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Specific Safety Areas
Laser Product Classification
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Standards compliance
FDA/CDRH regulations
IEC requirements
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365-374-059
Issue a, January 2002
™
The LambdaUnite
MSS product complies with the applicable IEC
standards and the Food and Drug Administration's Center for Devices
and Radiological Health (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"
(1-16)):
•
Class I,
•
Class IIIb or
•
Class IV.
Laser classification is dependent upon operating wavelength, output
power and fiber mode field diameter (core diameter).
The International Electro-Technical Commission (IEC) establishes
standards for the electrical and electronic industries. IEC 60825 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"
(1-16)):
•
Class 1,
•
Class 3A,
•
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 3A applies to all wavelengths.
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