Laser products conformance with iec 608251 and iec 606012. If the size or design of the product makes labeling impractical, the label should be included with the user information or on the package. This paper briefly describes to classify a laser product with main parameter on the basis of iec 60825 1. Iec 62471 first edition 200607 photobiological safety of lamps and lamp systems iec 60825 1 edition 2. It does not include manual reduction or termination of the emission.
Eye safety risk assessment of infrared emitting diodes. Guidance for industry and fda staff laser products. For laser products complying with iec 60825 1, 200108 edition 1. International electrotechnical commission iec standards iec 60825 2 ed.
In support of local and federal covid19 guidelines, we are unable. The look of iec laser labels is completely different from cfr 1040. Specifically, the european committee for electrotechnical standardization cenelec has adopted iec 825 1 as en 60825 1. The following bibliographic material is provided to assist you with your purchasing decision. Test report iec 603351 safety of household and similar.
Overview of iec 60825 laser safety labeling requirements. Equipment classification, requirements, and users guide. Laser safety classification according to iecen 608251. Laser classification standard dinen 608251 what does it. Iec 60825 1 amendment report this service includes radiation testing and preparation of an iec 60825 1 amendment to your existing iec 60825 1 report. Clarions laser labels in this category comply with iec 60825 1, which defines the content and design of laser safety labeling for international markets. Requirements for beam path components, beam stops and those other parts of a protective housing of a laser product which do not enclose the process zone are contained in iec 60825 1. Nenen iec 60825 1 is applicable to safety of laser products emitting laser radiation in the wavelength range 180 nm to 1 mm. Laser safety laser safety classifications general caution.
The checklist is intended for use by manufacturers of laser products and their agents to establish that each new or modified design complies with the requirements of iec 60825 1. Iec 60825 1 is applicable to safety of laser products emitting laser radiation in the wavelength range 180 nm to 1 mm. Laser products conformance with iec 608251 and iec. Laser safety is the safe design, use and implementation of lasers to minimize the risk of laser accidents, especially those involving eye injuries. Final guidance for industry and fda laser notice no. Limitations on classes of energy accessible at different locations controlled, restricted, unrestricted iec.
A laser product may consist of a single laser with or without a separate power supply or may incorporate one or more lasers in a complex optical, electrical, or mechanical system. Optical output power mw pulse width s repetition rate emitted wave length nm beam radiation angle deg. Laser products conformance with iec 608251 and iec 60601222. Since even relatively small amounts of laser light can lead to permanent eye injuries, the sale and usage of lasers is typically subject to government regulations.
Equipment classification and requirements, international electrotechnical commission, geneva. Cdrh will not object to conformance with many sections of iec 60825 1, as amended, and iec 60601222 as alternatives to comparable sections of 21 cfr 1040. The classification of an array of laser or led sources under the 2001 iec 60825 1 standard can be a complicated process. Has the status of a group safety publication in accordance with iec guide 104. A laser product may consist of a single laser with or without a separate power. For questions regarding this document contact jerome dennis, 2402763330.
Equipment classification, and requirements including. The iec international electrotechnical commission has recently published edition 3. Table 1 laser safety classifications based on iec 60825 1. Covers laser radiation in the wavelength range 180 nm to 1 mm, indicates safe working levels of laser radiation and introduces a system of classification of lasers and laser products according to their degree of hazard. In order to read a secure pdf, you will need to install the fileopen plugin on your computer. Technical corrigendum 1 2008, interpretation sheet 1 2007, interpretation sheet 2 2007 ansi iesna rp27. All laser and led depending on the led application products must be tested, classified and brought in compliance with the base standard. The fileopen plugin works with adobe reader and other viewers. Compliance of infrared communication products to iec 8251. Additionally, it addresses technical and safety issues which have arisen in the time following the previous second this is a free 7 page sample. It is important to note that the designation of this standard has changed. Standard iec 60601 1 and group safety publication iec 60825 1. Iec 60825 1 requires separate aperture labels for some classes of laser products. This technical report is applicable to laser products as described in iec 60825 1.
While the iec is a voluntary standards organization, its standards may be adopted as national standards. Laser compliance statement this laser product complies with en iec 60825 1 ed 2, 200703, and us fdacdrh flpps via the terms of. These all originate from the base laser safety standard, iec 60825 1. See below for determination of retinal photochemical hazard as specified in table 2 in iec en 60825 1. Iec system of conformity assessment schemes for electrotechnical equipment and components iecee. Equipment classification and requirements on may 2014. Safety of laser productsequipment classification, requirements and users guide iec 60825 1.
Available language s tc 76 optical radiation safety and laser equipment. P a p e 6 iec 60825 part 2 optical fiber communications systems std. Symbol iec 604175180, for class iii appliances, unless na the appliance is operated by batteries only na symbol iec 604175018, for class ii and class iii appliances incorporating a functional earth na symbol iec. Also republished as iec 62417, international electrotechnical commission, geneva, july 2006. In previous editions, leds were included in the scope of this standard, and were also included in other parts of the iec 60825 series, as e. The table below summarises the iec 60825 range of laser safety standards. Equipment classification, requirements and users guide allows for two iec. Laser safety standards update and impact on 850 nm serial. Equipment claccification, requirements and users guide. Equipment classification, requirements and users guide. Iec tr 60825 10 first edition 200202 safety of laser products. As measured under iec measurement conditions for classification. In various jurisdictions, standards bodies, legislation, and government regulations define classes of laser. The text led shall be substituted or added to the word laser as appropriate.