FDA Amendment 21 CFR Part 1040, Effective May 1980

(e) Test for determination of compliance. Tests on which certification pursuant to 1010.2 of this chapter is based shall account for all measurement errors and statistical uncertainties in the measurement process and, wherever applicable, for changes in radiation emission or degradation in radiation safety with age of the product. The measurements shall be made under those operational conditions and procedures that maximize the emission of radiation and with the measuring instrument so positioned and so oriented as to result in the maximum detection of the radiation by the instrument. However, the measuring instrument shall be no closer to the product than the minimum use distance. Such measurements shall be made at a test voltage up to 130 rootmean-square volts if the sunlamp product or ultraviolet lamp is designed to operate from nominal 100 to 120 rootmean-square volt power sources. If the sunlamp product or ultraviolet lamp is designed to operate from a power source having some voltage other than from nominal 100 to 120 rootmean-square volts, the measurement shall be made at a voltage up to 110 percent of the maximum nominal rootmean-square voltage specified by the manufacturer for the power source.

(f) Instructions to be provided to users. Each manufacturer of a sunlamp product and ultraviolet lamp shall provide or cause to be provided to purchasers and, upon request, to others at a cost not to exceed the cost of publication and distribution, instructions for safe use, including the following technical and safety information as applicable:

(1) Sunlamp products. The users’ instructions for a sunlamp product shall contain:

(i) A reproduction (color optional) of the label required in paragraph (d)(l) of this section prominently displayed at the beginning of the instructions.

(ii) A prominently displayed statement containing the words "DANGER—Ultraviolet radiation. Follow instructions. As with natural sunlight, overexposure can cause eye injury and sunburn; repeated exposure may cause premature aging of the skin and skin cancer. Medications or cosmetics applied to the skin may increase your sensitivity to ultraviolet light. Consult physician before using lamp if taking any medication or if you believe yourself especially sensitive to sunlight."

(iii) A statement of the maximum number of people who may be exposed to the product at the same time and a warning that only that number of protective eyewear has been provided.

(iv) Instructions for obtaining repairs and recommended replacement components and accessories which are compatible with the product, including compatible protective eyewear, ultraviolet lamps, timers, reflectors and filters, and which will, if installed or used as instructed, result in continued compliance with the standard.

(2) Ultraviolet lamps. The user’s instructions for an ultraviolet lamp not accompanying a sunlamp product shall contain:

(i) A reproduction (color optional) of the label required in paragraph (d)(2) of this section, prominently displayed at the beginning of the instructions.

(ii) A statement prominently displayed containing the words "DANGER—Ultraviolet radiation. Follow instructions. As with natural sunlight, overexposure can cause eye injury and sunburn; repeated exposure may cause premature aging of the skin and skin cancer. Medications or cosmetics applied to the skin may increase your sensitivity to ultraviolet light. Consult physician before using lamp if taking any medication or if you believe yourself especially sensitive to sunlight."

         (iii) A warning that the instructions accompanying the sunlamp product should always be followed to avoid or to minimize potential injury. (Sec. 358, 82 Stat. 1177-1179 (42 U.S.C. 263f).