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¹úÄڳ߶È/National standards

ÕÉÁ¿¡¢¿ØÖƺÍÊÔÑéÊÒÓõçÆøÉ豸µÄÄþ¾²ÒªÇó 

Electrical Equipment For Measurement, 
Control ,and Laboratory Use

IEC/EN 61010-1

GB4793.1
GB/T42125.1

ÕÉÁ¿¡¢¿ØÖƺÍÊÔÑéÊÒÓõçÆøÉ豸µÄÄþ¾²ÒªÇó
µÚ2-101²¿ÃÅ£ºÌåÍâÕï¶Ï(IVD)Ò½ÓÃÉ豸µÄרÓÃÒªÇó

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

ÕÉÁ¿¡¢¿ØÖƺÍʵÑéÊÒÓõçÆøÉ豸µÄÄþ¾²ÒªÇó£ºÊµÑéÊÒÓ÷ÖÎöºÍÆäËûÄ¿µÄ×Ô¶¯ºÍ°ë×Ô¶¯É豸µÄÌØÊâÒªÇó

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

ÕÉÁ¿¡¢¿ØÖƺÍʵÑéÊÒÓõĵçÉ豸 µç´Å¼æÈÝÐÔÒªÇó µÚ1²¿ÃÅ:ͨÓÃÒªÇó

Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements

IEC/EN 61326-1

GB/T 18268.1

ÕÉÁ¿¡¢¿ØÖƺÍʵÑéÊÒÓõçÉ豸.µç´Å¼æÈÝÐÔ(EMC)µÄÒªÇó.ÌØÊâÒªÇó.ʵÑéÊÒÕï¶Ï

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

Ãû³Æ

¹ú¼Ê³ß¶È

¹úÄڳ߶È

Ò½ÓõçÆøÉ豸 µÚ2²¿ÃÅ Ðĵçͼ»úÄþ¾²×¨ÓÃÒªÇó

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

IEC/EN 60601-2-25

GB 10793  
GB 9706.225

ÎÞ´´ÑªÑ¹¼ÆµÚ1²¿ÃÅ:ͨÓÃÒªÇó

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

EN ISO /ISO 81060-1

ÎÞ´´ÑªÑ¹¼Æ.µÚ3²¿ÃÅ:µç-»úѪѹÕÉÁ¿ÏµÍ³µÄÔö²¹ÒªÇó

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

EN 1060-3

Ò½ÓõçÆøÉ豸 µÚ2-27²¿ÃÅ£ºÐĵç¼à»¤Äþ¾²¼°»ùÌìÐÔÄÜרÓÃÒªÇó

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

Ò½ÓõçÆøÉ豸 µÚ2-26²¿ÃÅ£ºÄÔµçͼ»úÄþ¾²×¨ÓÃÒªÇó

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

IEC/EN 60601-2-26:2012
IEC 80601-2-26£º2019

GB 9706.26
GB9706.226

Ò½ÓõçÆøÉ豸 µÚ2-56²¿ÃÅ:ÁÙ´²ÌåμƵĻù±¾Äþ¾²ºÍÐÔÄܵÄרÓÃÒªÇó

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

Ѫѹ¼Æ

Non-invasive automated sphygmomanometers

ANSI/AAMI SP10

YY 0670

Ò½ÓõçÆøÉ豸--µÚ2-57²¿ÃÅ:ÖÎÁÆ¡¢Õï¶Ï¡¢¼à²âºÍÃÀÈÝ/ÃÀѧʹÓõķǼ¤¹â¹âÔ´É豸µÄ»ù±¾Äþ¾²ºÍ»ùÌìÐÔÄÜרÓÃÒªÇó

