Safety and Performance Requirements for Cabinet X-ray Security Screening and Industrial Quality Control Systems
This guidance is intended to assist manufacturers of cabinet X-ray systems with meeting the requirements of the Federal Food, Drug, and Cosmetic Act and applicable federal radiation safety regulations. It applies to cabinet X-ray systems used primarily for security screening and industrial quality control, including systems for inspecting baggage, food, circuit boards, and tires.
Recommended Actions
- Implement comprehensive quality control and testing program
- Develop complete technical documentation including:
- Design specifications
- Test procedures and results
- Quality control procedures
- Maintenance schedule
- Prepare and submit required product report before market entry
- Establish system for maintaining required records
- Implement process for accident reporting and recalls if needed
- Ensure proper labeling including certification, warnings and identification
- Establish annual reporting process
- For imported systems, designate US agent
- Train personnel on regulatory requirements and compliance procedures
- Regularly review compliance status and update documentation as needed
Key Considerations
Non-clinical testing
- Testing must demonstrate compliance with emission limit of 0.5 milliRoentgen in one hour at any point 5cm outside external surface
- Measurements must be averaged over 10 square cm area with no linear dimension greater than 5cm
- Testing must be done at maximum output settings
Human Factors
- Insertion of any part of human body through ports into primary beam must not be possible
- For systems designed to admit humans:
- Internal control to prevent/terminate X-ray generation
- No means to initiate X-rays from inside
- Audible and visible warning signals for 10 seconds before X-ray generation
- Visible warning signal during X-ray generation
Labelling
- Certification label permanently affixed stating compliance with standards
- Warning labels at controls: “Caution: X-Rays Produced When Energized”
- Warning labels at ports: “Caution: Do Not Insert Any Part of the Body When System is Energized–X-ray Hazard”
- Identification label with manufacturer name, place and date of manufacture
Safety
- Minimum of two safety interlocks on each door
- At least one safety interlock on each access panel
- Ground fault must not result in X-ray generation
- Key-actuated control required
- Two independent X-ray ON indicators
- Additional X-ray ON indicators visible from each door, access panel and port
Other considerations
- Permanent floor required
- Maintenance schedule must be provided
- Records and reports requirements including:
- Radiation Safety Requirements for Diagnostic X-Ray Systems and Components
- Reporting Requirements and Testing Standards for Cabinet X-ray Systems
- Cybersecurity for Networked Medical Devices with Off-The-Shelf Software
- Harmonization of Performance Standards for Diagnostic X-Ray Imaging Systems and Components with IEC Standards
Related references and norms
- NCRP 57: Instrumentation and Monitoring Methods for Radiation Protection
- NCRP 112: Calibration of Survey Instruments Used in Radiation Protection
Original guidance
- Safety and Performance Requirements for Cabinet X-ray Security Screening and Industrial Quality Control Systems
- HTML / PDF
- Issue date: 2007-09-18
- Last changed date: 2020-03-24
- Status: FINAL
- Official FDA topics: Medical Devices, Radiation-Emitting Products
- ReguVirta summary file ID: e46a4b67c497715b87f31e0edbc13498
This post is licensed under CC BY 4.0 by the author.