FDA Amendment 21 CFR Part 1040 Effective Sept. 1986

(2) Timer system.

(i) Each sunlamp product shall incorporate a timer system with multiple timer settings adequate for the recommended exposure time intervals for different exposure positions and expected results of the products as specified in the label required by paragraph (d) of this section.

(ii) The maximum timer interval(s) may not exceed the manufacturer’s recommended maximum exposure time(s) that is indicated on the label required by paragraph (d)(l)(iv) of this section.

(iii) No timer interval may have an error greater than 10 percent of the maximum timer interval of the product.

(iv) The timer may not automatically reset and cause radiation emission to resume for a period greater than the unused portion of the timer cycle, when emission from the sunlamp product has been terminated.

(v) The timer requirements do not preclude a product from allowing a user to reset the timer before the end of the preset time interval.

(3) Control for termination of radiation emission. Each sunlamp product shall incorporate a control on the product to enable the person being exposed to terminate manually/radiation emission from the product at any time without disconnecting the electrical plug or removing the ultraviolet lamp.

(4) Protective eyewear.

(i) Each sunlamp product shall be accompanied by the number of sets of protective eyewear that is equal to the maximum number of persons that the instructions provided under paragraph (e)(1)(ii) of this section recommend to be exposed simultaneously to radiation from such product.

(ii) The spectral transmittance to the eye of the protective eyewear required by paragraph (c)(4)(i) of this section shall not exceed a value of 0.001 over the wavelength range of greater than 200 nm 320 nm and a value of 0.01 over the wavelength range of greater than 320 nm through 400 nm, and shall be sufficient over the wavelength greater than 400 nm to enable the user to see clearly enough to reset the timer.

(5) Compatibility of lamps. An ultraviolet lamp may not be capable of insertion and operation in either the "single-contact medium screw" or the "double-contact medium screw" lampholders described in American National Standard C81.10-1976, Specifications for Electric Lamp Bases and Holders—Screw-Shell Types, which is incorporated by reference. Copies are available from the American National Standards Institute, 1430 Broadway, New York, NY 10018, or available for inspection at the Office of the Federal Register, 1100 L St. NW., Washington, D.C. 20408.