3.97 额定（值）..........................................................................................................................21 3.98 记录......................................................................................................................................21 3.99 * 加强绝缘..............................................................................................................................21 3.100 剩余风险..............................................................................................................................21 3.101 责任机构..............................................................................................................................21 3.102 风险......................................................................................................................................21 3.103 风险分析..............................................................................................................................21 3.104 风险评定..............................................................................................................................21 3.105 风险控制..............................................................................................................................21 3.106 风险评价..............................................................................................................................21 3.107 风险管理..............................................................................................................................21 3.108 风险管理文档......................................................................................................................22 3.109 安全工作载荷......................................................................................................................22 3.110 * 二次电路..............................................................................................................................22 3.111 自恢复热断路器..................................................................................................................22 3.112 * 隔离装置..............................................................................................................................22 3.113 用服人员..............................................................................................................................22 3.114 危害性..................................................................................................................................22 3.115 * 信号输入、输出部分（SIP/SOP）....................................................................................22 3.116 单一故障状态......................................................................................................................22 3.117 单一故障安全......................................................................................................................22 3.118 非移动式的..........................................................................................................................22 3.119 辅助绝缘..............................................................................................................................23 3.120 * 供电网..................................................................................................................................23 3.121 拉力安全因子......................................................................................................................23 3.122 抗拉强度..............................................................................................................................23 3.123 接线端子装置......................................................................................................................23 3.124 热断路器..............................................................................................................................23 3.125 热稳定..................................................................................................................................23 3.126 恒温器..................................................................................................................................23 3.127 工具......................................................................................................................................23 3.128 总载荷..................................................................................................................................23 3.129 接触电流..............................................................................................................................23 3.130 可移动的..............................................................................................................................24 3.131 限制区域..............................................................................................................................24 3.132 * B型应用部分.......................................................................................................................24 3.133 * BF型应用部分.....................................................................................................................24 3.134 * CF型应用部分.....................................................................................................................24 3.135 型式试验..............................................................................................................................24 3.136 可用性..................................................................................................................................24 3.137 可用性工程..........................................................................................................................24 3.138 验证......................................................................................................................................25 3.139 * 工作电压..............................................................................................................................25 4 通用要求..............................................................................................................................................25
4.1 * 医用电气设备或医疗电气系统的应用条件......................................................................25 4.2 * 医用电气设备或医疗电气系统的风险管理程序..............................................................25 4.3 * 基本性能..............................................................................................................................26 4.4 * 预期使用寿命......................................................................................................................26 4.5 * 医用电气设备或医疗电气系统的等效安全......................................................................26 4.6 * 与病人接触的医用电气设备或医疗电气系统..................................................................26
4