医疗器械测试标准
体外诊断类设备/in vitro diagnostic medicaldevices
序号
名称
国内标准
1
测量、控制和试验室用电气设备的安全要求
Electrical Equipment For Measurement,Control ,and Laboratory Use
IEC/EN 61010-1
GB4793.1
2
测量、控制和试验室用电气设备的安全要求第2-101部分：体外诊断(IVD)医用设备的专用要求
Safety requirements for electricalequipment for measurement, control and laboratory use –Part 2-101:Particular requirements for in vitro diagnostic (IVD)medicalequipm
IEC/EN 61010-2-101
YY 0648
3
测量、控制和实验室用电气设备的安全要求：实验室用分析和其他目的自动和半自动设备的特殊要求
Safety requirements for electricalequipment for measurement, control and laboratory use – Part 081: Particular requirements for automatic and semiautomaticlaboratory equipment for analysis and other purposes
IEC/EN 61010-2-081
GB4793.9
4
测量、控制和实验室用的电设备 电磁兼容性要求 第1部分:通用要求
Electrical equipment for measurement,control and laboratory use – EMC requirements - Part 1: Generalrequirements
IEC/EN 61326-1
GB/T 18268.1
5
测量、控制和实验室用电设备.电磁兼容性(EMC)的要求.特殊要求.实验室诊断
Electrical equipment for measurement,control and laboratory use – EMC requirements - Part 2-6:Particular requirements - In vitro diagnostic (IVD) medicalequipment
IEC/EN 61326-2-6
GB/T18268.26
医用电器设备检测标准/Medical Device testingstandards list
医用电气设备 第2部分 心电图机安全专用要求
Medical safety and electricalessential equipment performance - Part 2-25: of electrocardiographsParticular requirements
IEC/EN 60601-2-25
GB 10793
无创血压计第1部分:通用要求
Non-invasive sphygmomanometers - Part1: Requirements and test methods for non-automated measurementtype
EN ISO /ISO 81060-1
无创血压计.第3部分:电-机血压测量系统的补充要求
Non-invasive sphygmomanometers - Part3: Supplementary requirements for electro-mechanical blood pressuremeasuring systems
EN 1060-3
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 -- Part1-1: General requirements for safety - Collateral standard: Safetyrequirements for medical electrical systems
IEC/EN 60601-1-1
GB 9706.15
医用电气设备 第2-27部分：心电监护安全及基本性能专用要求
Medical electrical equipment - Part2-27: Particular requirements for the basic safety and essentialperformance of electrocardiographic monitoring equipment
IEC/EN 60601-2-27
GB 9706.25
7
医用电气设备 第2-26部分：脑电图机安全专用要求 Medicalelectrical equipment-Part 2-26: Particular requirements for thesafety of electroencephalographs
IEC/EN 60601-2-26:2012
IEC 80601-2-26：2019
GB 9706.26
8
医用电气设备 第2-56部分:临床体温计的基本安全和性能的专用要求Medical safety and electrical essential equipment-Partperformance2-56: of clinical Particular thermometers requirementsfor basic body temperature measurement
ISO/ EN ISO 80601-2-56
9
血压计Non-invasive automatedsphygmomanometers
ANSI/AAMI SP10
YY 0670
10
医用电气设备--第2-57部分:治疗、诊断、监测和美容/美学使用的非激光光源设备的基本安全和基本性能专用要求Medicalelectrical equipment - Part 2-57: Particular requirements for thebasic safety and essential performance of non-laser light sourceequipment intended for therapeutic, diagnostic, monitoring andcosmetic/aesthetic use
IEC/EN 60601-2-57
11
医用电气设备 第2-2部分:高频手术设备安全专用要求MedicalBasic Safety Electrical And Equipment Essential -Performance Part2-2: Particular Of High Requirements Frequency For SurgicalEquipment And High Frequency Surgical Accessories
IEC/EN/EN IEC 60601-2-2
GB 9706.4
12
医用电气设备第1部分：安全通用要求
Medical electrical equipment - Part 1:General requirements for basic safety and essential performance
ANSI/AAMI ES60601-1
EN /IEC60601-1
GB9706.1
13
