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Laser product classification
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Standards compliance
FDA/CDRH regulations
IEC requirements
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365-374-138A4
Issue 1, November 2003
®
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 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. 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 (1-16)):
•
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 3B requires strict engineering controls.
3.
Classification is under single fault conditions.
EN: Safety guide
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