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Safety Requirements for Medical Laser Delivery Systems and Interlock Mechanisms

This guidance addresses safety requirements for medical laser delivery systems, specifically focusing on interlock mechanisms at connection points between laser consoles and delivery systems, as well as accessories used in medical procedures.

  1. Implement mandatory safety interlocks at the laser console-delivery system connection points where the delivery system can be removed during operation
  2. Ensure user control mechanisms (e.g., foot switch) are positioned in close proximity to removable accessories at the distal end
  3. Consider implementing additional safety features such as smart accessories with auto-disable functionality
  4. Review and ensure compliance with 21 CFR 1040.11 requirements for laser product performance standards
  5. Document the safety control mechanisms implemented in the technical file
  6. Consider implementing calibration verification systems for accessories that can affect delivered output

Key Considerations

Safety

  • Safety interlocks are required at the laser console-delivery system connection point if the delivery system can be removed during operation or maintenance
  • Safety interlocks are not required for passive accessories attached to the distal end of the delivery system if:
    • The surgeon has control of emission through a foot switch or other control
    • The control point is in close proximity to the accessory

Other considerations

  • 21 CFR 1040.11: Performance standards for laser products

Original guidance

  • Safety Requirements for Medical Laser Delivery Systems and Interlock Mechanisms
  • HTML / PDF
  • Issue date: 1985-01-20
  • Last changed date: 2020-03-17
  • Status: FINAL
  • Official FDA topics: Medical Devices, Radiation-Emitting Products
  • ReguVirta summary file ID: e42aa0f3f93c0e6820d9a6f8cb7fb868
This post is licensed under CC BY 4.0 by the author.