一次性使用无菌导尿管产品质量标准研究  

Study on the Quality Standard of Sterile Urethral Catheter

作　　者：刘世红 赵永胜 刘功远 

机构地区：[1]甘肃省医疗器械检验检测所,兰州730101 [2]南京工业大学,南京211800

出　　处：《中国药事》2015年第9期921-925,共5页Chinese Pharmaceutical Affairs

摘　　要：目的:对一次性使用无菌导尿管进行产品质量调研和检验,探讨影响产品质量的因素,并对行业标准应增加的内容提出建议。方法:通过检验对数据进行统计比对,分析研究该产品的现行国际标准、行业标准、企业注册标准的不同之处。结果与结论:我国行业标准对该产品关键参数的要求是全面的,对产品的安全性和有效性均作了要求。但对扭结度、阀门标记、流量等,建议增加或修订必要的检验项目,将会对该产品的质量要求更为全面。Objective： To make a survey on the quality standard of the Sterile Urethral Catheter, so as to probe into the factors which affect the quality of products and to suggest the industry standard that needs to be replenished. Methods： Data analysis was carried out, and a comparison study was performed. Then, the difference among the current international standard, industry standard and enterprise registration standard was discussed. Results and Conclusion： The current standard of our country is basically comprehensive, which covered the security as well as validity of the products. However, it is suggested that other inspection items for kink degree, valve marking and rate of fl ow be added to make the standard more comprehensive.

关 键 词：医疗器械 一次性使用无菌导尿管 质量标准 国际标准 行业标准 注册标准 关键参数 扭结度 阀门标记 流量 修订建议 

分 类 号：R197.39[医药卫生—卫生事业管理]