摘要
目的:从技术审评角度,研究一次性使用导尿管产品的安全性和有效性。方法:基于各国行业标准和指南文件,对一次性使用导尿管的结构组成、作用机理、技术要求、风险分析、临床要求五个方面进行了分析研究,尤其是较为忽视的化学性能要求和涂层要求。结论:从技术审评角度,为保证导尿管产品的安全性和有效性,应加强对导尿管产品材料化学性能要求和生物学评价,增加对导尿管涂层的技术要求。
Objective：This article aim to study the safety and efficacy of catheters for single use.Methods：Based on standards and guidance from various countries and regions,a research is carried out focused on the structure,principle,technical performance,risk factors and clinical trial of catheters,especially chemical analysis and coatings which are neglected in China.Conclusions：To assure the safety and efficacy of catheters,chemical analysis and biocompatibility should be enhanced for catheter materials,and technical requirements should be added for catheter coatings.
出处
《中国医疗器械信息》
2010年第9期40-43,共4页
China Medical Device Information
关键词
导尿管
化学性能
生物学评价
涂层
catheters
chemical analysis
biocompatibility
coatings
