Ionising Radiation (Medical Exposure) Regulations 2000
| Jurisdiction | UK Non-devolved |
| Citation | SI 2000/1059 |
| Year | 2000 |
2000 No. 1059
HEALTH AND SAFETY
The Ionising Radiation (Medical Exposure) Regulations 2000
Made 13th April 2000
Laid before Parliament 14th April 2000
The Secretary of State, being the Minister designated1for the purposes of section 2(2) of the European Communities Act 19722in relation to the making of safety measures in regard to radioactive substances and the emission of ionising radiation, in exercise of the powers conferred by that section, hereby makes the following Regulations:—
Citation and commencement
1.—(1) These Regulations may be cited as the Ionising Radiation (Medical Exposure) Regulations 2000 and shall come into force—
(a)
(a) except for regulation 4(1) and 4(2) on 13th May 2000;
(b)
(b) as regards regulation 4(1) and 4(2) on 1st January 2001.
Interpretation
2.—(1) In these Regulations—
“adequate training” means training which satisfies the requirements of Schedule 2; and the expression “adequately trained” shall be similarly construed;
“appropriate authority” means the Secretary of State as regards England, the National Assembly for Wales as regards Wales, or the Scottish Ministers as regards Scotland;
“assessment” means prior determination of amount, parameter or method;
“child” means a person under the age of eighteen in England and Wales or a person under the age of sixteen in Scotland;
“clinical audit” means a systematic examination or review of medical radiological procedures which seeks to improve the quality and the outcome of patient care through structured review whereby radiological practices, procedures and results are examined against agreed standards for good medical radiological procedures, intended to lead to modification of practices where indicated and the application of new standards if necessary;
“diagnostic reference levels” means dose levels in medical radiodiagnostic practices or, in the case of radioactive medicinal products, levels of activity, for typical examinations for groups of standard-sized patients or standard phantoms for broadly defined types of equipment;
“dose constraint” means a restriction on the prospective doses to individuals which may result from a defined source;
“the Directive” means Council Directive 97/43/Euratom3laying down measures on health protection of individuals against the dangers of ionising radiation in relation to medical exposure;
“employer” means any natural or legal 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, medical exposures or practical aspects, at a given radiological installation;
“employer’s procedures” means the procedures established by an employer pursuant to regulation 4(1);
“equipment” means equipment which delivers ionising radiation to a person undergoing a medical exposure and equipment 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, a medical exposure;
“health screening” means a procedure using ionising radiation for early diagnosis in population groups at risk;
“individual detriment” means clinically observable deleterious effects that are expressed 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;
“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;
“medical exposure” means any exposure to which regulation 3 applies and which involves an individual being exposed to ionising radiation;
“medical physics expert” means a person who holds a science degree or its equivalent and who is experienced in the application of physics to the diagnostic and therapeutic uses of ionising radiation;
“medico-legal procedure” means a procedure performed for insurance or legal purposes without a medical indication;
“occupational health surveillance” means medical surveillance for workers;
“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 pursuant to regulation 5(3), medical physics experts as referred to in regulation 9 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 as referred to in regulation 11(3);
“patient dose” means the dose concerning patients or other individuals undergoing medical exposure;
“practical aspect” means the physical conduct of any of the exposures referred to in regulation 3 and any supporting aspects including handling and use of radiological equipment, and the assessment of technical and physical parameters including radiation doses, calibration and maintenance of equipment, preparation and administration of radioactive medicinal products and the development of films;
“practitioner” means a registered medical practitioner, dental practitioner or other health professional who is entitled in accordance with the employer’s procedures to take responsibility for an individual medical exposure;
“quality assurance” means any planned and systematic action necessary to provide adequate confidence that a structure, system, component or procedure will perform satisfactorily and safely complying with agreed standards and includes quality control;
“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 performance;
“radiodiagnostic” means pertaining toin vivo diagnostic nuclear medicine, medical diagnostic radiology and dental radiology;
“radioactive medicinal product” has the meaning given in the Medicines (Administration of Radioactive Substances) Regulations 19784;
“radiological” means pertaining to radiodiagnostic and radiotherapeutic procedures and interventional radiology or other planning and guiding radiology;
“radiological installation” means a facility containing equipment;
“radiotherapeutic” means pertaining to radiotherapy including nuclear medicine for therapeutic purposes;
“referrer” means a registered medical practitioner, dental practitioner or other health professional who is entitled in accordance with the employer’s procedures to refer individuals for medical exposure to a practitioner.
(2) In these Regulations—
(a)
(a) any reference to a numbered regulation or schedule is a reference to a regulation of or Schedule to these Regulations;
(b)
(b) any reference in a regulation to a numbered paragraph is a reference to the paragaph so numbered in that regulation.
Application
3. These Regulations shall apply to the following medical exposures—
(a) the exposure of patients as part of their own medical diagnosis or treatment;
(b) the exposure of individuals as part of occupational health surveillance;
(c) the exposure of individuals as part of health screening programmes;
(d) the exposure of patients or other persons voluntarily participating in medical or biomedical, diagnostic or therapeutic, research programmes;
(e) the exposure of individuals as part of medico-legal procedures.
Duties of Employer
4.—(1) The employer shall ensure that written procedures for medical exposures including the procedures set out in Schedule 1 are in place and—
(a)
(a) shall take steps to ensure that they are complied with by the practitioner and operator; or
(b)
(b) where the employer is concurrently practitioner or operator, he shall comply with these procedures himself.
(2) The employer shall ensure that written protocols are in place for every type of standard radiological practice for each equipment.
(3) The employer shall establish—
(a)
(a) recommendations concerning referral criteria for medical exposures, including radiation doses, and shall ensure that these are available to the referrer;
(b)
(b) quality assurance programmes for standard operating procedures;
(c)
(c) diagnostic reference levels for radiodiagnostic examinations falling within regulation 3(a), (b), (c) and (e) having regard to European diagnostic reference levels where available;
(d)
(d) dose constraints for biomedical and medical research programmes falling within regulation 3(d) where no direct medical benefit for the individual is expected from the exposure.
(4) The employer shall take steps to ensure that every practitioner or operator engaged by the employer to carry out medical exposures or any practical aspect of such exposures—
(a)
(a) complies with the provisions of regulation 11(1); and
(b)
(b) undertakes continuing education and training after qualification including, in the case of clinical use of new techniques, training related to these techniques and the relevant radiation protection requirements; or
(c)
(c) where the employer is concurrently practitioner or operator, he shall himself ensure that he undertakes such continuing education and training as may be appropriate.
(5) Where the employer knows or has reason to believe that an incident has or may have occurred in which a person, while undergoing a medical exposure was, otherwise than as a result of a malfunction or defect in equipment, exposed to ionising radiation to an extent much greater than intended, he shall make an immediate preliminary investigation of the incident and, unless that investigation shows beyond a reasonable doubt that no such overexposure has occurred, he shall forthwith notify the appropriate authority and make or arrange for a detailed investigation of the circumstances of the exposure and an assessment of the dose received.
(6) The...
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