European Communities (Medical Ionising Radiation Protection) Regulations 2002
Statutory Instruments
Source: Statutory Instruments

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paragraphs: These regulations may be cited as the European Communities (Medical Ionising Radiation Protection) Regulations, 2002.
Definitions
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paragraphs: For the purpose of these Regulations, the following terms have the meaning hereby assigned them:
“Medical Council” means the Council established by the Medical Practitioners Act, 1978 .
“Dental Council” means the Council established by the Dentists Act, 1985 .
“Radiological Protection Institute of Ireland” means the Institute established by the Radiological Protection Act, 1991 .
“The Minister” means the Minister for Health and Children
“Chief executive officer” means the chief executive officer of a health board established under the Health Act, 1970 , the chief executive officer of the Eastern Regional Health Authority and the chief executive officer of an area health board within the meaning of the Health (Eastern Regional Health Authority) Act, 1999 .
“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, with modification of practices where indicated and the application of new standards if necessary.
“Clinical responsibility” means responsibility regarding individual medical exposures attributed to a practitioner, notably: justification; optimisation; clinical evaluation of the outcome; co-operation with other specialists and the staff, as appropriate, regarding practical aspects; obtaining information, if appropriate, of previous examinations; providing existing radiological information and/or records to other practitioners and/or prescribers, as required; giving information on the risk of ionising radiation to patients and other individuals involved, as appropriate.
“Competent authority” means the Minister for Health and Children.
“Diagnostic reference levels” means dose levels in medical radio diagnostic practices or, in the case of radio-pharmaceuticals levels of activity for typical examinations for groups of standard-sized patients or standard phantoms for broadly defined types of equipment. These levels are expected not to be exceeded for standard procedures when good and normal practice regarding diagnostic and technical performance is applied.
“Dose Constraint” means a restriction on the prospective doses to individuals which may result from a defined source, for use at the planning stage in radiation protection whenever optimisation is involved.
“Exposure” means the process of being exposed to ionising radiation.
“Health screening” means a procedure using radiological installations for early diagnosis in population groups at risk.
“Holder” means any natural or legal person who has the legal responsibility under national law for a radiological installation.
“Medical exposure” means exposure of an individual to ionizing radiation for any of the purposes specified in regulation 4.
“Medical physicist” means an expert in radiation physics or radiation technology applied to exposure, whose training and competence to act is recognised by the competent authority, and who, as appropriate, acts or gives advice on patient dosimetry, on the development and use of complex techniques and equipment, on optimisation, on quality assurance, including quality control, and on other matters relating to radiation protection, concerning exposure.
“Medical radiological procedure” means any radio diagnostic or radio therapeutic procedure involving the use of ionising radiation on an individual for medical purposes.
“Medicolegal procedures” mean procedures performed for insurance or legal purposes without a medical indication.
“Occupational health surveillance” means the medical surveillance of workers.
“Patient dosimetry” means the dosimetry concerning patients or other individuals undergoing medical exposure.
“Practical Aspects” means the physical conduct of a medical exposure 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 radio-phamaceuticals and the development of films.
“Practitioner” means:-
(a) a person whose name is entered on the register established under Section 26 of the Medical Practitioners Act 1978 and who meets such other requirements as may be specified by the Medical Council from time to time to allow them to take responsibility for an individual medical exposure; or
(b) a person whose name is entered on the register established under Section 26 of the Dentists Act, 1985 and who meets such other requirements as may be specified by the Dental Council from time to time to allow them to take responsibility for an individual medical exposure; or
(c) a person whose name is entered on such other register or registers as the Minister may, from time to time, establish in relation to persons who are entitled to take clinical responsibility for an individual medical exposure and who meets such other requirements as the Minister may prescribe.
“Practitioner in charge” means a practitioner who has been appointed by the holder to be the person in charge of an installation.
“Prescriber” means
(a) a person whose name is entered on the register established under Section 26 of the Medical Practitioners Act, 1978 ; or
(b) a person whose name is entered on the register established under Section 26 of the Dentists Act, 1985 ; or
(c) a person whose name is entered on such other register or registers as the Minister may, from time to time, establish in relation to persons who are entitled to refer individuals for medical exposure to a practitioner and who meets such other requirements as the Minister may prescribe from time to time.
“Quality Assurance” means all those planned and systematic actions necessary to provide adequate confidence that a structure system, component or procedure will perform satisfactorily and comply with agreed standards.
“Quality control” means the set of operations (programming co-ordinating, implementing) intended to maintain or to improve quality. It covers monitoring, evaluation and maintenance at required levels of all characteristics of performance of equipment that can be defined, measured, and controlled.
“Radiation Safety Committee” means a committee established in accordance with regulation 22.
“Radiographer” means a person who has successfully completed an approved course of training for that category of persons and who is qualified to be employed as a radiographer by a health board.
“Radiological” means pertaining to radio diagnostic and radio therapeutic procedures, and intervention radiology or other planning and guiding radiology.
“Radiological installation” means a premises where patients are examined or treated and which contains radiological equipment.
“Radio diagnostic” means pertaining to in vivo diagnostic nuclear medicine, medical diagnostic radiology, and dental radiology.
“Radio therapeutic” means pertaining to radiotherapy including nuclear medicine for therapeutic purposes.
References
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paragraphs: In these regulations words or phrases shall have the meaning assigned to them under regulation 2 and references to regulations or paragraphs, except where otherwise indicated, shall be construed as a reference to an article or a paragraph in these regulations.
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paragraphs: 1. These regulations shall apply to the following medical exposure:
(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 healthy individuals or patients voluntarily participating in medical or biomedical, diagnostic or therapeutic, research programmes;
(e) the exposure of individuals as part of medico-legal procedures.
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paragraphs: 2. These regulations shall also apply to exposure of individuals knowingly and willingly helping (other than as part of their occupation) in the support and comfort of individuals undergoing medical exposure.
The RPII
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paragraphs: The provisions of these regulations shall be without prejudice to the rights and responsibilities of the Radiological Protection Institute of Ireland in relation to the custody, transportation, handling, holding storage, use manufacture, production, processing, importation, distribution exportation or other disposal of radioactive devices, nuclear devices or irradiating apparatus.