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Safety Considerations for Hand-Held X-Ray Equipment: Radiation Protection and Testing Requirements

This guidance addresses safety considerations for hand-held X-ray equipment, focusing on protecting operators from two main radiation exposure sources: leakage radiation through equipment housing and backscatter radiation from patients and nearby structures. It provides recommendations for manufacturers and FDA staff regarding safety procedures and information that should be provided to end users.

  1. Conduct comprehensive radiation exposure measurements at various distances and positions
  2. Design and implement adequate shielding in the device housing
  3. Develop external shielding solutions or remote operation capabilities
  4. Create detailed safety documentation including exposure data and safety procedures
  5. Prepare comprehensive labeling addressing all safety aspects
  6. Verify compliance with state-specific regulations where the device will be marketed
  7. Establish recommended exposure limits and safety protocols for operators
  8. Develop training materials for proper use of safety features
  9. Consider implementing monitoring systems for tracking exposure levels
  10. Create guidelines for protective equipment use

Key Considerations

Non-clinical testing

  • Measure exposure levels at distances closer than 1m from the unit
  • Perform exposure measurements at locations representative of operator positioning
  • Report exposure measurements at handgrips and control devices locations

Labelling

  • Provide adequate instructions for radiological safety procedures
  • Include exposure information near and around the unit in operator instructions
  • Describe safety procedures and precautions necessary to reduce operator exposure
  • Include information about exposure hazards and safety precautions for patients and assisting personnel

Safety

  • Limit radiation leakage from x-ray source assembly to air kerma of 0.88 mGy in one hour at one meter distance
  • Incorporate physical means to protect operator from leakage radiation
  • Include sufficient shielding surrounding the source assembly
  • Provide external shielding or means to increase distance between operator and unit
  • Consider implementing an equipment stand and remote switch option

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

Original guidance

  • Safety Considerations for Hand-Held X-Ray Equipment: Radiation Protection and Testing Requirements
  • HTML / PDF
  • Issue date: 2008-12-23
  • Last changed date: 2020-03-24
  • Status: FINAL
  • Official FDA topics: Medical Devices, Radiation-Emitting Products, Postmarket
  • ReguVirta summary file ID: 087796ba062700f19f93cd2c7d121dc5
This post is licensed under CC BY 4.0 by the author.