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    Our service

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

     
    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.
    Specialty

    Comprehensively guarantee quality and safety, promote compliance and innovation, demonstrate brand competitiveness, and achieve higher quality, healthier, safer, and greener sustainable development.
    AUTHORITY & TRUST
    QUALITY & VALUE
    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 CTI online customer service.

    ◉    Our Edge

    • CTI has qualified and experienced teams, ready to provide you professional consulting and services.
    • CTI has advanced laboratory equipment, ensuring accuracy and reliability of the test data.
    • CTI 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 CTI customer service for more details.

    What test method does CTI 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 CTI’s retention period of samples?

    Sample Return