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Viewing Optics Performance Requirements for Surveying Laser Products

This guidance clarifies the applicability of viewing optics performance requirements to sighting telescopes used in surveying laser products, specifically addressing the requirements under 21 CFR 1040.10(f)(8).

  1. Evaluate if your sighting telescope meets the Class I attenuation requirements when used with recommended targets
  2. Develop and implement appropriate warning labels and instructions regarding target usage
  3. Document the target specifications and recommendations as part of the product’s safety documentation
  4. Ensure compliance with 21 CFR 1040.10(f)(8) for all viewing optics components
  5. Include appropriate warnings on both the product exterior and in the user instructions
  6. Consider the entire system (telescope + recommended target) in safety assessments
  7. Implement quality controls to ensure consistent performance of the viewing optics system

Key Considerations

Non-clinical testing

  • Viewing optics must attenuate the beam reflected from the target to Class I level under all possible use conditions

Labelling

  • Specific warning required in instructions against using targets that give specular reflection or retroreflection
  • Supplemental warning may be added to the warning logotype on the exterior of the laser product regarding not viewing radiation with mirror-like targets

Safety

  • Sighting telescopes used for viewing laser light reflections are considered viewing optics and must comply with 21 CFR 1040.10(f)(8)
  • If a diffuse reflecting target is supplied or recommended, it is considered part of the viewing optics system

Other considerations

  • 21 CFR 1040.10: Performance standards for light-emitting products
  • 21 CFR 1040.11: Specific purpose laser products

Original guidance

  • Viewing Optics Performance Requirements for Surveying Laser Products
  • HTML / PDF
  • Issue date: 1976-08-05
  • Last changed date: 2020-03-16
  • Status: FINAL
  • Official FDA topics: Medical Devices, Radiation-Emitting Products
  • ReguVirta summary file ID: ebc029f40500b984bf8019cf514e5aa6
This post is licensed under CC BY 4.0 by the author.