Subdiv 3Special requirements for radiation apparatus

Subdivision 3—Special requirements for radiation apparatus 45—Prohibition on use of dental radiography apparatus with intra-oral X‑ray tube A person must not use dental radiography radiation apparatus that is designed to be used with the X‑ray tube inside a patient's mouth to irradiate a human being. Division 4—Radioactive materials Subdivision 1—Sale of radioactive materials and devices containing radioactive material 46—Application of Subdivision This Subdivision applies to a business during the course of which radioactive material, or a device that contains radioactive material, is sold, installed or maintained. 47—Duty to give Minister notice before carrying on certain business A person must not carry on a business to which this Subdivision applies unless the person has first given the Minister notice in writing that— (a) contains the full name and address of the person carrying on the business or, in the case of a company, the name of the company and the address of its registered office; and (b) states the number of persons who will in the course of carrying on the business handle any radioactive material or device containing any radioactive material; and (c) states whether or not any radioactive material or any device containing a radioactive material will be stowed or stored during the course of carrying on the business and, if so, where it is likely that it will be stowed or stored; and (d) if it is proposed to sell any radioactive material or any device containing a radioactive material—states details of the material or device. 48—Duty to give Minister notice of defective registrable device sold or installed in course of business (1) If, during the course of carrying on a business to which this Subdivision applies, a person sells or installs a registrable device and after the sale or installation becomes aware that— (a) the registrable device the person has sold or installed has a defect; or (b) registrable devices of the same class or kind as the registrable device the person has sold or installed have a defect, the person must, within 7 days of becoming aware of the defect, give the Minister notice in writing containing— (c) details of the defect; and (d) the class or kind of registrable device affected by the defect; and (e) the likely effects of the defect; and (f) details of the steps the person is taking or intends to take to rectify the defect. (2) A person who fails to comply with subregulation (1) is guilty of an offence. Maximum penalty: $20 000 or imprisonment for 5 years. (3) If a person gives a notice to the Minister in accordance with subregulation (1), the person must, within 7 days of becoming aware of— (a) any change in the information the person has already supplied; or (b) any additional information relating to the information already supplied, serve on the Minister a further notice in writing setting out full details of the change or the information additional to the information already supplied. (4) In this regulation— defect, in relation to a registrable device, means a fault in the design or the construction of the registrable device that is likely to increase the dose of ionising radiation that may be received by any person from the registrable device. 49—Person selling registrable device to give purchaser certain information If a person who carries on a business to which this Subdivision applies receives an order for the sale of a registrable device, the person must, if intending to sell the device, serve on the person to whom they intend to sell the device the information required by the Minister in the form approved by the Minister. 50—Duty to give Minister notice of sale of mobile registrable device If a person who carries on a business to which this Subdivision applies intends to deliver a mobile registrable device that the person has sold, the person must, at least 7 days before the intended delivery, give the Minister notice in writing containing— (a) the name of the person to whom the device has been sold; and (b) the address to which the device is to be delivered; and (c) full details of the device sold. 51—Duty to give Minister notice of intention to install fixed registrable device A person who carries on a business to which this Subdivision applies and who intends to install at any premises a registrable device that is to be fixed in place, the person must, at least 7 days before commencing the installation, give the Minister notice in writing containing— (a) the name of the person to whom the device has been sold; and (b) the address at which the device is to be installed; and (c) full details of the device to be installed. 52—Person supplying registrable device to ensure markings comply with ISO standard (1) Subject to subregulation (2), a person must not supply a registrable device unless the marking of the source capsule of the device complies with— (a) in the case of a registrable device 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 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. (2) Subregulation (1) does not apply in relation to person who supplies a registrable device if— (a) the registrable device contains a sealed radioactive source in respect of which a relevant code applies; and (b) the person can demonstrate compliance with the provisions of the relevant code that are expressed as mandatory provisions applying in relation to the sealed radioactive source. 