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Electromagnetic Compatibility for Medical Devices and Accessories: Testing, Documentation, and Labeling Requirements

This guidance applies to medical devices, including in vitro diagnostic products and accessories that are either electrically-powered or have functions/sensors implemented using electrical/electronic circuitry. It provides recommendations for EMC information that should be included in premarket submissions to demonstrate electromagnetic compatibility.

  1. Determine device classification and applicable EMC standards based on intended use
  2. Develop detailed EMC test plan including:
    • Device configurations and functions to be tested
    • Pass/fail criteria
    • Test methods and levels
    • Monitoring methods
  3. Perform comprehensive EMC testing:
    • Emissions testing
    • Immunity testing
    • Testing for common EM emitters if applicable
  4. Document all test results, modifications, and mitigations
  5. Prepare EMC-related labeling content
  6. Include complete EMC information package in premarket submission:
    • Device characteristics
    • Risk assessment
    • Test results
    • Labeling
    • Any deviations or allowances used
  7. For IDE/IND submissions, develop appropriate alternative EMC mitigations if needed
  8. Maintain EMC documentation in design history file

Key Considerations

Non-clinical testing

  • EMC testing should be performed on the final finished device
  • Testing should be done as a complete system with all accessories and components
  • Device should be tested in all intended operating modes and configurations
  • Testing should address both emissions and immunity
  • Testing should be appropriate for intended use environments (Professional Healthcare, Home Healthcare, Special Environments)

Software

  • For devices with software, firmware changes made to pass EMC testing must be documented
  • Software changes to address EMC issues must be analyzed for potential impacts on device safety and performance

Labeling

  • Must include EMC-related information for safe installation and use
  • Specify intended use environments
  • List compatible accessories and equipment
  • Describe expected behavior if functions are lost/degraded due to EMI
  • Include compliance levels for emissions and immunity tests
  • Provide precautions regarding EM energy sources
  • Include wireless specifications if applicable
  • Provide maintenance instructions for EMC
  • Include required markings and warnings

Safety

  • Must assess risks associated with device malfunction due to EMI
  • Must categorize severity of potential harm into three levels:
    • Device-related deaths and serious injuries
    • Device-related non-serious adverse events
    • Device-related events without harm

Other considerations

  • IEC 60601-1-2: Medical electrical equipment - EMC requirements and tests
  • IEC 61326-1: Electrical equipment for measurement, control and laboratory use - EMC requirements
  • ISO 14117: EMC test protocols for implantable cardiac devices
  • ASTM F2503: Safety marking in the MR environment
  • RTCA DO-160: Environmental conditions and test procedures for airborne equipment

Original guidance

  • Electromagnetic Compatibility for Medical Devices and Accessories: Testing, Documentation, and Labeling Requirements
  • HTML / PDF
  • Issue date: 2022-06-06
  • Last changed date: 2022-06-03
  • Status: FINAL
  • Official FDA topics: Radiation-Emitting Products, Medical Devices, Errors, Radiology, and Problems, Biologics, Radiological Health, Investigational Device Exemption (IDE), Safety - Issues
  • ReguVirta summary file ID: aa59fb8616a07d86d994a526a643d244
This post is licensed under CC BY 4.0 by the author.