9.7.1997   

EN

Official Journal of the European Communities

L 180/22

(1)

Whereas the Council has adopted Directives laying down the basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionizing radiation, as last amended by Directive 96/29/Euratom (3);

(2)

Whereas in accordance with Article 33 of the Treaty, each Member State is to lay down the appropriate provisions, whether by legislation, regulation or administrative action, to ensure compliance with the basic standards which have been established and take the necessary measures with regard to teaching, education and vocational training;

(3)

Whereas, on 3 September 1984 the Council adopted Directive 84/466/Euratom laying down the basic measures for the radiation protection of persons undergoing medical examination or treatment (4);

(4)

Whereas, as in 1984, medical exposure continues to constitute the major source of exposure to artificial sources of ionizing radiation of European Union citizens; whereas the use of ionizing radiation has enabled great progress to be made in many aspects of medicine; whereas practices causing medical exposure need to be carried out in optimized radiation protection conditions;

(5)

Whereas, recognizing the development of scientific knowledge in the field of radiation protection applied to medical exposure, the International Commission on Radiological Protection reviewed the subject in its 1990 and 1996 recommendations;

(6)

Whereas such developments make it necessary to repeal Directive 84/466/Euratom;

(7)

Whereas Directive 96/29/Euratom lays down basic safety standards for the protection of the workers administering the medical exposure and of the members of the public; whereas the same Directive ensures that the total of contributions to the exposure of the population as a whole, is kept under review;

(8)

Whereas health and safety requirements, including radiation protection aspects, regarding the design, manufacture and placing on the market of the medical devices are dealt with by Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (5); whereas pursuant to Article 1 (8) of that Directive, the relevant Directives adopted under the Euratom Treaty are not to be affected by its provisions; whereas it is necessary to set out radiation protection requirements for the medical use of radiological installations from the date of the commencement of their operation;

(9)

Whereas provisions need to be adapted for the protection as regards exposure incurred by volunteers and persons knowingly and willingly helping persons undergoing medical examination or treatment;

(10)

Whereas the Committee of Ministers of the Council of Europe adopted on 6 February 1990 Recommendation R(90)3 on medical research on human beings, concerning inter alia the setting up of an ethics committee;

(11)

Whereas detailed requirements are needed for the correct application of the justification and optimization principles in relation to exposure within the scope of this Directive;

(12)

Whereas responsibilities for administering medical exposure need to be set out;

(13)

Whereas appropriate training for the staff involved, the establishment of quality assurance and audit programmes, and inspections by the competent authorities are necessary to ensure that medical exposure is delivered under good radiation protection conditions;

(14)

Whereas specific provisions are necessary as regards special practice, pregnant and breastfeeding females, volunteers in research and helping persons;

(15)

Whereas potential exposure needs to be taken into account,

(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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Clinical audit: 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.

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Clinical Responsibility: responsibility regarding individual medical exposures attributed to a practitioner, notably: justification; optimization; clinical evaluation of the outcome; cooperation 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 ionizing radiation to patients and other individuals involved, as appropriate.

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Competent Authorities: any authority designated by a Member State.

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Diagnostic Reference Levels: dose levels in medical radiodiagnostic 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.

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Dose Constraint: 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 optimization is involved.

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Exposure: the process of being exposed to ionizing radiation.

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Health screening: a procedure using radiological installations for early diagnosis in population groups at risk.

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Holder: any natural or legal person who has the legal responsibility under national law for a given radiological installation.

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Individual Detriment: 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.

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Inspection: inspection is an investigation by any competent authority to verify compliance with national provisions on radiological protection for medical radiological procedures, equipment in use or radiological installations.

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Medical Physics Expert: an expert in radiation physics or radiation technology applied to exposure, within the scope of this Directive, whose training and competence to act is recognized by the competent authorities; and who, as appropriate, acts or gives advice on patient dosimetry, on the development and use of complex techniques and equipment, on optimization, on quality assurance, including quality control, and on other matters relating to radiation protection, concerning exposure within the scope of this Directive.

