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 R9-7-1402 - Definitions
General definitions: "Controlled area" means any area to which human access is restricted for the purpose of protection from nonionizing radiation.
"Direct supervision" means that a licensed practitioner supervises the use of a source for medical purposes while the practitioner is present inside the facility where the source is being used.
"Indirect supervision" means: for lasers or IPL devices used for hair removal procedures, there is at a minimum, responsible supervision and control by a licensed practitioner who is easily accessible by telecommunication.
"Licensed practitioner" (See R9-7-102)
"Medical director" means a licensed practitioner, as defined in R9-7-102, who delegates a laser, IPL, or other light-emitting medical device procedure to a non-physician and is qualified to perform the procedure within the scope of practice of the license.
"Nonexempt nonionizing source" means any system or device that contains a nonionizing source listed in R9-7-1302(F).
"Operator" means a person who is trained in accordance with this Article and knowledgeable about the control and function of a nonionizing device regulated under this Article.
"Other cosmetic procedure" means a method of using medical lasers or intense pulse light (IPL) devices approved by the Federal Food and Drug Administration (FDA), for the cosmetic purpose of spider vein removal, skin rejuvenation, non-ablative skin resurfacing, skin resurfacing, port wine stain removal, epidermal pigmented skin lesion removal, or tattoo removal; and does not include hair removal.
Laser definitions:
"Accessible emission limit (AEL)" means the maximum accessible emission level of laser or collateral radiation permitted within a particular class.
"Accessible radiation" means laser or collateral radiation to which human access is possible.
"Angular subtense" means the apparent visual angle, a, as calculated from the source size and distance from the eye.
"Aperture" means an opening in the protective housing or other enclosure of a laser product, through which laser or collateral radiation is emitted allowing human access to the radiation.
"Aperture stop" means an opening serving to limit the size and to define the shape of the area over which radiation is mea-sured.
"Certified laser product" means that the product is certified by a manufacturer in accordance with the requirements of 21 CFR 1040.10, 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 con-tains no future editions or amendments.
"CDRH" means the Center for Devices and Radiological Health.
"Classes of lasers" means the following categories of lasers, defined in 21 CFR 1040.10, April 1, 2004, which is incorpo-rated by reference, published by the Office of Federal Register National Archives and Records Administration, Washington, D.C. 20408, and on file with the Department: Class 1, Class 2, Class 2a, Class 3, Class 3a, Class 3b, and Class 4. This incorporation by reference contains no future editions or amendments.
"Collateral radiation" means any electronic product radiation, except laser radiation, emitted by a laser product as a result of operation of the laser or any component of the laser product that is physically necessary for operation of the laser The accessible emission limits for collateral radiation are specified in 21 CFR 1040.10, 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.
"Continuous wave" (cw) means the output of a laser that is operated in a continuous rather than a pulsed mode. For purposes of this Article, a laser operating with a continuous out-put for a period >= 0.25 seconds is regarded as a cw laser
"Cosmetic procedure protocol" means a delegated written authorization to select specific laser or IPL settings, initiate a laser or IPL procedure, and conduct necessary follow-up procedures.
"Demonstration laser" means any laser manufactured, designed, intended, or used for purposes of demonstration, entertainment, advertising display, or artistic composition.
"Embedded laser" means an enclosed laser with an assigned class number higher than the inherent capability of the laser system in which it is incorporated, where the system's lower classification is due to engineering features that limit accessible emission.
"Enclosed laser" means a laser that is contained within its own protective housing or the protective housing of a laser or laser system in which it is incorporated. Opening or removing the protective housing provides more access to laser radiation above the applicable MPE than is possible with the protective housing in place. (An embedded laser is a type of enclosed laser.)
"Federal performance standards for light-emitting products" means the regulations in 21CFR 1040.10, 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.
"Human access" means the capacity to intercept laser or collateral radiation by any part of the human body.
"Incident" means an event or occurrence that results in actual or suspected accidental exposure to laser radiation that has caused or is likely to cause biological damage.
"Integrated radiance" means radiant energy per unit area of a radiating surface per unit solid angle of emission, expressed in joules per square centimeter per steradian.
