ONETECH

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Business field
Business field

Medical Safety



Main Business Support

  • Provide testing and report writing services for CB approval and CE-MDR for medical devices used in medical environments (NRTL, CE, CB, Kolas)

    MEAS :
    Provide CB approval and CE -LVD and CE-IVDR testing and report writing services for subjects used for measurement, laboratory, clinical laboratory or self-diagnosis

01 Subject Items

Radiofrequency surgeon, ultrasound surgeon, cardiac defibrillator, ultrasound therapist, ultrasound stimulator, low-frequency stimulator, endoscopic device, laser device, injector, electrocardiogram (ECG) device, electrocardiogram monitor, non-invasive automatic blood pressure (NIBP), invasive blood pressure gauge (IBP), ultrasound image diagnostic device, CT X-ray device, mammogram X-ray device, portable electrocardiogram, multifunctional patient surveillance device, imaging and fluoroscopic X-ray device, thermometer, dental instrument, pulse oximeter (SpO2), dental oral external X-ray device, dental oral X-ray device, etc.

02 Application specifications for each test field

  • IEC/EN60601-1 Basic safety and essential performance of medical devices

    IEC/EN 60601-1-3 X-ray instrument radiation defense for diagnostics

    IEC/EN 60601-1-6 User-compatibility

    IEC/EN 60601-1-8 Alarm System

    IEC/EN 60601-1-9 Environmentally friendly design

    IEC/EN 60601-1-10 Physiological Closed Circuit Controller

    IEC/EN 60601-1-11 Home healthcare environment

    IEC/EN 60601-1-12 Emergency Medical Service Environment

    IEC/EN 60601-2-2 Radiofrequency Surgical Instruments

    IEC/EN 60601-2-3 Ultrahigh Frequency Surgical Instruments

    IEC/EN 60601-2-4 Cardiac Defibrillator

    IEC/EN 60601-2-5 Ultrasound Therapy Machine

    IEC/EN 60601-2-6 UHF Stimulator

    IEC/EN 60601-2-10 Low Frequency Stimulator

    IEC/EN 60601-2-18 Endoscope instrument

    IEC/EN 60601-2-22 Laser Instrument

    IEC/EN 60601-2-24 Pharmaceutical Injectors

    IEC/EN 60601-2-25 Electrocardiogram (ECG) instrument

    IEC/EN 60601-2-27 Electrocardiogram Monitor

    IEC/EN 80601-2-30 Non-Invasive Automatic Blood Pressure Monitor (NIBP)

    IEC/EN 60601-2-34 Invasive Blood Pressure Monitor (IBP)

    IEC/EN 60601-2-37 Ultrasonic Imaging Diagnostic Device

    IEC/EN 60601-2-44 X-ray apparatus for CT

  • IEC/EN 60601-2-45 Mammography X-ray device

    IEC/EN 60601-2-47 Portable ECG

    IEC/EN 60601-2-49 Multifunctional Patient Monitor

    IEC/EN 60601-2-54 X-ray equipment for imaging and fluoroscopy

    ISO 80601-2-56 Thermometer

    IEC/EN 80601-2-60 Dental Instruments

    ISO 80601-2-61 Pulse Oximeter (SpO2)

    IEC/EN 60601-2-63 Dental extra-oral X-ray equipment

    IEC/EN 60601-2-65 Dental intraoral X-ray equipment

    IEC/EN/KSC IEC 61010-1 Safety Requirements for Measurement, Control and Testing Laboratory Electrical Equipment Part 1: General Requirements

    IEC/EN 61010-1/2-101 Instruments for in vitro diagnostics (IVD)

    IEC/EN 61010-2-010: Laboratory equipment for material heating

    IEC/EN 61010-2-020 (*): Laboratory centrifuges

    IEC/EN 61010-2-031 (*): Hand-held probe assembly for electrical measurement and testing

    IEC/EN 61010-2-032 (*): Handle-type current cramps for electrical measurement and testing

    IEC/EN 61010-2-051: Laboratory instruments for mixing and stirring

    IEC/EN 61010-2-061 (*) Thermal Spray Ionization Atom Spectrometer

    IEC/EN 61010-2-081: Automatic, semi-automatic, or other instruments for laboratory use

    IEC/EN 61010-2-101: In vitro diagnostics (Ex. Blood glucose, urinary chemistry analyzer, etc.)

03 Main Test Equipment


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