Information for Products Employing Laser Devices and LEDs
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/Radiation-EmittingProducts/.
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.
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.