Several organizations concern
themselves with laser safety. These organizations include the American National
Standards Institute (ANSI), the Center for Devices and Radiological Health
(CDRH) of the Food and Drug Administration (FDA), the Department of Labor's
Occupational Safety and Health Administration (OSHA), and the Council of
Radiation Control Program Directors (CRCPD). Several state governments and
CRCPD have developed a model state standard for laser safety.
All laser devices distributed for
both human and animal treatment in the U.S. are subject to Mandatory
Performance Standards. They must meet the Federal laser product performance
standard and must submit an "initial report" to CDRH's Office of
Compliance prior to distributing the product (see
21 CFR 1000 - 1040). This performance standard specifies the safety
features and labeling that all laser products must have in order to provide
adequate safety to users and patients. A laser product manufacturer must
certify that each model complies with the standard before introducing the
laser into U.S. commerce. Compliance with standards must also be shown
before clinical investigations prior to device approval.
Certification of a laser product
means that each unit has passed a quality assurance test and that it
complies with the performance standard. The firm that certifies a laser
product assumes responsibility for product reporting, recordkeeping, and
notification of defects, noncompliances, and
accidental radiation occurrences, as specified in sections 21 CFR
1000-1010. A certifier of a laser product is required to report the product
via a Laser Product Report submitted to CDRH. Reporting guides and related
regulatory information are available from the Radiation-Emitting Products
web site. Distribution of any certified laser products internationally also
requires submission of the report.
The Food
and Drug Administration (FDA) recognizes four major hazard classes (I to
IV) of lasers, including three subclasses (IIa, IIIa, and IIIb). The higher
the class, the more powerful the laser and the potential to pose serious
danger if used improperly. Consumer laser products are generally in classes
I, II, and IIIa, while lasers for professional
use may be in classes IIIb and IV. The labeling
for Classes II–IV must include a warning symbol that states the class and
the output power of the product.
The FDA
requires labels on most laser products that contain a warning about the
laser radiation and other hazards, as well as a statement certifying that
the laser complies with FDA safety regulations.
Class FDA |
Class IEC |
Laser Product Hazard |
Product Examples |
I |
1, 1M |
Considered non-hazardous.
Hazard increases if viewed with optical aids, including magnifiers,
binoculars, or telescopes. |
|
IIa, II |
2, 2M |
Hazard increases when viewed
directly for long periods of time. Hazard increases if viewed with
optical aids. |
|
IIIa |
3R |
Depending on power and beam
area, can be momentarily hazardous when directly viewed or when staring
directly at the beam with an unaided eye. Risk of injury increases when
viewed with optical aids. |
|
IIIb |
3B |
Immediate skin hazard from
direct beam and immediate eye hazard when viewed directly. |
|
IV |
4 |
Immediate skin hazard and eye
hazard from exposure to either the direct or reflected beam; may also
present a fire hazard. |
|
U.S.C. TITLE 18, CHAPTER 2, Section 39A, signed into
law in 2012, makes it illegal to aim a laser pointer at an aircraft or
aircraft flight path.
OSHA standards
regarding lasers This website highlights OSHA standards, directives
(instructions for compliance officers), standard interpretations (official
letters of interpretation of the standards), and national consensus
standards related to laser hazards.
OSHA
Technical Manual on lasers and laser hazards.
International Regulations:
The International Electrotechnical Commission
(IEC) is the authoritative worldwide body responsible for developing
consensus global standards in the electrotechnical
field. IEC is dedicated to the harmonization and voluntary adoption of
these standards, supporting the transfer of electrotechnology,
assisting certification and promoting international trade.
Scientific/Medical:
All lasers pose
potential danger of skin, organ and tissue damage as a result of extended
exposure or staring into the beam. Thermal radiation due to heat generated
during extended contact is also a concern. People working with class 3B and
class 4 lasers can protect their eyes with safety goggles which are
designed to absorb light of a particular wavelength.
Infrared lasers with wavelengths beyond about 1.4 micrometers are often
referred to as "eye-safe" because the cornea strongly absorbs
light at these wavelengths, protecting the retina from damage. The label
"eye-safe" can be misleading, as it only applies to relatively
low power continuous wave beams. A high power or Q-switched laser at
these wavelengths can burn the cornea, causing severe eye damage, and even
moderate power lasers can injure the eye.