53—Person selling sealed radioactive source required to be registered to supply certification (1) Subject to subregulation (2), a person must not sell a sealed radioactive source that is required by the Act to be registered unless at the time of such sale the person supplies with the source— (a) in the case of a source built before 1 January 2012—a certificate that meets the relevant 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— (i) a certificate that— (A) complies with the requirements of 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; and (B) contains the following information: • the radionuclide contained in the device; • the activity of the radionuclide and the date on which it was measured; • the chemical form of the radionuclide; • the manufacturer of the device; • the model of the device or details of the encapsulation; • the recommended working life specified by the manufacturer; and (ii) if applicable— (A) a special form certificate; and (B) a container certificate. (2) Subregulation (1) does not apply in relation to person who sells a sealed radioactive source if— (a) the sealed radioactive source is contained in a device in respect of which a relevant code applies; and (b) the person can demonstrate compliance with the provisions of the relevant code that are expressed as mandatory provisions applying in relation to the device. 54—Duty to give Minister notice of sale of registered sealed radioactive source (1) If a person, not being a person who carries on a business to which this Subdivision applies, sells a sealed radioactive source that is registered by the Minister under the Act, the person must, within 7 days of the sale, give the Minister notice in writing containing— (a) the name and address of the registered owner of the source prior to the sale; and (b) the name and address of the person to whom the source has been sold; and (c) the registered number of the source. (2) This regulation does not apply in relation to the sale or disposal of a sealed radioactive source if notice of the sale or disposal has been given to the Minister in accordance with regulation 26. 55—Duty to give Minister notice of sales of radioactive material A person who carries on a business to which this Subdivision applies must— (a) within 3 months of first notifying the Minister in accordance with regulation 47; and (b) thereafter at intervals of not longer than 3 months, give the Minister notice in writing containing— (c) details of all sales of radioactive material made by the person during the preceding 3 months or since the last notice given by the person in accordance with this regulation; and (d) in respect of each sale— (i) the name and address of the person to whom the sale was made; and (ii) the radionuclides sold and total activity of each radionuclide sold; and (iii) if the device sold is a sealed radioactive source larger than 50 MBq—the activity of each such sealed radioactive source sold; and (iv) for each radionuclide sold, the total activity of each such radionuclide supplied in unsealed form. 56—Minister's power to require additional information (1) The Minister may, by notice in writing served on a person who has given notice in accordance with this Subdivision, require the person to supply such additional information as the Minister thinks fit. (2) A person on whom notice is served under subregulation (1) must comply with the notice within 28 days, or such longer period as the Minister may approve, of service of the notice. 57—Prohibition on selling consumer products (1) A person must not sell a consumer product. (2) In this regulation— consumer product means a device, article or thing that contains a radioactive material and is designed and constructed for personal or domestic use and not for use during the course of employment or the carrying on of an occupation, but does not include an approved ionisation chamber smoke detector or any device article or thing built before 1 January 1982. 58—Prohibition on selling non-complying ionisation chamber smoke detector A person must not sell an ionisation chamber smoke detector unless that model of detector complies with AS 3786–2014 Smoke alarms using scattered light, transmitted light or ionization as in force from time to time. Subdivision 2—Special requirements for the short-term hire of sealed radioactive sources 59—Duties applying in relation to short-term hire of sealed radioactive sources (1) A person who carries on a business during the course of which sealed radioactive sources are let on hire must, if the period of hire for a sealed radioactive source is 3 months or less— (a) maintain a register of sealed radioactive sources let on hire (the register) and enter in the register the following information in respect of each sealed radioactive source: (i) the registered number of the source; (ii) if the source is being moved in a vehicle for the purposes of the hire or loan—the registration number of that vehicle; (iii) the site, district or other locality at which the source is to be used while on hire; (iv) the name of the person to whom the source is let on hire; (v) the authorisation number for the radiation management licence held by the person to whom the source is let on hire authorising the possession of the source; (vi) the name of the person who takes charge of the source at the commencement of the hire period; (vii) the date on which the source is taken by the person who has taken charge of the source; (viii) the date on which the source is returned to the premises controlled by the person suppling the source on hire; and (b) ensure, before the supply on hire, that the person to whom the source is let on hire holds a radiation management licence authorising the possession of the source; and (c) ensure that the source is, before its supply on hire, compliant with a provision of these regulations applying in respect of the source (including any relevant code applying to the source under these regulations); and (d) ensure that appropriate systems and processes are in place for the ongoing maintenance of the source during the term of the hire. (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 a source to which subregulation (1) applies is returned to the premises controlled by the person supplying the source on hire, 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. (4) A person who takes a sealed radioactive source on hire for a period of 3 months or less must report any damage occurring to the source during the period of hire to the person who supplied the source for hire as soon as reasonably