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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.

  1. Review and update technical documentation to ensure compliance with radiation control requirements
  2. Implement comprehensive testing protocols for radiation safety features
  3. Develop and maintain quality control procedures
  4. Ensure proper labeling and warning systems are in place
  5. Establish regular maintenance and calibration schedules
  6. Create detailed installation and service documentation
  7. Train personnel on radiation safety requirements and emergency procedures
  8. Maintain records of radiation output measurements and safety tests
  9. Implement a system for tracking and addressing safety-related incidents
  10. 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

  • 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
This post is licensed under CC BY 4.0 by the author.