| 含药医疗器械产品检验方法的探讨 |
| |
| 引用本文： | 孙雪,冯晓明,卢大伟.含药医疗器械产品检验方法的探讨[J].药物分析杂志,2011(7). |
| |
| 作者姓名： | 孙雪 冯晓明 卢大伟 |
| |
| 作者单位： | 中国药品生物制品检定研究院; |
| |
| 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。
|
| 关 键 词： | 含药 医疗器械 检验 药械组合产品 |
Discussion of test methods of drug-containing medical devices |
| |
| SUN Xue,FENG Xiao-ming,LU Da-wei.Discussion of test methods of drug-containing medical devices[J].Chinese Journal of Pharmaceutical Analysis,2011(7). |
| |
| Authors: | SUN Xue FENG Xiao-ming LU Da-wei |
| |
| Institution: | SUN Xue,FENG Xiao-ming,LU Da-wei(National institutes for food and drug control,Beijing 100050,China) |
| |
| Abstract: | 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. |
| |
| Keywords: | drug-containing medical devices test combination products |
| 本文献已被 CNKI 等数据库收录！ |
|
