摘要
本文主要介绍了在医疗器械市场中的有关安全认证体系 ,它包括我国的CCC认证 ,欧盟的CE认证和美国的FDA市场准入510K规范。
This article introduces some safety certification systems in medical apparatus,including China Compulsory Certification,Conformity with European and Premarket Notificationof Certification of U.S.Food and Drug Ad-ministration.
出处
《医疗设备信息》
2004年第1期46-48,共3页
Information of Medical Equipment
关键词
医疗器械
安全认证
CCC认证
CE认证
FDA认证
medical apparatus
safety certification
China Compulsory Certification
Conformity with European
Certifi-cation of U.S.Food and Drug Administration
