CB产品第十五大类——医疗用电气设备

在国际医疗用电气设备的检测认证过程中，CB体系（IECEE CB Scheme）作为全球互认的重要桥梁，其标准规范的准确把握直接关系到产品能否顺利通关并进入目标市场。针对医疗用电气设备类产品的CB认证，涵盖了从诊断影像系统、患者生命支持与监护设备、手术及治疗仪器、体外诊断（IVD）分析仪器到各类家用健康医疗电气终端等多个维度的基本安全、主要性能（Essential Performance）、绝缘防护分级（MOPP/MOOP）及风险管理技术规范。以下是相关 CB 标准清单：

IEC 60601-1 医用电气设备 第1部分：基本安全和基本性能的通用要求 / Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

IEC 60601-1-1 医用电气设备 第1-1部分：通用安全要求 并列标准：医用电气系统安全要求 / Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems

IEC 60601-1-3 医用电气设备 第1-3部分：基本安全和基本性能的通用要求 并列标准：诊断X射线设备中的辐射防护 / Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment

IEC 60601-1-4 医用电气设备 第1-4部分：通用安全要求 并列标准：可编程医用电气系统 / Medical electrical equipment - Part 1-4: General requirements for safety - Collateral standard: Programmable electrical medical systems

IEC 60601-1-6 医用电气设备 第1-6部分：基本安全和基本性能的通用要求 并列标准：可用性 / Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability

IEC 60601-1-8 医用电气设备 第1-8部分：基本安全和基本性能的通用要求 并列标准：医用电气设备和医用电气系统中报警系统的通用要求、试验和指南 / Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

IEC 60601-1-9 医用电气设备 第1-9部分：基本安全和基本性能的通用要求 并列标准：环保设计要求 / Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design

IEC 60601-1-10 医用电气设备 第1-10部分：基本安全和基本性能的通用要求 并列标准：生理闭环控制器开发要求 / Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers

IEC 60601-1-11 医用电气设备 第1-11部分：基本安全和基本性能的通用要求 并列标准：家庭保健环境下使用的医用电气设备和医用电气系统的要求 / Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

IEC 60601-1-12 医用电气设备 第1-12部分：基本安全和基本性能的通用要求 并列标准：拟在专业医疗保健机构外部运送环境中使用的医用电气设备和医用电气系统的要求 / Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment

IEC 60601-2-1 医用电气设备 第2-1部分：能量为1MeV至50MeV电子加速器基本安全和基本性能专用要求 / Medical electrical equipment - Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV

IEC 60601-2-2 医用电气设备 第2-2部分：高频手术设备及高频附件的基本安全和基本性能专用要求 / Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories

IEC 60601-2-3 医用电气设备 第2-3部分：短波治疗设备的基本安全和基本性能专用要求 / Medical electrical equipment - Part 2-3: Particular requirements for the basic safety and essential performance of short-wave therapy equipment

IEC 60601-2-4 医用电气设备 第2-4部分：心脏除颤器的基本安全和基本性能专用要求 / Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators

IEC 60601-2-5 医用电气设备 第2-5部分：超声理疗设备的基本安全和基本性能专用要求 / Medical electrical equipment - Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment

IEC 60601-2-6 医用电气设备 第2-6部分：微波治疗设备的基本安全和基本性能专用要求 / Medical electrical equipment - Part 2-6: Particular requirements for the basic safety and essential performance of microwave therapy equipment

IEC 60601-2-7 医用电气设备 第2-7部分：诊断X射线发生装置高压发生器安全专用要求 / Medical electrical equipment - Part 2-7: Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators

IEC 60601-2-8 医用电气设备 第2-8部分：能量为10kV至1MV治疗X射线设备的基本安全和基本性能专用要求 / Medical electrical equipment - Part 2-8: Particular requirements for the basic safety and essential performance of therapeutic X-ray equipment operating in the range 10 kV to 1 MV

IEC 60601-2-10 医用电气设备 第2-10部分：神经和肌肉刺激器的基本安全和基本性能专用要求 / Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators

IEC 60601-2-11 医用电气设备 第2-11部分：γ射束治疗设备的基本安全和基本性能专用要求 / Medical electrical equipment - Part 2-11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipment

