The Ionising Radiation (Medical Exposure) Regulations 2017

Interpretation E+W+S

2.—(1) In these Regulations—

“accidental exposure” means an exposure of an individual as a result of an accident;

“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;

“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 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 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 which—

(a)

delivers ionising radiation to a person undergoing exposure; or

(b)

which directly controls or influences the extent of such exposure;

“evaluation” means interpretation of the outcome and implications of, and of the information resulting from, an exposure;

“health screening” means a procedure for early diagnosis in population groups at risk;

“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;

“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 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 a medical exposure and any supporting aspects, including handling and use of medical radiological equipment, the assessment of technical and physical parameters (including radiation doses), calibration and maintenance 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 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;

“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;

“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(1);

“relevant enforcing authority” means—

(a)

in England, the Care Quality Commission(2);

(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.

Commencement Information

I1 Reg. 2 in force at 6.2.2018, see reg. 1

(1)

2002 c. 17. Section 25 has been amended by paragraph 17 of Schedule 10 and Part 2 of Schedule 15 the Health and Social Care Act 2008 (c. 14), sections 220, 222 and 224 of and paragraphs 56 and 62 of Schedule 15 to the Health and Social Care act 2012 (c. 7), section 5(1) of the Health and Social Care (Safety and Quality) Act 2015 (c. 28), paragraph 1 and 2 of Schedule 4 to the Children and Social Work Act 2017 (c. 16).

(2)

Established by section 1 of the Health and Social Care Act 2008 (c. 14).