X-Ray Equipment Performance Standards and Radiation Safety Requirements
This guidance clarifies the federal regulations related to diagnostic x-ray equipment, including x-ray systems and their major components. It applies to equipment considered both medical devices and electronic products under the FD&C Act, subject to both medical device regulations and Electronic Product Radiation Control (EPRC) provisions. The guidance focuses specifically on EPRC requirements and does not address medical device requirements.
Recommended Actions
- Implement comprehensive quality control testing program
- Ensure proper labeling including certification, identification and warnings
- Provide complete assembly/installation instructions to assemblers
- Maintain records of testing, quality control and component compatibility
- Establish procedures for reporting defects and accidental radiation occurrences
- Validate software controls and displays meet requirements
- Verify beam quality and radiation safety requirements are met
- Document component compatibility specifications
- Train staff on regulatory requirements and compliance procedures
- Regularly review and update documentation to maintain compliance
Key Considerations
Non-clinical testing
- Manufacturers must have quality control procedures and testing programs
- Test programs described in Performance Standards must generally be used in manufacturer’s quality control testing program
- Alternative test procedures may be used if validated and adequate to ensure conformance
- Records of quality control testing must be maintained
Software
- Software performing x-ray control functions must incorporate required warning statements
- Access to software programs required for assembly/installation must be provided to assemblers
- Software certification and identification statements must be incorporated within code
Labelling
- Certification and identification labels must be in English
- Labels must be permanently affixed and readily accessible
- Warning labels required on control panels
- Model number and serial number must be accessible
- Date of manufacture must be included
- Manufacturer name and address required
Safety
- Minimum filtration and beam quality requirements must be met
- Maximum air kerma rates specified for fluoroscopic systems
- Leakage radiation limits must be maintained
- Beam limiting devices must meet alignment requirements
- Warning systems required for high-level control mode
Other considerations
- Assembly instructions must be provided to assemblers
- Component compatibility must be specified
- Records must be maintained for 5 years
- Accidental radiation occurrences must be reported
- Defects must be reported and corrected
Relevant Guidances
- Safety and Performance Requirements for Cabinet X-ray Security Screening and Industrial Quality Control Systems
- Radiation Control Requirements and Interpretations for Diagnostic X-ray Equipment
- Diagnostic X-Ray Systems: Component Labeling, Assembly, and Safety Requirements
- 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
- Technical Performance Assessment and Premarket Requirements for Digital Diagnostic Radiology Display Devices
- Assembly and Installation Requirements for Diagnostic X-ray Equipment and Components
- Assembly, Installation, Adjustment and Testing Information Requirements for Diagnostic X-Ray Systems
Related references and norms
- IEC 60601-2-68: Medical electrical equipment - Part 2-68: Particular requirements for X-ray-based image-guided radiotherapy equipment
- ISO 7000: Graphical symbols for use on equipment
- IEC 60417: Graphical symbols for use on equipment
Original guidance
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