practicable after the damage occurs. Subdivision 3—Accounting for and storage and labelling of radioactive materials 60—Registered occupier of premises in which unsealed radioactive material is kept or handled to maintain register of unsealed radioactive materials (1) The registered occupier of premises in which an unsealed radioactive material is kept or handled must— (a) maintain a register of unsealed radioactive materials; and (b) within 24 hours after each unsealed radioactive material kept or handled at the premises is first taken onto the premises, enter in the register an entry containing— (i) the radionuclide contained in the material; and (ii) the activity or nominal activity; and (iii) the date to which the activity refers; and (iv) the name of the person in whose care the material has been placed; and (v) the date upon which the material was first taken onto the premises. (2) Subregulation (1) does not apply in relation to premises in respect of which a radiation management licence authorising activities of a kind referred to in section 18(1) or 19(1) of the Act applies. 61—Person in possession of sealed radioactive source to maintain register of sealed radioactive sources A person in possession of a sealed radioactive source (whether or not registered by the Minister under the Act) must— (a) maintain a register of sealed radioactive sources; and (b) within 24 hours of taking possession of a sealed radioactive source, enter in the register the following information in respect of the source: (i) the name of the manufacturer of the source; (ii) the manufacturer's model or type number for the source; (iii) the serial number of the source; (iv) the radionuclide enclosed in the source; (v) if it is a non‑fissile neutron source—the target element; (vi) the activity or nominal activity of the radionuclide in the source; (vii) the date to which the activity of the radionuclide in the source refers; (viii) if the source is incorporated or mounted in an instrument or other equipment—sufficient information to identify the instrument or other equipment, including— (A) its manufacturer; and (B) its model; and (C) its serial number; and (D) its date of manufacture; and (E) the place where it is located (in the case of an instrument or other equipment installed in a fixed position) or the location where it is usually stored (in the case of an instrument or other equipment not so installed); (ix) the name of the person in whose care the source has been placed; (x) the date on which the person took possession of the source. 62—Storage of sealed radioactive sources and unsealed radioactive materials (1) If— (a) a sealed radioactive source or an unsealed radioactive material that is not incorporated into an instrument or in other equipment is not being used or handled; or (b) a sealed radioactive source or an unsealed radioactive material that is usually installed in a fixed position has been removed from that position; or (c) a sealed radioactive source or an unsealed radioactive material has been incorporated into a portable or mobile instrument or portable or mobile equipment that is not likely to be used in the near future, the person in possession of the sealed radioactive source or the registered occupier of the premises in which the unsealed radioactive material is kept (as the case may be) must— (d) store the source or material— (i) in the case of a sealed radioactive source—in accordance with the Code of Practice for the Security of Radioactive Sources; or (ii) in the case of an unsealed radioactive material—in accordance with the Code of Compliance for Facility Design and Shielding 2022 published by the Department, as in force from time to time; or (iii) in a manner approved by the Minister; and (e) take reasonable precautions to prevent unauthorised access to the source or material or unauthorised removal of the source or material from the place of storage; and (f) if it is reasonably foreseeable that, during a period of time, chemical, radiation or other action may weaken or rupture a container in which the source or material is stored so as to cause leakage from that container—provide suitable secondary containment adequate to contain the entire quantity of radioactive material. (2) Subregulation (1) does not apply in relation to person who is in possession of a sealed radioactive source if— (a) a relevant code applies in relation to the sealed radioactive source; and (b) the person can demonstrate compliance with the provisions of the relevant code that are expressed as mandatory provisions applying in relation to the sealed radioactive source. 63—Person in possession of sealed radioactive source etc to mark doors and entrances to areas where source or unsealed radioactive material kept (1) A person who is in possession of a sealed radioactive source or is the registered occupier of premises in which an unsealed radioactive material is kept, handled or stored must mark every door and every entrance to the area in which the source or material is kept, handled or stored with a sign that— (a) complies with the requirements of AS 1319–1994 Safety Signs for the Occupational Environment (as in force from time to time) applying to warning signs; and (b) if it bears words—bears the words "RADIATION AREA" or "STORE FOR RADIOACTIVE MATERIAL" or other words to that effect; and (c) bears the name and telephone number of a person to contact in the event of any emergency arising within or emanating from that area; and (d) bears the radiation symbol; and (e) has a total surface area of not less than 4 500 mm²; and (f) is clearly legible from a distance of 2 m. (2) Subregulation (1) does not apply in relation to person who is in possession of a sealed radioactive source if— (a) the sealed radioactive source is contained in a device in respect of which a relevant code applies; and (b) the person can demonstrate compliance with the provisions of the relevant code that are expressed as mandatory provisions applying in relation to the device.