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ISO/IEC18000-3.pdf
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
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
I 类 .......................................................................................................................................13
3.13
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
2
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
3
3.96 保护接地 ..............................................................................................................................20
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
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
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
6
16.5 隔离装置 ............................................................................................................................153
16.6 漏电流 ................................................................................................................................154
16.7 机械危险的防护 ................................................................................................................155
16.8 系统部件的电源中断 ........................................................................................................155
16.9 系统连接和布线 ................................................................................................................155
17 医用电气设备和医用电气系统的电磁兼容性 ................................................................................157
附录 A（信息性的）通用指导和基本原理 .............................................................................................158
附录 B 测试顺序 .....................................................................................................................................245
附录 C（细则）医疗设备和体系记号和标注的指导要求 .....................................................................248
附录 D（细则）标记符号(见第 6 章） ...................................................................................................250
附录 E（提供的信息） .............................................................................................................................258
附录 F 合适的电源测量电路 ....................................................................................................................260
附录 H (资料性的) ...................................................................................................................................262
附录 I 医疗系统面面观 ...........................................................................................................................275
附录 J 绝缘路径考察 ................................................................................................................................282
附录 K（提供的信息） .............................................................................................................................285
附录 L (规范性附录)使用无插入绝缘的绝缘绕线(见 8.8.2)................................................................289
7
医疗电气设备
第一部分：安全通用要求和基本规则
1 范围、目标和相关标准
1.1 范围
这个国家标准适用于医疗电气设备和医疗电气系统的基本安全和基本性能。以下简称为
医疗设备和医疗系统。
如果一个条款或子条款特别预期仅应用于医疗设备，或医疗系统，标题和条款或子条款
的正文会说明。如果不是这种情况，条款或子条款适用于医疗设备和医疗系统。
由于在本标准范围内的医疗设备或医疗设备系统的预期生理功能所固有的危害在本标
准中没有详细的规定，除了在 7.2.13 和 8.4.1 中。
注意： 也可见 4.2
这个标准可以应用于补偿或减轻疾病、伤害或残疾的设备。
不落入医疗设备定义的体外诊断设备由 IEC61010 系列标准覆盖。这个标准不适用于由
于植入医疗设备的植入部分，这个由 Iso14708－1 进行规定。
1.2 目标
本标准的目标是为了规定通用要求和作为专标的基础。
1.3 * 并列标准
在 IEC60601 系列中，并列标准规定基本安全和基本性能的通用要求，适用于：
－ 医疗设备的一类子类（例如，放射设备）；
－本标准中未完全提及的所有医疗设备的特定的特征。
适用的并列标准在颁布时成为规范并应和本标准一起应用。
注意 1：当评估 IEC60601-1 符合性时，允许独立评估其并列标准的符合性。
注意 2：当声称符合 IEC60601-1 时，声称需专门列出使用的并列标准。这允许声明的
读者了解哪个并列标准是评估的一部分。
注意 3:IEC 的成员维护一个有效国际标准的记录簿。任何使用这个标准的人需查询这个
记录簿来决定哪些并列标准被颁布。
如果医疗设备适用并列标准的同时也有专用标准存在，那么专用标准优先于并列标准。
1.4 * 专用标准
在 IEC60601 系列中，对于所考虑的特殊的医疗设备，专用标准可能修改、替代或删除
本标准中的适用的要求，并可能增加其他基本安全和基本性能的要求。
8
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