"Irradiance" means the time-averaged radiant power incident on an element of a surface divided by the area of that element, expressed in watts per square centimeter.
"Laser" See the definition in Article 1.
"Laser energy source" means any device intended for use in conjunction with a laser to supply energy for the operation of the laser. General energy sources, such as electrical supply mains or batteries, are not considered laser energy sources by the Department.
"Laser facility" means a facility where one or more lasers are used. For purposes of this definition a Class 1 facility is a facility that has one or more Class 1 lasers; a Class 2 facility is a facility that has one or more Class 2 or 2a lasers; a Class 3 facility is a facility that has one or more Class 3, 3a, or 3b lasers, and a Class 4 facility is a facility that has one or more Class 4 lasers. Facilities that contain more than one laser class are classified according to the highest laser class in use at the facility.
"Laser product" means any manufactured product or assemblage of components that constitutes, incorporates, or is intended to incorporate a laser or laser system. A laser or laser system that is intended for use as a component of an electronic product is itself considered a laser product.
"Laser protective device" means any device used to reduce or prevent exposure of personnel to laser radiation. This includes: protective eyewear, garments, engineering controls, and operational controls.
"Laser radiation" means all electromagnetic radiation emitted by a laser product, within the spectral range specified in the definition of "laser," which is produced as a result of controlled stimulated emission or that is detectable with radiation so produced through the appropriate aperture stop and within the appropriate solid angle of acceptance.
"Laser Safety Officer (LSO)" - means any individual, qualified by training and experience in the evaluation and control of laser hazards, who is designated by the registrant and has the authority and responsibility to establish and administer the laser radiation protection program for a particular class of facility.
"Laser system" means a laser in combination with an appropriate laser energy source with or without additional incorporated components.
"Limited exposure duration (Tmax)" means an exposure duration that is specifically limited by design or intended use.
"Maintenance" means performance of those adjustments or procedures specified in operator information provided by the manufacturer with the laser product, which are to be performed by the operator to ensure the intended performance of the product. The term does not include operation or service as defined in this Section.
"Maximum permissible exposure (MPE)" means the level of laser radiation to which a person may be exposed without hazardous effect or adverse biological changes in the eye or skin. MPE values for eye and skin exposure are listed in ANSI Z136.1-2000, American National Standard for Safe Use of Lasers, 2000 edition, which is incorporated by reference, published by the Laser Institute of America, 13501 Ingenuity Drive, Suite 128, Orlando, FL 32826, and on file with the Department. This incorporation by reference contains no future editions or amendments.
"Medical laser product" means any laser product that is a medical device defined in 21 U.S.C. 321(h) and is manufactured, designed, intended, or promoted for in vivo laser irradiation of any part of the human body for the purpose of: diagnosis, surgery, therapy, or relative positioning of the human body.
"Operation" means the performance of the laser product over the full range of its function. It does not include maintenance or service as defined in this Section.
"Protective housing" means those portions of a laser product that are designed to prevent human access to laser or collateral radiation in excess of the prescribed accessible emission limits under conditions specified in this Article.
"Pulse duration" means the time increment measured between the half-peak-power points at the leading and trailing edges of a pulse.
"Pulse interval" means the period of time between identical points on two successive pulses.
"Radiance" means the time-averaged radiant power per unit area of a radiating surface per unit solid angle of emission, expressed in watts per square centimeter per steradian.
"Radiant energy" means energy emitted, transferred, or received in the form of radiation, expressed in joules.
"Radiant exposure" means the radiant energy incident on an element of a surface divided by the area of that element, expressed in joules per square centimeter.
"Radiant power" means the time-averaged power emitted, transferred, or received in the form of radiation, expressed in watts.
"Rule of nines" means a method for estimating the extent of burns, expressed as a percentage of total body surface. In this method the body is divided into sections of 9 percent or multiples of 9 percent each: head and neck, 9 percent; anterior trunk, 18 percent; posterior trunk, 18 percent; upper limbs, 18 percent; lower limbs, 36 percent; and genitalia and perineum, 1 percent.
