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医疗器械检验

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官方标准
IEC61010-2-020:2006 测量 控制和实验室用电气设备的安全要求 - 第2-020部分:实验室离心机的特殊要求Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-020: Particular requirements for laboratory centrifuges
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ID: 57275
官方标准
IEC61010-2-010:2019 测量、控制和实验室用电气设备的安全要求第2-010部分:实验室用材料加热设备的特殊要求 Safety requirements for equipment for measurement,control and laboratory use - Part 2-010: Particular requirements for laboratory equipment for the heating of materials
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ID: 57276
官方标准
IEC61010-1:2010+AMD1:2016CSV 测量、控制和实验室用电气设备的安全要求第1部分:一般要求Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
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ID: 57277
官方标准
IEC61010-1:2010+Amd1:2016 测量、控制和实验室用电气设备的安全要求第1部分:通用要求 Safety requirements for electrical equipment for measurement,control,and laboratory use - Part 1: General requirements
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ID: 57278
官方标准
IEC61000-4-20:2022 电磁兼容性(EMC).第4-20部分:试验和测量技术.横向电磁(TEM)波导中的发射和抗扰度试验Electromagnetic compatibility (EMC) - Part 4-20: Testing and measurement techniques - Emission and immunity testing in transverse electromagnetic (TEM) waveguides
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ID: 57279
官方标准
IEC61000-3-3:2013 电磁兼容性(EMC).第3-3部分:限值.额定电流为每相16A且无条件连接的设备的公共低压供电系统中电压变化、电压波动和闪变的限制 Electromagnetic compatibility (EMC) - Part 3-3: Limits - Limitation of voltage changes, voltage fluctuations and flicker in public low-voltage supply systems, for equipment with rated current 16 A per phase and not subject to conditional connection
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ID: 57280
官方标准
IEC61000-3-2:2018+AMD1:2020+AMD2:2024CSV 电磁兼容性(EMC).第3-2部分:限值.谐波电流发射限值(设备输入电流每相≤16A)Electromagnetic compatibility (EMC) - Part 3-2: Limits - Limits for harmonic current emissions (equipment input current ≤ 16 A per phase)
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ID: 57281
官方标准
IEC60613:2010 用于医疗诊断的X射线管组件的电气和负载特性Electrical and loading characteristics of X-ray tube assemblies for medical diagnosis
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ID: 57282
官方标准
IEC60601-2-83:2019+Amd1:2022 医用电气设备第2-83部分:家用光治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
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ID: 57283
官方标准
IEC60601-2-83:2019 医用电气设备第2-83部分:家用光疗设备基本安全和基本性能的特殊要求Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment
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现行有效
ID: 57284
官方标准
IEC60601-2-7:1998 医用电气设备.第2-7部分:诊断X射线发生器的高压发生器安全的特殊要求Medical electrical equipment - Part 2-7: Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators
废止,仅限能力项目库范围内现行有效产品标准引用本标准及监督抽检时申请...
现行有效
ID: 57285
官方标准
IEC60601-2-66:2019 医用电气设备第2-66部分:助听器和助听器系统基本安全和基本性能的专用要求Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and essential performance of hearing aids and hearing aid systems
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ID: 57286
官方标准
IEC60601-2-62:2013 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
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ID: 57287
官方标准
IEC60601-2-6:2012+Amd1:2016+Amd2:2022 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
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ID: 57288
官方标准
IEC60601-2-57:2023 医用电气设备第2-57部分:治疗、诊断、监测和整形/医疗美容使用的非激光光源设备基本安全和基本性能的专用要求 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
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现行有效
ID: 57289
官方标准
IEC60601-2-57:2011 医疗电气设备 - 第2-57部分:针对治疗 诊断 监测和化妆品/美容用途的非激光光源设备的基本安全和基本性能的特殊要求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
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现行有效
ID: 57290
官方标准
IEC60601-2-52:2009+Amd1:2015 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
废止,仅限能力项目库范围内现行有效产品标准引用本标准及监督抽检时申请...
现行有效
ID: 57291
官方标准
IEC60601-2-50:2020/AMD1:2023 修改件1.医用电气设备.第2-50部分:婴儿光疗设备的基本安全和基本性能的特殊要求Amendment 1 - Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment
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ID: 57292
官方标准
IEC60601-2-5:2009 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
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现行有效
ID: 57293
官方标准
IEC60601-2-47:2012 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
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现行有效
ID: 57294
官方标准
IEC60601-2-46:2023 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
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现行有效
ID: 57295
官方标准
IEC60601-2-46:2016 医疗电气设备 - 第2-46部分:操作台的基本安全和基本性能的特殊要求Medical electrical equipment - Part 2-46: Particular requirements for the basic safety and essential performance of operating tables
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现行有效
ID: 57296
官方标准
IEC60601-2-44:2009+AMD1:2012+AMD2:2016CSV 医用电气设备第2-44部分:特殊要求 X射线设备的基本安全和基本性能 用于计算机断层扫描Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography
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现行有效
ID: 57297
官方标准
IEC60601-2-41:2021 医用电气设备第2-41部分:手术无影灯和诊断用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 luminaries and luminaries for diagnosis
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现行有效
ID: 57298
官方标准
IEC60601-2-40:2024 医用电气设备 第2-40部分:肌电及诱发反应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
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现行有效
ID: 57299
官方标准
IEC60601-2-40:2016 医用电气设备第2-40部分:肌电图和诱发反应设备的基本安全和基本性能的特殊要求Medical electrical equipment - Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment
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现行有效
ID: 57300
官方标准
ISO80601-2-56:2017+Amd1:2018 医用电气设备第2-56部分:用于体温测量的临床体温计的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
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现行有效
ID: 57401
官方标准
ISO80601-2-55:2018+AMD1:2023 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
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现行有效
ID: 57402
官方标准
ISO80601-2-55:2018/AMD1:2023 修改件1.医用电气设备.第2-55部分:呼吸气体监测仪的基本安全和基本性能的特殊要求Amendment 1 - Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
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现行有效
ID: 57403
官方标准
ISO80601-2-13:2011 医疗电气设备 - 第2-13部分:麻醉工作站的基本安全和基本性能的特殊要求Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation
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ID: 57404
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