Safety standards have been put in place for laser products to prevent injury to the user. IEC 60825-1 is an international standard for laser products and has become a common safety standard in IEC member countries. * IEC = International Electrotechnical Commission
FDA Laser Classifications
In the United States, laser product regulations are summarized by the FDA (CDRH) standard 21 CFR 1040.10. Laser products imported to or sold in the USA are required to meet the requirements of Part 1040.10. IEC 60825-1 may be adopted as an alternative to Part 1040.10 (per the CDRH-issued Laser Notice No. 50). However, this does not mean that all of the requirements for IEC 60825-1 are allowed by the CDRH, it is necessary to refer to Laser Notice No. 50 for details.
|Laser class||Class evaluation|
|Class I||Class I laser products are not regarded as dangerous.|
|Class IIa||Class IIa laser products emit a beam in the visible light band of 400 nm to 710 nm. Although looking at this beam for no more than a certain length of time (1,000 seconds) is not considered dangerous, looking at the beam for more than 1,000 seconds is considered dangerous.|
|Class II||Class II laser products emit a beam in the visible light band of 400 nm to 710 nm. Looking at the laser beam for long periods is considered dangerous. Generally, these laser products are positioned so that the eyes will be protected from prolonged exposure through natural aversive reactions (blinking).|
|Class IIIa||Looking at Class IIIa laser product beams temporarily or for long periods is considered dangerous but depends on the level of illuminance. Looking directly at the laser beam using optical instruments is considered dangerous.|
|Class IIIb||Exposure to Class IIIb laser product beams to the skin or eyes is considered dangerous even if only temporary.|
|Class IV||Not only is even temporary exposure to the skin or eyes considered dangerous, but exposure to diffuse reflected light is also considered harmful to the skin or eyes.|
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