In-House Manufactured Laser Products: Applicability of Federal Performance Standards
This guidance clarifies when in-house manufactured laser products used in manufacturing processes are subject to the Federal Performance Standard for Laser Products and other regulations.
Recommended Actions
- Assess whether your in-house laser manufacturing activities constitute “being engaged in the business” based on:
- Frequency of manufacture (one-time vs. continuous)
- Who uses the laser products
- Commercial nature of the operation
- If determined to be “engaged in the business”:
- Implement compliance with Federal Performance Standard
- Establish certification procedures
- Maintain required documentation
- If determined to be one-time construction:
- Document the one-time nature of the build
- Ensure usage is restricted to the place of construction
- Establish clear procedures for tracking any changes in manufacturing patterns that could affect regulatory status
Key Considerations
Safety
- Laser products made on a continuing basis and used by employees not directly involved in their manufacture must comply with the Federal Performance Standard
- One-time constructed laser products used only at the place of construction are exempt from the standard
Other considerations
- The determination of whether a company is “engaged in the business” of manufacturing depends on:
- 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: Performance Standards for Light-Emitting Products
Original guidance
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