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Diagnostic Electrocardiograph Devices - Performance Testing and Safety Requirements

This guidance applies to diagnostic electrocardiographs covered by ANSI/AAMI EC11-1991 standard, including devices that detect and measure ST segment level changes without alarms. It specifically excludes devices collecting ECG from non-external locations, interpretation devices, fetal monitors, ambulatory monitors, vectorcardiographs, and ECGs integrated into other medical devices.

  1. Prepare comprehensive device description including all required specifications and intended use
  2. Conduct performance testing either through comparison or standards conformance
  3. Complete environmental and safety testing appropriate for intended use environment
  4. Prepare EMC testing documentation based on chosen approach
  5. Ensure software documentation meets requirements based on level of concern
  6. Compile labeling documentation meeting all regulatory requirements
  7. Document comparison to predicate device with emphasis on similarities and differences
  8. Prepare regulatory submission documents including Safety and Effectiveness Summary
  9. For ST segment measurement features, ensure conformance to EC38 standard requirements
  10. Follow test report format guidelines for all testing documentation

Key Considerations

Non-clinical testing

  • Performance testing through either:
    • Comparison testing with predicate device
    • Conformance to EC11 standard
    • Conformance to equivalent standards
  • ST segment measurement must conform to applicable portions of EC38 standard
  • Environmental testing for expected use conditions
  • Electrical safety testing
  • EMC testing for emissions and immunity

Software

  • Documentation requirements based on level of concern (minor to moderate)
  • Follow “Guidance for Content of Premarket Submissions for Software Contained in Medical Devices”

Labelling

  • Must conform to labeling regulations in 21 CFR 807.87(e)
  • Include EC11 standard labeling requirements if applicable

Biocompatibility

  • Material descriptions required for all patient contacting materials

Safety

  • Electrical safety testing required
  • EMC testing for interference and immunity
  • Environmental hazard testing

Other considerations

  • ANSI/AAMI EC11-1991: Diagnostic Electrocardiographic Devices
  • ANSI/AAMI EC38-1994: Ambulatory Electrocardiographs
  • ANSI/AAMI ES1-1993: Safe current limits for electromedical apparatus
  • IEC 60601-1-2: Medical Electrical Equipment - EMC Requirements and Tests
  • IEC 68-2-6: Environmental Testing - Vibration
  • IEC 529: Classification of Degrees of Protection Provided by Enclosures

Original guidance

  • Diagnostic Electrocardiograph Devices - Performance Testing and Safety Requirements
  • HTML / PDF
  • Issue date: 1998-11-04
  • Last changed date: 2020-03-18
  • Status: FINAL
  • Official FDA topics: Medical Devices, Premarket
  • ReguVirta summary file ID: 4c43935888962fa5879acf508a234aec
This post is licensed under CC BY 4.0 by the author.