名稱/Title

國際標準/international standards

國內標準/National standards

測量、控制和試驗室用電氣設備的安全要求 

Electrical Equipment For Measurement, 
Control ,and Laboratory Use

IEC/EN 61010-1

GB4793.1
GB/T42125.1

測量、控制和試驗室用電氣設備的安全要求
第2-101部分：體外診斷(IVD)醫(yī)用設備的專用要求

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

測量、控制和實驗室用電氣設備的安全要求：實驗室用分析和其他目的自動和半自動設備的特殊要求

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

測量、控制和實驗室用的電設備 電磁兼容性要求 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

測量、控制和實驗室用電設備.電磁兼容性(EMC)的要求.特殊要求.實驗室診斷

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

名稱

國際標準

國內標準

醫(yī)用電氣設備 第2部分 心電圖機安全專用要求

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

IEC/EN 60601-2-25

GB 10793  
GB 9706.225

無創(chuàng)血壓計第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

無創(chuàng)血壓計.第3部分:電-機血壓測量系統(tǒng)的補充要求

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

EN 1060-3

醫(yī)用電氣設備 第2-27部分：心電監(jiān)護安全及基本性能專用要求

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

醫(yī)用電氣設備 第2-26部分：腦電圖機安全專用要求

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

醫(yī)用電氣設備 第2-56部分:臨床體溫計的基本安全和性能的專用要求

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

血壓計

Non-invasive automated sphygmomanometers

ANSI/AAMI SP10

YY 0670

醫(yī)用電氣設備--第2-57部分:治療、診斷、監(jiān)測和美容/美學使用的非激光光源設備的基本安全和基本性能專用要求

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

醫(yī)用電氣設備 第2-2部分:高頻手術設備安全專用要求

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

醫(yī)用電氣設備第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

醫(yī)用電氣設備第2-10部分:神經(jīng)和肌肉刺激器安全專用要求

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

醫(yī)用電氣設備 第2-30部分:自動循環(huán)無創(chuàng)血壓監(jiān)護設備的安全和基本性能專用要求

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

醫(yī)用電氣設備 第2-49部分：多參數(shù)患者監(jiān)護設備安全專用要求

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

醫(yī)用電氣設備.醫(yī)用脈搏血氧儀設備基本安全和主要性能專用要求

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

醫(yī)用電氣設備 第2-38部分:醫(yī)院電動床安全專用要求 
醫(yī)用電氣設備 第2-52部分:醫(yī)院電動床安全專用要求 

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

心電診斷設備

Diagnostic electrocardiographic devices       

ANSI/AAMI EC11

YY 1139

醫(yī)用電氣設備 第1-11部分：安全及基本性能的通用要求—并列標準：家庭醫(yī)療保健環(huán)境下使用的醫(yī)用電氣設備和系統(tǒng)

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

醫(yī)用體溫計.最大裝置小型電體溫計(非預測型和預測型)的性能

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

EN 12470-3
ASTM E1112

臨床體溫計.連續(xù)測量用電子體溫計的性能

Performance of electrical thermometers

EN 12470-4

YY 0785

紅外體溫計

infrared ear thermometers (with maximum device)

EN 12470-5
ASTM E1965-98

GB/T 21417.1

醫(yī)用電氣設備 第2部分：動態(tài)心電圖系統(tǒng)安全和基本性能專用要求

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

醫(yī)用電氣設備 第2部分：診斷和治療激光設備安全專用要求

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

醫(yī)用電氣設備.第2部分:手術無影燈和診斷用照明燈安全專用要求

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

醫(yī)用電氣設備 第2部分：手術臺安全專用要求

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

心電監(jiān)護儀電纜和導聯(lián)線

ECG trunk cables and patient leadwires

AAMI ANSI EC53

YY 0828

醫(yī)用電氣設備 第2-18部分:內窺鏡設備安全專用要求

Part performance 2-18: Particular of endoscopic requirements equipment

IEC/EN 60601-2-18

GB9706.19
GB 9706.218

醫(yī)用電氣設備 第1-2 部分：安全通用要求 并列標準：電磁兼容 要求和試驗

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

IEC/EN 60601-1-2

醫(yī)用電氣設備 - 第1-8 部分:基本安全和基本性能的通用要求 - 并列標準: 通用要求，醫(yī)療電氣設備和醫(yī)療電氣系中統(tǒng)報警系統(tǒng)的測試和指南

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

激光產(chǎn)品的安全 第1 部分:設備分類和要求

Safety of laser products —Part 1: Equipment classification and requirements

GB 7247.1

燈和燈系統(tǒng)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

呼吸治療設備,第1部分:霧化系統(tǒng)及其組成部分RESPIRATORY THERAPY EQUIPMENT –Part 1: Nebulizing systems and their components

EN13544-1
ISO 27427

YY 0109

醫(yī)用電氣設備--第2-24部分:輸液泵及控制器的基本安全和基本性能專用要求

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

醫(yī)用電氣設備--第2-34部分:有創(chuàng)血壓監(jiān)護設備的基本安全和基本性能專用要求

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

醫(yī)用電氣設備 2-60部分：牙科設備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

醫(yī)用設備 - 第一部分：醫(yī)用設備可用性工程的應用

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

醫(yī)用電氣設備 - 第1-6部分：基本安全和基本性能的通用要求 - 并列標準：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

