医疗电气设备检测_检测机构_测试报告_「北检研究院」第三方测试中心

医疗电气设备检测

检测咨询量：9位发布时间：2023-04-01 11:59:50 更新时间：2025-05-03 23:55:23

第三方医疗电气设备检测机构北检（北京）检测技术研究院拥有齐全的检测仪器和多领域检测团队，数据科学严谨，检测设备齐全。能提供全方位检测服务，7-15个工作日便可出具医疗电气设备检测报告。

在线咨询联系总部

检测项目（部分）

隔离

试验的通用要求

结构和布线

连续漏电流和患者辅助电流

外壳和罩盖

环境试验

电源供电的中断

外壳和防护罩

电压和/或能量限制

网电源部分元器件和布线

基本安全类型

悬挂物

不正常运行和故障

保护接地端子和连接

识别标记和文件

电介质强度

溢流液体泼洒泄漏受潮进液清洗消毒灭菌

测试ME设备的一般要求

可拆卸的保护装置

防火

对超温和其它危险的防护

结构要求概述

电信端口传导骚扰

对电击危险的防护-概述

谐波电流

输入功率

压力容器和受压部件

环境条件

电压波动和闪烁

元器件和组件

正常使用时的稳定性

机械强度

分类

超温

有关分类的要求

端子骚扰电压

检测样品（部分）

医疗电气设备

家用医疗保健环境使用的医疗电气设备或系统

医疗电气设备（EMI）

检测标准（部分）

国际标准 IEC TR 60601-4-2-2016 医疗电气设备--第4-2部分:指导和解释--电磁免疫力:医用电气设备和医用电气系统的性能　　

【适用范围】This part of IEC 60601 applies to the performance of MEDICAL ELECTRICAL EQUIPMENT or aMEDICAL ELECTRICAL SYSTEM in the presence of ELECTROMAGNETIC DISTURBANCES. Hereafter MEDICAL ELECTRICAL EQUIPMENT or a MEDICAL ELECTRICAL SYSTEM are referred to asME EQUIPMENT or an ME SYSTEM.

【中国标准分类】 L23 电子元件【国际标准分类】 31.220.10-插头和插座装置、连接器

国际标准 IEC 60336-2005 医疗电气设备.医疗诊断用X射线管组件.焦点的特性

【适用范围】Applies to focal spots in medical diagnostic X-ray tube assemblies or medical use operating at X-ray tube voltages up to and including 200 kV. Describes the test methods for evaluating focal spot characteristics and the means for indicating compliance.

【中国标准分类】 C43 医药器械【国际标准分类】 11.040.50-射线照相设备

国际标准 IEC 60601-1-9-2013 医疗电气设备--第1-3部分：基本安全和重要性能的一般要求--附属标准：诊断X射线设备中辐射防护

【适用范围】This International Standard applies to the reduction of adverse ENVIRONMENTAL IMPACTS ofMEDICAL ELECTRICAL EQUIPMENT hereafter referred to as ME EQUIPMENT.MEDICAL ELECTRICAL SYSTEMS are excluded from the scope of this collateral standard.

【中国标准分类】 C39 医药器械【国际标准分类】 11.040.01-医疗设备综合

国际标准 ISO 60601-1-11-2010 医疗电气设备--第1-9部分：基本安全和主要性能的总体要求--间接标准：环境意识设计要求

【适用范围】This International Standard applies to the reduction of adverse ENVIRONMENTAL IMPACTS of MEDICAL ELECTRICAL EQUIPMENT hereafter referred to as ME EQUIPMENT.MEDICAL ELECTRICAL SYSTEMS are excluded from the scope of this collateral standard.

【中国标准分类】 C39 医药器械【国际标准分类】 11.040.01-医疗设备综合

国际标准 IEC 60601-1-6-2004 医疗电气设备--第2-41部分:诊断用手术照明和灯具的基本安全性和必要性能的详细要求

【适用范围】This particular standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of SURGICALLUMINAIRES AND LUMINAIRES FOR DIAGNOSIS hereafter referred to as ME EQUIPMENT.This particular standard does not apply to– headlights;– endoscopes laparoscopes and their light sources which are covered by IEC 60601-2-18;– luminaires used in dentistry which are covered by ISO 9680;– luminaires for general purposes which are covered by IEC 60598-2-1 and IEC 60598-2-4;– luminaires dedicated to therapeutic purposes;– special purpose lights with different conditions of use such as UV lights for dermatologicaldiagnosis slit lamps for ophthalmology lights for surgical microscopes and lights forsurgical navigation systems;– lights connected to surgical instruments;– luminaires of an emergency lighting which are covered by IEC 60598-2-22.

