Use of Visible Laser Beam as Emission Indicator for Class II and Class IIIa Laser Products
This guidance addresses the use of emitted laser beam as an emission indicator for Class II and Class IIIa laser products, specifically focusing on visible laser radiation. It aims to align CDRH standards with international standards (IEC and ANSI) regarding emission indicators requirements.
Recommended Actions
- Review current emission indicator designs for Class II and Class IIIa laser products
- Consider using the emitted laser beam itself as the emission indicator for visible laser radiation
- Document the rationale for using the laser beam as the emission indicator in technical documentation
- Monitor for future amendments to the standard regarding beam attenuators and emission indicators
- Ensure compliance with other applicable requirements of 21 CFR 1040.10 not affected by this notice
- Consider alignment with international standards (IEC and ANSI) for emission indicator requirements
Key Considerations
Human Factors
- The emitted beam must be observable by the operator for certain types of visible laser products to perform their intended functions (leveling, pointing, or aiming)
- It is considered unlikely that laser safety eyewear would be used with Class II or Class IIIa laser products
Safety
- The emitted laser beam itself can serve as the indication of emission of visible laser radiation
- Previous requirement (21 CFR 1040.10(f)(5)(i)) for Class II and Class IIIa laser systems to incorporate a visible or audible emission indicator is no longer enforced
Other considerations
- CDRH plans to propose amendments to remove requirements for beam attenuators and emission indicators for Class II and Class IIIa laser systems
Relevant Guidances
- Beam Attenuator and Emission Indicator Requirements for Class II and IIIa Visible Laser Systems
- 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
Related references and norms
- IEC 825-1:1994: Safety of laser products
- ANSI Z136.1:1993: Safe Use of Lasers
Original guidance
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