Beam Attenuator and Emission Indicator Requirements for Class II and IIIa Visible Laser Systems
This guidance addresses the requirements for beam attenuators and emission indicators in Class II and IIIa laser systems, specifically focusing on visible laser systems. It provides policy clarification regarding the omission of these features under specific conditions.
Recommended Actions
- Review existing Class II and IIIa visible laser systems to identify opportunities for design simplification
- Evaluate current emission control mechanisms to ensure they meet the requirements for omitting beam attenuators
- Assess momentary on switches to confirm they provide clear tactile feedback
- Document design decisions and justifications for omitting beam attenuators or emission indicators
- Maintain compliance records with relevant CFR requirements
- Monitor for future amendments to the standard as indicated in the guidance
- Consider submitting comments to the Non-Medical Radiological Devices Branch if there are concerns or suggestions regarding the policy
Key Considerations
Human Factors
- Clear, tactile indication of emission must be provided when using a normally off, momentary on switch
Safety
- Beam attenuator can be omitted if the laser system incorporates a specific, suitable means of emission control (e.g., switch)
- Emission indicator (visible or audible) can be omitted if the laser system uses a normally off, momentary on switch
- The momentary on switch must only operate while physical pressure is applied
Other considerations
- Applies only to Class II and IIIa visible laser systems
- Compliance with 21 CFR 1040.10(f)(6)(ii) for alternative means of radiation protection
- Compliance with 21 CFR 1010.4 for variances related to emission indicators
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 1010.4: Variances
- 21 CFR 1003.11: Regulatory Requirements for Notification of Defects
- 21 CFR 1003.21: Notification to Affected Persons
- 21 CFR 1003.30: Exemption from Notification Requirements
Original guidance
- Beam Attenuator and Emission Indicator Requirements for Class II and IIIa Visible Laser Systems
- HTML / PDF
- Issue date: 1993-06-07
- Last changed date: 2020-03-17
- Status: FINAL
- Official FDA topics: Medical Devices, Radiation-Emitting Products, Radiological Health
- ReguVirta summary file ID: af2f219102628e3026eddf72861f8cec
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