according to their working principle and industry standard YY 0325-2016“Disposable Sterile urethral Catheters for single use”,summarize the key points and precautions for each indicator.The indicators include bending resistance,flow rate,temperature measurement accuracy,and ethylene oxide residue.The purpose of this article is to standardize the test procedures for related performance tests,and provide reference opinions for the R&D personnel,test engineers,factory inspectors,and other relevant personnel of catheter manufacturers,as well as the third-party labs’test engineer.

关 键 词：导尿管 耐弯曲性 电阻法 气相色谱法 

分 类 号：TH789[机械工程—仪器科学与技术]