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医疗器械检验 CMA检测标准

一单一库 · 检验检测机构资质认定能力项目

1,613
标准数量
1,613
能力项目

医疗器械检验是CMA能力项目库(一单一库)重要领域之一。自2026年6月1日起,所有医疗器械检验方向的检验检测机构须在库内匹配对应标准方可出具CMA报告。

本领域当前收录 1,613 条标准编号(含1,613个能力项目),所有数据来源于国家标准全文公开系统(openstd.samr.gov.cn),持续更新中。

标准编号 标准名称 状态 CCS ICS
IEC60601-1-8:2006+AMD1:2012+AMD2:2020 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:通用要求,医用电气设备和医用电气系统中报警系统的测试和指南Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General req 现行
IEC60601-1:2005+Amd1:2012+Amd2:2020 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 现行
IEC60601-1:2012 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 现行
IEC60601-2-10:2012+Amd1:2016+Amd2:2023 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 现行
IEC60601-2-16:2025 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 hae 现行
IEC60601-2-18:2009 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 现行
IEC60601-2-2:2017+Amd1:2023 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 freque 现行
IEC60601-2-22:2019 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 现行
IEC60601-2-24:2012 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 eletrical equipment- Part2-24:Particular requirements for the basic safety and essential performance of infusion pumps and controllers 现行
IEC60601-2-25:2011 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 现行
IEC60601-2-27:2011 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 现行
IEC60601-2-34:2024 医用电气设备第2-34部分:有创血压监护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 现行
IEC60601-2-35:2020+AMD1:2023 医用电气设备 第2-35部分:医用毯、垫或床垫式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 ma 现行
IEC60601-2-37:2024 医用电气设备第2-37部分:超声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 requiements for the basic safety and essential performance of ultrasonic medical diagnostic an monitoring equip 现行
IEC60601-2-39:2024 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 现行
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 现行
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 diagn 现行
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 现行
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 现行
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 现行
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 现行
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 现行
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 现行
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 (H 现行
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 现行
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 现行
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 现行
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 现行
IEC61010-2-020:2016 测量、控制和实验室用电气设备的安全要求 第2-020部分:实验室用离心机的特殊要求Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-020: Particular requirements for laboratory centrifuges 现行
IEC61010-2-040:2020 测量、控制和实验室用电气设备的安全要求第2-040部分:用于处理医用材料的灭菌器和清洗消毒器的特殊要求 Safety requirements for electrical equipment for measurement, control, and laboratory use-Part 2-040: Particular requirements for sterilizers and wa 现行