The Federal performance standard for laser products (21 CFR 1040.10 and 1040.11) will be applicable to products manufactured on or after August 2, 1976. The standard provides for the classification of laser products into one of four progressively more hazardous classes: Class I, II, III or IV. Accessible emission limits for each class are a function of the wavelength and emission duration and are given in Tables I-A, I-B and I-C of 21 CFR 1040.lO(d). To assist manufacturers and others who may need to calculate or determine accessible emission limits, the Bureau of Radiological Health has computed the values of these limits at selected wavelengths and sampling intervals using the formulas in the tables. The computed results are presented in tabular form.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
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