[Code of Federal Regulations]
[Title 10, Volume 1]
[Revised as of January 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 10CFR35.59]

[Page 565-566]
 
                            TITLE 10--ENERGY
 
                CHAPTER I--NUCLEAR REGULATORY COMMISSION
 
PART 35--MEDICAL USE OF BYPRODUCT MATERIAL--Table of Contents
 
                Subpart C--General Technical Requirements
 
Sec. 35.59  Requirements for possession of sealed sources and brachytherapy sources.

    (a) A licensee in possession of any sealed source or brachytherapy 
source shall follow the radiation safety and handling instructions 
supplied by the manufacturer, and shall maintain the instructions for 
the duration of source use in a legible form convenient to users.
    (b) A licensee in possession of a sealed source shall:
    (1) Test the source for leakage before its first use unless the 
licensee has a certificate from the supplier indicating that the source 
was tested within six months before transfer to the licensee; and
    (2) Test the source for leakage at intervals not to exceed six 
months or at other intervals approved by the Commission or an Agreement 
State and described in the label or brochure that accompanies the 
source.
    (c) To satisfy the leak test requirements of this section, the 
licensee must:
    (1) Take a wipe sample from the sealed source or from the surfaces 
of the device in which the sealed source is mounted or stored on which 
radioactive contamination might be expected to accumulate or wash the 
source in a small volume of detergent solution and treat the entire 
volume as the sample;
    (2) Take teletherapy and other device source test samples when the 
source is in the ``off'' position; and
    (3) Measure the sample so that the leakage test can detect the 
presence of 0.005 microcuries of radioactive material on the sample.
    (d) A licensee shall retain leakage test records for five years. The 
records must contain the model number, and serial number if assigned, of 
each source tested, the identity of each source radionuclide and its 
estimated activity, the measured activity of each test sample expressed 
in microcuries, a description of the method used to measure each test 
sample, the date of the test, and the signature of the Radiation Safety 
Officer.
    (e) If the leakage test reveals the presence of 0.005 microcurie or 
more of removable contamination, the licensee shall:
    (1) Immediately withdraw the sealed source from use and store it in 
accordance with the requirements in parts 20 and 30 of this chapter; and
    (2) File a report within five days of the leakage test with the 
appropriate NRC Office listed in Sec. 30.6 of this chapter, with a copy 
to Director, Office of Nuclear Material Safety and Safeguards, U.S. 
Nuclear Regulatory Commission, Washington, DC 20555, describing the 
equipment involved, the test results, and the action taken.
    (f) A licensee need not perform a leakage test on the following 
sources:
    (1) Sources containing only byproduct material with a half-life of 
less than 30 days;
    (2) Sources containing only byproduct material as a gas;
    (3) Sources containing 100 microcuries or less of beta or gamma-
emitting material or 10 microcuries or less of alpha-emitting material;
    (4) Sources stored and not being used. The licensee shall, however, 
test each such source for leakage before any use or transfer unless it 
has been leakage-tested within six months before the date of use or 
transfer; and
    (5) Seeds of iridium-192 encased in nylon ribbon.
    (g) A licensee in possession of a sealed source or brachytherapy 
source

[[Page 566]]

shall conduct a quarterly physical inventory of all such sources in its 
possession. The licensee shall retain each inventory record for five 
years. The inventory records must contain the model number of each 
source, and serial number if one has been assigned, the identity of each 
source radionuclide and its nominal activity, the location of each 
source, and the signature of the Radiation Safety Officer.
    (h) A licensee in possession of a sealed source or brachytherapy 
source shall measure the ambient dose rates quarterly in all areas where 
such sources are stored. This does not apply to teletherapy sources in 
teletherapy units or sealed sources in diagnostic devices.
    (i) A licensee shall retain a record of each survey required in 
paragraph (h) of this section for three years. The record must include 
the date of the survey, a plan of each area that was surveyed, the 
measured dose rate at several points in each area expressed in millirem 
per hour, the survey instrument used, and the signature of the Radiation 
Safety Officer.

[51 FR 36951, Oct. 16, 1986, as amended at 52 FR 31611, Aug. 21, 1987; 
53 FR 19247, May 27, 1988]