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Medical Radiological Procedure: any procedure concerning medical exposure.

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Medico-legal procedures: procedures performed for insurance or legal purposes without a medical indication.

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Occupational health surveillance: the medical surveillance for workers as specified by Member States or competent authorities.

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Patient dose: the dose, concerning patients or other individuals undergoing medical exposure.

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Patient dosimetry: the dosimetry concerning patients or other individuals undergoing medical exposure.

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Practical Aspects: the physical conduct of any of the exposure referred to in Article 1 (2) 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-pharmaceuticals and the development of films.

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Practitioner: a medical doctor, dentist or other health professional, who is entitled to take clinical responsibility for an individual medical exposure in accordance with national requirements.

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Prescriber: a medical doctor, dentist or other health professional, who is entitled to refer individuals for medical exposure to a practitioner, in accordance with national requirements.

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Quality Assurance: all those planned and systematic actions necessary to provide adequate confidence that a structure, system, component or procedure will perform satisfactorily complying with agreed standards.

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Quality control: is a part of quality assurance. The set of operations (programming, coordinating, 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.

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Radiological: pertaining to radiodiagnostic and radio-therapeutic procedures, and interventional radiology or other planning and guiding radiology.

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Radiological installation: a facility containing radiological equipment.

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Radiodiagnostic: pertaining to in vivo diagnostic nuclear medicine, medical diagnostic radiology, and dental radiology.

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Radiotherapeutic: pertaining to radiotherapy including nuclear medicine for therapeutic purposes.

(a)

(b)

all individual medical exposures shall be justified in advance taking into account the specific objectives of the exposure and the characteristics of the individual involved.

If a type of practice involving a medical exposure is not justified in general, a specific individual exposure of this type could be justified in special circumstances, to be evaluated on a case-by-case basis.

The prescriber and the practitioner as specified by Member States, shall seek, where practicable, to obtain previous diagnostic information or medical records relevant to the planned exposure and consider these data to avoid unnecessary exposure.

(c)

medical exposure for biomedical and medical research shall be examined by an ethics committee, set up in accordance with national procedures and/or by the competent authorities.

(d)

special attention shall be given to the justification of those medical exposures where there is no direct health benefit for the person undergoing the exposure and especially for those exposures on medico-legal grounds.

1.

(a)

promote the establishment and the use of diagnostic reference levels for radiodiagnostic examinations, as referred to in Article 1 (2) (a), (b), (c) and (e), and the availability of guidance for this purpose having regard to European diagnostic reference levels where available;

(b)

ensure that for each biomedical and medical research project as mentioned in Article 1 (2) (d):

(c)

ensure that special attention be given, to keep the dose arising from the medico-legal exposure referred to in Article 1 (2) (e) as low as reasonably achievable.

(a)

dose constraints are established for exposure, as referred to in Article 1 (3), of those individuals knowingly and willingly helping (other than as part of their occupation) in the support and comfort of patients undergoing medical diagnosis or treatment where appropriate;

(b)

appropriate guidance is established for exposure as referred to in Article 1 (3);

(c)

in the case of a patient undergoing a treatment or diagnosis with radionuclides, where appropriate the practitioner or the holder of the radiological installation provides the patient or legal guardian with written instructions, with a view to the restriction of doses to persons in contact with the patient as far as reasonably achievable and to provide information on the risks of ionizing radiation.

These instructions shall be handed out before leaving the hospital or clinic or a similar institution.

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all radiological equipment in use is kept under strict surveillance regarding radiation protection,

—

an up-to-date inventory of radiological equipment for each radiological installation is available to the competent authorities,

—

appropriate quality assurance programmes including quality control measures and patient dose or administered activity assessments are implemented by the holder of the radiological installation, and

—

acceptance testing is carried out before the first use of the equipment for clinical purposes, and thereafter performance testing on a regular basis, and after any major maintenance procedure.

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of children,

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as part of a health screening programme,

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involving high doses to the patient, such as interventional radiology, computed tomography or radiotherapy.

1.