Radiation Safety Requirements for Diagnostic X-Ray Systems and Components
This guidance provides clarification on radiation control regulations specifically for diagnostic X-Ray equipment. It aims to help manufacturers understand and comply with radiation safety requirements for diagnostic X-ray systems and their components.
Recommended Actions
- Review and update technical documentation to ensure compliance with radiation control requirements
- Implement comprehensive testing protocols for radiation safety features
- Develop and maintain quality control procedures
- Ensure proper labeling and warning systems are in place
- Establish regular maintenance and calibration schedules
- Create detailed installation and service documentation
- Train personnel on radiation safety requirements and emergency procedures
- Maintain records of radiation output measurements and safety tests
- Implement a system for tracking and addressing safety-related incidents
- Regular review and update of safety procedures and documentation
Key Considerations
Non-clinical testing
- Performance testing of radiation output control mechanisms
- Verification of radiation protection features
- Testing of beam limitation devices
- Verification of exposure reproducibility
Labelling
- Clear marking of X-ray controls and indicators
- Warning labels regarding radiation hazards
- Operating instructions must be provided
- Technical parameters must be displayed
Safety
- Beam limiting device requirements
- Maximum radiation leakage limits
- Exposure control timing accuracy
- Radiation protection requirements for operator and patient
- Emergency stop mechanisms
- Proper functioning of warning systems
Other considerations
- Quality control procedures
- Installation requirements
- Maintenance schedules
- Record keeping requirements
Relevant Guidances
- Radiation Control Requirements and Interpretations for Diagnostic X-ray Equipment
- Diagnostic X-Ray Systems: Component Labeling, Assembly, and Safety Requirements
- X-Ray Equipment Performance Standards and Radiation Safety Requirements
- Harmonization of Performance Standards for Diagnostic X-Ray Imaging Systems and Components with IEC Standards
- Assembly and Installation Requirements for Diagnostic X-ray Equipment and Components
- Assembly, Installation, Adjustment and Testing Information Requirements for Diagnostic X-Ray Systems
- Safety Considerations for Hand-Held X-Ray Equipment: Radiation Protection and Testing Requirements
Related references and norms
- IEC 60601-1-3: Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
- IEC 60601-2-28: Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
Original guidance
- Radiation Safety Requirements for Diagnostic X-Ray Systems and Components
- HTML
- Issue date: 1989-02-28
- Last changed date: 2019-02-09
- Status: FINAL
- Official FDA topics: Medical Devices, Radiation-Emitting Products, Radiology
- ReguVirta summary file ID: 117c7bf3e0c0bed1ab9943896ffa4a1a
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