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.
What You Need to Know? 👇
What is the purpose of emission indicators in Class II and Class IIIa laser products?
Emission indicators provide visible or audible signals during laser radiation emission exceeding Class I limits, as required by 21 CFR 1040.10(f)(5)(i). They alert operators when potentially hazardous laser radiation is being emitted.
Can the laser beam itself serve as an emission indicator for visible laser products?
Yes, according to Laser Notice 49, the FDA does not object to using the emitted laser beam as the emission indicator for Class II and Class IIIa visible laser products, eliminating the need for separate indicators.
Why did FDA change its position on emission indicators for lower-class laser products?
The FDA recognized that separate emission indicators provided little safety benefit while creating regulatory burden. The change aligns US standards with international standards (IEC 825-1:1994) and ANSI Z136.1:1993, improving global harmonization.
What are the visibility requirements for emission indicators through protective eyewear?
According to 21 CFR 1040.10(f)(5)(iv), any visible emission indicator must remain clearly visible through protective eyewear specifically designated for the laser’s wavelength(s), ensuring operators can detect laser operation while protected.
Do Class II and Class IIIa lasers typically require safety eyewear during operation?
No, it’s considered very unlikely that laser safety eyewear would be used with Class II or Class IIIa laser products, as these are generally considered safe for brief exposure under normal use conditions.
What types of laser applications benefit from observing the emitted beam directly?
Visible laser products used for leveling, pointing, or aiming applications require operators to observe the beam path directly to perform their intended functions effectively, making the beam itself a practical emission indicator.
What You Need to Do 👇
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