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FDA's Laser Notice 50: a step toward global harmonization

机译:FDA激光通告50:迈向全球统一的一步

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摘要

The US Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH) issued Laser Notice 50 in July, 2001. This Notice is a preliminary step that FDA has taken to harmonize US regulations for laser products with the IEC (International Electrotechnical Commission) standards for Safety of Laser Products. The paper discusses rationale for the changes and describes some of the implementation issues including comparisons between the current standards. The impact on the regulated industry and the user community is that the same laser hazard classification scheme is used and that engineered safety features are consistent in the world markets.
机译:美国食品和药物管理局(FDA),设备与放射卫生中心(CDRH)于2001年7月发布了第50号激光通告。该通告是FDA为使美国激光产品法规与IEC(International电工委员会)激光产品安全标准。本文讨论了更改的理由,并描述了一些实施问题,包括当前标准之间的比较。对受管制的行业和用户社区的影响是,使用了相同的激光危害分类方案,并且工程安全特性在世界市场上是一致的。

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