摘要
目的:本文简要介绍了药械组合产品的界定原则、含药医疗器械的定义和分类,分析了针对含药医疗器械产品评价的特殊性。结合含药医疗器械的发展,对其检验标准、检验项目和检验方法逐一进行阐述,并对含药器械检验的规范化提出一些可供参考的方案。
This article briefly introduced the classification and jurisdiction of combination products and the definition and classification of drug-containing medical devices,and described the special requirements for the evaluation of drug-containing medical devices.Taking into account of the development of drug-containing medical devices,the standards,test items and methods were also described.Some options on the standardization of drug-containing device testing were proposed.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2011年第7期1430-1433,共4页
Chinese Journal of Pharmaceutical Analysis
关键词
含药
医疗器械
检验
药械组合产品
drug-containing
medical devices
test
combination products
