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Lasers
How lasers are classifiedThe level of a laser's hazard in a product is defined by the Class the laser falls in. Class I is non-hazardous and Class IV is the most hazardous. There are two classifications to consider:
The Class of the product is based upon the amount of laser radiation accessible to the user during normal operation of the product. Although a product may be classified as Class I, the product may incorporate a Class I, IIa, II, IIIa, IIIb or Class IV laser diode internally. This is the laser radiation accessible to service personnel during a service function. For example, a laser product such as a copy machine could have Class I laser radiation accessible to the user. Inside the product there could be Class IV laser radiation accessible to service personnel. The CDRH and how it applies to youU.S. Federal Law mandates that all manufacturers of Laser products submit an Product Report to be filed with the Center for Devices and Radiological Health (CDRH) before they can legally sell products in the United States. Manufacturers must request a Product Report from the CDRH, a department of the Food and Drug Administration. The CDRH will send the manufacturer a Product Report and a copy of the 21CFR, the U.S. Government Code of Federal Regulations No. 21, at no charge. The Product Report must contain construction and performance details describing how the product complies with the 21CFR. After the CDRH receives the Product Report, they will assign an accession number and fax the number to the manufacturer, authorizing them to sell the Laser product in the United States. UL Listing is contingent upon the manufacturer filing with the CDRH. For more information on the 21CFR and the CDRH, visit their web site at www.fda.gov/cdrh/. What UL can do to helpUL is familiar with CDRH requirements and can generate a complete, accurate Product Report for your product that is ready to be filed with the CDRH. Federal Law specifies that this is a self-certification procedure and the manufacturer must file the report. UL will measure the laser radiation, classify the product, instruct you on required markings and construction features and ship you a ready to be filed Product Report in compliance with 21CFR. UL's laser testing program is designed to provide you with the level of service that meets your specific needs. For example, you may only want the measurement data provided by a third party, not a full report. We can perform and give you just the data you need. How IEC 60825-1 and 60825-2 fit into the pictureIn order to sell products with lasers globally, you must be able to provide technical documentation showing compliance with the applicable requirements: IEC 60825-1, the International Standard for the Safety of Laser Products, or IEC 60825-2, the International Standard for the Safety of Fiber Optic Systems. UL can generate an IEC 60825-1/60825-2 report for your laser product as an adjunct service. We will measure the laser radiation, classify the product and instruct you as to the required markings and construction features. UL is able to support and declare compliance with these requirements. Contact informationFor your laser product service needs, please contact Winn Henderson at Winn.Henderson@us.ul.com, or by telephone at +1-919-549-1324 Contact Customer ServiceUL Customer Service Professionals are available from 7:00 AM - 6:00 PM across all North American time zones to provide you with a quote or project status, or to offer you assistance in resolving non-technical questions. Contact a customer service professional, learn how to submit a product for testing or begin the product submission process.
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In order to legally market and sell products that contain lasers in the United States and internationally, there are a number of regulations that manufacturers must follow. UL can assist you in meeting these requirements in a timely and efficient manner. In effect, we can open the doors for you to market your laser-based product worldwide.