Diagnostic X-Ray Systems: Component Labeling, Assembly, and Safety Requirements
This guidance clarifies radiation control regulations for diagnostic X-ray equipment, specifically focusing on certification of components, assembly requirements, identification of X-ray components, responsibilities, information requirements, warning labels, leakage radiation, beam quality, and aluminum equivalency requirements.
Recommended Actions
- Review and update component labeling to ensure compliance with model/serial number requirements
- Verify warning label placement on control panels is conspicuous
- Develop comprehensive installation testing procedures and documentation
- Update assembly instructions to include required compliance testing
- Create and maintain lists of compatible components
- Implement positive means to ensure minimum filtration requirements
- Review and update technical documentation regarding beam quality specifications
- Establish clear procedures for reporting assembly completion within 15 days
- Verify accessibility of all required labels after installation
- Document measurement basis for technique factors
Key Considerations
Non-clinical testing
- Final compliance testing must be performed by assemblers at installation as specified in manufacturer instructions
- Leakage radiation testing must be performed with blocked beam at the end of the beam limiting device
- Beam quality testing for capacitor energy storage equipment must use maximum selectable discharge
Labelling
- Warning labels must be conspicuous and visible on the main control panel
- Model and serial numbers must be permanently inscribed and accessible to view
- Labels must include the word “model” or “type” and “serial number”
- Labels must be accessible without unbolting or relocating the system
- Labels should not be placed against walls or behind locked panels
Safety
- Minimum filtration must be ensured through positive means (not removable by operators)
- Maximum line current specifications must be provided for various tube unit ratings
- Clear indication required for which tube is selected in multiple tube head systems
Other considerations
- Manufacturers must provide installation and operating instructions at cost of publication/distribution
- Compatible components must be listed in documentation
- Assemblers must follow manufacturer instructions for installation
- Date of installation is when system is released for patient use
Relevant Guidances
- X-Ray Equipment Performance Standards and Radiation Safety Requirements
- Assembly, Installation, Adjustment and Testing Information Requirements for Diagnostic X-Ray Systems
- Harmonization of Performance Standards for Diagnostic X-Ray Imaging Systems and Components with IEC Standards
- Assembly and Installation Requirements for Diagnostic X-ray Equipment and Components
Original guidance
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