Illinois Administrative Code › Title 32 - ENERGY › Part 335 - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart A - GENERAL INFORMATION › Section 335.20 - Definitions

Current through Register Vol. 48, No. 28, July 12, 2024
"Area of use" means a portion of a physical structure that
				  has been set aside for the purpose of receiving, using or storing radioactive
				  material.
"Associate Radiation Safety Officer" means an individual who,
				  for this Part only, meets the requirements in Sections
				  335.9010
				  and
				  335.9180
				  and is currently identified as an Associate Radiation Safety Officer for the
				  types of use of radioactive material for which the individual has been assigned
				  duties and tasks by the Radiation Safety Officer on a specific medical use
				  license issued by the Agency, U.S. Nuclear Regulatory Commission or an
				  Agreement State or on medical use permit issued by a U.S. Nuclear Regulatory
				  Commission master material licensee.
"Authorized user" means a physician, dentist or podiatrist
				  who meets the requirements in Subpart J or is identified as being authorized to
				  use radioactive material on a specific medical use license issued by the
				  Agency, the U.S. Nuclear Regulatory Commission, or an Agreement State; a
				  medical use permit issued by a U.S. Nuclear Regulatory Commission master
				  material licensee; a permit issued by a U.S. Nuclear Regulatory Commission or
				  Agreement State broad scope medical use licensee; or a permit issued by a U.S.
				  Nuclear Regulatory Commission master material license broad scope medical use
				  permittee.
"Authorized medical physicist" means an individual who meets
				  the requirements in Sections
				  335.9150(a)
				  and 335.9180; or is identified as an authorized medical physicist or
				  teletherapy physicist on a specific medical use license issued by the U.S.
				  Nuclear Regulatory Commission or an Agreement State, a medical use permit
				  issued by a U.S. Nuclear Regulatory Commission master material licensee, a
				  permit issued by a U.S. Nuclear Regulatory Commission or an Agreement State
				  broad scope medical use licensee, or a permit issued by a U.S. Nuclear
				  Regulatory Commission master material license broad scope medical use
				  permittee.
"Case" means the performance of a clinical procedure on a
				  patient.
"Classroom and laboratory training" means planned instruction
				  outlined in a syllabus and offered by an individual or organization. It is
				  comprised of lectures, demonstrations, hands-on laboratory exercises and
				  tests.
"Client's address" means the area of use or a temporary job
				  site for the purpose of providing mobile medical service in accordance with
				  Section
				  335.2120.
"Clinical procedure" means a method of using radioactive
				  material for patient care in which the material or its radiation is
				  administered to the patient. A specific clinical procedure specifies, either
				  explicitly or in context, the indication for the procedure, the purpose
				  (diagnosis or therapy), the radionuclide and its chemical and physical form,
				  the dosage or dose and method of administration and patient follow-up.
				  Diagnostic clinical procedures also include the method of collecting raw data,
				  manipulating the data and interpreting the final results, which may be images,
				  graphs or numbers.
"Dentist" means an individual licensed by a state or
				  territory of the United States, the District of Columbia or the Commonwealth of
				  Puerto Rico to practice dentistry.
"Gamma stereotactic radiosurgery" means the use of external
				  radiation in conjunction with a stereotactic guidance device to very precisely
				  deliver a therapeutic dose to a tissue volume.
"High dose rate remote afterloader" means a brachytherapy
				  device that remotely delivers a dose rate in excess of 12 gray (1200 rads) per
				  hour at the point or surface where the dose is prescribed.
"Intravascular brachytherapy" means a type of brachytherapy
				  in which the brachytherapy sources are placed into blood vessels at the point
				  where the dose is prescribed for the treatment of in-stent restenosis.
"Low dose rate remote afterloader" means a brachytherapy
				  device that remotely delivers a dose rate of less than or equal to 2 gray (200
				  rads) per hour at the point or surface where the dose is prescribed.
"Management" means the chief executive officer or other
				  individual having the authority to manage or administer the licensee's
				  activities, or those individuals' delegates.
"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
				  Section
				  335.1080.
