Standard classification for lasers

Newsgroups: sci.electronics
Subject: CDRH Laser regulations
Date: 28 Feb 94 10:33:39 CST
Organization: University of Kansas Academic Computing Services

As posted by the Center for Devices and Radiological Health (CDRH) regulation 21 CFR 1040.10 and 21 CFR 1040.11, the standard classification for lasers are as follows:

Class I laser product

No known biological hazard. The light is shielded from any possible viewing by a person and the laser system is interlocked to prevent the laser from being on when exposed. (large laser printers such as the DEC LPS-40 has a 10mW HeNe driving it which is a Class IIIb laser, but the printer is interlocked so as to prevent any contact with the exposed laser beam, hence the device produces no known biological hazard, even though the actual laser is Class IIIb. This would also apply to CD players and small laser printers, as they are Class I devices).

Class II laser products

Power up to 1 milliwatt. These lasers are not considered a optically dangerous device as the eye reflex will prevent any occular damage. (I.E. when the eye is hit with a bright light, the eye lid will automatically blink or the person will turn thier head so as to remove the bright light. This is called the reflex action or time. Class II lasers won't cause eye damage in this time period. Still, one wouldn't want to look at it for an extended period of time.) Caution labels (yellow) should be placed on the laser equipment. No known skin exposure hazard exist and no fire hazard exist.

Class IIIa laser products

Power output between 1 milliwatt and 5 milliwatt. These lasers can produce spot blindness under the right conditions and other possible eye injuries. Products that have a Class IIIa laser should have a laser emission indicator to tell when the laser is in operation. They should also have a Danger label and output aperature label attatched to the laser and/or equipment. A key operated power switch SHOULD be used to prevent unauthorized use. No known skin hazard of fire hazard exist.

Class IIIb laser products

Power output from 5 milliwatts to 500 milliwatts. These lasers are considered a definate eye hazard, particularly at the higher power levels, which WILL cause eye damage. These lasers MUST have a key switch to prevent unathorized use, a laser emission indicator, a 3 to 5 second time delay after power is applied to allow the operator to move away from the beam path and a mechanical shutter to turn the beam off during use. Skin may be burned at the higher levels of power output as well as the flash point of some materials which could catch fire. (I have seen 250mW argons set a piece of red paper on fire in less than 2 seconds exposure time !) A red DANGER label and aperature label MUST be affixed to the laser.

Class IV laser products

Power output >500 milliwatts. These CAN and WILL cause eye damage. The Class IV range CAN and WILL cause materials to burn on contact as well as skin and clothing to burn. These laser systems MUST have:

A key lockout switch to prevent unauthorized use Inter-locks to prevent the system from being used with the protective covers off Emission indicators to show that the laser is in use Mechanical shutters to block the beam Red DANGER labels and aperature labels affixed to the laser

The reflected beam should be considered as dangerous as the primary beam. (again, I have seen a 1,000 watt CO2 laser blast a hole through a piece of steel, so imagine what it would do to your eye !)

Registration of laser systems

Any laser system that has a power output of greater than 5 milliwatts MUST be registered with the FDA and Center for Devices and Radiological Health if it has an exposed beam, such as for entertainment (I.E. Laser light shows) or for medical use (such as surgery) where someone other than the operator may come in contact with it. (this is called a 'varience' and I have filled them out and submitted them and they ARE a royal pain in the backside !)