# The Ionising Radiation (Medical Exposure) Regulations 2017, Regulation 2: Interpretation Extent: E+W+S (1) In these Regulations— “accidental exposure” means an exposure of an individual in error when no exposure was intended; “adequate training” means training which satisfies the requirements of Schedule 3 and the expression “adequately trained” is to be construed accordingly; “assessment” means prior determination of amount, parameter or method; “carers and comforters” means individuals knowingly and willingly incurring an exposure to ionising radiation by helping, other than as part of their occupation, in the support and comfort of individuals undergoing or having undergone an exposure; “clinical audit” means a systematic examination or review of medical radiological procedures which seeks to improve the quality and outcome of patient care through structured review, whereby medical radiological practices, procedures and results are examined against agreed standards for good medical radiological procedures, with modification of practices, where indicated, and the application of new standards if necessary; “clinical evaluation” means interpretation of the information resulting from an exposure, including the outcome and implications; “diagnostic reference levels” means dose levels in medical radiodiagnostic or interventional radiology practices, or, in the case of radio-pharmaceuticals, levels of activity, for typical examinations for groups of standard-sized individuals or standard phantoms for broadly defined types of equipment; “dose reference levels” means dose levels in radiotherapeutic practices for typical localisation or verification exposures for groups of standard-sized individuals or standard phantoms for broadly defined types of equipment; “dose constraint” means a restriction set on the prospective doses of individuals which may result from a given radiation source; “employer” means any person who, in the course of a trade, business or other undertaking, carries out (other than as an employee), or engages others to carry out, those exposures described in regulation 3(1) or practical aspects, at a given radiological installation; “employer’s procedures” means the procedures established by an employer pursuant to regulation 6(1); “equipment” means equipment (including any software) which— (a)delivers ionising radiation to a person undergoing exposure; ... (b)... directly controls or influences the extent of such exposure ; or (c)directly assists an operator in carrying out a clinical evaluation; “ethics committee” means— (a)an ethics committee established or recognised in accordance with Part 2 of the Medicines for Human Use (Clinical Trials) Regulations 2004; (b)the Ethics Committee constituted by regulations made by the Scottish Ministers under section 51(6) of the Adults with Incapacity (Scotland) Act 2000; or (c)any other committee established to advise on the ethics of research investigations in human beings, and recognised for that purpose by or on behalf of the Secretary of State, the Scottish Ministers or the Welsh Ministers; ... “health screening” means a procedure for early diagnosis in population groups at risk; “individual detriment” means clinically observable deleterious effects in individuals or their descendants, the appearance of which is either immediate or delayed and, in the latter case, implies a probability rather than a certainty of appearance; “interventional radiology” means the use of X-ray imaging techniques to facilitate the introduction and guidance of devices in the body for diagnostic or treatment purposes; “ionising radiation” means the transfer of energy in the form of particles or electromagnetic waves of a wavelength of 100 nanometres or less or a frequency of 3 × 1015 hertz or more capable of producing ions directly or indirectly; “Licensing Authority”— (a)for the purpose of licensing any practitioner in respect of the administration of radioactive substances means the Secretary of State; (b)for the purpose of licensing any employer in respect of the administration of radioactive substances means— (i)in England, the Secretary of State; (ii)in Scotland, the Scottish Ministers; and (iii)in Wales, the Welsh Ministers; “medical exposure” means an exposure coming within any of paragraphs (a) to (e) of regulation 3(1); “medical physics expert” means an individual or a group of individuals, having the knowledge, training and experience to act or give advice on matters relating to radiation physics applied to exposure, whose competence in this respect is recognised by the Secretary of State; “medical radiological” means pertaining to radiodiagnostic and radiotherapeutic procedures, and interventional radiology or other medical uses of ionising radiation for planning, guiding and verification purposes; “medical radiological procedure” means any procedure giving rise to a medical exposure; “non-medical imaging exposure” means any deliberate exposure of humans for imaging purposes using medical radiological equipment, where the primary intention of the exposure is not to bring a health benefit to the individual being exposed; “operator” means any person who is entitled, in accordance with the employer’s procedures, to carry out practical aspects including those to whom practical aspects have been allocated, medical physics experts and, except where they do so under the direct supervision of a person who is adequately trained, persons participating in practical aspects as part of practical training; “patient dose” means the dose concerning patients or other individuals undergoing exposures to which these Regulations apply; “practical aspect” means the physical conduct of an exposure to which these Regulations apply and any supporting aspects, including handling and use of equipment, the assessment of technical and physical parameters (including radiation doses), calibration ... of equipment, preparation and administration of radio-pharmaceuticals, clinical evaluation and image processing; “practitioner” means a registered health care professional who is entitled in accordance with the employer’s procedures to take responsibility for the justification of an individual exposure; “quality assurance” means all those planned and systematic actions necessary to provide adequate assurance that a structure, system, component or procedure will perform satisfactorily in compliance with generally applicable standards and quality control is a part of quality assurance; “quality control” means the set of operations (programming, coordinating, implementing) intended to maintain or to improve quality and includes monitoring, evaluation and maintenance at required levels of all characteristics of performance of equipment that can be defined, measured, and controlled; “radiation protection adviser” means an individual who, or a body which is competent to advise on radiation protection in relation to occupational and public exposures; “radioactive substance” means any substance that contains one or more radionuclides the activity or activity concentration of which cannot be disregarded from a radiation protection point of view; “radioactive waste adviser” means an individual who, or a body which is competent to provide expert advice on radioactive waste management and environmental radiation protection; “radiodiagnostic” means pertaining to in-vivo diagnostic nuclear medicine, medical diagnostic radiology using ionising radiation, and dental radiology; “radiological installation” means a facility where exposures to which these Regulations apply are performed; “radiotherapeutic” means pertaining to radiotherapy, including nuclear medicine for therapeutic purposes; “referrer” means a registered health care professional who is entitled in accordance with the employer’s procedures to refer individuals for exposure to a practitioner; “registered health care professional” means a person who is a member of a profession regulated by a body mentioned in section 25(3) of the National Health Service Reform and Health Care Professions Act 2002; “relevant enforcing authority” means— (a)in England, the Care Quality Commission; (b)in Scotland, the Scottish Ministers; and (c)in Wales, the Welsh Ministers; “unintended exposure” means any exposure to ionising radiation which is significantly different from the exposure intended for a given purpose. (2) In these Regulations, where an individual is— (a) an employer; (b) a referrer; (c) an operator; or (d) a practitioner, and is also an individual coming within at least one other of sub-paragraphs (a) to (d), that individual is subject to each of the duties applying to every person described in a sub-paragraph which also describes that individual. --- Source: https://www.legislation.gov.uk/uksi/2017/1322/regulation/2 (the official version) Page: https://openlegislation.uk/ionising-radiation-medical-exposure-regulations-2017/regulation-2 Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.