Subdiv 5Special requirements for sealed radioactive sources

Subdivision 5—Special requirements for sealed radioactive sources 74—Design and construction of capsules and source holders (1) A capsule must be designed and constructed so that any radioactive material within the capsule remains effectively enclosed within the capsule— (a) during all the conditions that are likely to arise when the source is being put to its normal use; and (b) during all the conditions that are likely to arise if the source is involved in an accident of a kind that could arise when the source is being put to its normal use. (2) For the purposes of this regulation, a capsule complies with the requirements of subregulation (1) if it complies with— (a) in the case of a capsule for a source built before 1 January 2012—the requirements of International Standard ISO 2919:1999 (E) Radiation protection – sealed radioactive sources – General requirements and classification published by the International Organisation for Standardisation as in force from time to time; or (b) in any other case—the requirements of the International Standard ISO 2919:2012 (E) Radiological protection – sealed radioactive sources – General requirements and classification published by the International Organisation for Standardisation as in force from time to time, as those requirements relate to the usage to which the sealed radioactive source is to be put, as expressed in Table 4 of that standard. (3) Subregulation (1) does not apply in relation to a capsule if— (a) the capsule is contained in a device in respect of which a relevant code applies; and (b) the device is compliant with the relevant code. 75—Sealed radioactive source to be used in device etc If a sealed radioactive source is to be used in a device, article or thing, the radionuclide to be used in the source must be one— (a) the activity of which is not greater than is necessary for the satisfactory operation of the device, article or thing beyond its normal working life; and (b) the energy and type of radiation emitted from which are appropriate to the use for which the device, article or thing has been designed; and (c) the half life of which is as short as is practicable; and (d) is not an alpha emitter unless there are no other radionuclides readily available with the necessary properties. 76—Minister's power to require owner of sealed radioactive source to carry out tests (1) The Minister may, by notice in writing given to the owner of a sealed radioactive source, direct the owner to carry out in respect of the source such tests as the Minister directs. (2) A notice under subregulation (1) must— (a) identify the source to be tested; and (b) specify the method to be used in carrying out the tests; and (c) specify the time within which the tests must be carried out; and (d) specify the frequency at which the tests are to be carried out; and (e) specify the criteria to be used in deciding whether or not the source passes the tests. (3) A person who has been required by the Minister to carry out tests in accordance with this regulation must— (a) carry out the tests as directed; and (b) keep a register for the purpose of recording such tests; and (c) within 14 days of carrying out tests in accordance with this regulation—make an entry in the register containing— (i) sufficient details to identify the source tested; and (ii) the date of the tests; and (iii) the results of the tests; and (d) if directed by the Minister to do so—submit the results of the test to the Minister. (4) If a source fails to pass a test carried out under this regulation, the owner of the source must immediately— (a) cease to use the source; and (b) prevent any other person from using the source; and (c) notify the Minister that the source has failed to pass the test. 77—Owner of sealed radioactive source to keep register of location if moved for use (1) If in order to use a sealed radioactive source it is necessary for that source to be moved away from the premises controlled by the owner of the source, the owner must, in respect of the source— (a) keep a separate register for the purpose of establishing, so far as is possible, the location of a sealed radioactive source at any given time; and (b) in respect of the source, make entries in the register containing— (i) registered number of the source; and (ii) if the source is being moved in a vehicle—the vehicle's registration number under the Motor Vehicles Act 1959; and (iii) the site, district or other locality at which the source is to be used; and (iv) if the source is to be used under a contract between the owner and another person—the name of the other person; and (v) the name of the person who has taken charge of the source; and (vi) the date on which the source was taken by the person who has taken charge of the source; and (vii) the date on which the source was returned to the premises controlled by the owner. (2) A person who takes charge of a sealed radioactive source to which subregulation (1) applies must sign the register on the date on which they take charge of the source. (3) When the source is returned to the premises controlled by the owner, the person returning it must sign the register on the date on which it is returned and indicate in the register— (a) details of any abnormal occurrence which had occurred while the person was in charge of the source, being an occurrence that— (i) is indicative of some fault or defect in the source, its capsule, container or source control mechanism; and (ii) may have damaged the source, its capsule, container or source control mechanism; and (b) details of any fault or defect the person observed in the source, source capsule, source container or source control mechanism. 78—Duty of person administering human brachytherapy using sealed radioactive source (1) If a sealed radioactive source is used for the purpose of human brachytherapy, the person administering the brachytherapy must, if the patient undergoing treatment is in hospital, post on the patient's bed a sign containing— (a) the radiation symbol; and (b) the number of sealed radioactive sources being used to treat the patient; and (c) the type and activity of each source being used to treat the patient; and (d) the equivalent dose rate 1m from the patient and the time the equivalent dose rate was measured; and (e) the date on which the equivalent dose rate was measured; and (f) the name and signature of the person who measured the equivalent dose rate; and (g) the name and phone number of the person to be contacted in the event of a radiation incident involving any of the sealed radioactive sources being used to treat the patient. (2) If a sign has been placed on a patient's bed under subregulation (1), a person must not interfere with or remove the sign unless the person is removing it to make an entry on it or until— (a) the patient is discharged from the hospital; or (b) all sealed radioactive sources are removed from the patient; or (c) the equivalent dose rate 1m from the patient falls below 1 µSv/h. (3) This regulation does not apply to the use of a sealed radioactive source for brachytherapy if that source is used in a remote controlled afterloading device.