【中国标准分类】 C39 电气照明【国际标准分类】 11.040.55-诊断设备

国际标准 IEC 60601-2-41-2009 医疗电气设备.第2-29部分:放射疗法模拟器的基本安全和重要性能的特殊要求

【适用范围】Replacement:This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE ofRADIOTHERAPY SIMULATORS hereafter referred to as ME EQUIPMENT.If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only or toME SYSTEMS only the title and content of that clause or subclause will say so. If that is not thecase the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS as relevant.HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMSwithin the scope of this standard are not covered by specific requirements in this standardexcept in 7.2.13 and 8.4.1 of the general standard.NOTE See also 4.2 of the general standard.Addition:This particular standard refers to those applicable collateral standards that are listed inClause 2 of the general standard and Clause 2 of this particular standard.The following collateral standard does not apply:– IEC 60601-1-10.

【中国标准分类】 C38 医药器械【国际标准分类】 11.040.55-诊断设备

国际标准 IEC 60601-2-2-2006 医疗电气设备-第2-13部分:麻醉系统基本性能和安全特殊要求

【适用范围】AdditionThis Particular Standard specifies safety and essential performance requirements for an ANAESTHETIC SYSTEM (as defined in 2.101.7) as well as individual devices designed for use inan ANAESTHETIC SYSTEM.This Particular Standard does not apply to:- ANAESTHETIC SYSTEM(s) intended for use with flammable anaesthetic agents as determined by Annex DD - portable ANAESTHETIC SYSTEM(s) for use in remote sites open fields for rescue operations or in disaster areas - dental analgesia apparatus.

【中国标准分类】 C14 医药【国际标准分类】 11.040.10-麻醉、呼吸和复苏设备

国际标准 IEC 60601-2-44-2001 医疗电气设备--第4-3部分:指南和说明--第3版IEC 60601-1和新要求建议书中不明或未解决安全方面的考虑

【适用范围】

【中国标准分类】 C37 医药器械【国际标准分类】 11.040-医疗设备

国际标准 IEC 60601-2-20-2020 医疗电气设备--第2-20部分:婴儿运输保温箱的基本安全和基本性能的特殊要求

【适用范围】This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT
TRANSPORT INCUBATOR equipment as defined in 201.3.208 also referred to as ME EQUIPMENT.
If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only or to
ME SYSTEMS only the title and content of that clause or subclause will say so. If that is not the
case the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS as relevant.
HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS
within the scope of this document are not covered by specific requirements in this document
except in 7.2.13 and 8.4.1 of the general standard.
NOTE See also 4.2 of the general standard.
This particular standard specifies safety requirements for INFANT TRANSPORT INCUBATORS but
alternate methods of compliance with a specific clause by demonstrating equivalent safety
will not be judged as non-compliant if the MANUFACTURER has demonstrated in his RISK
that the RISK presented by the HAZARD has been found to be of an
MANAGEMENT FILE
acceptable level when weighed against the benefit of treatment from the device.
This particular standard does not apply to:
– devices supplying heat via BLANKETS PADS or MATTRESSES in medical use; for information
see IEC 60601-2-35 [1] ;
– INFANT INCUBATORS which are not INFANT TRANSPORT INCUBATOR; for information see
IEC 60601-2-19 [2];
– INFANT RADIANT WARMERS; for information see IEC 60601-2-21 [3];
– INFANT PHOTOTHERAPY; for information see IEC 60601-2-50 [4].

