FDA Classification and Requirements for Laser Illuminated Projectors (LIPs) (Laser Notice No. 57)
标准简介
Classification and Requirements for Laser Illuminated Projectors (LIPs) (Laser Notice No. 57)[附网盘链接]是FDA发布的FDA标准，适用于美国。标准截图
![Classification and Requirements for Laser Illuminated Projectors (LIPs) (Laser Notice No. 57)[附网盘链接]](/img/20210914103617plbe7.jpg)
标准文档说明
标准文档类型为Classification and Requirements for Laser Illuminated Projectors (LIPs) (Laser Notice No. 57)[附网盘链接]高清PDF版本（文字版），标准文档内可进行搜索，可以复制原文，可粘贴。标准部分原文
Classification and Requirements for Laser Illuminated Projectors (LIPs) (Laser Notice No. 57) Guidance for Industry and Food and Drug Administration Staff This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff or Office responsible for this guidance as listed on the title page. I. Introduction This guidance describes FDA’s policy with respect to certain laser illuminated projectors that comply with International Electrotechnical Commission (IEC) standards during laser product 1
classification under the Electronic Product Radiation Control provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that apply to electronic products. For purposes of this guidance, the term “laser illuminated projector” (LIP) refers to a type of 2
demonstration laser product regulated under 21 CFR 1040.10(b)(13) that is designed to project a display image without the use of raster-scanned collimated laser beams. LIPs may be used in locations such as indoor or outdoor cinema theaters, laser shows, presentations at conventions, as image/data projectors in an office setting, or in a home. Lasers are being used in LIPs as an alternative to conventional lamps in projectors. Although these LIPs emit laser light from extended sources and their uncollimated beams do not present the same hazards as other lasers, they are laser products that present risks and must undergo classification in accordance with 21 CFR 1040.10(c). Under 21 CFR 1040.10(c), FDA recognizes four major hazard classes (I to IV) of lasers, including three subclasses (IIa, IIIa, and IIIb). Under this classification procedure higher laser 1
The requirements for classifying laser products are set forth in 21 CFR part 1040. 2
The term “demonstration laser product” is defined under 21 CFR 1040.10(b)(13) to mean “any laser product manufactured, designed, intended, or promoted for purposes of demonstration, entertainment, advertising display, or artistic composition.”
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