Current through Register 1531, September 27, 2024
(A) The licensee or registrant in possession
of any sealed source shall assure that:
(1)
Each sealed source, except as specified in 105 CMR 120.223(B), is tested for
leakage or contamination and the test results are received before the sealed
source is put into use unless the licensee or registrant has a certificate from
the transferor indicating that the sealed source was tested within six months
before transfer to the licensee or registrant.
(2) Each sealed source that is not designed
to emit alpha particles is tested for leakage or contamination at intervals not
to exceed six months or at alternative intervals approved by the Agency, after
evaluation of information specified by
105
CMR 120.128(N), an Agreement
State, a Licensing State, or the U.S. Nuclear Regulatory Commission.
(3) Each sealed source that is designed to
emit alpha particles is tested for leakage or contamination at intervals not to
exceed three months or at alternative intervals approved by the Agency, after
evaluation of information specified by
105
CMR 120.128(N), an Agreement
State, a Licensing State, or the Nuclear Regulatory Commission.
(4) For each sealed source that is required
to be tested for leakage or contamination, at any other time there is reason to
suspect that the sealed source might have been damaged or might be leaking, the
licensee or registrant shall assure that the sealed source is tested for
leakage or contamination before further use.
(5) Tests for leakage for all sealed sources,
except brachytherapy sources manufactured to contain radium, shall be capable
of detecting the presence of 185 Bq (0.005 µCi) of radioactive material
on a test sample. Test samples shall be taken from the sealed source or from
the surfaces of the container in which the sealed source is stored or mounted
on which one might expect contamination to accumulate. For a sealed source
contained in a device, test samples are obtained when the source is in the
"off" position.
(6) The test for
leakage for brachytherapy sources manufactured to contain radium shall be
capable of detecting an absolute leakage rate of 37 Bq (0.001 µCi) of
radon-222 in a 24 hour period when the collection efficiency for radon-222 and
its daughters has been determined with respect to collection method, volume and
time.
(7) Tests for contamination
from radium daughters shall be taken on the interior surface of brachytherapy
source storage containers and shall be capable of detecting the presence of 185
Bq (0.005 µCi) of a radium daughter which has a half-life greater than
four days.
(B) A
licensee or registrant need not perform test for leakage or contamination on
the following sealed sources:
(1) Sealed
sources containing only radioactive material with a half-life of less than 30
days;
(2) Sealed sources containing
only radioactive material as a gas;
(3) Sealed sources containing 3.7 MBq (100
µCi) or less of beta or photon-emitting material or 370 kBq (10
µCi) or less of alpha-emitting material;
(4) Sealed sources containing only
hydrogen-3;
(5) Seeds of
iridium-192 encased in nylon ribbon; and
(6) Sealed sources, except teletherapy and
brachytherapy sources, which are stored, not being used and identified as in
storage. The licensee or registrant shall, however, test each such sealed
source for leakage or contamination and receive the test results before any use
or transfer unless it has been tested for leakage or contamination within 6
months before the date of use or transfer.
(C) Tests for leakage or contamination from
sealed sources shall be performed by persons specifically authorized by the
Agency, an Agreement State, a Licensing State, or the U.S. Nuclear Regulatory
Commission to perform such services.
(D) Test results shall be kept in units of
becquerel or microcurie and maintained for inspection by the Agency.
(E) The following shall be considered
evidence that a sealed source is leaking:
(1)
The presence of 185 Bq (0.005 µCi) or more of removable contamination on
any test sample.
(2) Leakage of 37
Bq (0.001 µCi) of radon-222 per 24 hours for brachytherapy sources
manufactured to contain radium.
(3)
The presence of removable contamination resulting from the decay of 185 Bq
(0.005 µCi) or more of radium.
(F) The licensee or registrant shall
immediately withdraw a leaking sealed source from use and shall take action to
prevent the spread of contamination. The leaking sealed source shall be
repaired or disposed of in accordance with this
105 CMR
120.200.
(G) Reports of test results for leaking or
contaminated sealed sources shall be made pursuant to
105 CMR
120.288.
