摘要
本文通过采用非接触性研究中的内容分析方法,从美国食品药品监督管理局(FDA)网站,以及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并进行总结分析,了解美国、欧盟对X射线诊断设备相关法律法规的要求,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 FDA website and 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 FDA and EU,from which China should draw experience,to improve guidance,thus to guarantee the safety and efficacy of device.
出处
《中国医疗设备》
2011年第3期72-75,共4页
China Medical Devices
关键词
X射线诊断设备
医疗器械法规文件
辐射安全
质量保证
X-ray diagnostic equipment
medical device law documents
radiation safety
quality assurance
