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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.

  1. Review and update component labeling to ensure compliance with model/serial number requirements
  2. Verify warning label placement on control panels is conspicuous
  3. Develop comprehensive installation testing procedures and documentation
  4. Update assembly instructions to include required compliance testing
  5. Create and maintain lists of compatible components
  6. Implement positive means to ensure minimum filtration requirements
  7. Review and update technical documentation regarding beam quality specifications
  8. Establish clear procedures for reporting assembly completion within 15 days
  9. Verify accessibility of all required labels after installation
  10. 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


Original guidance

  • Diagnostic X-Ray Systems: Component Labeling, Assembly, and Safety Requirements
  • HTML / PDF
  • Issue date: 1989-03-01
  • Last changed date: 2020-03-02
  • Status: FINAL
  • Official FDA topics: Medical Devices, Radiation-Emitting Products
  • ReguVirta summary file ID: ac59f77eda1f6499b07d11a80da293f1
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