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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: |
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Class |
Hazard
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Applications |
Description |
|
I |
LASER is usually self-contained within a small enclosure, and is considered
non-hazardous. |
LASER printers
CD players
DVD players
Computer Mouse |
Power up to 1 milliwatt. 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 operating when enclosure is opened. |
|
II
IIa
|
Visible LASER or LASER system that cannot cause eye damage unless viewed
directly for an extended period of time. |
Interior (bank or museum alarm systems)
Retail bar code scanners |
Power up to 1 milliwatt. These LASERS are not considered
optically dangerous devices, as the eye reflex will prevent any ocular damage.
(i.e.: the person will automatically blink or the person will turn their head so
as to avoid the bright light. This is called the reflex action or time. Class II
LASERS won't cause eye damage in this time period. However, you 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 fire or skin exposure hazards exist. |
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IIIa
|
LASERS that normally do not present a risk of injury if viewed
momentarily with the unaided eye, but may present a greater risk if viewed using
magnifiers, binoculars, or telescopes.
|
CD/DVD Burners
Holography
Industrial LASERS
Hand-Held LASERS
LASER leveling devices
|
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 aperture label attached to the LASER and/or equipment. A key
operated power switch SHOULD be used to prevent unauthorized use. No known skin
or fire hazards exist. |
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IIIb
|
LASER can cause eye damage if viewed directly |
LASER light shows
Open cut healing
Research LASERS
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Power output from 5 milliwatts to 500 milliwatts. These
LASERS are definitely an eye hazard, particularly at the higher power levels,
which WILL cause eye damage. These LASERS MUST have a key switch to prevent
unauthorized use, a LASERS emission indicator, 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. A red
DANGER label and aperture label MUST be affixed to the laser. |
|
IV
|
LASER may cause severe eye injury with short
duration exposure to the direct or reflected beam.
This class LASER may also cause severe skin
damage and present a fire hazard.
Cobalt Series LASERS
fall into this class. |
Holography
LASER light shows
Industrial LASERS
Research LASERS
Surgical LASERS
LASERS used to perform LASIK eye
surgery
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Power output over 500 milliwatts. These CAN and WILL cause
eye damage. The Class IV range WILL cause materials such as skin or clothing to
burn. The reflected beam should be considered as dangerous as the primary beam.
These LASER systems MUST have a key lockout switch to prevent
unauthorized use, Interlocks to prevent the system from being used with the
protective covers off, Emission indicators to show that the laser is in use, and
mechanical aperture shutters to block the beam.
DANGER labels and aperture labels must be affixed to the
LASER.
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