Arizona Administrative Code › Title 9 - HEALTH SERVICES › Chapter 7 - DEPARTMENT OF HEALTH SERVICES - RADIATION CONTROL › Article 14 - REGISTRATION OF NONIONIZING RADIATION SOURCES AND STANDARDS FOR PROTECTION AGAINST NONIONIZING RADIATION › Section R9-7-1413 - Tanning Equipment Standards

Current through Register Vol. 30, No. 28, July 12, 2024
A. A registrant operating a tanning facility
				shall use sunlamp products that are certified by the manufacturer to comply
				with 21 CFR
				1040.20, April 1, 2004, which is incorporated
				by reference, published by the Office of Federal Register National Archives and
				Records Administration, Washington, D.C. 20408, and on file with the
				Department. This incorporation by reference contains no future editions or
				amendments. For sun-lamp products in use before the effective date of this
				Article, the Department shall determine compliance based on the standard in
				effect at the time of manufacture, as shown on the equipment identification
				label.
B. A registrant shall
				replace burned-out or defective lamps or filters, before any use of a tanning
				device.
C. A registrant shall
				replace a burned-out or defective lamp or filter with a lamp or filter intended
				for use in that equipment, as specified on the sunlamp product label, or that
				is equivalent to a lamp or filter specified on the sunlamp product label under
				the FDA regulations and polices applicable to the sunlamp product at the time
				of manufacture. If an equivalent lamp or filter is used instead of the Original
				Equipment Manufacturer (OEM) lamp or filter specified on the product label, the
				registrant shall maintain a copy of the equivalency certification, provided by
				the lamp supplier, on file for review by Department inspectors.
D. A registrant shall ensure that each
				sunlamp product has a timer and control system that complies with
				21 CFR
				1040.20(c), April 1, 2004,
				which is incorporated by reference, published by the Office of Federal Register
				National Archives and Records Administration, Washington, D.C. 20408, and on
				file with the Department. This incorporation by reference contains no future
				editions or amendments. In addition the registrant shall ensure that:
1. The timer interval does not exceed the
				manufacturer's maximum, recommended exposure time;
2. The timer is functional and accurate to
				within +/- 10% of the maximum timer interval of the product;
3. The timer does not automatically reset and
				cause radiation emission to resume for a period greater than the unused portion
				of the timer cycle;
4. The timer is
				tested annually for accuracy;
5.
				For a new facility (including existing facilities with change of ownership) a
				remote timer control system is installed before operation of sunlamp products.
				For an existing facility that has sunlamp products not equipped with a remote
				timer control system, a remote timer control system (outside of the sunlamp
				product room) is installed no later than 6 months after the effective date of
				this Section; and
6. Each sunlamp
				product is equipped with an emergency shutoff mechanism that allows manual
				termination of the UV exposure by the user.