摘要
我国现行体外诊断医用设备安全标准GB4793.1-2007和YY0648-2008中,未对体外诊医用设备系统安全要求进行规定。本文论述了体外诊断医用设备系统电击危害原理及相关评估建议。
There is no protection against electric shock hazards for IVD systems in the current national medical electrical equipment safety standards GB4793.1-2007 and YY0648-2008. This article discussed the principles and recommendations of the evaluation of protection against electric shock hazards for IVD systems.
出处
《中国医疗器械信息》
2014年第9期51-54,共4页
China Medical Device Information
关键词
体外诊断医用设备
系统
电击防护
IVD, Systems, protection against electric shock hazards
