Radiation Control Requirements and Interpretations for Diagnostic X-ray Equipment
This guidance clarifies the radiation control regulations for diagnostic X-ray equipment, focusing on product identification, certification, noncompliances, defects, and key definitions. It provides interpretations of various sections of the Performance Standard for Diagnostic X-ray Equipment (21 CFR Subchapter J) published in 1972.
Recommended Actions
- Review and update quality control programs to ensure absolute compliance with numerical limits
- Establish procedures for:
- Proper documentation and reporting
- Defect investigation and correction
- Product identification and certification
- Develop comprehensive user and assembler instructions
- Implement proper labeling systems
- Create process to track and investigate potential defects or noncompliance
- Establish clear documentation of design features that maintain acceptable radiation levels over product lifetime
- Review and update testing procedures to ensure compliance with absolute limits
- Train staff on definitions and requirements for different equipment types
- Establish process for handling repairs vs new manufacture situations
- Create system to maintain records of all required documentation and certifications
Key Considerations
Non-clinical testing
- Numerical limits stated in the standard are to be treated as absolute limits
- Manufacturers must design testing and quality control programs to ensure limits are not exceeded
- Normal roundoff procedures are not allowed if they result in exceeding any limit
Labelling
- Warning labels must be placed appropriately on equipment
- Product identification and certification information must be included
- Instructions for users and assemblers must be provided
Safety
- Manufacturers are responsible for defects or noncompliance unless proven to be caused by user modification/abuse
- Defects related to radiation safety must be reported and corrected
- Normal wear resulting in excessive radiation is manufacturer’s responsibility
- Burned-out X-ray tubes are not considered safety defects if they produce no radiation
Other considerations
- Definitions provided for X-ray tables, tabletops and cradles
- Clarification on what constitutes “commerce” and “reassembly”
- Requirements for documentation and reporting
- Responsibilities of manufacturers vs users
Relevant Guidances
- X-Ray Equipment Performance Standards and Radiation Safety Requirements
- Assembly and Installation Requirements for Diagnostic X-ray Equipment and Components
- 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
- Safety and Performance Requirements for Cabinet X-ray Security Screening and Industrial Quality Control Systems
Related references and norms
- 21 CFR 1020.30-32: Performance Standard for Diagnostic X-Ray Equipment
Original guidance
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