标准解读

《YY 1139-2013 心电诊断设备》是中国国家食品药品监督管理总局发布的一项关于心电图机等心电诊断设备的技术标准。该标准规定了心电诊断设备的基本安全要求和性能要求，旨在确保这些医疗设备能够准确、可靠地记录心脏的电活动，从而为临床诊断提供有效依据。

根据这一标准，心电诊断设备应满足一系列具体条件，包括但不限于电气安全、电磁兼容性以及功能性能等方面的要求。在电气安全方面，强调了设备必须具备良好的绝缘性能与接地措施，以防止使用者受到电击伤害；同时，还对漏电流进行了严格限制。电磁兼容性方面，则要求设备能够在预期使用环境中正常工作而不受外部电磁干扰影响，并且自身也不会对外部其他电子设备造成干扰。至于性能要求部分，涵盖了信号采集精度、频率响应范围等多个维度，保证了心电波形的真实再现及其分析结果的准确性。


如需获取更多详尽信息，请直接参考下方经官方授权发布的权威标准文档。

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  • 2013-10-21 颁布
  • 2014-10-01 实施
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