Arizona Administrative Code › Title 9 - HEALTH SERVICES › Chapter 7 - DEPARTMENT OF HEALTH SERVICES - RADIATION CONTROL › Article 7 - MEDICAL USES OF RADIOACTIVE MATERIAL › Section R9-7-702 - Definitions.

Current through Register Vol. 30, No. 28, July 12, 2024
"Authorized medical physicist" means an individual who meets
				  the requirements in
				  R9-7-711.
				  For purposes of ensuring that personnel are adequately trained, an authorized
				  medical physicist is a "qualified expert" as defined in Article 1.
"Authorized nuclear pharmacist" means a pharmacist who meets
				  the requirements in
				  R9-7-712.
"Authorized user" means a physician, dentist, or podiatrist
				  who meets the requirements in
				  R9-7-719,
				  R9-7-721,
				  R9-7-723,
				  R9-7-727,
				  R9-7-728,
				  or
				  R9-7-744.
"Brachytherapy" means a method of radiation therapy in which
				  a sealed source or group of sealed sources is utilized to deliver beta or gamma
				  radiation at a distance of up to a few centimeters, by surface, intracavitary,
				  intraluminal, or interstitial application.
"CT" means computerized tomography.
"High dose rate after loading brachytherapy" means the
				  treating of human disease using the radiation from a radioactive sealed source
				  containing more than 1 curie of radioactive material. The radioactive material
				  is introduced into a patient's body using a device that allows the therapist to
				  indirectly handle the radiation source during the treatment. For purposes of
				  the requirements in this Article "pulse dose rate after loading brachytherapy"
				  is included in this definition.
"Human research subject" means an individual who is or
				  becomes a participant in research overseen by an IRB, either as a recipient of
				  the test article or as a control. A subject may be either a healthy human, in
				  research overseen by the RDRC, or a patient. "Institutional review board" (IRB)
				  is defined in
				  R9-7-704(B).
"Manual brachytherapy" means a type of brachytherapy in which
				  the brachytherapy sources (e.g., seeds, ribbons) are manually placed topically
				  on or inserted either into the body cavities that are in close proximity to a
				  treatment site or directly into the tissue volume.
"Medical event" means an event that meets the criteria in
				  R9-7-745.
"Medical institution" means an organization in which several
				  medical disciplines are practiced.
"Medical use" means the intentional internal or external
				  administration of radioactive material, or the radiation from it, to an
				  individual under the supervision of an authorized user.
"Nuclear cardiology" means the diagnosis of cardiac disease
				  using radiopharmaceuticals.
"PET" means positron emission tomography.
"Physically present" means that a supervising medical
				  professional is in proximity to the patient during a radiation therapy
				  procedure so that immediate emergency orders can be communicated to ancillary
				  staff, should the occasion arise.
"Prescribed dosage" means the specified activity or range of
				  activity of unsealed radioactive material as documented:
In a written directive; or
In accordance with the directions of the authorized user for
				  procedures performed in accordance with the uses described in Exhibit A.
"Prescribed dose" means:
For gamma stereotactic radiosurgery, the total dose as
				  documented in the written directive;
For teletherapy, the total dose and dose per fraction as
				  documented in the written directive;
For manual brachytherapy, either the total source strength
				  and exposure time or the total dose, as documented in the written directive;
				  or
For remote brachytherapy after loaders, the total dose and
				  dose per fraction as documented in the written directive.
"Radiation Safety Officer" (RSO) for purposes of this
				  Article, and in addition to the definition in Article 1 means an individual
				  who:
Meets the requirements in
				  R9-7-710,
				  or
Is identified as a radiation safety officer on:
A specific medical use license issued by the NRC or Agreement
				  State; or
A medical use permit issued by a NRC master material
				  licensee.
"Radioactive drug" is defined in
				  21 CFR
				  310.3(c) and includes a
				  "radioactive biological product" as defined in
				  21
				  CFR 600.3, April 1, 2006, both of which are
				  incorporated by reference, published by the Office of Federal Register,
				  National Archives and Records Administration, Washington, DC 20408, and on file
				  with the Department. These incorporated materials contain no future editions or
				  amendments.
"Radioactive Drug Research Committee" (RDRC) means the
				  committee established by the licensee to review all basic research involving
				  the administration of a radioactive drug to human research subjects, taken from
				  21 CFR
				  361.1, April 1, 2006, which is incorporated
				  by reference, published by the Office of Federal Register, National Archives
				  and Records Administration, Washington, DC 20408, and on file with the
				  Department. This incorporation by reference contains no future editions or
				  amendments. Research is considered basic re-search if it is done for the
				  purpose of advancing scientific knowledge, which includes basic information
				  regarding the metabolism (including kinetics, distributions, dosimetry, and
				  localization) of a radioactive drug or regarding human physiology,
				  pathophysiology, or biochemistry. Basic research is not intended for immediate
				  therapeutic or diagnostic purposes and is not intended to determine the safety
				  and effectiveness of a radioactive drug in humans.
"Radiopharmaceutical" means any drug that exhibits
				  spontaneous disintegration of unstable nuclei with the emission of nuclear
				  particles or photons and includes any nonradioactive reagent kit or nuclide
				  generator that is intended to be used in the preparation of any such
				  sub-stance. For purposes of this Article radiopharmaceutical is equivalent to
				  radioactive drug.
"Remote after loading brachytherapy device" means a device
				  used in radiation therapy that allows the authorized user to insert, from a
				  remote location, a radiation source into an applicator that has been previously
				  inserted in an individual requiring treatment.
"Sealed Source and Device Registry" means the national
				  registry that contains all the registration certificates, generated by both NRC
				  and the Agreement States, that summarize the radiation safety information for
				  the sealed sources and devices and describe the licensing and use conditions
				  approved for the product.
"Stereotactic radiosurgery" means the use of external
				  radiation in conjunction with a stereotactic guidance device to very precisely
				  deliver a dose.
"Teletherapy" means therapeutic irradiation in which the
				  sealed source of radiation is at a distance from the body.
"Therapeutic dosage" means a dosage of unsealed radioactive
				  material that is intended to deliver a radiation dose to a patient or human
				  research subject for palliative or curative treatment.
"Therapeutic dose" means a radiation dose delivered from a
				  source containing radioactive material to a patient or human research subject
				  for palliative or curative treatment.
"Treatment site" means the anatomical description of the
				  tissue intended to receive a radiation dose, as described in a written
				  directive.
"Unit dosage" means a dosage prepared for medical use for
				  administration as a single dosage to a patient or human research subject
				  without any further manipulation of the dosage after it is initially
				  prepared.
"Written directive" means an authorized user's written order
				  for the administration of radioactive material or radiation from radioactive
				  material to a specific patient or human research subject, as specified in
				  R9-7-707.