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Reporting Requirements and Testing Standards for Cabinet X-ray Systems

This guidance document provides instructions for manufacturers on how to submit initial and supplemental reports for cabinet X-ray systems pursuant to 21 CFR 1020.40. It covers reporting requirements related to radiation safety testing and compliance with federal performance standards for cabinet X-ray systems used in various applications like baggage screening and industrial inspection.

  1. Develop comprehensive test protocols for radiation emission measurements
  2. Implement quality control procedures for critical components including:
    • Incoming inspection
    • Life testing
    • Sampling plans
  3. Create complete documentation package including:
    • Circuit diagrams
    • Shielding specifications
    • Interlock system details
    • Warning labels and signage
    • Installation/maintenance manuals
  4. Establish procedures for:
    • Regular calibration of test equipment
    • Component failure analysis
    • Ground fault testing
    • Safety interlock verification
  5. Prepare reporting templates for:
    • Initial submissions
    • Supplemental reports
    • Test results documentation
  6. Train personnel on:
    • Testing procedures
    • Documentation requirements
    • Safety standards compliance
  7. Implement tracking system for:
    • Report submissions
    • Test records
    • Product modifications
    • Component changes
  8. Review compliance periodically to ensure continued adherence to standards

Key Considerations

Non-clinical testing

  • Direct radiation measurements must be performed to verify compliance with emission limits
  • Testing must evaluate effects of:
    • Scattering objects and placement
    • Safety interlock operation
    • Shipping/transport impacts on shielding
    • Line voltage fluctuations
    • Service adjustments
    • Final acceptance testing
  • Sampling plans and test procedures must be documented

Human Factors

  • Controls and indicators must be accessible and visible to operators
  • Warning labels required at control locations
  • Special requirements for systems designed to admit humans (warning signals, internal controls)

Labelling

  • Certification statement required
  • Manufacturer name and address
  • Date and place of manufacture
  • Model and serial numbers
  • Warning labels at control locations
  • Labels must be permanent and legible

Safety

  • X-ray emission limited to 0.5 mR/hr at 5cm from external surface
  • Safety interlocks required on doors and access panels
  • Key-activated control required
  • Ground fault analysis required
  • Critical component testing required

Other considerations

  • 21 CFR 1020.40: Performance Standard for Cabinet X-ray Systems
  • 21 CFR 1002: Records and Reports
  • 21 CFR 1003: Notification of Defects
  • 21 CFR 1005: Importation Requirements

Original guidance

  • Reporting Requirements and Testing Standards for Cabinet X-ray Systems
  • HTML / PDF
  • Issue date: 1975-02-01
  • Last changed date: 2020-03-16
  • Status: FINAL
  • Official FDA topics: Medical Devices, Radiation-Emitting Products, Radiological Health
  • ReguVirta summary file ID: 0b2d97d814700287277041ae6b8aab8b
This post is licensed under CC BY 4.0 by the author.