Information
for Products Employing Laser Devices and LEDs
United States
Federal law states that a product that employs
a laser diode is a laser product. Typical
laser products include CD players, laser pointers,
fiber optic telecommunications equipment and
the like. Federal law requires that laser
products comply with the laser safety requirements
of the Center for Devices and Radiological
Health (CDRH), a division of the Food and
Drug Administration (FDA). Laser safety requirements
are contained in 21CFR Parts 1010 and 1040.
The requirements vary depending on the class
of laser and the class is determined by power
and wavelength characteristics of the laser
source. Manufacturers of laser products are
required to submit a report to the CDRH attesting
to compliance with all applicable sections
of 21CFR prior to placing laser products on
the market. In addition to this report filing,
manufacturers are also required to maintain
certain records and may be required to submit
periodic reports to the CDRH. Currently U.S.
requirements only apply to laser diode sources
and not to LEDs. For further information,
refer to http://www.fda.gov/cdrh/radhlth/.
Canada
Canadian law requires that laser products
comply with the Canadian Radiation Emitting
Devices Act, REDR C1370. Compliance with U.S.
FDA requirements is sufficient evidence of
compliance with Canadian law. The primary
difference being that Canada requires notification
of non-compliance of marketed equipment where
the US requires notification that equipment
is compliant before it is placed onto the
market. For further information, refer to
http://laws.justice.gc.ca/en/R-1/C.R.C.-c.1370/index.html.
European Union
Compliance with European Directives such
as the Low Voltage, Medical Devices, Machinery
or even the General Product Safety Directives
require that laser products comply with EN
60825-1 (laser products) and, if applicable,
EN 60825-2 (fiber optic laser products) in
addition to other requirements of the Directives.
Compliance is assured through a successful
investigation to the applicable laser standard
as well as the applicable end-product standard
(e.g. EN 60950) and is demonstrated by the
manufacturer’s self-declaration and
application of the CE mark. European requirements
apply to both laser diode-based products and
LED products, which is a major difference
from US requirements.
If you are interested
in learning about how MET can assist you in
your Laser Safety Certifications, please contact
your Account Manager.
