4.7 * 医用电气设备的单一故障条件..........................................................................................26 4.8 医用电气设备的器件..........................................................................................................27 4.9 * 医用电气设备中对高完善性器件的使用..........................................................................28 4.10 * 电源......................................................................................................................................29 4.11 输入功率..............................................................................................................................29 5 * 医用电气设备测试的通用要求..........................................................................................................30
5.1 * 类型测试..............................................................................................................................30 5.2 * 样品量..................................................................................................................................30 5.3 环境温度，湿度，大气压力..............................................................................................30 5.4 其它条件..............................................................................................................................30 5.5 供电电压，电流类型，供电类型，频率..........................................................................30 5.6 维修和更改..........................................................................................................................31 5.7 * 潮湿预处理作业..................................................................................................................31 5.8 测试序列..............................................................................................................................32 5.9 * 应用部分和可触及部分的鉴定..........................................................................................32 6 * 医疗设备和医疗系统的分类..............................................................................................................34
6.1 综述......................................................................................................................................34 6.2 * 电击保护..............................................................................................................................34 6.3 * 有害的进液或微粒的保护..................................................................................................34 6.4 消毒的方法..........................................................................................................................35 6.5 富氧环境的适用性..............................................................................................................35 6.6 * 操作模式..............................................................................................................................35 7 医疗电气设备识别，标识和文件......................................................................................................35
7.1 通用......................................................................................................................................35 7.2 设备或设备部件的外部标记..............................................................................................36 7.3 设备或设备内部的要求（参见表C.2）...........................................................................39 7.4 控制器件和仪表的标记（也可见表C.3）.......................................................................41 7.5 安全符号..............................................................................................................................42 7.6 符号......................................................................................................................................43 7.7 导线绝缘的颜色..................................................................................................................43 7.8 * 指示灯和按钮......................................................................................................................44 7.9 随机文件..............................................................................................................................44 8 * 医疗设备电气危险的防护...................................................................................................................49
8.1 对电击防护的基本要求......................................................................................................49 8.2 和网电源相关的要求..........................................................................................................49 8.3 应用部分的分类..................................................................................................................50 8.4 电压、电流和能量的限制..................................................................................................50 8.5 部件的隔离..........................................................................................................................52 8.6 * 设备的保护接地、功能接地和电位均衡..........................................................................59 8.7 漏电流和患者辅助电流......................................................................................................61 8.8 绝缘......................................................................................................................................76 8.9 * 爬电距离和电气间隙..........................................................................................................80 8.10 元器件和电线......................................................................................................................90 8.11 网电源部分、元器件和布线..............................................................................................91 9 医疗设备和医疗系统的机械危险防护..............................................................................................96
9.1 医疗设备的机械危险..........................................................................................................96 9.2 * 与活动部件相关的危险......................................................................................................97 9.3 * 与边、角、面相关的危险................................................................................................102 9.4 * 不稳定危险........................................................................................................................102 9.5 * 飞散部件危险....................................................................................................................107 9.6 声能（包括次声和超声）和振动....................................................................................107
5