FDA Amendment 21 CFR Part 1040 Effective Sept. 1986

(3) "Irradiance" means the radiant power incident on a surface at a specified location and orientation relative to the radiating surface divided by the area of the surface, as the area becomes vanishingly small, expressed in units of watts per square centimeter (W/cm2).

(4) "Maximum exposure time" means the greatest continuous exposure time interval recommended by the manufacturer of the product.

(5) "Maximum timer interval" means the greatest time interval setting on the timer of a product.

(6) "Protective eyewear" means any device designed to be worn by users of a product to reduce exposure of the eyes to radiation emitted by the product.

(7) "Spectral irradiance" means the irradiance resulting from radiation within a wavelength range divided by the wavelength range as the range becomes vanishingly small, expressed in units of watts per square centimeter per nanometer (W/(cm/nm).

(8) "Spectral transmittance" means the spectral irradiance transmitted through protective eyewear divided by the spectral irradiance incident on the protective eyewear.

(9) "Sunlamp product" means any electronic product designed to incorporate one or more ultraviolet lamps and intended for irradiation of any part of the living human body, by ultraviolet radiation with wavelengths in air between 200 nm and 400 nm, to induce skin tanning.

(10) "Timer" means any device incorporated into a product that terminates radiation emission after a pre-set time interval.

(11) "Ultraviolet lamp" means any lamp that produces ultraviolet radiation in the wavelength interval of 200 nm to 400 nm in air and that is intended for use in any sunlamp product.

(c) Performance requirements

(1) Irradiance ratio limits. For each sunlamp product and ultraviolet lamp, the ratio of the irradiance within the wave-length range of greater than 200 nm through 260 nm to the irradiance within the wavelength range of greater than 260 nm through 320 nm may not exceed 0.003 at any distance and direction from the product or lamp.