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Classification of Large Laser-Based Materials Processing Machines with Walk-In Workstations

This guidance addresses the classification and protective housing requirements for large laser-based materials processing machines, specifically those with walk-in workstations. It clarifies when such equipment can be classified as Class I laser products despite having enclosures large enough for human entry.

  1. Implement adequate protective housing that prevents human access when closed
  2. Install safety interlocks according to the standard requirements
  3. Develop and implement a detection system for human presence within the enclosure
  4. Create clear user documentation regarding safety procedures
  5. Apply appropriate warning labels to the enclosure
  6. Ensure the product is classified in the lowest possible class while maintaining functionality
  7. Document compliance with all safety requirements for Class I laser product classification
  8. Establish verification procedures to ensure all safety systems function as intended

Key Considerations

Human Factors

  • A means must be provided to detect the presence of persons within the enclosure and/or prevent laser operation when someone is inside

Labelling

  • The enclosure must be properly labeled as required by the standard
  • User information must clearly instruct operators to avoid procedures that could give access to hazardous levels of laser radiation

Safety

  • The enclosure must be adequate to prevent human access to laser radiation when closed
  • Safety interlocks must be implemented as required by the standard
  • The protective housing must prevent access to laser or collateral radiation except when necessary for the product’s intended function

Other considerations

  • No specific norms or standards are referenced in this guidance

Original guidance

  • Classification of Large Laser-Based Materials Processing Machines with Walk-In Workstations
  • HTML / PDF
  • Issue date: 1985-10-21
  • Last changed date: 2020-03-17
  • Status: FINAL
  • Official FDA topics: Medical Devices, Radiation-Emitting Products
  • ReguVirta summary file ID: 7332d4d17df0c29f8896b92edeefe894
This post is licensed under CC BY 4.0 by the author.