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.
Recommended Actions
- Implement fluoroscopic irradiation time display according to FDA’s interpretation
- Ensure last-image-hold feature meets timing requirements for exposure termination
- Design emergency fluoroscopy mode with recovery capabilities within 10 minutes
- Verify all required displays are functioning in normal operation mode
- Document compliance with exposure termination timing requirements
- Implement continuous pressure control mechanisms for fluoroscopic exposure
- Ensure all safety features and displays are properly integrated into the system
- 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
- Fluoroscopic irradiation time is cumulative duration of operator-applied continuous pressure
- Last-image-hold quality should be adequate to avoid additional radiation exposure
Relevant Guidances
- Harmonization of Performance Standards for Diagnostic X-Ray Imaging Systems and Components with IEC Standards
- X-Ray Equipment Performance Standards and Radiation Safety Requirements
- Technical Performance Assessment and Premarket Requirements for Digital Diagnostic Radiology Display Devices
Related references and norms
- 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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