IEC 60601-2-12 医用电气设备 第2-12部分：肺呼吸机安全专用要求 / Medical electrical equipment - Part 2-12: Particular requirements for the safety of lung ventilators - Critical care ventilators

IEC 60601-2-16 医用电气设备 第2-16部分：血液透析、血液透析滤过和血液滤过设备的基本安全和基本性能专用要求 / Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment

IEC 60601-2-17 医用电气设备 第2-17部分：自动控制式近距离放射治疗后装设备的基本安全和基本性能专用要求 / Medical electrical equipment - Part 2-17: Particular requirements for the basic safety and essential performance of automatically-controlled brachytherapy afterloading equipment

IEC 60601-2-18 医用电气设备 第2-18部分：内窥镜设备的基本安全和基本性能专用要求 / Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment

IEC 60601-2-19 医用电气设备 第2-19部分：婴儿培养箱的基本安全和基本性能专用要求 / Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators

IEC 60601-2-20 医用电气设备 第2-20部分：婴儿运输培养箱的基本安全和基本性能专用要求 / Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators

IEC 60601-2-21 医用电气设备 第2-21部分：婴儿辐射保暖台的基本安全和基本性能专用要求 / Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers

IEC 60601-2-22 医用电气设备 第2-22部分：外科、整形、治疗和诊断用激光设备的基本安全和基本性能专用要求 / Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment

IEC 60601-2-23 医用电气设备 第2-23部分：经皮血气监护仪的基本安全和基本性能专用要求 / Medical electrical equipment - Part 2-23: Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment

IEC 60601-2-24 医用电气设备 第2-24部分：输液泵和输液控制器的基本安全和基本性能专用要求 / Medical electrical equipment - Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers

IEC 60601-2-25 医用电气设备 第2-25部分：心电图机的基本安全和基本性能专用要求 / Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs

IEC 60601-2-26 医用电气设备 第2-26部分：脑电图机的基本安全和基本性能专用要求 / Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs

IEC 60601-2-27 医用电气设备 第2-27部分：心电监护设备的基本安全和基本性能专用要求 / Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment

IEC 60601-2-28 医用电气设备 第2-28部分：医用诊断X射线管组件的基本安全和基本性能专用要求 / Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis

IEC 60601-2-31 医用电气设备 第2-31部分：带内部电源的体外心脏起搏器的基本安全和基本性能专用要求 / Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source

IEC 60601-2-32 医用电气设备 第2部分：X射线设备附属设备安全专用要求 / Medical electrical equipment - Part 2: Particular requirements for the safety of associated equipment of X-ray equipment

IEC 60601-2-33 医用电气设备 第2-33部分：医疗诊断用磁共振设备的基本安全和基本性能专用要求 / Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis

IEC 60601-2-34 医用电气设备 第2-34部分：直接式有创血压监测设备的基本安全和基本性能专用要求 / Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment

IEC 60601-2-35 医用电气设备 第2-35部分：使用毯、垫或床垫且在医疗中用于加热的加热设备的基本安全和基本性能专用要求 / Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use

IEC 60601-2-36 医用电气设备 第2-36部分：体外引发碎石设备的基本安全和基本性能专用要求 / Medical electrical equipment - Part 2-36: Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy

IEC 60601-2-37 医用电气设备 第2-37部分：超声医疗诊断和监护设备的基本安全和基本性能专用要求 / Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment

IEC 60601-2-38 医用电气设备 第2-38部分：电动医用病床的安全专用要求 / Medical electrical equipment - Part 2-38: Particular requirements for the safety of electrically operated hospital beds

IEC 60601-2-39 医用电气设备 第2-39部分：腹膜透析设备的基本安全和基本性能专用要求 / Medical electrical equipment - Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment

IEC 60601-2-40 医用电气设备 第2-40部分：肌电图及诱发电位设备的基本安全和基本性能专用要求 / Medical electrical equipment - Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment

IEC 60601-2-41 医用电气设备 第2-41部分：手术照明灯和诊断照明灯的基本安全和基本性能专用要求 / Medical electrical equipment - Part 2-41: Particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for diagnosis

IEC 60601-2-43 医用电气设备 第2-43部分：介入操作用X射线设备的基本安全和基本性能专用要求 / Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures

