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

Current through Register Vol. 30, No. 28, July 12, 2024
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]/2
k
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.