Performance Standards for Diagnostic X-Ray Systems and Major Components
This guidance covers performance standards for medical diagnostic x-ray systems and their major components, including radiographic, fluoroscopic, and computed tomography (CT) systems. It specifically addresses new requirements for equipment manufactured on or after June 10, 2006.
Recommended Actions
- Review and update warning labels on control panels
- Implement new display requirements for fluoroscopic irradiation time and air kerma
- Update user documentation with required mode of operation information
- Verify compliance with new HVL and aluminum equivalent material requirements
- Implement maintenance schedules for air kerma display systems
- Ensure proper labeling for modified equipment
- Verify field limitation compliance for fluoroscopic imaging assemblies
- Implement and verify Last-Image-Hold functionality requirements
- Document any system modifications in system records
- Train staff on new display features and safety requirements
Key Considerations
Non-clinical testing
- Minimum HVL requirements have been increased for x-ray systems manufactured after June 10, 2006
- Maximum aluminum equivalent material between patient and image receptor has been increased
- Display of AKR and cumulative air kerma values must not deviate from actual values by more than ±35%
Human Factors
- Warning label must be legible and accessible on the control panel
- Clear indication required for LIH (Last-Image-Hold) radiograph vs. fluoroscopic image
- Audible signal required for every 5 minutes of fluoroscopic irradiation time
Labelling
- New warning statement required on control panel
- Modified equipment must bear label indicating compliance with 21 CFR 1020.32(h)(2)
- Systems with SSD less than 45 cm must be labeled for extremity use only
Software
- Display requirements for fluoroscopic irradiation time
- Requirements for AKR and cumulative air kerma display updates and accuracy
- Display requirements for Last-Image-Hold (LIH) functionality
Safety
- New requirements for minimum source-skin distance
- Optional filtration requirements for high-power fluoroscopic systems
- Field limitation requirements for circular and rectangular image receptors
Other considerations
- Documentation requirements for system modifications by owners
- Maintenance schedule requirements for air kerma display systems
- Detailed mode of operation information must be provided in user manual
Relevant Guidances
- X-Ray Equipment Performance Standards and Radiation Safety Requirements
- Assembly and Installation Requirements for Diagnostic X-ray Equipment and Components
- Harmonization of Performance Standards for Diagnostic X-Ray Imaging Systems and Components with IEC Standards
- Cybersecurity for Networked Medical Devices with Off-The-Shelf Software
- Content of Premarket Submissions for Device Software Functions
- Off-The-Shelf Software in Medical Devices: Documentation Requirements for Premarket Submissions
Related references and norms
- IEC: Standards for radioscopy terminology and definitions
- International Commission on Radiation Units and Measurements: Kerma definition and units
Original guidance
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