IEC 60601-2-44 医用电气设备 第2-44部分：X射线计算机体层摄影设备（CT机）的基本安全和基本性能专用要求 / Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography

IEC 60601-2-45 医用电气设备 第2-45部分：乳腺X射线设备及乳腺摄影立体定位设备的基本安全和基本性能专用要求 / Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices

IEC 60601-2-46 医用电气设备 第2-46部分：手术台的基本安全和基本性能专用要求 / Medical electrical equipment - Part 2-46: Particular requirements for the basic safety and essential performance of operating tables

IEC 60601-2-47 医用电气设备 第2-47部分：动态心电图系统的基本安全和基本性能专用要求 / Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems

IEC 60601-2-49 医用电气设备 第2-49部分：多参数患者监护设备的基本安全和基本性能专用要求 / Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment

IEC 60601-2-50 医用电气设备 第2-50部分：婴儿光治疗设备的基本安全和基本性能专用要求 / Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment

IEC 60601-2-52 医用电气设备 第2-52部分：医用病床的基本安全和基本性能专用要求 / Medical electrical equipment - Part 2-52: Particular requirements for the basic safety and essential performance of medical beds

IEC 60601-2-54 医用电气设备 第2-54部分：放射摄影和透视用X射线设备的基本安全和基本性能专用要求 / Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy

IEC 60601-2-57 医用电气设备 第2-57部分：用于治疗、诊断、监测和整形/美学使用的非激光光源设备基本安全和基本性能专用要求 / Medical electrical equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use

IEC 60601-2-62 医用电气设备 第2-62部分：高强度超声治疗（HITU）设备的基本安全和基本性能专用要求 / Medical electrical equipment - Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment

IEC 60601-2-63 医用电气设备 第2-63部分：口外成像牙科X射线机基本安全和基本性能专用要求 / Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment

IEC 60601-2-65 医用电气设备 第2-65部分：口内成像牙科X射线机基本安全和基本性能专用要求 / Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment

IEC 60601-2-66 医用电气设备 第2-66部分：听力及听力辅具设备基本安全和基本性能专用要求 / Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and essential performance of hearing instruments and hearing systems

IEC 60601-2-68 医用电气设备 第2-68部分：用于放射治疗中基于电子加速器、轻离子束治疗和放射性核素射束治疗的X射线图像引导放射治疗设备的基本安全和基本性能专用要求 / Medical electrical equipment - Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment

IEC 60601-2-75 医用电气设备 第2-75部分：光动力治疗和光动力诊断设备的基本安全和基本性能专用要求 / Medical electrical equipment - Part 2-75: Particular requirements for the basic safety and essential performance of photodynamic therapy and photodynamic diagnosis equipment

IEC 60601-2-76 医用电气设备 第2-76部分：低能量电离气体止血设备的基本安全和基本性能专用要求 / Medical electrical equipment - Part 2-76: Particular requirements for the basic safety and essential performance of low energy ionized gas haemostasis equipment

IEC 60601-2-83 医用电气设备 第2-83部分：家用光疗设备的基本安全和基本性能专用要求 / Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment

IEC 80601-2-26 医用电气设备 第2-26部分：脑电图机的基本安全和基本性能专用要求 / Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs

IEC 80601-2-30 医用电气设备 第2-30部分：自动非侵入式血压计的基本安全和基本性能专用要求 / Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers

IEC 80601-2-35 医用电气设备 第2-35部分：使用毯、垫或床垫且在医疗中用于加热的加热设备的基本安全和基本性能专用要求 / Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use

IEC 80601-2-49 医用电气设备 第2-49部分：多参数患者监护仪的基本安全和基本性能专用要求 / Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors

IEC 80601-2-52 医用电气设备 第2-52部分：医用病床的基本安全和基本性能专用要求 / Medical electrical equipment - Part 2-52: Particular requirements for the basic safety and essential performance of medical beds

IEC 80601-2-58 医用电气设备 第2-58部分：眼科手术用晶状体摘除设备及玻璃体切割设备的基本安全和基本性能专用要求 / Medical electrical equipment - Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery

IEC 80601-2-60 医用电气设备 第2-60部分：牙科设备的基本安全和基本性能专用要求 / Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment