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

Ò½ÓõçÆøÉ豸 µÚ2-2²¿ÃÅ:¸ßƵÊÖÊõÉ豸Äþ¾²×¨ÓÃÒªÇó

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

Ò½ÓõçÆøÉ豸µÚ1²¿ÃÅ£ºÄþ¾²Í¨ÓÃÒªÇó 

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

ANSI/AAMI ES60601-1 
EN /IEC60601-1

GB9706.1

Ò½ÓõçÆøÉ豸µÚ2-10²¿ÃÅ:Éñ¾­ºÍ¼¡Èâ´Ì¼¤Æ÷Äþ¾²×¨ÓÃÒªÇó

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

Ò½ÓõçÆøÉ豸 µÚ2-30²¿ÃÅ:×Ô¶¯Ñ­»·ÎÞ´´ÑªÑ¹¼à»¤É豸µÄÄþ¾²ºÍ»ùÌìÐÔÄÜרÓÃÒªÇó

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

Ò½ÓõçÆøÉ豸 µÚ2-49²¿ÃÅ£º¶à²ÎÊý»¼Õ߼໤É豸Äþ¾²×¨ÓÃÒªÇó

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

Ò½ÓõçÆøÉ豸.Ò½ÓÃÂö²«ÑªÑõÒÇÉ豸»ù±¾Äþ¾²ºÍÖ÷ÒªÐÔÄÜרÓÃÒªÇó

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

Ò½ÓõçÆøÉ豸 µÚ2-38²¿ÃÅ:Ò½Ôºµç¶¯´²Äþ¾²×¨ÓÃÒªÇó 
Ò½ÓõçÆøÉ豸 µÚ2-52²¿ÃÅ:Ò½Ôºµç¶¯´²Äþ¾²×¨ÓÃÒªÇó 

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

ÐĵçÕï¶ÏÉ豸

Diagnostic electrocardiographic devices       

ANSI/AAMI EC11

YY 1139

Ò½ÓõçÆøÉ豸 µÚ1-11²¿ÃÅ£ºÄþ¾²¼°»ùÌìÐÔÄܵÄͨÓÃÒªÇó—²¢Áг߶ȣº¼ÒÍ¥Ò½ÁƱ£½¡»·¾³ÏÂʹÓõÄÒ½ÓõçÆøÉ豸ºÍϵͳ

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

Ò½ÓÃÌåμÆ.×î´ó×°ÖÃСÐ͵çÌåμÆ(·ÇÔ¤²âÐͺÍÔ¤²âÐÍ)µÄÐÔÄÜ

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

EN 12470-3
ASTM E1112

ÁÙ´²ÌåμÆ.Á¬ÐøÕÉÁ¿Óõç×ÓÌåμƵÄÐÔÄÜ

Performance of electrical thermometers

EN 12470-4

YY 0785

ºìÍâÌåμÆ

infrared ear thermometers (with maximum device)

EN 12470-5
ASTM E1965-98

GB/T 21417.1

Ò½ÓõçÆøÉ豸 µÚ2²¿ÃÅ£º¶¯Ì¬ÐĵçͼϵͳÄþ¾²ºÍ»ùÌìÐÔÄÜרÓÃÒªÇó

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

Ò½ÓõçÆøÉ豸 µÚ2²¿ÃÅ£ºÕï¶ÏºÍÖÎÁƼ¤¹âÉ豸Äþ¾²×¨ÓÃÒªÇó

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

Ò½ÓõçÆøÉ豸.µÚ2²¿ÃÅ:ÊÖÊõÎÞÓ°µÆºÍÕï¶ÏÓÃÕÕÃ÷µÆÄþ¾²×¨ÓÃÒªÇó

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

Ò½ÓõçÆøÉ豸 µÚ2²¿ÃÅ£ºÊÖÊǫ̃Äþ¾²×¨ÓÃÒªÇó

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

Ðĵç¼à»¤ÒǵçÀº͵¼ÁªÏß

ECG trunk cables and patient leadwires

AAMI ANSI EC53

YY 0828

Ò½ÓõçÆøÉ豸 µÚ2-18²¿ÃÅ:ÄÚ¿ú¾µÉ豸Äþ¾²×¨ÓÃÒªÇó

Part performance 2-18: Particular of endoscopic requirements equipment

IEC/EN 60601-2-18

GB9706.19
GB 9706.218

Ò½ÓõçÆøÉ豸 µÚ1-2 ²¿ÃÅ£ºÄþ¾²Í¨ÓÃÒªÇó ²¢Áг߶ȣºµç´Å¼æÈÝ ÒªÇóºÍÊÔÑé

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

IEC/EN 60601-1-2

Ò½ÓõçÆøÉ豸 - µÚ1-8 ²¿ÃÅ:»ù±¾Äþ¾²ºÍ»ùÌìÐÔÄܵÄͨÓÃÒªÇó - ²¢Áг߶È: ͨÓÃÒªÇó£¬Ò½ÁƵçÆøÉ豸ºÍÒ½ÁƵçÆøϵÖÐͳ±¨¾¯ÏµÍ³µÄ²âÊÔºÍÖ¸ÄÏ

