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Performance Testing and Safety Requirements for Single-Use Cutaneous Recording Electrodes

This guidance covers non-invasive, single-use cutaneous electrodes intended for recording purposes on normal, healthy, clean, intact skin. These Class II devices are regulated under 21 CFR 882.1320 (GXY). The guidance excludes electrodes for stimulation, MR use, reuse, dry electrodes, and those regulated under different regulations.

  1. Verify device design characteristics match intended use and patient population
  2. Conduct electrical performance testing (AC Impedance, Offset Voltage, etc.)
  3. Perform adhesive performance testing
  4. Complete shelf life validation
  5. Conduct biocompatibility evaluation
  6. If applicable, ensure lead wire compliance with safety standards
  7. Prepare Declaration of Conformity (DoC) documentation for all required tests
  8. Consider Pre-Submission if additional testing beyond guidance scope is needed
  9. Prepare test results summary for all evaluations
  10. Ensure all manufacturing materials and processes are documented if using biocompatibility rationale

Key Considerations

Non-clinical testing

  • AC Impedance: Maximum 2 kOhms (average), 3 kOhms (individual pair)
  • Offset Voltage: Maximum 100 mV
  • Combined offset instability and internal noise: Maximum 150 µV
  • Bias Current Tolerance: Maximum 100 mV
  • Adhesive Performance:
    • Pull Test: ≤5% separation in 90% of tests
    • Conformability: ≤10% separation after 1 hour
    • Fluid Tolerance: ≤10% separation within 15 minutes after saline exposure

Biocompatibility

  • Required testing for surface devices with intact skin contact:
    • Cytotoxicity
    • Sensitization
    • Irritation or Intracutaneous Reactivity

Safety

  • For electrode lead wires: Must comply with conductive connection requirements as per ES 60601-1

Other considerations

  • ANSI/AAMI EC12: Disposable ECG Electrodes
  • IEC 60601-2-2: Medical electrical equipment – Part 2-2: Particular requirements for basic safety and essential performance of high frequency surgical equipment
  • ES 60601-1: Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance
  • ISO 10993-1: Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process

Original guidance

  • Performance Testing and Safety Requirements for Single-Use Cutaneous Recording Electrodes
  • HTML / PDF
  • Issue date: 2020-08-14
  • Last changed date: 2020-08-13
  • Status: FINAL
  • Official FDA topics: Medical Devices, 510(k), Premarket, Neurological
  • ReguVirta summary file ID: ed12a8d922c3a4dbab851ac094fb16ac
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