Medical Devices & EMI / EMC

The increased use, distribution, and complexity of medical devices have prompted the need to address electromagnetic interference (EMI) and compatibility (EMC) issues.  Exponent engineers, scientists, and medical doctors have the capability both to evaluate the potential level of EMI/EMC and to assess the clinical significance for a diverse range of medical devices and clients.  This is especially important for Class III medical devices such as pacemakers and ICDs.

Medical devices are susceptible to EMI due to a variety of factors including:

  • Some devices are designed to interact with magnets, allowing them to be re-programmed or monitored using magnets from outside the body.
  • Magnetically susceptible materials used in some implants experience forces in a large magnetic field e.g., from MRI
  • DC/AC/ RF fields can generate currents and voltages on leads/loops

Examples of medical devices with potential sensitivity to electromagnetic fields include:

  • Pacing devices: defibrillators (ICDs), pacemakers (ICPs), etc.
  • Some neurological stimulators/shunts
  • Hydrocephalus Shunt Valve
  • Vagus Nerve Stimulator (VNS)
  • Drug infusion pumps
  • Cochlear Implants
  • Reed Switches (magnetically actuated switch)

Specific services that Exponent consultants employ to answer clients’ needs may include:

  • Return to work safety evaluation after receiving a new medical device
  • Technical interface with medical device manufacturer personnel regarding safety concerns
  • Immunity testing of medical devices

Exponent has expertise in evaluating products with respect both to manufacturer limits and to national/international standards used for assessment of medical devices such as:

  • Active Implantable Medical Devices (AIMDs) 
    • ANSI/AAMI/ISO 14117 (EMC test protocols; supersedes AAMI PC69-2007)
    • ANSI/AAMI/ISO 14708-3 (Implantable neurostimulators)
    • ANSI/AAMI/ISO 14708-4 (Implantable infusion pumps)
    • EN 45502-1 (General Requirements for Safety)
    • EN 45502-2-1 (Cardiac Pacemakers)
    • EN 45502-2-2 (Tachyarrythmia)
    • EN 45502-2-3 (cochlear and auditory brainstem implants)
    • EN 50527-1 (Procedure to assess exposure to electromagnetic fields)

  • Magnetic Resonance Imaging (MRI) ASTM F2052
    • ASTM F2213
    • ASTM F2182
    • ISO/TS 10874
    • ISO/TS 10974

  • IEC 60601 Series (Medical Electrical Equipment) 
    • IEC 60601-1-1 (General requirements for safety)
    • IEC 60601-1-2 (General requirements for EMC of medical devices)
    • IEC 60601-1-4 (General requirements for programmable electrical medical systems)
    • IEC 60601-2-3 (Requirements for short-wave therapy equipment)
    • IEC 60601-2-4 (Requirements for cardiac defibrillators)
    • IEC 60601-2-6 (Requirements for microwave therapy equipment)

  • IEC 61000 Series (Electromagnetic Compatibility)
    • IEC 61000-3-2 (Limits for harmonic current emissions)
    • IEC 61000-3-3 (Limits for voltage changes)
    • IEC 61000-4-2 (Electrostatic discharge immunity test)
    • IEC 61000-4-3 (Radiated, radio-frequency, electromagnetic field immunity test)
    • IEC 61000-4-4 (Electrical fast transient/burst immunity test)
    • IEC 61000-4-5 (Surge immunity test)
    • IEC 61000-4-6 (Conducted disturbances, induced by RF fields)
    • IEC 61000-4-8 (Power frequency magnetic field immunity test)
    • IEC 61000-4-11 (Testing and measurement techniques)

  • Non-active surgical implants 
    • ISO 13630
    • ISO 14630