医用电气设备可触及金属部件保护接地要求分析  

Analysis of protective earth requirement for touched metal parts of medical electrical equipment

作　　者：刘继广 王伟 邓振进 徐勤[4] 尹勇 

机构地区：[1]国家医用诊断仪器工程技术研究中心可靠性检测实验室,广东深圳518057 [2]上海医疗器械检测所,上海201318 [3]湖南省医疗器械检验检测所,长沙410019 [4]深圳出入境检验检疫局,广东深圳518057 [5]通标标准技术服务(上海)有限公司,上海201612

出　　处：《医疗卫生装备》2017年第2期95-97,108,共4页Chinese Medical Equipment Journal

基　　金：国家科技支撑计划(2015BAI10B00)

摘　　要：目的 :探讨医用电气设备可触及金属部件的保护接地要求,帮助制造商理解国家标准对保护接地的要求,以便合理设计产品。方法:通过研究国家标准对可触及金属部件的隔离方法,分析保护接地配合基本绝缘隔离方法的防护原理,讨论隔离方法(2)——用保护接地的金属部件隔离的特征条件,并举例对麻醉机的呼吸系统结构及电击防护方式进行分析。结果:对于不满足保护接地和双重绝缘或加强绝缘的可触及金属部件,如果基本绝缘失效时,可触及金属部件不带电,则通过结构检查,可判定可触及金属部件满足国家标准要求。结论:只有对标准条款进行深入全面的理解,通过结构检查对被测设备的电气结构有清晰的认识,才能对可触及金属部件是否需要保护接地或双重绝缘或加强绝缘做出准确公正的判断。Objective To study the protective earth requirement for touched metal parts of medical electrical equipment to improve the manufacturer′s understanding on national standards. Methods The isolation methods for the touched metal parts in national standards were studied, and the principle of protective earth combined with insulation separating was analyzed.The characteristics of the second isolation method was discussed, and the respiratory system structure and electroshock protection of the anaesthetic machine were taken as examples. Results The touched metal parts with no measures for grounding, double isolation or reinforced insulation was determined by structure detection to meet the requirements of national standards in case basic insulation ceased to be effective and the parts were uncharged. Conclusion The necessities to gift the touched metal parts with measures for grounding, double isolation or reinforced insulation should depend on the understanding on national standards and electrical construction of the equipment under test by structure detection.

关 键 词：医用电气设备 可触及金属部件 保护接地 电气结构 医用电气安全标准 

分 类 号：R318.6[医药卫生—生物医学工程] R197.39[医药卫生—基础医学]