IEC 80601-2-77 医用电气设备 第2-77部分：医疗机器人 第2-77部分：手术辅助机器人设备的基本安全和基本性能专用要求 / Medical electrical equipment - Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment

IEC 80601-2-78 医用电气设备 第2-78部分：医疗机器人 第2-78部分：用于康复、评估、补偿或缓解的医用机器人的基本安全和基本性能专用要求 / Medical electrical equipment - Part 2-78: Particular requirements for the basic safety and essential performance of medical robots intended for rehabilitation, assessment, compensation or alleviation

IEC 80601-2-89 医用电气设备 第2-89部分：医用外骨骼的基本安全和基本性能专用要求 / Medical electrical equipment - Part 2-89: Particular requirements for the basic safety and essential performance of medical exoskeletons

IEC 81001-5-1 健康软件和健康IT系统安全性、有效性和保障 第5-1部分：安全性 产品生命周期中的活动 / Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycle

ISO 10079-1 医用吸引设备 第1部分：电动吸引设备 / Medical suction equipment - Part 1: Electrically powered suction equipment

ISO 80601-2-12 医用电气设备 第2-12部分：重症护理呼吸机的基本安全和基本性能专用要求 / Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators

ISO 80601-2-13 医用电气设备 第2-13部分：麻醉工作站的基本安全和基本性能专用要求 / Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation

ISO 80601-2-55 医用电气设备 第2-55部分：呼吸气体监护仪的基本安全和基本性能专用要求 / Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors

ISO 80601-2-56 医用电气设备 第2-56部分：体温测量的临床体温计基本安全和基本性能专用要求 / Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement

ISO 80601-2-61 医用电气设备 第2-61部分：脉搏血氧仪设备的基本安全和基本性能专用要求 / Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment

ISO 80601-2-67 医用电气设备 第2-67部分：省氧设备的基本安全和基本性能专用要求 / Medical electrical equipment - Part 2-67: Particular requirements for basic safety and essential performance of oxygen-conserving equipment

ISO 80601-2-69 医用电气设备 第2-69部分：氧气浓缩器的基本安全和基本性能专用要求 / Medical electrical equipment - Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment

ISO 80601-2-70 医用电气设备 第2-70部分：睡眠呼吸暂停治疗设备的基本安全和基本性能专用要求 / Medical electrical equipment - Part 2-70: Particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment

ISO 80601-2-72 医用电气设备 第2-72部分：依赖呼吸机患者用家用呼吸机的基本安全和基本性能专用要求 / Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential performance of home healthcare ventilators for ventilator-dependent patients

ISO 80601-2-74 医用电气设备 第2-74部分：呼吸湿化设备的基本安全和基本性能专用要求 / Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment

ISO 80601-2-79 医用电气设备 第2-79部分：呼吸功能障碍呼吸支持设备的基本安全和基本性能专用要求 / Medical electrical equipment - Part 2-79: Particular requirements for basic safety and essential performance of medical electrical equipment for ventilatory support in respiratory impairment

ISO 80601-2-80 医用电气设备 第2-80部分：呼吸功能不全呼吸支持设备的基本安全和基本性能专用要求 / Medical electrical equipment - Part 2-80: Particular requirements for basic safety and essential performance of medical electrical equipment for ventilatory support in respiratory insufficiency

ISO 80601-2-84 医用电气设备 第2-84部分：紧急医疗服务环境中使用的呼吸机基本安全和基本性能专用要求 / Medical electrical equipment - Part 2-84: Particular requirements for the basic safety and essential performance of ventilators for the emergency medical services environment

ISO 80601-2-85 医用电气设备 第2-85部分：脑组织血氧仪设备的基本安全和基本性能专用要求 / Medical electrical equipment - Part 2-85: Particular requirements for the basic safety and essential performance of cerebral tissue oximeter equipment

ISO 80601-2-87 医用电气设备 第2-87部分：高频呼吸机的基本安全和基本性能专用要求 / Medical electrical equipment - Part 2-87: Particular requirements for basic safety and essential performance of high-frequency ventilators

ISO 80601-2-90 医用电气设备 第2-90部分：高流量呼吸治疗设备的基本安全和基本性能专用要求 / Medical electrical equipment - Part 2-90: Particular requirements for basic safety and essential performance of high-flow respiratory therapy equipment