球压，医疗电气

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