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.
Recommended Actions
- Develop comprehensive test protocols for radiation emission measurements
- Implement quality control procedures for critical components including:
- Incoming inspection
- Life testing
- Sampling plans
- Create complete documentation package including:
- Circuit diagrams
- Shielding specifications
- Interlock system details
- Warning labels and signage
- Installation/maintenance manuals
- Establish procedures for:
- Regular calibration of test equipment
- Component failure analysis
- Ground fault testing
- Safety interlock verification
- Prepare reporting templates for:
- Initial submissions
- Supplemental reports
- Test results documentation
- Train personnel on:
- Testing procedures
- Documentation requirements
- Safety standards compliance
- Implement tracking system for:
- Report submissions
- Test records
- Product modifications
- Component changes
- 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
- Detailed documentation of system design and components required
- Information on installation, maintenance and safety procedures must be provided to users
- Quality control and testing procedures must be documented
- Life testing data required for critical components
Relevant Guidances
- Safety and Performance Requirements for Cabinet X-ray Security Screening and Industrial Quality Control Systems
- X-Ray Equipment Performance Standards and Radiation Safety Requirements
- Harmonization of Performance Standards for Diagnostic X-Ray Imaging Systems and Components with IEC Standards
Related references and norms
- 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
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