Radiological protection for persons undergoing medical examination or treatment
This Directive lays down the general principles of the protection of individuals from radiation due to exposure for medical reasons and other associated practices involving ionising radiation.
This Directive repeals Directive 84/466 Euratom laying down basic measures for the radiation protection of persons undergoing medical examination or treatment. It also supplements Directive 96/29/Euratom.
Objective and scope
Medical exposure continues to constitute the major source of EU citizens' exposure to artificial sources of ionising radiation. However, the use of ionising radiation has allowed great progress in many areas of medicine. It is therefore essential that practices involving medical exposure are carried out in optimised radiation protection conditions. This is also the objective of this Directive.
The Directive applies to the following types of exposure:
- exposure of patients as part of their own medical diagnosis or treatment,
- exposure of individuals as part of occupational health surveillance,
- exposure of individuals as part of health screening programmes,
- exposure of individuals voluntarily participating in medical research programmes,
- exposure of individuals as part of medico-legal procedures.
Medical exposure must show a sufficient net benefit compared with the individual detriment that the exposure might cause, taking into account the benefits and risks of available alternative techniques.
All individual medical exposures must be justified in advance, taking into account the specific objectives of the exposure and the characteristics of the individual involved. Cases of medical exposure for biomedical and medical research must be examined by an ethics committee, set up in accordance with national procedures and/or by the competent authorities.
Special attention must be given to the justification of medical exposures for medico-legal purposes.
In general, exposure which cannot be justified should be prohibited.
All doses due to medical exposure must be kept as low as reasonably achievable consistent with obtaining the required diagnostic information.
Member States must promote the establishing and use of diagnostic reference levels for radiodiagnostic examinations, having regard to European diagnostic reference levels.
For each medical research project, Member States must ensure that:
- the individuals concerned are participating voluntarily,
- those individuals are informed about the risks of this exposure,
- a dose constraint is established for individuals for whom no direct medical benefit is expected from this exposure,
- in the case of patients who voluntarily agree to undergo an experimental diagnostic or therapeutic practice and who are expected to receive a diagnostic or therapeutic benefit from this practice, the target levels of doses shall be planned on an individual basis by the practitioner and/or prescriber.
Member States must ensure that dose constraints are established for exposure of individuals in contact with exposed patients. Instructions must be handed out before the patient leaves the medical institution.
Member States must ensure that any medical exposure is effected under the clinical responsibility of a practitioner.
Written protocols for every type of standard radiological practice must be established for each piece of equipment. In addition, recommendations concerning referral criteria for medical exposure must be made available to the prescribers of medical exposure.
Radiotherapeutic practices must be carried out with the assistance of a medical physics expert. For radiological practices, such an expert may be consulted on an advisory basis.
Clinical audits must be carried out in accordance with national procedures, and corrective measures must be taken where diagnostic reference levels are consistently exceeded.
Member States must ensure that practitioners receive theoretical and practical training. Continuing training must be provided after qualification. Member States must also encourage the introduction of a course on radiation protection in the basic curriculum of medical and dental schools.
Member States must take steps to avoid the unnecessary proliferation of radiological equipment. They must ensure that all radiological equipment in use is kept under strict surveillance regarding radiation protection, that an up-to-date inventory is available to the competent authorities, and that appropriate quality assurance programmes are implemented by the holder of the installation. Acceptance testing must be carried out before the first use of all equipment, and thereafter performance testing on a regular basis, and after any major maintenance procedure.
The competent authorities must ensure that the holders of radiological installations take the necessary steps to improve inadequate or defective features of the equipment.
In the case of fluoroscopy, examinations without an image intensification or equivalent techniques are prohibited. Moreover, fluoroscopic examinations without devices to control the dose rate shall be limited to justified circumstances.
Special practices and protection
Appropriate radiological equipment, practical techniques and ancillary equipment must used for medical exposure:
- of children,
- as part of a health screening programme,
- involving high doses to the patient.
Special attention must be given to the protection of women during pregnancy and while breast-feeding.
Member States must ensure that all reasonable steps are taken to reduce the probability and magnitude of accidental or unintended doses to patients.
Estimates of population doses
Member States must ensure that the distribution of individual dose estimates from medical exposure is determined for the population and, where necessary, for relevant reference groups.
Member States must ensure that the provisions introduced in compliance with this Directive are enforced by means of an inspection system.
Entry into force
Deadline for transposition in the Member States
OJ L 180 of 09.07.1997