【中国标准分类】 C46 医药器械【国际标准分类】 11.040.10-麻醉、呼吸和复苏设备

国际标准 IEC TR 60601-4-3-2018 医疗电气设备第4-3部分:指南和说明--IEC 60601-1第三版中未处理的安全方面的考虑和新要求的建议

【适用范围】This part of IEC 60601 which is a Technical Report contains a series of recommendations
developed by an expert working group of IEC subcommittee 62A in response to questions of
interpretation of IEC 60601-1:2005 and related collateral standards in the IEC 60601 series.
This document is primarily intended to be used by:
– MANUFACTURERS of MEDICAL ELECTRICAL EQUIPMENT;
– test laboratories and others responsible for assessment of compliance with
IEC 60601-1:2005 IEC 60601-1:2005/AMD1:2012 IEC 60601-1-8:2006
IEC 60601-1-8:2006/AMD1:2012 IEC 60601-1-11:2010 IEC 60601-1-11:2015 and
IEC 60601-1-12:2014;
– those developing subsequent editions of IEC 60601-1.
The recommendations in the first edition of IEC TR 62296 were considered in preparing the
third edition of IEC 60601-1. Similarly it is expected that these recommendations within
IEC 60601-4-3 will be considered when preparing future revisions of IEC 60601-1 and related
collateral standards in the IEC 60601 series.
The object of this document is to make the recommendations/interpretations available to
those interested in the application of the third edition of IEC 60601-1 and applicable collateral
standards.
NOTE There might be other acceptable solutions which are not reflected in this document. The reader is reminded
that although a majority of the National Committee members of IEC/SC 62A have approved publication of this
document the contents remain the opinion of the expert members having participated in the drafting of the
document. These recommendations/interpretations are the result of considerations by this group of nominated
experts and have not been formally adopted through any National Committee voting procedure. Distribution is only
for information.

【中国标准分类】 C37 医药器械【国际标准分类】 11.040.01-医疗设备综合

国际标准 IEC TR 60601-4-1-2017 医疗电气设备--第4-1部分:指导和解释--电磁免疫力:采用一定程度自治权的医用电气设备和医用电气系统　　

【适用范围】This Part of IEC 60601 is intended to help a MANUFACTURER through the key decisions and steps to be taken to perform a detailed RISK MANAGEMENT and USABILITY ENGINEERING PROCESSES for MEDICAL ELECTRICAL EQUIPMENT or a MEDICAL ELECTRICAL SYSTEM hereafter referred to as MEE or MES employing a DEGREE OF AUTONOMY (DOA). This document provides a definition of DOA of MEE or MES and a MEDICAL ROBOT and also provides guidance on:
– methodologies to perform the RISK MANAGEMENT PROCESS and USABILITY ENGINEERING for an MEE or MES with a DOA;
– considerations of BASIC SAFETY and ESSENTIAL PERFORMANCE for an MEE and MES with a DOA; and
– identifying the use of DOA and similar concepts in existing ISO/IEC standards dealing with MEE or MES with the goal to facilitate alignment of standards by consistent use of the concept of DOA; and
– distinguishing between MEDICAL ROBOTS and other MEE and MES.
Unless specified otherwise this document considers MEE and MES together.
The MANUFACTURER of an MEE or MES with a DOA is expected to design and manufacture an MEE or MES that fulfils its INTENDED USE and does not have unacceptable RISK throughout its LIFE-CYCLE.
This document provides guidance to help the MANUFACTURER in complying with the requirements of IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012 for MEE and MES with DOA. The document is also intended as guidance for future standard writers.
There are no prerequisites to this document.

【中国标准分类】 C37 医药器械【国际标准分类】 11.040.01-医疗设备综合

国际标准 IEC TR 60601-4-4-2017 医疗电气设备--第4-4部分:指导和解释--电磁免疫力:创建警报系统相关要求时特定标准的作者指南

【适用范围】This document is intended to assist writers when drafting ALARM SYSTEM-related requirements for particular standards in the IEC 60601 and IEC 80601 or ISO 80601 series of standards.

【中国标准分类】 C37 医药器械【国际标准分类】 11.040.01-医疗设备综合

国际标准 IEC 60789-2005 医疗电气设备--放射性核素成象装置的性能和试验条件--安格型γ射线照相机

【适用范围】This International Standard specifies test methods for declaring the characteristics of Anger type gamma cameras. The latter are composed of a collimator a detector shield and a radiation detector assembly together with recording and display devices.It is not within the scope of this standard to address the safety requirements to be followed by manufacturers according to IEC 60601-1.

