By law, any product that uses a laser diode is considered a laser product and is regulated accordingly. Typical laser products include CD players, laser pointers, fiber optic telecommunications equipment and the like.
For example, laser products to be marketed in the United States require compliance with the laser safety requirements of the Devices and Radiological Health Center (CDRH), a division of the Food and Drug Administration (FDA). The requirements vary depending on the laser class, and the class is determined by the power and wavelength characteristics of the laser source.
Manufacturers of laser products are required to submit a report to CDRH certifying compliance with all applicable parts of the 21CFR before placing laser products on the market. In addition to this report filing, manufacturers may also be required to keep certain records and submit periodic reports to CDRH. Currently, US requirements apply only to laser diode sources, not LEDs.
Canadian law requires laser products to comply with the Canadian Radiation Emitting Devices Act, REDR C1370. Compliance with US FDA requirements is sufficient proof of compliance with Canadian law.
The primary difference is that Canada requires notification of non-conformity of marketed equipment, while the USA requires notification that the equipment is compatible before it is placed on the market.
Avrupa Birliği
In addition to other requirements of the Directives, compliance with European Directives such as low Voltage, medical Devices, machines and even General Product Safety Directives requires that laser products comply with EN 60825-1 (laser products) and EN 60825-2 (fiber optic laser products), if applicable. .
Conformity is ensured by successful research of the applicable laser standard as well as the applicable end product standard (eg 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 key difference from US requirements.
EUROLABIf you want to learn how we can help you with your Laser Safety Certificates, you can consult our expert team immediately.
EUROLAB, with its highly expert team and internationally accredited laboratories, Laser Safety Standards and Features Tests It performs all test, analysis, measurement, evaluation and report generation services completely and reliably.
To get an appointment, to get more detailed information or to request an evaluation, you can ask us to fill in our form and reach you.
