IEC 中 单通道和多通道心电图机
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国际 标准
IEC
60601-2-51
第1版
2003-02
医用电气设备 第 2-51 部分： 单通道和多通道心电图机的记录和分析的主要性能和安全专用要求
分析的主要性能和安全专用要求》
2
目录
前言（略） 引言（略） 第 一 篇 概 述 ..............................................................................................................................................................................5 1. 适用范围和目的 .............................................................................................................................................................................5
*1.1 范围.............................................................................................................................................................................................5 1.2 目的...............................................................................................................................................................................................5 1.3 专用标准.....................................................................................................................................................................................5 术语和定义 ..........................................................................................................................................................................................6 2.101 心电分析 ANALYSING ELECTROCARDIOGRAPH........................................................................................................6 2.102 校准 CALIBRATION（“CAL”） ...........................................................................................................................................6 2.103 校准电压 CALIBRATION VOLTAGE..................................................................................................................................6 2.104 威尔逊导联中心点 CENTRAL TERMINAL ACCORDING TO WILSON（CT）.............................................................6 2.105 通道 CHANNEL......................................................................................................................................................................6 2.106 共模抑制...................................................................................................................................................................................6 2.107 共模型直流偏置电压 ...............................................................................................................................................................6 2.108 ECG 记录 ECG RECORD ..................................................................................................................................................6 2.109 有效记录宽度 ...........................................................................................................................................................................6 2.110 心电图 ELECTROCARDIOGRAM（ECG）........................................................................................................................7 2.111 心电图机 ELECTROCARDIOGRAPH（ecg）...................................................................................................................7 2.113 滤波器 FILTER（S） .............................................................................................................................................................7 2.114 导联线 LEAD WIRE（S）.....................................................................................................................................................7 2.115 导联 LEAD （S） ..................................................................................................................................................................7 2.117 多通道心电图机 MALTICHANNEL ELECTROCARDIOGRAPH ......................................................................................7 2.119 噪声 NOISE.............................................................................................................................................................................7 2.120 标准灵敏度 NORMAL SENSITIVITY...................................................................................................................................7 2.121 过载允差 OVERLOAD TOLERANCE..................................................................................................................................7 2.122 患者电缆 PATIENT CABLE...................................................................................................................................................7 2.123 心电记录仪...............................................................................................................................................................................7 2.124 戈氏（金伯杰）参考点 REFERENCE POINT ACCORDING TO GOLDBERGER .......................................................7 2.126 单通道心电图机 SINGLE CHANNEL ELECTROCARDIOGRAPH..................................................................................8 2.127 测试 TEST...............................................................................................................................................................................8 2.128 时间常数 TIME CONSTANT.................................................................................................................................................8 2.129 波形识别点 WAVE RECOGNITION POINTS .....................................................................................................................8 4.0 对试验的通用要求 .......................................................................................................................................................................8 4.6 其他条件.......................................................................................................................................................................................8 4.11 试验顺序.....................................................................................................................................................................................8 6. 识别、标记和文件 .........................................................................................................................................................................8 *6.1 设备或设备部件的外部标记 .....................................................................................................................................................8 第 二 篇 环境条件 ......................................................................................................................................................................10 第 三 篇 对电击危险的防护 ........................................................................................................................................................10 第 四 篇 对机械危险的防护 ....................................................................................................................................................10 第 五 篇 对不需要的或过量的辐射危险的防护.........................................................................................................................10 第 六 篇 对易燃麻醉混合气点燃危险的防护...............................................................................................................................10 第 七 篇 对超温和其他安全方面危险的防护...............................................................................................................................10
IEC
60601-2-51
第1版
2003-02
医用电气设备 第 2-51 部分： 单通道和多通道心电图机的记录和分析的主要性能和安全专用要求
分析的主要性能和安全专用要求》
2
目录
前言（略） 引言（略） 第 一 篇 概 述 ..............................................................................................................................................................................5 1. 适用范围和目的 .............................................................................................................................................................................5
*1.1 范围.............................................................................................................................................................................................5 1.2 目的...............................................................................................................................................................................................5 1.3 专用标准.....................................................................................................................................................................................5 术语和定义 ..........................................................................................................................................................................................6 2.101 心电分析 ANALYSING ELECTROCARDIOGRAPH........................................................................................................6 2.102 校准 CALIBRATION（“CAL”） ...........................................................................................................................................6 2.103 校准电压 CALIBRATION VOLTAGE..................................................................................................................................6 2.104 威尔逊导联中心点 CENTRAL TERMINAL ACCORDING TO WILSON（CT）.............................................................6 2.105 通道 CHANNEL......................................................................................................................................................................6 2.106 共模抑制...................................................................................................................................................................................6 2.107 共模型直流偏置电压 ...............................................................................................................................................................6 2.108 ECG 记录 ECG RECORD ..................................................................................................................................................6 2.109 有效记录宽度 ...........................................................................................................................................................................6 2.110 心电图 ELECTROCARDIOGRAM（ECG）........................................................................................................................7 2.111 心电图机 ELECTROCARDIOGRAPH（ecg）...................................................................................................................7 2.113 滤波器 FILTER（S） .............................................................................................................................................................7 2.114 导联线 LEAD WIRE（S）.....................................................................................................................................................7 2.115 导联 LEAD （S） ..................................................................................................................................................................7 2.117 多通道心电图机 MALTICHANNEL ELECTROCARDIOGRAPH ......................................................................................7 2.119 噪声 NOISE.............................................................................................................................................................................7 2.120 标准灵敏度 NORMAL SENSITIVITY...................................................................................................................................7 2.121 过载允差 OVERLOAD TOLERANCE..................................................................................................................................7 2.122 患者电缆 PATIENT CABLE...................................................................................................................................................7 2.123 心电记录仪...............................................................................................................................................................................7 2.124 戈氏（金伯杰）参考点 REFERENCE POINT ACCORDING TO GOLDBERGER .......................................................7 2.126 单通道心电图机 SINGLE CHANNEL ELECTROCARDIOGRAPH..................................................................................8 2.127 测试 TEST...............................................................................................................................................................................8 2.128 时间常数 TIME CONSTANT.................................................................................................................................................8 2.129 波形识别点 WAVE RECOGNITION POINTS .....................................................................................................................8 4.0 对试验的通用要求 .......................................................................................................................................................................8 4.6 其他条件.......................................................................................................................................................................................8 4.11 试验顺序.....................................................................................................................................................................................8 6. 识别、标记和文件 .........................................................................................................................................................................8 *6.1 设备或设备部件的外部标记 .....................................................................................................................................................8 第 二 篇 环境条件 ......................................................................................................................................................................10 第 三 篇 对电击危险的防护 ........................................................................................................................................................10 第 四 篇 对机械危险的防护 ....................................................................................................................................................10 第 五 篇 对不需要的或过量的辐射危险的防护.........................................................................................................................10 第 六 篇 对易燃麻醉混合气点燃危险的防护...............................................................................................................................10 第 七 篇 对超温和其他安全方面危险的防护...............................................................................................................................10