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.
Recommended Actions
- Implement mandatory safety interlocks at the laser console-delivery system connection points where the delivery system can be removed during operation
- Ensure user control mechanisms (e.g., foot switch) are positioned in close proximity to removable accessories at the distal end
- Consider implementing additional safety features such as smart accessories with auto-disable functionality
- Review and ensure compliance with 21 CFR 1040.11 requirements for laser product performance standards
- Document the safety control mechanisms implemented in the technical file
- 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
- Additional safety mechanisms for laser accessories are encouraged, including:
- Laser Products - Performance Standards and Safety Requirements
- Laser Products - Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 Standards
- Software Validation for Medical Device Production, Quality Systems, and Device Components
- Content of Premarket Submissions for Device Software Functions
- Design Considerations and Recommendations for Interoperable Medical Devices
Related references and norms
- 21 CFR 1040.11: Performance standards for laser products
Original guidance
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