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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
    Ball Pressure Testing

    Ball pressure is to ensure the mechanical strength and heat resistance of a product's insulation material meet requirements, as to guarantee its insulation characteristics is not reduced. The ball pressure test, which is used to evaluate how safe the insulating materials are, is one of the most important tests for safety of medical electrical products.

    Ball Pressure Testing

    ◉    Service Background

    Ball Pressure: Ball pressure is to ensure the mechanical strength and heat resistance of a product's insulation material meet requirements, as to guarantee its insulation characteristics is not reduced. The test is done with the shell made of insulating material placed in a horizontal position, then using a steel ball to apply pressure to the tested surface with a specific force. In addition, the test is also carried out in a heating box at a specific temperature. After the test, the diameter of the indentation from the steel ball should not be greater than 2mm. The ball pressure test, which evaluates the safety characteristics of insulating materials, 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

    1. Testing of active medical device
    2. EMC testing and debugging service
    3. Reliability Testing
    4. NMPA registration testing service
    5. Validation of product life
    6. Failure mode analysis
    7. biocompatibility test
    8. Software evaluation
    9. Global marketing access
    10. US agent service
    11. EU representative service
    12. 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

    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

    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