§ 232.40. Requirements for license.  


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  • No sunlamp product or ultraviolet lamp intended for use in any sunlamp product shall be installed in any tanning facility, the use of which is offered to the public for a fee or any other consideration, unless such products or facilities have been found to be in compliance with the following standards.

    (a)

    The tanning unit and all the component parts thereof manufactured on or after May 7, 1980 shall meet the provisions of 21 CFR, Part 1040 and all subsequent amendments.

    (b)

    Other performance standards or units manufactured before May 7, 1980.

    (1)

    For each sunlamp product and ultraviolet lamp, the ratio of the irradiance within the wavelength range of greater than two hundred (200) nanometers through two hundred sixty (260) nanometers to the irradiance within the wavelength range of greater than two hundred sixty (260) nanometers through four hundred (400) nanometers shall not exceed 0.003 at any distance or direction from the product or lamp.

    (2)

    Each sunlamp product shall incorporate a timing device with multiple timer settings adequate for the manufacturer's recommended exposure intervals to produce the expected results.

    (3)

    The timing device shall not provide a timing interval in excess of the product's recommended maximum exposure time. This requirement does not preclude the ability of the user to reset the time. 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. The timer interval may not have an error greater than ten (10) percent of the maximum timer interval of the product.

    (4)

    Each sunlamp product shall incorporate a control on the product to enable the user to manually terminate radiation without pulling the electrical plug or coming in contact with the ultraviolet lamp.

    (5)

    Each sunlamp product shall be accompanied by the number of sets of protective eyewear that is equal to the maximum number of persons intended to be exposed simultaneously to product radiation. The eyewear shall be provided by the manufacturer and shall meet or exceed product recommendations.

    (6)

    Each ultraviolet lamp contained within the sunlamp product shall be shielded so as to not come into contact with the user. A screen or transparent cover shall be used for this purpose.

    (7)

    Each sunlamp product in which the person is in a standing position shall provide a handrail for the user to hold onto during operation of the tanning facility. Each tanning facility shall have, clearly marked, the appropriate position the user is to assume prior to operation.

    (8)

    Each sunlamp product shall prominently display the following label:

    "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 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."

    (9)

    Each tanning facility shall be so equipped to dissipate heat that the interior temperature does not exceed one hundred (100) degrees Fahrenheit. (87-Or-212, § 1, 11-6-87)