IEC60601-1第三版(中文版)(6)

9.7 压力容器与受压部件........................................................................................................108 9.8 支撑系统相关风险............................................................................................................110 10 对不希望和过量辐射危险的防护....................................................................................................114

10.1 X射线辐射.........................................................................................................................114 10.2 α、β、γ、中子和其他微粒辐射................................................................................115 10.3 微波辐射............................................................................................................................115 10.4 * 激光和发光二极管（LEDs）............................................................................................115 10.5 其他可视的电磁辐射........................................................................................................115 10.6 红外线辐射........................................................................................................................116 10.7 紫外线辐射........................................................................................................................116 11 对超温和其他安全方面危险的防护................................................................................................116

11.1 * 医用电气设备的超温........................................................................................................116 11.2 * 防火....................................................................................................................................119 11.3 * 医用电气设备外壳火的结构要求....................................................................................124 11.4 * 预期在易燃麻醉气体中使用的医用电气设备和医用电气系统.....................................125 11.5 * 预期在易燃介质中使用的医用电气设备和医用电气系统............................................126 11.6 溢流、泼洒、泄漏、进液或颗粒物质、清洗、消毒、灭菌和与医用电气设备一起使用物质的兼容性....................................................................................................................................126 11.7 医用电气设备和医用电气系统的生物兼容性................................................................127 11.8 * 医用电气设备供电电源/网电源的中断..........................................................................128 12 * 仪器控制精度和危险输出的防止..................................................................................................128

12.1 仪器控制精度....................................................................................................................128 12.2 可用性................................................................................................................................128 12.3 报警系统............................................................................................................................128 12.4 危险输出的防止................................................................................................................128 13 * 危险情况和故障状态......................................................................................................................129

13.1 特定的危险情况................................................................................................................129 13.2 单一故障状态....................................................................................................................130 14 可编程电气医疗系统........................................................................................................................135

14.1 * 通用要求............................................................................................................................135 14.2 * 文档体系............................................................................................................................136 14.3 * 风险管理计划....................................................................................................................136 14.4 * PEMS开发生命周期...........................................................................................................136 14.5 * 问题解决方法....................................................................................................................136 14.6 风险管理程序....................................................................................................................137 14.7 * 需求规格............................................................................................................................137 14.8 * 架构....................................................................................................................................137 14.9 * 设计执行............................................................................................................................138 14.10 * 验证....................................................................................................................................138 14.11 * PEMS 确认..........................................................................................................................138 14.12 PEMS更改...........................................................................................................................139 15 医用电气设备的结构........................................................................................................................139

15.1 医用电气设备控制器与指示器的布置............................................................................139 15.2 可维护性............................................................................................................................139 15.3 机械强度............................................................................................................................140 15.4 医用电气设备器件及总体装配........................................................................................143 16 电气系统（以下简称系统）............................................................................................................152

16.1 系统的通用要求................................................................................................................152 16.2 系统的随机文件................................................................................................................152 16.3 电源....................................................................................................................................153 16.4 外壳....................................................................................................................................153

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