Medical Devices and In-Vitro Diagnostic (IVD) Medical Devices

Medical Devices and In-Vitro Diagnostic (IVD) Medical Devices 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 & regulations.

Our testing suite spans the entirety of your design & 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.

Our experts thoroughly analyze physical performance, chemical composition, microbiological factors, and potential risks. Through rigorous tests, we ensure that your medical devices adhere to global regulations and are safe for use in healthcare settings. With TÜV SÜD's proven track record, you can be rest assured that industry professionals and consumers globally will recognize your medical devices for their functionality and safety.

 

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 most medical products for national and international requirements.
  • Comprehensive Environmental simulation test facilities for temperature, humidity, altitude, thermal shock, shock & vibration, combined vibration, water, and dust facilities.
  • Testing Equipment and Instrumentation
    • LC-MS-QTOF
    • GC-MS/Headspace
    • ICP MS
    • TOC
    • Biosafety Cabinet
    • CO2 Incubators
    • BOD Incubators
    • Shaker
    • Permeability tester
    • Impact tester
    • Precision balances
    • Environmental Chambers
    • Automated Colony Counters
    • ELISA Reader
    • Cooling Centrifuges

TESTS CONDUCTED

  • Physical Testing of Medical Devices and IVDs
    • Electrical Safety Testing
    • MRI Safety Testing
    • Functional Safety
    • EMC Testing
    • Environmental Testing
    • NRTL
    • IECEE CB Scheme
  • Chemical / Biological Testing of Medical Devices and IVDs
    • Microbiological Testing for Medical Devices
    • Chemical Testing for Medical Devices
    • Chemical Characterisation of Medical Devices
    • Biocompatibility Testing
    • Extractables and Leachable analysis 
    • Toxicological Risk Assessment 
    • Biological Evaluation Plan and Report
    • MRI Safety Testing 
    • Microbiology
    • Packaging Testing
    • Transport and Simulation
  • Cybersecurity in Medical Devices and IVDs
    • Cybersecurity Testing and Assessment Services
    • Medical Devices and IVDs Security Testing (Penetration Testing)

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)
  • ISO 17025
  • OECD GLP
  • DSIR
  • CDCSO

*In process

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
    • Biocompatibility Testing: ISO 10993 series 
    • Extractables & Leachables Testing: ISO 10993-18 and 17
    • Microbiology: ISO 11137, ISO 17664 and USP<85>
    • Packaging: IEC 60721, IEC 60529, IEC 60068, ISTA % ASTM
    • Cyber Security: IEC 62443
    • MRI Safety: ASTM Series, ASTM F2052, F2213, F2182, F2119, F2503

WHY CHOOSE TÜV SÜD FOR 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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