CENTER FOR DEVICES & RADIOLOGICAL HEALTH
In the U.S., a division of the Food and Drug Administration known as the Center for Devices and Radiological Health (CDRH) regulates the manufacturing and classification of U.S. radiation-emitting devices. Because laser light is a form of radiation, CDRH works to ensure that manufacturers of laser products follow specific guidelines designed to protect consumers. We at Power Technology, Inc. have an obligation to the government, to ourselves, and, most importantly, to our customers to make certain that our products adhere to the regulations set forth by CDRH. If our customers have any questions concerning laser safety they are encouraged to contact our on-staff Laser Safety Officer.
The Code of Federal Regulations (CFR) is the set of government guidelines established by CDRH that manufacturers of various products must adhere to. Specifically, guidelines 21 CFR 1040.10 and 1040.11 detail the standards that all laser products must meet. To comply with federal regulations, all laser system manufacturers must ensure that their products contain mandated safety features, must register their products with CDRH, and must properly label each device with its respective warning data. CDRH classifies lasers based on exposure times, wavelength, and power.
INTERNATIONAL ELECTROTECHNICAL COMMISSION
The International Electrotechnical Commission (IEC) is the leading global organization that establishes international standards for electronics, electro-optics, and related technologies. For laser product manufacturers, this means that IEC creates safety standards that work to improve the quality of laser products, as well as to improve human safety. Specifically, Amendment 2 of IEC standard 60825-1 lays out the safety regulations that laser manufacturing companies must meet in order to be compliant. In January 2004, our laser diode products officially met all European standards for laser safety and became IEC-compliant.
Until recent years, companies manufacturing laser products for sale in North America and Europe had to conduct different safety tests for each geographic location. However, CDRH issued Laser Notice Number 50 in July 2001. This notice indicates that CDRH will accept compliance with portions of IEC 60825-1 as an alternative to meeting certain requirements published by CDRH itself, mainly with regard to labeling. The result: Europe and North America have an agreed-upon set of labeling requirements applicable to both markets. These common standards will undoubtedly help to remove technical barriers resulting from differing certification criteria in Europe and the U.S.
LABELING ON POWER TECHNOLOGY, INC. PRODUCTS
You'll find that each of our laser modules has a yellow, IEC-compliant label on it. PTI no longer uses the white and yellow CDRH-style labeling. The IEC classification scheme is as follows. Clickhere for a more printer-friendly explanation (in PDF format) of our labeling system.
No risk to eyes or skin
These laser products pose no risk to eyes or skin under normal operations and conditions, including occasions when users view the beam directly with optics that could concentrate the output into the eye.
|Class 1 component label||Class 1 system label|
Low risk to eyes, no risk to skin
Class 1M laser products have a wavelength range of 302.5 to 10 6nm. Like Class 1 laser products, Class 1M products are safe to eyes and skin under normal conditions, including when users view the laser beam directly. However, users should not incorporate optics that could concentrate the output into the eyes (e.g., a telescope with a 1M laser emitting a well-collimated beam).
|Class 1M component label||Class 1M system label|
Low risk to eyes, no risk to skin
Class 2 lasers emit visible (400 to 700nm) output below 1mW. These products emit light that poses very little risk to the human eye, even when viewing the beam directly with optics that could concentrate the output into the eye. The eye’s natural aversion response to bright light prevents injury to the eye. However, these lasers do pose a dazzle hazard.
|Class 2 component label||Class 2 system label|
Low risk to eyes, no risk to skin
Laser products classified as 2M emit visible output below 1mW in the 400 to 700nm range. Like Class 2 laser products, Class 2M products pose relatively little risk to eyes and no risk to skin under normal conditions, including when users view the laser beam directly. The eye’s natural aversion response to bright light prevents damage to the eye. However, users should not incorporate optics that could concentrate the output into the eyes (e.g., a telescope with a 1M laser emitting a well-collimated beam).
|Class 2M component label||Class 2M system label|
Low risk to eyes, low risk to skin
This class is similar to CDRH’s 3A class. Class 3R lasers emit between 1 and 5mW of output power in the 302.5 to 10 6nm wavelength range. IEC reserves the 3R classification for those laser products that yield output of up to a factor of five over the maximum allowed for Class 2 in the 400 to 700nm wavelength range and up to a factor of five over the maximum allowed for Class 1 for other wavelengths. Designation “R” indicates “reduced requirements,” requirements that are less stringent than those reserved for 3B lasers. The risk of injury from directly viewing a Class 3R laser beam remains relatively low, but users should take greater care to avoid direct eye exposure, especially when handling invisible output.
|Class 3R component label||Class 3R system label|
Medium risk to eyes, low risk to skin
Class 3B lasers emit between 5 and 500mW of output power in the 302.5 to 10 6nm wavelength range . They are hazardous to the eye when viewed directly, even when taking aversion responses to light into account. However, scattered light is typically safe to the eye. Higher power 3B lasers are a hazard to the skin, but the natural aversion response to localized heating typically prevents skin burns.
|Class 3B component label||Class 3B system label|
High risk to eyes and skin
Class 4 lasers emit output power above 500mW. Direct exposure to Class 4 laser output is hazardous to both eyes and skin. Scattered light may also be hazardous to eyes. These lasers may be fire hazards.
|Class 4 component label||Class 4 system label|
LASER DIODE CONTROL UNIT
The Laser Diode Control Unit (LDCU) is a turnkey power source that enables us to offer OEM laser products as complete laser systems. The LDCU incorporates a number of CDRH mandated safety features, including an emission indicator and 5-second activation delay, to bring end users into compliance with U.S. government regulations. OEMs are responsible for integrating their own safety features to meet government standards. Click here for more information about the LDCU.