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Centre Testing International Co., Ltd. (NG28) is the pioneer and leader in the TIC Industry which provides one-stop solutions on testing, inspection, certification, calibration, audit, training & technical services.

 
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By Industry

Our service capabilties cover the upstream and downstream of the supply chain including textile and apparel,toys,electronic appliances,medical health,food...andother industries.
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Specialty

Comprehensively guarantee quality and safety, promote compliance and innovation, demonstrate brand competitiveness, and achieve higher quality, healthier, safer, and greener sustainable development.
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Transformer Double Voltage/ Double Frequency Testing

The linear transformer winding of medical electrical equipment needs to have sufficient insulation to prevent dangerous situations that may arise from overheating in internal short circuits. The transformer voltage and frequency doubling test, which evaluates quality and electrical safety characteristics, is one of the most important tests for safety of medical electrical products.

Transformer Double Voltage/ Double Frequency Testing

?    Service Background

Transformer Voltage and Frequency Doubling：The linear transformer winding of medical electrical equipment needs to have sufficient insulation to prevent dangerous situations that may arise from overheating in internal short circuits. For transformer’s winding with rated voltage less than or equal to 500V, or rated frequency less than or equal to 60Hz, 5 times the rated voltage or maximum rated frequency will be will be used, applying a frequency not less than 5 times the rated frequency at both ends of the winding. During the testing process, the insulation should not be broken. The transformer voltage and frequency doubling test, which evaluates quality and electrical safety characteristics, is one of the most important tests for safety of medical electrical products

Medical device testing is the basis for medical devices to enter the global market. If a product is to be exported to the European Union or the United States, then corresponding tests will need to be done to meet the EU or US standards.

?    Other Services of Medical Devices

  • Testing of active medical device
  • EMC testing and debugging service
  • Reliability Testing
  • NMPA registration testing service
  • Validation of product life
  • Failure mode analysis
  • biocompatibility test
  • Software evaluation
  • Global marketing access
  • US agent service
  • EU representative service
  • Training Service

?    Medical Device Testing Standards

In Vitro Diagnostic Medical Devices

SN

Title

International Standard

National Standard

1

Electrical Equipment For Measurement, Control, and Laboratory Use

IEC/EN 61010-1

GB4793.1

2

Safety requirements for electrical equipment for measurement, control and laboratory use –Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment

IEC/EN 61010-2-101

YY 0648

3

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

GB4793.9

4

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

IEC/EN 61326-1

GB/T 18268.1

5

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

 

 

 

 

Medical Device Testing Standards List

SN

Title

International Standard

National Standard

1

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

IEC/EN 60601-2-25

GB 10793

2

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

EN ISO /ISO 81060-1

 

3

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

EN 1060-3

 

4

Medical electrical equipment -- Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems

IEC/EN 60601-1-1

GB 9706.15

5

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

7

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

8

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        

 

9

Non-invasive automated sphygmomanometers

ANSI/AAMI SP10

YY 0670

10

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

 

11

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

12

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

ANSI/AAMI ES60601-1

EN /IEC60601-1

GB9706.1

13

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

IECC/EN 60601-2-10

YY 0607

14

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

15

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

IEC/EN 60601-2-49/IEC 80601-2-49

YY 0668

16

Medical electrical equipment — Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment

EN ISO 9919

ISO / EN ISO 80601-2-61

YY 0784

18

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

IEC/EN 60601-2-52

YY 0571

19

Part 2-51: Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs

IEC/EN 60601-2-51

YY 0782-2010

20

Diagnostic electrocardiographic devices

ANSI/AAMI EC11

YY 1139

21

Electrocardiographic

ANSI/AAMI EC13

YY1079

22

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

 

23

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

EN 12470-3

ASTM E1112

 

24

Performance of electrical thermometers

EN 12470-4

YY 0785

25

infrared ear thermometers (with maximum device)

EN 12470-5

ASTM E1965-98

GB/T 21417.1

26

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

27

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

28

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

29

Part 2-46: Particular requirements for the basic safety and essential performance of operating tables

IEC/EN 60601-2-46

YY 0570

30

ECG trunk cables and patient leadwires

AAMI ANSI EC53

YY 0828

31

Part performance 2-18: Particular of endoscopic requirements equipment

IEC/EN 60601-2-18

GB9706.19

32

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

IEC/EN 60601-1-2

YY 0505

37

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

38

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

IEC/EN 60825-1

AS/NZS 2211.1

GB 7247.1

39

Photobiological safety of lamps and lamp systems

IEC /EN62471

AS/NZS IEC 62471

IEC IEC/TR 62778

IEC/TR 62471-2

GB/T 20145

40

RESPIRATORY THERAPY EQUIPMENT –Part 1: Nebulizing systems and their components

EN13544-1

YY 0109

41

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

42

Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment

IEC/EN 60601-2-34

YY0783

43

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

IEC/EN 80601-2-60

 

44

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

45

Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability

IEC/EN 60601-1-6

 

46

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

IEC/EN 60601-2-19

 

GB 11243

47

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

 

48

Clinical electronic thermometer

 

GB/T21416

49

Medical device software — Software life cycle processes

IEC62304

YY/T 0664

50

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

ISO10079-1

 

51

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

EN 60601-2-37

GB 9706.9-2008

GB10152-2009

52

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

IEC 61157

GB/T16846

UD2

UD3

53

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

IEC 61205

YY/T 0751

54

ultrasonic Doppler fetal heartbeat detector

 

YY 0448

55

ultrasonic Doppler fetal monitor

 

YY/T0449

56

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

57

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

IEC62127-1

YY/T 0865.1

?    Applicable Products

Medical devices (including: thermometers, oximeters, sphygmomanometers, fetal heartbeat detector, electrocardiographs Color ultrasound system, X-ray machines, etc.)

?    Sample Requirements

Complete and fully-functional samples. For more specific details, please contact NG28 online customer service.

?    Our Edge

  • NG28 has qualified and experienced teams, ready to provide you professional consulting and services.
  • NG28 has advanced laboratory equipment, ensuring accuracy and reliability of the test data.
  • NG28 is a third-party testing and certification organization, trusted by customers globally and your endorsement of quality
  • We rely on our worldwide laboratory networks to provide you a comprehensive one-stop testing and certification solution.

?    FAQ

How long is the lead-time for medical device testing?

Actual lead-times are based on the product and standards, please contact NG28 customer service for more details.

What test method does NG28 use for medical device testing?

The applied test and standards are carried out according to the export requirements or to the clients’ needs.

What is NG28’s retention period of samples?

Sample Return

 

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