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).
What You Need to Know? 👇
What are the FDA requirements for viewing optics in laser surveying equipment?
Viewing optics in laser surveying equipment must comply with 21 CFR 1040.10(f)(8). The telescope and target function as a viewing optic system, requiring beam attenuation to Class I levels under all possible uses for compliance.
Can manufacturers use diffusely reflecting targets to meet laser safety requirements?
Yes, if manufacturers supply or recommend specific diffusely reflecting targets with proper instructions and warnings for exclusive use, and the viewing optic attenuates reflected beams to Class I levels, the product can achieve compliance.
What warnings are required for laser surveying equipment with sighting telescopes?
Manufacturers must include specific warnings against using specular or retroreflective targets in instructions. Additional warnings about not viewing radiation with mirror-like targets may be added to the required exterior warning logotype per 21 CFR 1040.10(g).
How does target type affect laser safety classification in surveying equipment?
Target type significantly impacts safety. Diffuse targets reflect lower radiation levels, while retroreflective or specular mirror targets can approach the laser’s full power level, potentially exceeding safe viewing limits through the telescope.
What constitutes a viewing optic system in laser surveying products?
A viewing optic system includes both the sighting telescope and the target used for viewing laser light reflections. The FDA considers this combination as an integrated viewing optics system subject to specific performance requirements.
Can laser surveying equipment maintain higher power while ensuring viewing safety?
Yes, by using appropriate diffusely reflecting targets and proper viewing optic attenuation. This allows maintaining necessary laser power for daylight visibility while ensuring reflected radiation through the telescope remains at safe Class I levels.
What You Need to Do 👇
Recommended Actions
- Evaluate if your sighting telescope meets the Class I attenuation requirements when used with recommended targets
- Develop and implement appropriate warning labels and instructions regarding target usage
- Document the target specifications and recommendations as part of the product’s safety documentation
- Ensure compliance with 21 CFR 1040.10(f)(8) for all viewing optics components
- Include appropriate warnings on both the product exterior and in the user instructions
- Consider the entire system (telescope + recommended target) in safety assessments
- 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
- Target specifications and recommendations become part of the product’s safety considerations
- Manufacturer-supplied targets can be considered an integral part of the viewing optics system
Relevant Guidances 🔗
- 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
- Laser Illuminated Projectors (LIPs) - Classification, Safety Requirements and Labeling
Related references and norms 📂
- 21 CFR 1040.10: Performance standards for light-emitting products
- 21 CFR 1040.11: Specific purpose laser products