[Code of Federal Regulations]
[Title 21, Volume 8, Parts 800 to 1299]
[Revised as of April 1, 1999]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1040.20]
[Page 615-618]
TITLE 21--FOOD AND DRUGS
SERVICES--(Continued)
PART 1040--PERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTS--Table of Contents
Sec. 1040.20 Sunlamp products and ultraviolet lamps intended for use in sunlamp products.
(a) Applicability. (1) The provisions of this section, as amended,
are applicable as specified herein to the following products
manufactured on or after September 8, 1986.
(i) Any sunlamp product.
(ii) Any ultraviolet lamp intended for use in any sunlamp product.
(2) Sunlamp products and ultraviolet lamps manufactured on or after
May 7, 1980, but before September 8, 1986, are subject to the provisions
of this section as published in the Federal Register of November 9, 1979
(44 FR 65357).
(b) Definitions. As used in this section the following definitions
apply:
(1) Exposure position means any position, distance, orientation, or
location relative to the radiating surfaces of the sunlamp product at
which the user is intended to be exposed to ultraviolet radiation from
the product, as recommended by the manufacturer.
(2) Intended means the same as ``intended uses'' in Sec. 801.4.
(3) Irradiance means the radiant power incident on a surface at a
specified location and orientation relative to the radiating surface
divided by the area of the surface, as the area becomes vanishingly
small, expressed in units of watts per square centimeter (W/
cm<SUP>2</SUP>).
(4) Maximum exposure time means the greatest continuous exposure
time interval recommended by the manufacturer of the product.
(5) Maximum timer interval means the greatest time interval setting
on the timer of a product.
(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<SUP>2</SUP>/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 200 and 400 nanometers, 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 that produces ultraviolet
radiation in the wavelength interval of 200 to 400 nanometers in air and
that 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 200 nanometers through 260
nanometers to the irradiance within the wavelength range of greater than
260 nanometers through 320 nanometers may not exceed 0.003 at any
distance and direction from the product or lamp.
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(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)(1)(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 nanometers 320
nanometers and an value of 0.01 over the wavelength range of greater
than 320 nanometers through 400 nanometers, and shall be sufficient over
the wavelength greater than 400 nanometers 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, 800 North Capitol Street, NW., suite
700, Washington, DC 20408.
(d) Label requirements. In addition to the labeling requirements in
part 801 and the certification and identification requirements of
Secs. 1010.2 and 1010.3, each sunlamp product and ultraviolet lamp shall
be subject to the labeling requirements prescribed in this paragraph and
paragraph (e) of this section.
(1) Labels for sunlamp products. Each sunlamp product shall have a
label(s) which contains:
(i) A warning statement with the words ``DANGER--Ultraviolet
radiation. Follow instructions. Avoid overexposure. As with natural
sunlight, overexposure can cause eye and skin injury and allergic
reactions. Repeated exposure may cause premature aging of the skin and
skin cancer. WEAR PROTECTIVE EYEWEAR; FAILURE TO MAY RESULT IN SEVERE
BURNS OR LONG-TERM INJURY TO THE EYES. Medications or cosmetics may
increase your sensitivity to the ultraviolet radiation. Consult
physician before using sunlamp if you are using medications or have a
history of skin problems or believe yourself especially sensitive to
sunlight. If you do not tan in the sun, you are unlikely to tan from the
use of this product.''
(ii) Recommended exposure position(s). Any exposure position may be
expressed either in terms of a distance specified both in meters and in
feet (or in inches) or through the use of markings or other means to
indicate clearly the recommended exposure position.
(iii) Directions for achieving the recommended exposure position(s)
and a warning that the use of other positions may result in
overexposure.
(iv) A recommended exposure schedule including duration and spacing
of
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sequential exposures and maximum exposure time(s) in minutes.
(v) A statement of the time it may take before the expected results
appear.
(vi) Designation of the ultraviolet lamp type to be used in the
product.
(2) Labels for ultraviolet lamps. 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) Label specifications. (i) Any label prescribed in this paragraph
for sunlamp products shall be permanently affixed or inscribed on an
exterior surface of the product when fully assembled for use so as to be
legible and readily accessible to view by the person being exposed
immediately before the use of the product.
(ii) Any label prescribed in this paragraph for ultraviolet lamps
shall be permanently affixed or inscribed on the product so as to be
legible and readily accessible to view.
(iii) If the size, configuration, design, or function of the sunlamp
product or ultraviolet lamp would preclude compliance with the
requirements for any required label or would render the required wording
of such label inappropriate or ineffective, or would render the required
label unnecessary, the Director, Office of Compliance (HFZ-300), Center
for Devices and Radiological Health, on the Center's own initiative or
upon written application by the manufacturer, may approve alternate
means of providing such label(s), alernate wording for such label(s), or
deletion, as applicable.
(iv) In lieu of permanently affixing or inscribing tags or labels on
the ultraviolet lamp as required by Secs. 1010.2(b) and 1010.3(a), the
manfacturer 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. The name of the manufacturer and month and year of manufacture
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, Office of Compliance (HFZ-300), Center for
Devices and Radiological Health, with the key to such code or symbols
and the location of the coded information or symbols on the ultraviolet
lamp. The label or tag affixed or inscribed on the lamp packaging may
provide either the month and year of manufacture without abbreviation,
or information to allow the date to be readily decoded.
(v) A label may contain statements or illustrations in addition to
those required by this paragraph if the additional statements are not
false or misleading in any particular; e.g., if they do not diminish the
impact of the required statements; and are not prohibited by this
chapter.
(e) 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, adequate instructions
for use to avoid or to minimize potential injury to the user, including
the following technical and safety information as applicable:
(1) Sunlamp products. The users' instructions for a sunlamp product
shall contain:
(i) A reproduction of the label(s) required in paragraph (d)(1) of
this section prominently displayed at the beginning of the instructions.
(ii) 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.
(iii) Instructions for the proper operation of the product including
the function, use, and setting of the timer and other controls, and the
use of protective eyewear.
(iv) Instructions for determining the correct exposure time and
schedule for persons according to skin type.
(v) Instructions for obtaining repairs and recommended replacement
components and accessories which are compatible with the product,
including
[[Page 618]]
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 users' instructions for an ultraviolet
lamp not accompanying a sunlamp product shall contain:
(i) A reproduction of the label(s) required in paragraphs (d)(1)(i)
and (2) of this section, prominently displayed at the beginning of the
instructions.
(ii) A warning that the instructions accompanying the sunlamp
product should always be followed to avoid or to minimize potential
injury.
(iii) A clear identification by brand and model designation of all
lamp models for which replacement lamps are promoted, if applicable.
(f) Test for determination of compliance. Tests on which
certification pursuant to Sec. 1010.2 is based shall account for all
errors and statistical uncertainties in the process and, wherever
applicable, for changes in radiation emission or degradation in
radiation safety with age of the product. Measurements for certification
purposes shall be made under those operational conditions, lamp voltage,
current, and position as recommended by the manufacturer. For these
measurements, the measuring instrument shall be positioned at the
recommended exposure position and so oriented as to result in the
maximum detection of the radiation by the instrument.
(The information collection requirements contained in paragraphs (d) and
(e) were approved by the Office of Management and Budget under control
number 0910-0195)
[50 FR 36550, Sept. 6, 1985]