FDA Amendment 21 CFR Part 1040, Effective May 1980

§1040.20 Sunlamp products and ultraviolet lamps intended for use in sunlamp products.

(a) Applicability. The provisions of this section are applicable as specified herein to the following products manufactured on or after May 7, 1980.

(1) Any sunlamp product.

(2) Any ultraviolet lamp intended for use in any sunlamp product.

(b) Definitions. As used in this section the following definitions apply:

(1) "Intended" means the same as "intended uses" in 801.q of this chapter.

(2) "Irradiance" means the radiant power incident on a surface divided by the area of the surface, as the area becomes vanishingly small, expressed in units of watts per square centimeter (W/cm2). 

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

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

(5) "Minimum use distance" means the least distance from the ultraviolet lamp at which the user should be exposed to radiation from the product, as recommended by the manufacturer.

(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 180 nm and 320 nm, to induce skin tanning.

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

(11) "Ultraviolet lamp" means any lamp which produces
radiation in the wavelength interval of 180 nm to 320 nm in air and is intended for use in any sunlamp product.

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