中国医疗设备2011，Vol.26Issue(3)：72-75,4.DOI:10.3969/j.issn.1674-1633.2011.03.025
浅谈X射线诊断设备国内外相关法律文件要求
Discussion about Domestic and International Law Documents of X-ray Diagnostic Equipment
迟戈 1王亚南 2李非 1马艳彬 1李竹 1梁文1
作者信息
- 1. 辽宁省食品药品监督管理局技术审评中心,辽宁,沈阳,110003
- 2. 辽宁省医疗器械产品质量监督检验所,辽宁,沈阳,110179
- 折叠
摘要
Abstract
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, thug to guarantee the safety and efficacy of device.关键词
X射线诊断设备/医疗器械法规文件/辐射安全/质量保证分类
社会科学引用本文复制引用
迟戈,王亚南,李非,马艳彬,李竹,梁文..浅谈X射线诊断设备国内外相关法律文件要求[J].中国医疗设备,2011,26(3):72-75,4.
