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Compaq 21CFR1040.10 10Gb/s 10GBase-LR Single-Mode Fibre 1310nm 10km Fibre Channel Duplex SC Connecto...
- Defines laser hazard classifications from Class I to Class IV based on accessible emission limits
- Mandates specific safety features such as interlocks, key switches, and emission indicators
- Specifies required warning labels, aperture designations, and user documentation standards
- Applicable to all laser products manufactured, imported, or sold in the United States
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Product Overview
21 CFR 1040.10 is the United States federal performance standard for laser products, administered by the FDA's Center for Devices and Radiological Health (CDRH). It establishes mandatory safety requirements, classification systems, and labeling standards for all laser-emitting devices marketed in the U.S.
Technical Information
| Regulatory Authority | FDA / CDRH |
| Regulation Title | 21 CFR 1040.10 Laser Products |
Additional Specifications
| Classification System | Class I, IIa, II, IIIa, IIIb, IV |
| Compliance Requirement | Mandatory for US Market Access |
Product Description
21 CFR 1040.10 provides the legal framework for laser safety in the US. It includes detailed Accessible Emission Limits (AEL) for various wavelengths and pulse durations. Manufacturers must certify that their products comply with these standards through the submission of product reports to the FDA. The regulation covers engineering controls, labeling, and informational requirements to ensure user safety during operation and maintenance, and is often used in conjunction with Laser Notice No. 50 for international alignment.