醫(yī)用電氣設備 第2部分:嬰兒培養(yǎng)箱安全專用要求

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

IEC/EN 60601-2-19

GB 9706.219

醫(yī)療電氣設備-第1-9部分:基本安全和重要性能的一般要求.附屬標準:環(huán)境意識設計的要求

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

醫(yī)用電子體溫計

Clinical electronic thermometer

GB/T21416

醫(yī)療器械軟件 軟件生存周期過程

Medical device software — Software life cycle processes

IEC62304 

YY/T 0664

醫(yī)用吸引設備 第1部分: 電動吸引設備 安全要求

Medical suction equipment Part 1: Electrically powered suction equipment — Safety requirements

ISO10079-1

YY/T 0636.1

醫(yī)用電氣設備 第2-37部分：超聲醫(yī)療診斷監(jiān)視設備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

醫(yī)用超聲診斷設備聲輸出公布要求

IEC 61157

GB/T16846

醫(yī)療診斷超聲波設備的聲輸出報告用標準方法

Ultrasonics  dental  descaler systems; measurement and declaration of the output characteristics

IEC 61205

YY/T 0751

超聲多普勒胎兒心率儀

ultrasonic Doppler fetal heartbeat detector

YY 0448

超聲多普勒胎兒監(jiān)護儀

ultrasonic Doppler fetal monitor

YY/T0449

超聲理療設備

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

超聲 水聽器 第1部分：40MHz 以下醫(yī)用超聲場的測量和特征描繪 

ultrasonic-Hydrophone Part 1: Measurement and characterization of medical ultrasonic fields to 40MHZ

IEC62127-1

YY/T 0865.1

醫(yī)用內窺鏡

IEC/EN 60601-2-18

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

醫(yī)用膠囊式內窺鏡

YY 1298

醫(yī)用內窺鏡照明用光纜

YY/T 0763

醫(yī)用電子內窺鏡

YY 1587

醫(yī)用內窺鏡 內窺鏡功能供給裝置 攝像系統(tǒng)

YY/T1603

環(huán)境試驗要求及試驗方法

GB/T14710

產(chǎn)品加速老化試驗方法

IEC62506

GB/T34986

便攜式和便攜式裝置用密封含堿性電解液二次電池的安全要求

Secondary cells and batteries containing alkaline or other non-acid electrolytes- Safety requirements for portable sealed secondary cells,and for batteries made from them,for use in portable applications

IEC/EN 62133
IEC62133-1
IEC62133-2

GB31241

聯(lián)合國《關于危險貨物運輸?shù)慕ㄗh書 標準與試驗手冊》38.3 章

recommendations on the transportation of dangerous goods manual of tests and criteria

UN DOT 38.3

家用和類似用途電器的安全 口腔衛(wèi)生器具的特殊要求

Household and similar electrical appliances- Safety Particular requirements for for oral and hygiene appliances

IEC/EN60335-2-52
AS/NZS60335.2.52

GB 4706.59

家用和類似用途電器的安全加濕器的特殊要求 Household and similar electrical appliances - Safety - Particular requirements for humidifiers

IEC/EN 60335-2-98
AS/NZS 60335.2.98

GB 4706.48

家用和類似用途電器的安全按摩器具的特殊要求

Household and similar electrical appliances - Safety - Particular requirements for massage appliances

IEC/EN 60335-2-32
AS/NZS 60335.2.32
AS/NZS 60335.2.32

GB 4706.10

家用和類似用途電器的安全 暖腳器和熱腳墊的特殊要求

Household and similar electrical appliances - Safety - Particular requirements for foot warmers and heating mats

IEC/EN60335-2-81
AN/NZS 60335.2.81

GB4706.80

家用和類似用途電器的安全紫外線和紅外線輻射皮膚器具 的特殊要求

Household and similar electrical appliances - Safety - Particular requirements for appliances for skin exposure to optical radiation

IEC/EN 60335-2-27
AS/NZS60335.2.27

GB4706.85

家用和類似用途電器的安全結合激光和強烈光源的美容和美容護理器具的特殊要求

Household and similar electrical appliances - Safety - Part 2-113: Particular requirements for cosmetic and beauty care appliances incorporating lasers and intense light sources

IEC/EN60335-2-113

工作頻段/Frequency

測試標準

典型產(chǎn)品

Typical products

FCC

CE-RED

2400MHZ-2483.5MHZ

FCC part 15
FCC part 18

EN300328
EN301489-1/17 EN60950-1/EN62368-1
EN62479/EN62311

藍牙，WLAN，ZIgBee等
Blue tooth, WLAN,Zigbee etc.

LTD band 1/3/7/8/20/22/28/33/34/38/40/42/43

禁用Prohibited

EN301 983-13
EN301 489-1/-52

利用LTE功能傳輸數(shù)據(jù) Use LTE function to transfer data

LTD band 2/4/5/7/12/13/17/41

FCC part 22
FCC part 24
FCC part 27

禁用/Prohibited

利用LTE功能傳輸數(shù)據(jù) Use LTE function to transfer data

868MHZ

禁用Prohibited

EN300 220
EN301 489-1/3
EN60950-1/EN62368
EN62479

用ASK、FSK類調制傳輸數(shù)據(jù)類Use ASK, FSK function to transfer data

433.92MHZ

FCC part 15
FCC part 18

EN300 220
EN301 489-1/3
EN60950-1/EN62368
EN62479

用ASK、FSK類調制傳輸數(shù)據(jù)類 Use ASK, FSK function to transfer data