心电监护及算法认证测试

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心电监护及算法认证测试

实验室具备CB、CNAS、CMA、A2LA等检测资质

提供覆盖电气安全、EMC、无线功能、网络安全等多项目检测

服务背景

随着全球监管持续收紧，欧盟MDR、美国FDA 510(k)、日本PMDA等法规对设备的电气安全、电磁兼容与性能准确性提出了更高要求。对心电监护设备而言，心律失常自动识别算法的灵敏度与特异度，直接决定预警的准确性；蓝牙、Wi-Fi等无线功能的普及，也使无线共存与射频合规成为上市的必答题。

SGS依托中国上海、广州、深圳三地专业实验室，检测能力覆盖全品类有源电生理及生命体征监测产品，包括心电图机、多参数监护仪、除颤监护仪、脑电图机等。

服务内容

心电监护及生命体征监测设备的安规测试以IEC 60601-1（对应国标GB 9706.1）通用要求为基础，专用标准主要包括IEC 60601-2-25（对应GB 9706.225）、IEC 60601-2-27（对应GB 9706.227）、IEC 60601-2-47（对应YY 9706.247）、IEC 80601-2-30（对应YY 9706.230）、ISO 80601-2-56（对应YY 9706.256）、ISO 80601-2-61（对应YY 9706.261）等；电磁兼容测试依据IEC 60601-1-2（对应YY 9706.102）；心律失常算法性能评价依据ANSI/AAMI EC57。上述测试均按现行有效版本执行，详见下表。

心电监护电生理类安规EMC检测标准分为：

检测项目	国际标准编号	标准名称（中文 / English）	对应国标/行标
安规	IEC 60601-1	基本安全和基本性能通用要求 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance	GB 9706.1-2020
	IEC 60601-1-6	可用性 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability	YY/T 9706.106-2021
	IEC 60601-1-8	报警系统通用要求、测试与指南 Medical electrical equipment - Part 1-8: Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems	YY 9706.108-2021
	IEC 60601-1-11	家庭护理环境用设备要求 Medical electrical equipment - Part 1-11: Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment	YY 9706.111-2021
	IEC 60601-1-12	急救医疗环境用设备要求 Medical electrical equipment - Part 1-12: Collateral standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment	YY 9706.112-2021
软件生命周期	IEC 62304	医疗器械软件软件生存周期过程 Medical device software - Software life cycle processes	YY/T 0664-2020
专用标准	IEC 60601-2-4	心脏除颤器专用要求 Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators	GB 9706.204-2022
	IEC 60601-2-10	神经和肌肉刺激器专用要求 Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators	YY 9706.210-2021
	IEC 60601-2-23	经皮分压监护设备专用要求 Medical electrical equipment - Part 2-23: Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment	暂无直接对应
	IEC 60601-2-25	心电图机专用要求 Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs	GB 9706.225-2021
	IEC 80601-2-26	脑电图机专用要求 Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs	GB 9706.226-2021
	IEC 60601-2-27	心电监护设备专用要求 Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment	GB 9706.227-2021
	IEC 80601-2-30	自动无创血压计专用要求 Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers	YY 9706.230-2023
	IEC 60601-2-34	有创血压监护设备专用要求 Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment	YY 9706.234-2021
	IEC 60601-2-37	超声诊断和监护设备专用要求 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment	GB 9706.237-2020
	IEC 60601-2-40	肌电图机及诱发反应设备专用要求 Medical electrical equipment - Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment	YY 9706.240-2021
	IEC 60601-2-47	动态心电图系统专用要求 Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems	YY 9706.247-2021
	IEC 80601-2-49	多参数患者监护设备专用要求 Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors	YY 9706.249-2023
	ISO 80601-2-55	呼吸气体监护仪专用要求 Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors	GB 9706.255-2022
	ISO 80601-2-56	临床体温计专用要求 Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement	YY 9706.256-2023
	ISO 80601-2-61	脉搏血氧仪专用要求 Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment	YY 9706.261-2023
	ISO 80601-2-85	脑组织血氧仪专用要求 Medical electrical equipment - Part 2-85: Particular requirements for the basic safety and essential performance of cerebral tissue oximeter equipment	暂无直接对应
	ANSI/AAMI EC12	一次性使用心电电极 Disposable ECG electrodes	YY/T 0196-2005（相关标准，非采标）
	ANSI/AAMI EC53	心电监护仪电缆和导联线 ECG trunk cables and patient leadwires	YY 0828-2011（相关标准，非采标）
	ANSI/AAMI EC57	心脏节律和ST段测量算法性能评价 Testing and reporting performance results of cardiac rhythm and ST segment measurement algorithms	暂无直接对应
	ANSI/AAMI BP22	血压传感器 Blood pressure transducers	YY 0781-2025（相关标准，非采标）
EMC	IEC 60601-1-2	并列标准：电磁兼容要求和试验 Medical electrical equipment - Part 1-2: Collateral standard: Electromagnetic disturbances - Requirements and tests	YY 9706.102-2021
网络安全	IEC 81001-5-1	健康软件产品生命周期中的安全活动 Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycle	暂无直接对应

注：上述检测均按标准现行有效版本执行；GB/YY 9706系列为修改采用（MOD）对应IEC/ISO标准，与国际标准存在技术差异；YY/T 0196、YY 0828，YY0781为相关国内标准（非采标）；IEC 60601-2-23、ISO 80601-2-85、ANSI/AAMI EC57、IEC 81001-5-1暂无直接对应的国内标准。