Current through Register No. 40, October 3, 2024
(a) An application
for a specific license to manufacture and distribute sources and devices
containing byproduct material to persons licensed pursuant to He-P 4035 for use
as a calibration, transmission, or reference source, or sources for the uses in
manual brachytherapy, or sealed sources for diagnosis, or sealed source for the
use in a remote afterloader unit, teletherapy unit, or gamma stereotactic
radiosurgery unit in accordance with He-P 4035 shall be approved if:
(1) The applicant satisfies the general
requirements in He-P 4030.09;
(2) The applicant submits the following
radiation safety information for each type of source or device:
a. The byproduct material contained, its
chemical and physical form, and amount;
b. Details of design and construction of the
source or device;
c. Procedures
for, and results of, prototype tests to demonstrate that the source or device
maintains its integrity under stresses likely to be encountered in normal use
and accidents;
d. For devices
containing byproduct material, the radiation profile of a prototype
device;
e. Details of quality
control procedures to ensure that production sources and devices meet the
standards of the design and prototype tests;
f. Procedures and standards for calibrating
sources and devices;
g. Legend and
methods for labeling sources and devices for their radioactive content;
and
h. Instruction for handling and
storing the source or device from the radiation safety standpoint, as follows:
1. These instructions shall be included on a
durable label attached to the source or device or attached to a permanent
storage container for the source or device; or
2. If the instructions are too lengthy for
such label, they may be summarized on the label and printed in detail on a
brochure which is referenced on the label;
(3) The label affixed to the source or
device, or to the permanent storage container for the source or device,
contains the following information:
a. The
radionuclide;
b.
Quantity;
c. Date of assay;
and
d. A statement that includes
the name of source or device which is licensed by DHHS/RHS for distribution to
persons licensed pursuant to He-P 4035 or under equivalent licenses of the
Nuclear Regulatory Commission, an agreement state, or licensing state;
and
(4) The source or
device has been registered in the Sealed Source and Device Registry.
(b) In the event the applicant
desires that the source or device be required to be tested for leakage of
radioactive material at intervals longer than 6 months:
(1) The application shall include sufficient
information to demonstrate that such longer interval is justified by
performance characteristics of the source or device or similar sources or
devices and by design features that have a significant bearing on the
probability or consequences of leakage of radioactive material from the source;
and
(2) In determining the
acceptable interval for test of leakage of radioactive material, DHHS/RHS will
consider information that includes, but is not limited to:
a. Primary containment (source capsule)
;
b. Protection of primary
containment;
c. Method of sealing
containment;
d. Containment
construction materials;
e. Form of
contained radioactive material;
f.
Maximum temperature withstood during prototype tests;
g. Maximum pressure withstood during
prototype tests;
h. Maximum
quantity of contained radioactive material;
i. Radiotoxicity of contained radioactive
material; and
j. Operating
experience with identical sources or devices or similarly designed and
constructed sources or devices.
(See Revision Note at part heading for He-P 4032) #6942,
eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07
