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Document 31997L0043
Radiological protection for persons undergoing medical examination or treatment
This summary has been archived and will not be updated. See
'Setting basic safety standards for exposure to ionising radiation (from 2018)'
,
'Dangers arising from ionising radiation (from 2018)'
for an updated information about the subject.
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.
ACT
Council Directive 97/43/Euratom of 30 June 1997 on health protection of individuals against the dangers of ionising radiation in relation to medical exposure, and repealing Directive 84/466/Euratom.
SUMMARY
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:
Justification
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.
Optimisation
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:
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.
Clinical responsibility
Member States must ensure that any medical exposure is effected under the clinical responsibility of a practitioner.
Procedures
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.
Training
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.
Equipment
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:
Special attention must be given to the protection of women during pregnancy and while breast-feeding.
Accident prevention
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.
Inspection
Member States must ensure that the provisions introduced in compliance with this Directive are enforced by means of an inspection system.
References
Act |
Entry into force |
Deadline for transposition in the Member States |
Official Journal |
Directive 97/43/Euratom |
09.07.1997 |
13.05.2000 |
OJ L 180 of 09.07.1997 |
RELATED ACTS
Council Directive 89/618/Euratom of 27 November 1989 on informing the general public about health protection measures to be applied and steps to be taken in the event of a radiological emergency [Official Journal L 357 of 7.12.1989]
Last updated: 17.08.2006