"Medical institution" means:
An organization, other than a medical clinic, private medical
				  practice or mobile nuclear medicine service, that holds a specific license
				  issued by the Agency and that practices more than two medical disciplines;
				  or
A medical clinic, private practice or mobile nuclear medicine
				  service that holds a specific license issued by the Agency and is authorized
				  under Section
				  335.2140,
				  335.5010
				  (for therapy procedures only),
				  335.7010
				  or
				  335.8010
				  to use radioactive material.
"Medical use" means the intentional internal or external
				  administration of radioactive material or the radiation from radioactive
				  material to patients or human research subjects under the supervision of an
				  authorized user.
"Medium dose rate remote afterloader" means a brachytherapy
				  device that remotely delivers a dose rate of greater than 2 gray (200 rads) per
				  hour, but less than or equal to 12 gray (1200 rads) per hour at the point or
				  surface where the dose is prescribed.
"Mobile medical service" means the transportation of
				  radioactive material to, and its medical use at, the client's address.
"Ophthalmic physicist" means an individual who meets the
				  requirements in Sections 335.7100(b) and 335.9180; and is identified as an
				  ophthalmic physicist on a specific medical use license issued by the Agency,
				  the U.S. Nuclear Regulatory Commission, or an Agreement State; a medical use
				  permit issued by a U.S. Nuclear Regulatory Commission master material licensee;
				  a permit issued by the Agency, the U.S. Nuclear Regulatory Commission, or an
				  Agreement State broad scope medical use licensee; or a permit issued by a U.S.
				  Nuclear Regulatory Commission master material license broad scope medical use
				  permittee.
"Output" means the exposure rate, dose rate or a quantity
				  related in a known manner to these rates from a brachytherapy source or a
				  teletherapy, remote afterloader or gamma stereotactic radiosurgery unit for a
				  specified set of exposure conditions.
"Patient intervention" means actions by the patient or human
				  research subject, whether intentional or unintentional, such as dislodging or
				  removing treatment devices or prematurely terminating the
				  administration.
"Physically present" means within audible range and in such
				  proximity that immediate assistance can be given if required.
"Podiatrist" means an individual licensed by a state or
				  territory of the United States, the District of Columbia or the Commonwealth of
				  Puerto Rico to practice podiatry.
"Preceptor" means an individual who provides, directs, or
				  verifies training and experience required for an individual to become an
				  authorized user, an authorized medical physicist, an authorized nuclear
				  pharmacist, a Radiation Safety Officer, or an Associate Radiation Safety
				  Officer.
"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 pursuant to Sections
				  335.3010
				  and
				  335.4010.
"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 and intravascular brachytherapy,
				  either the total dose or the total source strength and exposure time, as
				  documented in the written directive; or
for remote brachytherapy afterloaders, the total dose and
				  dose per fraction as documented in the written directive.
"Pulsed dose rate remote afterloader" means a special type of
				  remote afterloading brachytherapy device that uses a single source capable of
				  delivering dose rates in the "high dose rate" range, and:
is approximately one-tenth of the activity of typical high
				  dose rate remote afterloader sources; and
is used to simulate the radiobiology of a low dose rate
				  treatment by inserting the source for a given fraction of each hour.
"Radiation Safety Officer" means an individual who:
meets the requirements in Sections
				  335.9010
				  and 335.9180; or
is identified as a Radiation Safety Officer on:
a specific medical use license issued by the Agency, the U.S.
				  Nuclear Regulatory Commission, or an Agreement State; or
a medical use permit issued by a U.S. Nuclear Regulatory
				  Commission master material licensee.
"Structured educational program" means an educational program
				  designed to impart particular knowledge and practical education through
				  interrelated studies and supervised training.
"Teletherapy" means a method of radiation therapy in which
				  collimated gamma rays are delivered at a distance from the patient or human
				  research subject.
"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.
"Type of use" means use of radioactive material under Section
				  335.2140, 335.3010, 335.4010, 335.5010, 335.6010, 335.7010 or 335.8010.
"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.
"Visiting authorized user" means a temporary (i.e., less than
				  60 days each year) authorized user who is not identified on the license of the
				  licensee being visited and who has been approved by the Radiation Safety
				  Committee in accordance with Section
				  335.1060(b).
"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
				  Section
				  335.1110.