active medical devices

Active Medical Device Testing

How its tested matters - Your trusted partner

How its tested matters - Your trusted partner

At TÜV SÜD, we combine expert medical product testing knowledge with a global network of internationally accredited laboratories and facilities, providing a one-stop solution. Our testing regimen subjects your product to a comprehensive evaluation in line with the rigorous standards of the medical devices industry, which serves as a testament to your product's compliance with global standards and regulations.

Our testing suite spans the entirety of your design and production cycle - from prototype testing to CB certification and lab tests for ergonomic, electrical, mechanical, and functional safety assessments, as well as software testing, to ensure a holistic review of your medical devices.

 

TESTING INFRASTRUCTURE

  • Complete EMI/EMC testing with a 10m Semi-Anechoic chamber for the standard EN/IEC 60601-1-2 and all EN/IEC 60601-2 standards
  • Sophisticated Wireless testing facilities to support regulatory requirements of Bluetooth, WiFi, SRD and Cellular technologies. Major standards supported include ETSI/EN 300 328, ETSI/EN 301 893, ETSI/EN 302 502, ETSI/EN 300 220, ETSI/EN 300 330, ETSI/EN 300 440, FCC Part 15, Part 22, Part 24, RSS standards
  • Electrical / Medical safety test facilities to test the majority of Medical products for National and International requirements
  • Comprehensive Environmental simulation test facilities for Temperature, humidity, altitude, thermal shock, shock and vibration, combined vibration, water and dust facilities
  • Global Market access services for all Medical devices

 

TESTS CONDUCTED

   

EMI/EMC CAPABILITIES 

  • Tests and Capabilities
    • Radiated Emission
      Up to 40Ghz frequency range within 10m Semi-Anechoic chamber
    • Conducted Emission
      10Khz - 108Mhz. Three Phase up to 200A
    • Current Harmonics
      up to 32A
    • Voltage Flicker & Fluctuations
      up to 32A
    • Electrostatic Discharge
      ± 30KV. Both Commercial & Automotive
    • Radiated Susceptibility
      20Mhz – 6.0Ghz up to 100V/m
    • Electrical Fast Transient
      Three Phase up to ± 5.0KV
    • Surge Immunity
      Three Phase up to ± 7.0KV
    • Ring Wave Immunity
      Three Phase up to ± 7.0KV
    • Conducted Susceptibility
      From 10Khz – 230Mhz up to 30Vrms
    • Bulk current injection
      From 10Khz – 400Mhz up to 400mA
    • Power Frequency Magnetic Fields
      up to 300A/m (Continuous); 1000A/m (Short Time)
    • Pulse Magnetic Field
      up to 1000A/m
    • AC & DC Dips and Interruptions
      Three Phase up to 32A
    • Automotive Transients
      Transient Emission, Pulses (1, 2a, 2b,3a, 3b & 4), DC 80V/50A

 

ACCREDITATION FOR THE LAB

  • National Accreditation Board for Testing and Calibration Laboratories (NABL)
  • American Association for Laboratory Accreditation 
  • IECEE CB Testing Laboratory (CBTL)
  • German Safety (GS)
  • Nationally Recognized Testing Laboratory (NRTL)

 

STANDARDS WE TEST AGAINST

  • Major Medical Standards
    • IEC 60601-1
      General requirements for basic safety and essential performance of Medical electrical equipment
    • IEC 60601-1-8
      General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
    • IEC 60601-1-11
      Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
    • IEC 60601-2-4
      Requirements for the basic safety and essential performance of cardiac defibrillators
    • IEC 60601-2-12
      Requirements for the basic safety and essential performance of critical care ventilators
    • IEC 60601-2-13
      Requirements for the safety and essential performance of anesthetic systems
    • IEC 60601-2-25
      Requirements for the basic safety and essential performance of electrocardiographs
    • IEC 60601-2-27
      Requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
    • IEC 60601-2-30
      Requirements for the Safety, Essential Performance of Automatic Cycling Non-Invasive BP Monitoring Equipment
    • IEC 60601-2-37
      Requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
    • IEC 60601-2-47
      Requirements for the basic safety and essential performance of ambulatory electrocardiographic systems
    • IEC 80601-2-49
      Requirements for the basic safety and essential performance of multifunction patient monitoring equipment
    • ISO 80601-2-61
      Requirements for basic safety and essential performance of pulse oximeter equipment
    • IEC 61010-1
      Safety requirements for electrical equipment for measurement, control, and laboratory use
    • IEC 61010-2-101
      Requirements for in vitro diagnostic (IVD) medical equipment
    • IEC 60601-1-2
      General requirements for basic safety and essential performance. Collateral Standard: Electromagnetic disturbances. Requirements and tests
    • IEC 61326-2-6
      Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment

 

WHY CHOOSE TÜV SÜD FOR ACTIVE MEDICAL DEVICES TESTING?

  • Global Recognition
    Test reports and certificates from TÜV SÜD laboratories are traceable, recognized, and accepted globally
  • Comprehensive Suite of Services
    TÜV SÜD’s test laboratories provide compliance testing, verification, validation, engineering, and re-engineering activities of Medical Devices
  • State-of-the-art Facilities
    TÜV SÜD’s 10m Semi-Anechoic chamber is designed and constructed to accommodate testing of complex medical products such as CT, MRI, X-ray equipment
  • Timely Market Updates
    Our market access teams keep a constant watch on the change in global regulations, standards, and requirements and update the medical product fraternity on possible impact on their products and product families
  • Flexible Certification Schemes
    Medical manufacturers can include a wide range of medical products under a single report and certificate, which helps to streamline regulatory processes for a seamless market entry

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