IEC60601-1第三版(中文)

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国际标准 IEC60601-1

医用电气设备——

第一部分：安全通用要求和基本准则

MEDICAL ELECTRICAL EQUIPMENT –

Part 1: General requirements for basic safety

and essential performance

1 范围、目标和相关标准 ........................................................................................................................8

1.1 范围 ........................................................................................................................................8

1.2 目标 ........................................................................................................................................8

1.3 * 并列标准 ................................................................................................................................8

1.4 * 专用标准 ................................................................................................................................8

2 * 规范参考 ................................................................................................................................................9

3 * 术语和定义 ............................................................................................................................................9

3.1 调节孔盖 ................................................................................................................................9

3.2 可触及部分 ............................................................................................................................9

3.3 附件 ........................................................................................................................................9

3.4 随机文件 ..............................................................................................................................10

3.5 电气间隙 ..............................................................................................................................10

3.6 设备连接装置 ......................................................................................................................10

3.7 设备电源输入插口 ..............................................................................................................10

3.8 * 应用部分 ..............................................................................................................................10

3.9 * 基本绝缘 ..............................................................................................................................11

3.10 * 基本安全 ..............................................................................................................................12

3.11 AP 类 .....................................................................................................................................12

3.12 APG 类 ...................................................................................................................................12

3.13 I类.......................................................................................................................................13

3.14 II 类 .....................................................................................................................................13

3.15 清晰可见 ..............................................................................................................................13

3.16 冷态 ......................................................................................................................................13

3.17 * 高完善性器件 ......................................................................................................................13

3.18 * 连续工作 ..............................................................................................................................13

3.19 爬电距离 ..............................................................................................................................13

3.20 * 除颤防护的应用部分 ..........................................................................................................13

3.21 * 可拆卸的电源线 ..................................................................................................................13

3.22 * 直接心脏应用 ......................................................................................................................13

3.23 * 双重绝缘 ..............................................................................................................................13

3.24 * 持续率 ..................................................................................................................................14

3.25 对地漏电流 ..........................................................................................................................14

3.26 * 外壳 ......................................................................................................................................14

3.27 * 基本性能 ..............................................................................................................................14

3.28 预期使用寿命 ......................................................................................................................14

3.29 F 型隔离（浮动）应用部分（以下称为 F 型应用部分） ...............................................14

3.30 固定 ......................................................................................................................................14

3.31 与空气混合的易燃麻醉气体 ..............................................................................................14

3.32 与氧或氧化亚氮混合的易燃麻醉气体 ..............................................................................14

3.33 * 功能连接 ..............................................................................................................................14

3.34 功能接地导线 ......................................................................................................................14

3.35 * 功能接地端子 ......................................................................................................................15

3.36 防护 ......................................................................................................................................15

3.37 手持 ......................................................................................................................................15

3.38 * 伤害 ......................................................................................................................................15

3.39 危险 ......................................................................................................................................15

3.40 * 危险状况 ..............................................................................................................................15

3.41 高压 ......................................................................................................................................15

3.42 水压测试压力 ......................................................................................................................15

3.43 绝缘配合 ..............................................................................................................................15

3.44 预期使用预期用途 ............................................................................................................15

3.45 内部电源 ..............................................................................................................................16

3.46 内部供电 ..............................................................................................................................16

3.47 泄漏电流 ..............................................................................................................................16

3.48 网电源连接器 ......................................................................................................................16

3.49 * 网电源部分 ..........................................................................................................................16

3.50 * 网电插头 ..............................................................................................................................16

3.51 网电变压器 ..........................................................................................................................16

3.52 网电源接线端子 ..................................................................................................................16

3.53 网电瞬态电压 ......................................................................................................................16

3.54 电网电压 ..............................................................................................................................16

3.55 制造厂 ..................................................................................................................................17

3.56 * 最大网电压 ..........................................................................................................................17

3.57 * 最大容许工作压力 ..............................................................................................................17

3.58 * 操作者保护方式 ..................................................................................................................17

3.59 * 患者保护方式 ......................................................................................................................17

3.60 * 保护措施 ..............................................................................................................................17

3.61 机械危险 ..............................................................................................................................17

3.62 机械防护装置 ......................................................................................................................17

3.63 * 医用电气设备 ......................................................................................................................17

3.64 * 医疗电气系统 ......................................................................................................................18

3.65 可移动的 ..............................................................................................................................18

3.66 * 型式标记 ..............................................................................................................................18

3.67 * 多孔输出插座 ......................................................................................................................18

3.68 * 网络/数据接合 ....................................................................................................................18

3.69 标称（值） ..........................................................................................................................18

3.70 正常状态 ..............................................................................................................................18

3.71 正常使用 ..............................................................................................................................18

3.72 客观凭证 ..............................................................................................................................18

3.73 * 操作者 ..................................................................................................................................18

3.74 过流释放器 ..........................................................................................................................19

3.75 * 富氧环境 ..............................................................................................................................19

3.76 患者 ......................................................................................................................................19

3.77 * 患者辅助漏电流 ..................................................................................................................19

3.78 * 患者连接 ..............................................................................................................................19

3.79 * 患者环境 ..............................................................................................................................19

3.80 患者漏电流 ..........................................................................................................................19

3.81 * 峰值工作电压 ......................................................................................................................19

3.82 PEMS 开发周期 ....................................................................................................................19

3.83 PEMS 确认 .............................................................................................................................19

3.84 永久性安装 ..........................................................................................................................19

3.85 便携的 ..................................................................................................................................20

3.86 电位均衡导线 ......................................................................................................................20

3.87 电源软电线 ..........................................................................................................................20

3.88 程序 ......................................................................................................................................20

3.89 过程 ......................................................................................................................................20

3.90 可编程电气医疗系统 ..........................................................................................................20

3.91 可编程电气子系统 ..............................................................................................................20

3.92 正确安装的 ..........................................................................................................................20

3.93 保护接地导线 ......................................................................................................................20

3.94 保护接地连接 ......................................................................................................................20

3.95 保护接地端子 ......................................................................................................................20

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标签： #IEC60601 #第三版 #中文

摘要：

1国际标准IEC60601-1医用电气设备——第一部分：安全通用要求和基本准则MEDICALELECTRICALEQUIPMENT–Part1:Generalrequirementsforbasicsafetyandessentialperformance21范围、目标和相关标准........................................................................................................................81.1范围.....................................

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