【中国标准分类】 C39 医药器械【国际标准分类】 11.040.50-射线照相设备

国际标准 IEC 61557-16-2014 小于等于1000 V交流电以及1500 V直流电低压配电系统的电气安全--保护措施的测试测量或监测设备--第16部分:电气设备和/或医疗电气设备保护措施有效性的测试设备

【适用范围】This part of IEC 61557 defines performance requirements for test and measurement equipment to determine the effectiveness of the protective measures of electrical measures for electrical equipment and/or medical electrical equipment described in IEC 62353.

【中国标准分类】 C39 电工仪器仪表【国际标准分类】 11.040.50-射线照相设备

国际标准 IEC 62220-1-3-2008 医疗电气设备.数字X射线成像装置的特性.第1-3部分:探测量子效率的测定.动态成像用探测器

【适用范围】This part of IEC 62220 specifies the method for the determination of the DETECTIVE QUANTUMEFFICIENCY (DQE) of DIGITAL X-RAY IMAGING DEVICES as a function of AIR KERMA and of SPATIALFREQUENCY for the working conditions in the range of the medical application as specified bythe MANUFACTURER. The intended users of this part of IEC 62220 are manufacturers and wellequipped test laboratories.This Part 1-3 is restricted to DIGITAL X-RAY IMAGING DEVICES that are used for dynamic imagingsuch as but not exclusively direct and indirect flat panel-detector based systems.It is not recommended to use this part of IEC 62220 for digital X-RAY IMAGE INTENSIFIER-basedsystems.NOTE 1 This negative recommendation is based on the low frequency drop vignetting and geometrical distortionpresent in these devices which may put severe limitations on the applicability of the measurement methodsdescribed in this standard.This part of IEC 62220 is not applicable to:– DIGITAL X-RAY IMAGING DEVICES intended to be used in mammography or in dentalradiography;– COMPUTED TOMOGRAPHY; and– systems in which the X-ray field is scanned across the patient.NOTE 2 The devices noted above are excluded because they contain many parameters (for instance beamqualities geometry time dependence etc.) which differ from those important for dynamic imaging. Some of thesetechniques are treated in separate standards (IEC 62220-1 and IEC 62220-1-2).

【中国标准分类】 C43 医药器械【国际标准分类】 11.040.50-射线照相设备

国际标准 IEC 62220-1-2-2007 医疗电气设备--数字X光成像装置的特点--第1-2部分：量子检出效率的测定--乳房造影术采用的检测器

【适用范围】This part of IEC 62220 specifies the method for the determination of the DETECTIVE QUANTUM EFFICIENCY (DQE) Of DIGITAL X-RAY IMAGING DEVICES 3S a function of AIR KERMA and of SPATIAL FREQUENCY for the working conditions in the range of the medical application as specified by the MANUFACTURER. The intended users of this part of IEC 62220 are manufacturers and well equipped test laboratories.This Part 1-2 is restricted to DIGITAL X-RAY IMAGING DEVICES that are used for mammographic imaging such as but not exclusively CR systems direct and indirect flat panel detector based systems scanning systems (CCD based or photon-counting). This part of IEC 62220 is not applicable to- DIGITAL X-RAY IMAGING DEVICES intended to be used in general radiography or in dental radiography;- computed tomography;and- devices for dynamic imaging (where series of images are acquired as in fluoroscopic or cardiac imaging).NOTE The devices noted above are excluded because they contaih many parameters (for instance beam qualities geometry time dependence etc.) which differ from those important for mammography. Some of these techniques are treated in separate standards (IEC 62220-1 and IEC 62220-1-3) as has been done for other topics for instance for speed and contrast in IEC and ISO standards.