医用电气设备第2-10部分:神经和肌肉刺激器安全专用要求Medicalelectrical equipment - Part 2-10 : particular requirements for thesafety of nerve and muscle stimulators
IECC/EN 60601-2-10
YY 0607
14
医用电气设备第2-30部分:自动循环无创血压监护设备的安全和基本性能专用要求Medical electrical equipment - Part2-30: Particular requirements for basic safety and essentialperformance of automated non-invasive sphygmomanometers
IEC/EN 80601-2-30
YY 0667
15
医用电气设备 第2-49部分：多参数患者监护设备安全专用要求Medicalelectrical equipment-Part 2-49:Particular requiremens for thesafety of multifunction patient monitoring equipment
IEC/EN 60601-2-49/IEC 80601-2-49
YY 0668
16
医用电气设备.医用脉搏血氧仪设备基本安全和主要性能专用要求Medicalelectrical equipment — Part 2-61: Particular requirements for basicsafetyand essential performance of pulseoximeter equipment
EN ISO 9919
ISO / EN ISO 80601-2-61
YY 0784
18
医用电气设备 第2-38部分:医院电动床安全专用要求
医用电气设备 第2-52部分:医院电动床安全专用要求 Medicalelectrical equipment - Part 2: Particular requirements for thesafety of electrically operated hospital beds
IEC/EN 60601-2-52
YY 0571
19
医用电气设备 第2-51部分：记录和分析型单道和多道心电图机安全和基本性能专用要求
Part 2-51: Particular requirements forsafety, including essentialperformance,of recording and analysingsingle channel and multichannelelectrocardiographs
IEC/EN 60601-2-51
YY 0782-2010
20
心电诊断设备Diagnostic electrocardiographicdevices
ANSI/AAMI EC11
YY 1139
21
心电监护设备Electrocardiographic
ANSI/AAMI EC13
YY1079
22
医用电气设备第1-11部分：安全及基本性能的通用要求—并列标准：家庭医疗保健环境下使用的医用电气设备和系统
Part 1-11: General requirements forbasic safety and essential performance –Collateral Standard:Requirements for medical electrical equipment and
medical electrical systems used in thehome healthcare environment
IEC/EN 60601-1-11
23
医用体温计.大装置小型电体温计(非预测型和预测型)的性能
Performance of compact electricalthermometers (non-predictive and predictive) with maximumdevice
EN 12470-3
ASTM E1112
24
临床体温计.连续测量用电子体温计的性能
Performance of electricalthermometers
EN 12470-4
YY 0785
25
红外体温计
infrared ear thermometers (withmaximum device)
EN 12470-5
ASTM E1965-98
GB/T 21417.1
26
医用电气设备 第2部分：动态心电图系统安全和基本性能专用要求
Part 2-47: Particular requirements forthe basic safety and essential performance of ambulatoryelectrocardiographic systems
IEC/EN 60601-2-47
ANSI/AAMI EC38:2007
AAMI/ANSI/ISO 60601-2-47:2012
YY 0885
27
医用电气设备 第2部分：诊断和治疗激光设备安全专用要求
Part 2-22: Particular requirements forbasic safety and essential performance ofsurgical,cosmetic,therapeutic and diagnostic laser equipment
IEC/EN 60601-2-22
GB 9706.20
28
医用电气设备.第2部分:手术无影灯和诊断用照明灯安全专用要求
Part 2-41: Particular requirements forthe basic safety and essential performance of surgical luminairesand luminaires for diagnosis
IEC/EN 60601-2-41
YY 0627
29
医用电气设备 第2部分：手术台安全专用要求Part 2-46:Particular requirements for the basic safety and essentialperformance of operating tables
IEC/EN 60601-2-46
YY 0570
30
心电监护仪电缆和导联线
ECG trunk cables and patientleadwires
AAMI ANSI EC53
YY 0828
31
医用电气设备 第2-18部分:内窥镜设备安全专用要求
Part performance 2-18: Particular ofendoscopic requirements equipment
IEC/EN 60601-2-18
GB9706.19
32
医用电气设备 第1-2 部分：安全通用要求 并列标准：电磁兼容要求和试验
Medical electrical equipment-Part1-2:General requirements for safety Collateral standard:Electromagnetic compatibility-Requirements and tests
IEC/EN 60601-1-2
YY 0505
37
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，医疗电气设备和医疗电气系中统报警系统的测试和指南