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

¼¤¹â²úÎïµÄÄþ¾² µÚ1 ²¿ÃÅ:É豸·ÖÀàºÍÒªÇó

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

GB 7247.1

µÆºÍµÆϵͳµÄ¹âÉúÎïÄþ¾²ÐÔ

Photobiological safety of lamps and lamp systems

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

GB/T 20145

ºôÎüÖÎÁÆÉ豸,µÚ1²¿ÃÅ:Îí»¯ÏµÍ³¼°Æä×é³É²¿ÃÅRESPIRATORY THERAPY EQUIPMENT –Part 1: Nebulizing systems and their components

EN13544-1
ISO 27427

YY 0109

Ò½ÓõçÆøÉ豸--µÚ2-24²¿ÃÅ:ÊäÒº±Ã¼°¿ØÖÆÆ÷µÄ»ù±¾Äþ¾²ºÍ»ùÌìÐÔÄÜרÓÃÒªÇó

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

Ò½ÓõçÆøÉ豸--µÚ2-34²¿ÃÅ:Óд´ÑªÑ¹¼à»¤É豸µÄ»ù±¾Äþ¾²ºÍ»ùÌìÐÔÄÜרÓÃÒªÇó

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

Ò½ÓõçÆøÉ豸 2-60²¿ÃÅ£ºÑÀ¿ÆÉ豸µÄ»ù±¾Äþ¾²ºÍ»ùÌìÐÔÄÜ

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

Ò½ÓÃÉ豸 - µÚÒ»²¿ÃÅ£ºÒ½ÓÃÉ豸¿ÉÓÃÐÔ¹¤³ÌµÄÓ¦ÓÃ

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

Ò½ÓõçÆøÉ豸 - µÚ1-6²¿ÃÅ£º»ù±¾Äþ¾²ºÍ»ùÌìÐÔÄܵÄͨÓÃÒªÇó - ²¢Áг߶ȣº¿ÉÓÃÐÔ

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

Ò½ÓõçÆøÉ豸 µÚ2²¿ÃÅ:Ó¤¶ùÅàÑøÏäÄþ¾²×¨ÓÃÒªÇó

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

IEC/EN 60601-2-19

GB 9706.219

Ò½ÁƵçÆøÉ豸-µÚ1-9²¿ÃÅ:»ù±¾Äþ¾²ºÍÖØÒªÐÔÄܵÄÒ»°ãÒªÇó.Á¥Êô³ß¶È:»·¾³ÒâʶÉè¼ÆµÄÒªÇó

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

Ò½Óõç×ÓÌåμÆ

Clinical electronic thermometer

GB/T21416

Ò½ÁÆÆ÷еÈí¼þ Èí¼þÉú´æÖÜÆÚ¹ý³Ì

Medical device software — Software life cycle processes

IEC62304 

YY/T 0664

Ò½ÓÃÎüÒýÉ豸 µÚ1²¿ÃÅ: µç¶¯ÎüÒýÉ豸 Äþ¾²ÒªÇó

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

ISO10079-1

YY/T 0636.1

Ò½ÓõçÆøÉ豸 µÚ2-37²¿ÃÅ£º³¬ÉùÒ½ÁÆÕï¶Ï¼àÊÓÉ豸»ù±¾Äþ¾²ºÍ»ùÌìÐÔÄܵÄÌØÊâÒªÇó

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

Ò½Óó¬ÉùÕï¶ÏÉ豸ÉùÊä³öÐû²¼ÒªÇó

IEC 61157

GB/T16846

Ò½ÁÆÕï¶Ï³¬Éù²¨É豸µÄÉùÊä³ö³ÂËßÓó߶ÈÒªÁì

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

IEC 61205

YY/T 0751

³¬Éù¶àÆÕÀÕÌ¥¶ùÐÄÂÊÒÇ

ultrasonic Doppler fetal heartbeat detector

YY 0448

³¬Éù¶àÆÕÀÕÌ¥¶ù¼à»¤ÒÇ

ultrasonic Doppler fetal monitor

YY/T0449

³¬ÉùÀíÁÆÉ豸

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

³¬Éù Ë®ÌýÆ÷ µÚ1²¿ÃÅ£º40MHz ÒÔÏÂÒ½Óó¬Éù³¡µÄÕÉÁ¿ºÍÌØÕ÷Ãè»æ 

