X-Ray Equipment Performance Standards and Radiation Safety Requirements
This guidance clarifies the federal regulations related to diagnostic x-ray equipment, including x-ray systems and their major components. It applies to equipment considered both medical devices and electronic products under the FD&C Act, subject to both medical device regulations and Electronic Product Radiation Control (EPRC) provisions. The guidance focuses specifically on EPRC requirements and does not address medical device requirements.
What You Need to Know? 👇
What are the key certification requirements for diagnostic x-ray equipment manufacturers?
Manufacturers must certify each component meets applicable Performance Standards when installed according to instructions, provide permanent certification and identification labels, and supply adequate assembly/testing instructions to assemblers.
When must diagnostic x-ray components be certified before introduction into commerce?
Components must be certified at the time of delivery to distributors or dealers. Section 538(a)(1) prohibits introducing non-compliant electronic products into commerce without proper certification.
Can uncertified diagnostic x-ray components be imported for research purposes?
Yes, under limited circumstances using Form FDA 2877 Declaration C for research/training, or Declaration D for reconditioning. Components must be exported or destroyed when purpose is complete.
Who is responsible for equipment compliance after installation and sale?
The certifying manufacturer remains responsible for compliance throughout equipment life when properly maintained according to provided maintenance schedules, unless noncompliance results from improper installation/assembly by others.
What labeling requirements apply to diagnostic x-ray system controls using computers?
Computer-based controls require the same certification, identification, and warning labels as traditional controls. Labels can be physical or electronic, with warning statements continuously displayed during acquisition mode.
Are there specific requirements for diagnostic x-ray systems in mobile vehicles?
No specific mobile requirements exist, but manufacturers should provide installation/maintenance instructions accounting for adverse environmental conditions that mobile systems may encounter during operation.
What You Need to Do 👇
Recommended Actions
- Implement comprehensive quality control testing program
- Ensure proper labeling including certification, identification and warnings
- Provide complete assembly/installation instructions to assemblers
- Maintain records of testing, quality control and component compatibility
- Establish procedures for reporting defects and accidental radiation occurrences
- Validate software controls and displays meet requirements
- Verify beam quality and radiation safety requirements are met
- Document component compatibility specifications
- Train staff on regulatory requirements and compliance procedures
- Regularly review and update documentation to maintain compliance
Key Considerations
Non-clinical testing
- Manufacturers must have quality control procedures and testing programs
- Test programs described in Performance Standards must generally be used in manufacturer’s quality control testing program
- Alternative test procedures may be used if validated and adequate to ensure conformance
- Records of quality control testing must be maintained
Software
- Software performing x-ray control functions must incorporate required warning statements
- Access to software programs required for assembly/installation must be provided to assemblers
- Software certification and identification statements must be incorporated within code
Labelling
- Certification and identification labels must be in English
- Labels must be permanently affixed and readily accessible
- Warning labels required on control panels
- Model number and serial number must be accessible
- Date of manufacture must be included
- Manufacturer name and address required
Safety
- Minimum filtration and beam quality requirements must be met
- Maximum air kerma rates specified for fluoroscopic systems
- Leakage radiation limits must be maintained
- Beam limiting devices must meet alignment requirements
- Warning systems required for high-level control mode
Other considerations
- Assembly instructions must be provided to assemblers
- Component compatibility must be specified
- Records must be maintained for 5 years
- Accidental radiation occurrences must be reported
- Defects must be reported and corrected
Relevant Guidances 🔗
- Safety and Performance Requirements for Cabinet X-ray Security Screening and Industrial Quality Control Systems
- Radiation Control Requirements and Interpretations for Diagnostic X-ray Equipment
- Diagnostic X-Ray Systems: Component Labeling, Assembly, and Safety Requirements
- Harmonization of Performance Standards for Diagnostic X-Ray Imaging Systems and Components with IEC Standards
- Cybersecurity for Networked Medical Devices with Off-The-Shelf Software
- Technical Performance Assessment and Premarket Requirements for Digital Diagnostic Radiology Display Devices
- Assembly and Installation Requirements for Diagnostic X-ray Equipment and Components
- Assembly, Installation, Adjustment and Testing Information Requirements for Diagnostic X-Ray Systems
Related references and norms 📂
- IEC 60601-2-68: Medical electrical equipment - Part 2-68: Particular requirements for X-ray-based image-guided radiotherapy equipment
- ISO 7000: Graphical symbols for use on equipment
- IEC 60417: Graphical symbols for use on equipment