FDA Amendment 21 CFR Part 1040, Effective May 1980

(c) Performance requirements.

(1) Irradiance ratio limits. For each sunlamp product and ultraviolet lamp, the ratio of the irradiance within the
wavelength range of greater than 180 nm through 260 nm to the irradiance within the wavelength range of greater than 260 nm through 320 nm shall not exceed 0.003 at any distance and direction from the product or lamp.

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

(ii) The maximum timer interval shall not exceed the recommended maximum exposure time as indicated on the label required by paragraph (d)(1)(vii) of this section, or 10 minutes, whichever is less. This requirement does not preclude a product from allowing a user to reset the timer before the end of the preset time interval. No timer interval shall have an error greater than 10 percent of the maximum timer interval of the product.

(3) Control for termination of radiation emission. Each sunlamp product shall incorporate a control on the product to enable the user manually to terminate radiation emission from the product at any time with-out disconnecting the electrical plug or removing the ultraviolet lamp.

(4) Resumption of radiation emission. When radiation emission from a sunlamp product has been terminated for any reason, including termination by a timer, resumption of such emission shall not be possible until the product is reactivated manually by the user.

(5) 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 (f)(1)(iii) of this section recommend to be exposed simultaneously to radiation from such product.

(ii) The spectral transmittance of the protective eyewear required by paragraph (c)(5)(i) of this section shall not exceed a value of 0.001 over the wavelength range of greater than 180 nm through 320 nm and a value of 0.01 over the wavelength range of greater than 320 nm through 360 nm, and shall be sufficient over the wavelengths greater than 360 nm to enable the user to see clearly enough to read the labels and reset the timer.

(6) Compatibility of lamps. An ultraviolet lamp shall not be capable of insertion and operation in any of the following lampholders:

(i) "Single-contact medium screw," described in American National Standard C81.10-1976.

(ii) "Double-contact medium screw," described in American National Standard C81.10-1976.