摘要
该文对一次性使用无菌导尿管进行介绍,对导尿管的类型和特点进行分析,对与之配合使用的润滑剂和涂层进行了分类概述,对其监管类别、风险评估、涉及的国行标和指导原则、条例通告进行阐述,并简要介绍临床评价关注点。对其注册申报时的审评要求、安全性及有效性进行探讨,从技术审评角度展开思考,希望对此类医疗器械注册及技术审评工作有助益。
This article introduces the disposable sterile catheter,analyzes the type and characteristics of the catheter,and classifies the lubricants and coatings used in combination with it,its regulatory categories,risk assessment,the national standards and guidelines,and the notices of the regulations are elaborated,and the clinical evaluation concerns are briefly introduced.Discussing the review requirements,safety and effectiveness at the time of registration,and thinking from the perspective of technical review,I hope to benefit from such medical device registration and technical review work.
作者
湛娜
ZHAN Na(Center for Medical Device Technology Evaluation,State Food and Drug Administration,Beijing,100081 China)
出处
《中国卫生产业》
2019年第34期180-182,共3页
China Health Industry
关键词
导尿管
润滑剂
技术审评
风险评估
Catheter
Lubricant
Technical review
Risk assessment
