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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。
This article examines the legal documentation of X-ray diagnostic equipment collected from the FDA website and the European Union Directive on medical devices by using content analysis methods in non-contact studies to understand how the United States, the European Union, X-ray diagnostic equipment related laws and regulations, and prompts China should be enlightened, improve the relevant guidelines to ensure the safe and effective use of X-ray diagnostic equipment.