Medical electrical equipment- Part1-8: General requirements for safety Collateral standard: Generalrequirements, tests and guidance for alarm systems in medicalelectrical equipment and medical electrical systems
IEC/EN 60601-1-8
YY0709
38
激光产品的安全 第1 部分:设备分类和要求
Safety of laser products —Part 1:Equipment classification and requirements
IEC/EN 60825-1
AS/NZS 2211.1
GB 7247.1
39
灯和灯系统的光生物安全性
Photobiological safety of lamps andlamp systems
IEC /EN62471
AS/NZS IEC 62471
IEC IEC/TR 62778
IEC/TR 62471-2
GB/T 20145
40
呼吸治疗设备,第1部分:雾化系统及其组成部分
RESPIRATORY THERAPY EQUIPMENT –Part 1:Nebulizing systems and
their components
EN13544-1
YY 0109
41
医用电气设备--第2-24部分:输液泵及控制器的基本安全和基本性能专用要求
Medical electrical equipment –Part2-24: Particular requirements for the basic safety and essentialperformance of infusion pumps and controllers
IEC/EN 60601-2-24
GB 9706.27
42
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 - Part2-34: Particular requirementsfor the basic safety and essentialperformance of invasive bloodpressure monitoring equipment
IEC/EN 60601-2-34
YY0783
43
医用电气设备 2-60部分：牙科设备的基本安全和基本性能Medicalelectrical equipment –Part 2-60: Particular requirements for thebasic safety and essential performance of dental equipment
IEC/EN 80601-2-60
44
医用设备 - 部分：医用设备可用性工程的应用
Medical devices IEC devices 62366-1: -Part 2015 1: IEC Application 62366: 2007+A1:2014 of usabilityengineering
IEC/EN 62366-1
YY/T 1474
45
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 - Part1-6: General requirements for basic safety and essentialperformance - Collateral s tandard: Usability
IEC/EN 60601-1-6
46
医用电气设备 第2部分:婴儿培养箱安全专用要求
Medical electrical equipment -Part2:Particular requirements for safety ofbaby incubators
IEC/EN 60601-2-19
GB 11243
47
医疗电气设备-第1-9部分:基本安全和重要性能的一般要求.附属标准:环境意识设计的要求
Medical electrical equipment Part 1-9:General requirements for basic safety and essential performance–Collateral Standard: Requirements for environmentally consciousdesign
IEC/EN 60601-1-9
48
医用电子体温计
Clinical electronic thermometer
GB/T21416
49
医疗器械软件 软件生存周期过程
Medical device software — Softwarelife cycle processes
IEC62304
YY/T 0664
50
医用吸引设备 第1部分: 电动吸引设备 安全要求
Medical suction equipment Part 1:Electrically powered suction equipment — Safety requirements
ISO10079-1
51
医用电气设备第2-37部分：超声医疗诊断监视设备基本安全和基本性能的特殊要求
Medical electrical equipment — Part2-37: Particular requirements for the basic safety and essentialperformance of ultrasonic medical diagnostic and monitoringequipment
EN 60601-2-37
GB 9706.9-2008
GB10152-2009
52
医用超声诊断设备声输出公布要求
Standard means for the reporting ofthe acoustic output of medical diagnostic ultrasonic equipment
IEC 61157
GB/T16846
UD2
UD3
53
医疗诊断超声波设备的声输出报告用标准方法
Ultrasonics dental descaler systems; measurement and declaration of the outputcharacteristics
IEC 61205
YY/T 0751
54
超声多普勒胎儿心率仪/ultrasonic Doppler fetalheartbeat detector
YY 0448
55
超声多普勒胎儿监护仪ultrasonic Doppler fetalmonitor
YY/T0449
56
超声理疗设备
Medical electrical equipment — Part2-5: Particular requirements for the basic safety and essentialperformance of ultrasonic physiotherapy equipment
IEC/EN 60601-2-5
YY/T1090
GB9706.7
57
超声 水听器 第1部分：40MHz 以下医用超声场的测量和特征描绘ultrasonic-Hydrophone Part 1: Measurement and characterization ofmedical ultrasonic fields to 40MHZ
IEC62127-1
YY/T 0865.1
