医疗器械有源产品测试

名称/Title

国际标准/international standards

国内标准/National standards

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
GB/T42125.1

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 electrical equipment for measurement, control andlaboratory use –Part 2-101: Particular requirements for in vitro diagnostic (IVD) medicalequipm

IEC/EN 61010-2-101

YY 0648
GB/T42125.16

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 electrical equipment for measurement, control and laboratory use – Part  081: Particular requirements for automatic and semiautomatic laboratory equipment for analysis and other purposes

IEC/EN 61010-2-081

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: General requirements

IEC/EN 61326-1

GB/T 18268.1

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) medical equipment

IEC/EN 61326-2-6

GB/T18268.26

名称

国际标准

国内标准

医用电气设备 第2部分 心电图机安全专用要求

Medical safety and electrical essential equipment performance - Part 2-25: of electrocardiographs Particular requirements

IEC/EN 60601-2-25

GB 10793  
GB 9706.225

无创血压计第1部分:通用要求

Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type

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 - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems

EN 1060-3

/

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 - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment

IEC/EN 60601-2-27

GB 9706.25
GB9706.227

医用电气设备 第2-26部分：脑电图机安全专用要求

Medical electrical equipment-Part 2-26: Particular requirements for the safety of electroencephalographs

IEC/EN 60601-2-26:2012
IEC 80601-2-26：2019

GB 9706.26
GB9706.226

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-Part performance2-56: of clinical Particular thermometers requirements for basic body temperature measurement

ISO/ EN ISO 80601-2-56         

YY 9706.256

血压计

Non-invasive automated sphygmomanometers

ANSI/AAMI SP10

YY 0670

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

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

IEC/EN 60601-2-57

YY 9706.257

医用电气设备 第2-2部分:高频手术设备安全专用要求

Medical Basic Safety Electrical And Equipment Essential -Performance Part 2-2: Particular Of High Requirements Frequency For Surgical Equipment And High Frequency Surgical Accessories
                                                   

IEC/EN/EN IEC 60601-2-2       

GB 9706.4
GB 9706.204

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

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

Medical electrical equipment - Part 2-10 : particular requirements for the safety of nerve and muscle stimulators

IEC/EN 60601-2-10

YY 0607
GB9706.210

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 - Part 2-30: Particular requirements for basic safety and essential performance of automated non-invasive sphygmomanometers    

IEC/EN 80601-2-30

YY 0667
YY 9706.230

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

Medical electrical equipment-Part 2-49:Particular requiremens for the safety of multifunction patient monitoring equipment

IEC/EN 80601-2-49

YY 0668
YY 9706.249

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

Medical electrical equipment — Part 2-61: Particular requirements for basic safetyand essential performance of pulseoximeter equipment

ISO / EN ISO 80601-2-61

YY 0784
YY 9706.261

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 

Medical electrical equipment - Part 2: Particular requirements for the safety of electrically operated hospital beds          

IEC/EN 60601-2-52

YY 0571
YY 9706.252

心电诊断设备

Diagnostic electrocardiographic devices       

ANSI/AAMI EC11

YY 1139

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 for basic safety and essential performance –Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

IEC/EN 60601-1-11 

YY 9706.111

医用体温计.最大装置小型电体温计(非预测型和预测型)的性能

Performance of compact electrical thermometers (non-predictive and predictive) with maximum device

EN 12470-3
ASTM E1112

/

临床体温计.连续测量用电子体温计的性能

Performance of electrical thermometers

EN 12470-4

YY 0785

红外体温计

infrared ear thermometers (with maximum device)

EN 12470-5
ASTM E1965-98

GB/T 21417.1

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 for the basic safety and essential performance of ambulatory electrocardiographic systems

IEC/EN 60601-2-47
ANSI/AAMI EC38:2007
AAMI/ANSI/ISO 60601-2-47:2012

YY 0885
YY 9706.247

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 for basic safety and essential performance of surgical,cosmetic,therapeutic and diagnostic laser equipment

IEC/EN 60601-2-22

GB 9706.20
GB9706.222

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 for the basic safety and essential performance of surgical luminaires and luminaires for diagnosis

IEC/EN 60601-2-41

YY 0627
YY 9706.241

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 essential performance of operating tables

IEC/EN 60601-2-46

YY 0570
YY 9706.246

心电监护仪电缆和导联线

ECG trunk cables and patient leadwires

AAMI ANSI EC53

YY 0828

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 of endoscopic requirements equipment

IEC/EN 60601-2-18

GB9706.19
GB 9706.218

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-Part 1-2:General requirements for safetyCollateral standard :Electromagnetic compatibility-Requirements and tests

IEC/EN 60601-1-2

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- Part 1-8: General requirements for safety Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

IEC/EN 60601-1-8

YY0709
YY 9706.108

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

GB 7247.1

灯和灯系统的光生物安全性

Photobiological safety of lamps and lamp systems

IEC /EN62471
AS/NZS IEC 62471
IEC IEC/TR 62778
IEC/TR 62471-2

GB/T 20145

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
ISO 27427

YY 0109

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 –Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers

IEC/EN 60601-2-24

GB 9706.27 
GB 9706.224

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 requirementsfor the basic safety and essential performance of invasive bloodpressure monitoring equipment

IEC/EN 60601-2-34

YY0783
YY 9706.234

医用电气设备 2-60部分：牙科设备的基本安全和基本性能

Medical electrical equipment –Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment

IEC/EN 80601-2-60

GB 9706.260

医用设备 - 第一部分：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 usability engineering

IEC/EN 62366-1

YY/T 1474

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 - Part 1-6: General requirements for basic safety and essential performance - Collateral s tandard: Usability

IEC/EN 60601-1-6

YY/T 9706.106

医用电气设备 第2部分:婴儿培养箱安全专用要求

Medical electrical equipment -Part 2:Particular requirements for safety of baby incubators

IEC/EN 60601-2-19

GB 9706.219

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 conscious design

 IEC/EN 60601-1-9

医用电子体温计

Clinical electronic thermometer

GB/T21416

医疗器械软件 软件生存周期过程

Medical device software — Software life cycle processes

IEC62304 

YY/T 0664

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

YY/T 0636.1

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 —Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment

IEC/EN 60601-2-37

GB 9706.9
GB10152
GB9706.237

Standard means for the reporting of the acoustic output of medical diagnostic ultrasonic equipment

医用超声诊断设备声输出公布要求

IEC 61157

GB/T16846

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 output characteristics

IEC 61205

YY/T 0751

超声多普勒胎儿心率仪

ultrasonic Doppler fetal heartbeat detector

YY 0448

超声多普勒胎儿监护仪

ultrasonic Doppler fetal monitor

YY/T0449

超声理疗设备

Medical electrical equipment —Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment

IEC/EN 60601-2-5

YY/T1090
GB9706.7
GB9706.205

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 of medical ultrasonic fields to 40MHZ

IEC62127-1

YY/T 0865.1

医用内窥镜

IEC/EN 60601-2-18

YY 0068.1, YY 0068.2, YY/T 0068.3 ,YY 0068.4

医用胶囊式内窥镜

YY 1298

医用内窥镜照明用光缆

YY/T 0763

医用电子内窥镜

YY 1587

医用内窥镜 内窥镜功能供给装置 摄像系统

YY/T1603

环境试验要求及试验方法

GB/T14710

产品加速老化试验方法

IEC62506

GB/T34986