Testing for Leakage or Contamination of Sealed Sources

(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 :Ci) 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 :Ci) 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 :Ci) 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 :Ci) or less of beta or photon-emitting material or 370 kBq (10 :Ci) 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 :Ci) or more of removable contamination on any test sample. (2) Leakage of 37 Bq (0.001 :Ci) 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 :Ci) 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. SURVEYS AND MONITORING