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.
What You Need to Know? 👇
What certification labeling is required for imported diagnostic X-ray components?
A certification label is not required on the outside of packages containing certified components. However, you must file a declaration upon entry as described in Title 19, Part 12, Section 12.91(b) for customs compliance.
How should assemblers report the installation date on Form FD-2579?
The installation date is when the X-ray system is released by the assembler for use on human patients. Assemblers have 15 days from this date to complete and distribute Form FD-2579, regardless of formal acceptance or payment.
Can certified components be installed with modified non-compliant existing equipment?
No, unless strict criteria under Section 1020.30(d)(2) are met, including that existing components are certifiable but unlabeled due to manufacture date, and no compatible certified alternatives exist commercially.
Where must identification labels be placed on X-ray components for compliance?
Labels must be readily accessible without unbolting, unlocking, or relocating the system. They should be on the outside, not against walls. If behind removable panels, wording must indicate label location.
What testing requirements must manufacturers include in assembly instructions?
Manufacturers must provide specific requirements for assemblers to perform FDA performance standard tests at installation, including thorough equipment requirements, step-by-step instructions, and data recording requirements for compliance demonstration.
What constitutes “positive means” for ensuring minimum filtration in X-ray beams?
Positive means requires equipment design that prevents easy filter removal and reduces probability of operation without proper filters. Special tools for routine filter removal are not acceptable; filters should remain in place without operator intervention.
What You Need to Do 👇
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 đź”—
- 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