【中国标准分类】 C39 医药器械【国际标准分类】 11.040.50-射线照相设备

国际标准 IEC 62220-1-2003 医疗电气设备-数字X射线成像设备-第1部分:量子效率测定

【适用范围】Specifies the method for the determination of the detective quantum efficiency (DQE) of digital X-ray imaging devices as a function of exposure and of spatial frequency for the working conditions in the range of the medical application as specified by th

【中国标准分类】 C39 医药器械【国际标准分类】 11.040.50-射线照相设备

国际标准 IEC 62353-2007 医疗电气设备.医疗电气设备的循环试验和维修后试验

【适用范围】This International Standard applies to testing of MEDICAL ELECTRICAL EQUIPMENT and MEDICALELECTRICAL SYSTEMS hereafter referred to as ME EQUIPMENT and ME SYSTEMS or parts of suchequipment or systems which comply with IEC 60601-1 before PUTTING INTO SERVICE duringMAINTENANCE INSPECTION SERVICING and after REPAIR or on occasion of RECURRENT TESTS toassess the safety of such ME EQUIPMENT or ME SYSTEMS or parts thereof. For equipment notbuilt to IEC 60601-1 these requirements may be used taking into account the safety standardsfor the design and information in the instructions for use of that equipment.This standard contains tables with allowable values relating to different editions ofIEC 60601-1. For the purpose of this standard the application of measuring methods isindependent of the edition according to which the ME EQUIPMENT OR ME SYSTEM is designed.This standard contains:– "general requirements

【中国标准分类】 C43 医药器械【国际标准分类】 11.040.50-射线照相设备

国际标准 IEC 62563-1-2016 医疗电气设备--医学图像显示系统--第1部分:评价方法

【适用范围】This part of IEC 62563 describes the evaluation methods for testing medical IMAGE DISPLAYSYSTEMS.The scope of this International Standard is directed to practical tests that can be visuallyevaluated or measured using basic test equipment. More advanced or more quantitativemeasurements can be performed on these devices but these are beyond the scope of thisdocument.This standard applies to medical IMAGE DISPLAY SYSTEMS which can display image information on greyscale and colourIMAGE DISPLAY SYSTEMS . This standard applies to medical IMAGE DISPLAY SYSTEMS used fordiagnostic (interpretation of medical images toward rendering clinical diagnosis) or viewing(viewing medical images for medical purposes other than for providing a medicalinterpretation) purposes and therefore having specific requirements in terms of image quality.Head mounted IMAGE DISPLAY SYSTEMS and IMAGE DISPLAY SYSTEMS used for confirmingpositioning and for operation of the system are not covered by this standard. Handheld IMAGEDISPLAY SYSTEMS might require additional or modified versions of the procedures described inthis standard.It is not in the scope of this standard to define the requirements of acceptance and constancytests nor the frequencies of constancy tests.

【中国标准分类】 C43 医药器械【国际标准分类】 11.040.50-射线照相设备

国际标准 IEC 62563-1-2009 医疗电气设备--第2-84部分:紧急医疗服务环境中呼吸机的基本安全和基本性能的特殊要求

【适用范围】This document applies to the basic safety and essential performance of an EMS ventilator in
combination with its accessories hereafter also referred to as ME equipment:
-- intended for patients who need differing levels of support from artificial ventilation including
ventilator-dependent patients;
-- intended to be operated by a healthcare professional operator;
-- intended for use in the EMS environment; and
-- intended for invasive or non-invasive ventilation.
NOTE 1 An EMS ventilator can also be used for transport within a professional healthcare facility.

【中国标准分类】 C46 医药器械【国际标准分类】 11.040.10-麻醉、呼吸和复苏设备

国际标准 IEC 80601-2-78-2019 医疗电气设备--第2-78部分:康复、评估、补偿或减轻用医疗机器人的基本安全和基本性能的特殊要求

【适用范围】This part of IEC 80601 applies to the general requirements for BASIC SAFETY and ESSENTIAL
PERFORMANCE Of MEDICAL ROBOTS that physically interact with a PATIENT with an IMPAIRMENT to
support or perform REHABILITATION ASSESSMENT COMPENSATION or ALLEVIATION related to the
PATIENT'S MOVEMENT FUNCTIONS as intended by the MANUFACTURER.
If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only or to
ME SYSTEMS only the title and content of that clause or subclause will say so. If that is not the
case the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS as relevant.
NOTE See also 4.2 of the general standard.
This particular standard does not apply to
• external limb prosthetic devices (use ISO 22523)
• electric wheelchairs (use ISO 7176 (all parts))
• diagnostic imaging equipment (e.g. MRI use IEC 60601-2-33) and
• personal care ROBOTS (use ISO 13482).

【中国标准分类】 C37 医药器械【国际标准分类】 11.040.01-医疗设备综合