Laser Product Classification - Alcatel-Lucent 1643 AMS User's Operation Manual

Safety

Laser product classification

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Standards compliance
The 1643 AM and 1643 AMS product complies with the applicable IEC standards and
the Food and Drug Administration's Center for Devices and Radiological Health
(FDA/CDRH) regulations.
FDA/CDRH regulations
Laser products are classified in accordance with the FDA/CDRH - 21 CFR 1010 and
1040. The classification scheme is based on the ability of the laser emission to cause
injury to the eye or skin during normal operating conditions.
In the United States, lasers and laser systems in the infrared wavelength range (greater
than 700 nm) are assigned to one of the following classes (please refer to
"FDA/CDRH laser classification" (p.
• Class I,
• Class IIIb, or
• Class IV.
Laser classification is dependent upon operating wavelength, output power, and fiber
mode field diameter (core diameter).
IEC requirements
The International Electro-Technical Commission (IEC) establishes standards for the
electrical and electronic industries. The IEC 60825 standard has been established for
the worldwide safety of laser products.
According to the IEC classification, lasers and laser systems in the infrared wavelength
range (greater than 700 nm) are assigned to one of the following classes (please refer
to "IEC laser classification" (p.
• Class 1,
• Class 1M,
• Class 3R,
• Class 3B, or
• Class 4.
There are some major differences between the FDA/CDRH regulations and the IEC
requirements:
1. The Accessible Emission Limits (AEL) are different.
2. Class 1M applies to all wavelengths.
3. Class 3B requires strict engineering controls.
4. Classification is under single fault conditions.
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Alcatel-Lucent - Proprietary
See notice on first page
365-312-807R7.2
Issue 4, May 2007