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Product Code: JLA_6_1_49

Jerome E. Dennis
Office of Compliance and Surveillance Center for Devices and Radiological Heath, US Food and Drug Administration, Silver Springs, MD, U.S.A.

The most recent amendments to the Federal performance standard for laser products became effective in 1985 and 1986. At this time, the Center for Devices and Radiological Health (CDRH) is making public its intention to amend the standard again and is inviting suggestions and comments. The amendments that are now under consideration are based upon advances in the sciences of photobiology and hazard evaluation. They are also intended to harmonize with developments in international standards for similar products, and to clarify and facilitate administration of the CDRH standard. Many of them were developed in cooperation with representatives of industry, professional societies, trade associations, and representatives on national and international standards committees. This discussion will explain the amendment process, provide a brief history of what has transpired thus far, and explain in some detail many of the amendments that are being considered. Among these are reduction of the emission durations for the classification of some laser products depending on their intended application, extension of Class IIIa to include invisible laser radiation products, revision of the applicability requirements for safety interlocks, revision of the tables of accessible emission limits for the laser product classes, increase in the class levels for which certain performance requirements are applicable, allowance of more flexibility in labeling, delegation of some approval authorities to a lower level of management, and new requirements for the higher classes of medical laser products. Many of the amendments are being considered to achieve a higher degree of consistency with the standards of the International Electrotechnical Commission (IEC) standards 825 and 601‐2‐22.

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