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Performance Standard Requirements for Fluoroscopic X-Ray Systems: Timing, Safety Features and Display Requirements

This guidance clarifies FDA's interpretation of specific performance standard requirements for fluoroscopic equipment under 21 CFR 1020.30 and 1020.32. It applies to image-intensified fluoroscopic x-ray systems, both stationary and mobile, classified under 21 CFR 892.1650, including interventional fluoroscopic systems.

  1. Implement fluoroscopic irradiation time display according to FDA’s interpretation
  2. Ensure last-image-hold feature meets timing requirements for exposure termination
  3. Design emergency fluoroscopy mode with recovery capabilities within 10 minutes
  4. Verify all required displays are functioning in normal operation mode
  5. Document compliance with exposure termination timing requirements
  6. Implement continuous pressure control mechanisms for fluoroscopic exposure
  7. Ensure all safety features and displays are properly integrated into the system
  8. Develop procedures for emergency fluoroscopy mode operation and recovery

Key Considerations

Software

  • Emergency fluoroscopy mode should provide automatic or manual recovery methods within 10 minutes
  • Last-image-hold feature must be available following termination of fluoroscopic exposure

Labelling

  • Display of fluoroscopic irradiation time at fluoroscopist’s working position
  • Display of x-ray tube potential and current, air kerma rate and cumulative air kerma

Safety

  • Continuous pressure required by operator for fluoroscopic exposure
  • Exposure must terminate within 0.1 sec of release for exposures >0.5 sec
  • Exposure must terminate within 0.5 sec of release for exposures ≤0.5 sec
  • Emergency fluoroscopy mode allowed during equipment malfunction for interventional procedures

Other considerations

  • IEC 60601-2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures
  • IEC 60601-2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
  • IEC 61910-1:2014: Radiation dose documentation – Part 1: Radiation dose structured reports for radiography and radioscopy
  • IEC 60601-1-3:2008/AMD1:2013: General requirements for basic safety and essential performance – Collateral standard: Radiation protection in diagnostic X-ray equipment

Original guidance

  • Performance Standard Requirements for Fluoroscopic X-Ray Systems: Timing, Safety Features and Display Requirements
  • HTML / PDF
  • Issue date: 2019-05-08
  • Last changed date: 2019-05-07
  • Status: FINAL
  • Official FDA topics: Medical Devices, Radiation-Emitting Products, Radiological Health
  • ReguVirta summary file ID: 337fe152d7a7baf946f369475f4ba91a
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