Texas Register, Volume 32, Number 23, Pages 3077-3422, June 8, 2007 Page: 3,140
This periodical is part of the collection entitled: Texas Register and was provided to The Portal to Texas History by the UNT Libraries Government Documents Department.
Extracted Text
The following text was automatically extracted from the image on this page using optical character recognition software:
(II) a permit issued by an NRC master material
licensee that is authorized to permit the medical use of radioactive ma-
terial;
(III) a permit issued by a specific licensee with
broad scope authorization issued by the agency, the NRC, an agreement
state, or licensing state authorizing the medical or veterinary use of
radioactive material; or
(IV) a permit issued by an NRC master material
licensee with broad scope authorization that authorizes the medical use
of radioactive material.
(6) Brachytherapy--A method of radiation therapy in
which plated, embedded, activated, or sealed sources are utilized to
deliver a radiation dose at a distance of up to a few centimeters, by
surface, intracavitary, intraluminal, or interstitial application.
(7) Brachytherapy sealed source--A sealed source or
a manufacturer-assembled source train, or a combination of these
sources that is designed to deliver a therapeutic dose within a distance
of a few centimeters.
(8) High dose-rate remote afterloader--A device that re-
motely delivers a dose rate in excess of 1200 rads (12 gray (Gy)) per
hour at the point or surface where the dose is prescribed.
(9) Institutional Review Board (IRB)--Any board, commit-
tee, or other group formally designated by an institution and approved
by the United States Food and Drug Administration (FDA) to review,
approve the initiation of, and conduct periodic review of biomedical
research involving human subjects.
(10) Low dose-rate remote afterloader--A device that re-
motely delivers a dose rate of less than or equal to 200 rads (2 Gy) per
hour at the point or surface where the dose is prescribed.
(11) Management--The chief executive officer or other in-
dividual delegated the authority to manage, direct, or administer the
licensee's activities.
(12) Manual brachytherapy--A type of brachytherapy in
which the sealed sources, for example, seeds and ribbons, are manually
inserted either into the body cavities that are in close proximity to a
treatment site or directly in the tissue volume.
(13) Medical event--An event that meets the criteria in sub-
section (uuu)(1) of this section.
(14) Medical institution--An organization in which several
medical disciplines are practiced.
(15) Medical use--The intentional internal or external ad-
ministration of radioactive material, or the radiation from radioactive
material, to patients or human research subjects under the supervision
of an authorized user.
(16) Medium dose-rate afterloader--A device that remotely
delivers a dose rate greater than 200 rads (2 Gy) and less than or equal
to 1200 rads (12 Gy) per hour at the point or surface where the dose is
prescribed.
(17) Mobile nuclear medicine service--A licensed service
authorized to transport radioactive material to, and medical use of
the material at, the client's address. Services transporting calibration
sources only are not considered mobile nuclear medicine licensees.
(18) Output--The exposure rate, dose rate, or a quantity
related in a known manner to these rates from a teletherapy unit, a
brachytherapy source, a remote afterloader unit, or a gamma stereo-
tactic radiosurgery unit, for a specified set of exposure conditions.(19) Patient--A human or animal under medical care and
treatment.
(20) Preceptor--An individual who provides, directs,
or verifies the training and experience required for an individual
to become an authorized user, an authorized medical physicist, an
authorized nuclear pharmacist, or a radiation safety officer.
(21) Permanent facility--A building or buildings that are
identified on the license within the state of Texas and where radioactive
material may be prepared, received, used, or stored. This may also
include an area or areas where administrative activities related to the
license are performed.
(22) Prescribed dosage--The specified activity or range of
activity of a radiopharmaceutical as documented in a written directive
or in accordance with the directions of the authorized user for proce-
dures in subsections (ff) and (hh) of this section.
(23) Prescribed dose--Prescribed dose means one of the
following:
(A) for gamma stereotactic radiosurgery, the total dose
as documented in the written directive;
(B) for teletherapy, the total dose and dose per fraction
as documented in the written directive;
(C) for brachytherapy, either the total sealed source
strength and exposure time, or the total dose, as documented in the
written directive; or
(D) for remote afterloaders, the total dose and dose per
fraction as documented in the written directive.
(24) Pulsed dose-rate remote afterloader--A special type of
remote afterloading device that uses a single sealed source capable of
delivering dose rates greater than 1200 rads (12 Gy) per hour, but is
approximately one-tenth of the activity of typical high dose-rate remote
afterloader sealed sources and is used to simulate the radiobiology of
a low dose rate remote afterloader treatment by inserting the sealed
source for a given fraction of each hour.
(25) Radiation safety officer (RSO)--For purposes of this
section, an individual who:
(A) meets the requirements in subsections (h) and (m)
of this section or;
(B) is identified as an RSO on one of the following:
(i) a specific license issued by the agency, NRC,
agreement state, or licensing state license that authorizes the medical
or veterinary use of radioactive material; or
(ii) a permit issued by an NRC master material li-
censee that authorizes the medical or veterinary use of radioactive ma-
terial.
(26) Sealed source and device registry--The national reg-
istry that contains all the registration certificates, generated by both the
NRC and the agreement states, that summarize the radiation safety in-
formation for sealed sources and devices and describe the licensing and
use conditions approved for the product.
(27) Stereotactic radiosurgery--The use of external radia-
tion in conjunction with a guidance device to very precisely deliver a
dose to a tissue volume by the use of three-dimensional coordinates.
(28) Technologist--Technologist is defined as either of the
following:32 TexReg 3140 June 8, 2007 Texas Register
Upcoming Pages
Here’s what’s next.
Search Inside
This issue can be searched. Note: Results may vary based on the legibility of text within the document.
Tools / Downloads
Get a copy of this page or view the extracted text.
Citing and Sharing
Basic information for referencing this web page. We also provide extended guidance on usage rights, references, copying or embedding.
Reference the current page of this Periodical.
Texas. Secretary of State. Texas Register, Volume 32, Number 23, Pages 3077-3422, June 8, 2007, periodical, June 8, 2007; Austin, Texas. (https://texashistory.unt.edu/ark:/67531/metapth97400/m1/63/?rotate=90: accessed July 16, 2024), University of North Texas Libraries, The Portal to Texas History, https://texashistory.unt.edu.; crediting UNT Libraries Government Documents Department.