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

IEC62127-1

YY/T 0865.1

Ò½ÓÃÄÚ¿ú¾µ

IEC/EN 60601-2-18

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

Ò½ÓýºÄÒʽÄÚ¿ú¾µ

YY 1298

Ò½ÓÃÄÚ¿ú¾µÕÕÃ÷ÓùâÀÂ

YY/T 0763

Ò½Óõç×ÓÄÚ¿ú¾µ

YY 1587

Ò½ÓÃÄÚ¿ú¾µ ÄÚ¿ú¾µ¹¦Ð§¹©Ó¦×°Öà ÉãÏñϵͳ

YY/T1603

»·¾³ÊÔÑéÒªÇó¼°ÊÔÑéÒªÁì

GB/T14710

²úÎï¼ÓËÙÀÏ»¯ÊÔÑéÒªÁì

IEC62506

GB/T34986

±ãЯʽºÍ±ãЯʽװÖÃÓÃÃܷ⺬¼îÐÔµç½âÒº¶þ´Îµç³ØµÄÄþ¾²ÒªÇó

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

ÁªºÏ¹ú¡¶¹ØÓÚΣÏÕ»õÎïÔËÊäµÄ½¨ÒéÊ頳߶ÈÓëÊÔÑéÊֲᡷ38.3 ÕÂ

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

UN DOT 38.3

¼ÒÓúÍÀàËÆÓÃ;µçÆ÷µÄÄþ¾² ¿ÚÇ»ÎÀÉúÆ÷¾ßµÄÌØÊâÒªÇó

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

¼ÒÓúÍÀàËÆÓÃ;µçÆ÷µÄÄþ¾²¼ÓʪÆ÷µÄÌØÊâÒªÇó Household and similar electrical appliances - Safety - Particular requirements for humidifiers

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

GB 4706.48

¼ÒÓúÍÀàËÆÓÃ;µçÆ÷µÄÄþ¾²ÍÆÄÃÆ÷¾ßµÄÌØÊâÒªÇó

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

¼ÒÓúÍÀàËÆÓÃ;µçÆ÷µÄÄþ¾² Å¯½ÅÆ÷ºÍÈȽŵæµÄÌØÊâÒªÇó

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

¼ÒÓúÍÀàËÆÓÃ;µçÆ÷µÄÄþ¾²×ÏÍâÏߺͺìÍâÏß·øÉäƤ·ôÆ÷¾ß µÄÌØÊâÒªÇó

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

¼ÒÓúÍÀàËÆÓÃ;µçÆ÷µÄÄþ¾²½áºÏ¼¤¹âºÍÇ¿ÁÒ¹âÔ´µÄÃÀÈݺÍÃÀÈÝ»¤ÀíÆ÷¾ßµÄÌØÊâÒªÇó

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

ÊÂÇéƵ¶Î/Frequency

²âÊԳ߶È

µäÐͲúÎï

Typical products

FCC

CE-RED

2400MHZ-2483.5MHZ

FCC part 15
FCC part 18

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

À¶ÑÀ£¬WLAN£¬ZIgBeeµÈ
Blue tooth, WLAN,Zigbee etc.

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

½ûÓÃProhibited

EN301 983-13
EN301 489-1/-52

ÀûÓÃLTE¹¦Ð§´«ÊäÊý¾Ý 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

½ûÓÃ/Prohibited

ÀûÓÃLTE¹¦Ð§´«ÊäÊý¾Ý Use LTE function to transfer data

868MHZ

½ûÓÃProhibited

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

ÓÃASK¡¢FSKÀàµ÷ÖÆ´«ÊäÊý¾ÝÀàUse ASK, FSK function to transfer data

433.92MHZ

FCC part 15
FCC part 18

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

ÓÃASK¡¢FSKÀàµ÷ÖÆ´«ÊäÊý¾ÝÀà Use ASK, FSK function to transfer data