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.
(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.
(d) Label requirements. In addition to the labeling requirements in Part 801 of this chapter and the certification and identification requirements of 1010.2 and 1010.3 of this chapter, each sunlamp product and ultraviolet lamp shall be subject to the labeling requirements prescribed in this paragraph and paragraph (f) of this section. All labels prescribed in this paragraph shall be permanently affixed or inscribed on an exterior surface of the product so as to be legible and readily accessible to view when the product is fully assembled for use.
(1) Each sunlamp product shall have a label which contains:
(i) 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.”
(ii) Designation of the ultraviolet lamp type which is to be used in the product.
(iii) A recommended minimum use distance specified both in meters and in feet (or in inches).
(iv) Directions for measuring the minimum use distance.
(v) A warning that exposure at distances less than the minimum use distance is not recommended.
(vi) A warning to use protective eyewear whenever the product is energized.
(vii) A recommended maximum exposure time in minutes.
(viii) A recommendation for duration, frequency and spacing of sequential exposures.
(ix) A statement of the time it may take before the expected results appear.
(2) Each ultraviolet lamp shall have a label which contains:
(i) The words “Sunlamp-DANGER—Ultraviolet radiation.
Follow instructions.”
(ii) The model identification.
(iii) The words “Use ONLY in fixture equipped with a timer.”
(3) In lieu of permanently affixing or inscribing tags or labels on the ultraviolet lamp as required by 1010.2(b) and 1010.3(a) of this chapter, the manufacturer of the ultraviolet lamp may permanently affix or inscribe such required tags or labels on the lamp packaging uniquely associated with the lamp, if the name of the manufacturer and month and year of manufacture are permanently affixed or inscribed on the exterior surface of the ultraviolet lamp so as to be legible and readily accessible to view. When the tags or labels required by 1010.2(b) and 1010.3(a) of this chapter are affixed or inscribed on the ultraviolet lamp packaging, the name of the manufacturer and month and year of manufacture required to be permanently affixed or inscribed on the exterior surface of the lamp may be expressed in code or symbols, if the manufacturer has previously supplied the Director, Bureau of Radiological Health, with the key to such code or symbols and the location of the coded information or symbols on the ultraviolet lamp.
(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).
