摘要
采用非接触性研究中的内容分析方法,通过对从欧盟医疗器械指令上收集的有关X射线诊断设备法律文件进行总结分析,了解欧盟对X射线诊断设备相关法律法规要求,并提示我国应从中得到启示,完善相关指导原则,以确保X射线诊断设备安全、有效地使用。
By content analysis in non-contact research,law documents relevant to X-ray Diagnostic Equipment were collected from EU Medical Devices Directive,Of which,the federal regulation was mainly analyzed.A set of comprehensive lawful system for X-ray Diagnostic Equipment has been established by EU,from which China should draw experience,to improve guidances,thus guarantee the safety and efficacy of device.
出处
《中国医疗器械信息》
2011年第3期36-38,共3页
China Medical Device Information
关键词
X射线诊断设备
医疗器械指令
指导原则
X-ray diagnostic equipment
medical devices directive
guidance