"Safety interlock" means a device associated with the protective housing of a laser product to prevent human access to excessive radiation.
"Sampling interval" means the time interval during which the level of accessible laser or collateral radiation is sampled by a measurement process. The magnitude of the sampling interval in units of seconds is represented by the symbol "t".
"Secured enclosure" means an area to which casual access is impeded by various means, such as a door secured by a lock, latch, or screws.
"Service" means the performance of those procedures or adjustments described in the manufacturer's service instructions that may affect any aspect of the product's performance. The term does not include maintenance or operation as defined in this Section.
"Tmax" See limited exposure duration.
"Uncertified laser product" means any laser that has not been certified in accordance with the requirements of 21CFR 1040.10, 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 con-tains no future editions or amendments.
Radio frequency and microwave radiation definitions:
"Accessible emission level" means the level of radio frequency radiation emitted from any source, expressed in terms of power density in milliwatts per square centimeter or electric and magnetic field strength, as applicable, and to which human access is normally possible.
"Far field region" means the area in which locally uniform distribution of electric and magnetic field strengths exists in planes transverse to the direction of propagation The far field region is presumed to exist at distances greater than 2D2/[LAMBDA] from the antenna, where [LAMBDA] is the wavelength and D is the largest antenna aperture dimension.
"Maximum permissible exposure MPE" means the rms and peak electric and magnetic field strengths, their squares, or the plane-wave equivalent power densities associated with these fields and the induced and contact currents to which a person may be exposed without harmful effect and with an acceptable safety factor
"Near field region" means the area near an antenna in which the electric and magnetic field components vary considerably in strength from point to point. For most antennas the outer boundary of the region is presumed to exist at a distance [LAMBDA]/2k from the antenna surface, where [LAMBDA] is the wave length.
"Radio frequency controlled area" means any location to which access is controlled for the purpose of protection from radio frequency radiation.
"Radio frequency source" means a source or system that produces electromagnetic radiation in the radio frequency spec-trum.
"Radio frequency radiation" means electromagnetic radiation (including microwave radiation) with frequencies in the range of 0.3 megahertz to 100 gigahertz.
"Root-mean-square (rms)" means the effective value, or the value associated with joule heating, of a periodic electromagnetic wave. The rms is obtained by taking the square root of the mean of the squared value of a function.
"Safety device" means any mechanism incorporated into a radio frequency source that is designed to prevent human access to excessive levels of radio frequency radiation.
Ultraviolet, high intensity light, and intense pulsed light source definitions:
"EPA" means the United States Environmental Protection Agency.
"FDA" means the United States Food and Drug Administration.
"High intensity mercury vapor discharge (HID) lamp" means any lamp, including a mercury vapor or metal halide lamp that incorporates a high-pressure arc discharge tube with a fill that consists primarily of mercury and is contained within an outer envelope, except the tungsten filament self-ballasted mercury vapor lamp.
"Intense pulsed light device (IPL)" means, for purposes of R9-7-1438, any lamp-based device that produces an incoherent, filtered, and intense light.
"Maximum exposure time" means the greatest continuous exposure time interval recommended by the manufacturer of a product.
"Protective sunlamp eyewear" means any device designed to be worn by a user of a product to reduce exposure of the eyes to radiation emitted by the product.
"Sanitize" means treat the surfaces of equipment and devices using an EPA or FDA registered product that provides a specified concentration of chemicals, for a specified period of time, to reduce the bacterial count, including pathogens, to a safe level.
"Self-extinguishing lamp" means any HID lamp that ceases operation in conformance with the requirements of the performance standard in 21 CFR 1040.30(d), 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.
"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.
"Timer" means any device incorporated into a product that terminates radiation emission after a preset time interval.
"Ultraviolet lamp" means any light source that produces ultraviolet radiation and that is intended for use in any sunlamp product.
"Ultraviolet radiation" means electromagnetic radiation in the wavelength interval from 200 to 400 nanometers in air.
"User" means any member of the public who is provided access to a tanning device in exchange for a fee or other compensation, or any individual who, in exchange for a fee or other compensation, is afforded use of a tanning device as a condition or benefit of membership or access.
