CELEX: 51980PC0821
Language: en
Date: 1980-12-08
Title: Proposal for a Council Directive laying down basic measures for the radiation protection of persons undergoing medical examinations or treatment

No C 350/20                          Official Journal of the European Communities                                31. 12. 80
               Proposal for a Council Directive laying down basic measures for the radiation protection of
                                 persons undergoing medical examinations or treatment
                          (Submitted by the Commission to the Council on 18 December 1980)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,                          Whereas it must be recognized also that the number of
                                                                  radiological installations and the variety of uses of
Having regard to the Treaty establishing the European             ionizing radiation are increasing; whereas any resultant
Atomic Energy Community, and in particular Article 31             unjustified increase in public exposure must be
thereof,                                                          prevented;
Having regard to the proposal from the Commission,                Whereas given the growing use of ionizing radiation and
drawn up after obtaining the opinion of a group of               the proliferation of techniques, it is necessary to ensure
persons appointed by the Scientific and Technical                that users have the necessary competence and experience
Committee,                                                       to avoid inappropriate uses of these techniques; whereas
                                                                 any unnecessary proliferation of radiological installations
Having regard       to the opinion     of the     European       must be avoided;
Parliament,
                                                                 Whereas it is therefore appropriate that other provisions
Having regard to the opinion of the Economic and Social          be enacted to complement those contained in the
Committee,                                                       abovementioned Directive, laying down suitable
                                                                 measures relating to the radiation protection of patients,
Whereas the Council has adopted a Directive laying
down the basic safety standards for the health protection
of the general public and workers against the dangers of
ionizing radiation;                                              HAS ADOPTED THIS DIRECTIVE:
Whereas the standards also relate to problems of
radiation protection connected with the use of ionizing                                     Article 1
radiation for diagnostic and therapeutic purposes;
                                                                 Member States shall take all appropriate measures to
Whereas, on the one hand, apart from natural                     ensure that radiological procedures are carried out under
background radiation, medical exposure to radiation is           the responsibility of doctors or dentists engaged in
at present by far the major source of exposure to ionizing       radiology, who have a recognized competence in
radiation; whereas this problem has been repeatedly              radiation protection and who have received an adequate
reviewed by the World Health Organization, the United            training in radiation protection which is approved by the
Nations Scientific Committee on the Effects of Atomic            administrative authority and which is appropriate to the
Radiation and the International Commission on                    techniques used in medical and dental diagnostic
Radiological      Protection,   which      have     already      radiology, in radiotherapy or in nuclear medicine.
recommended measures with a view to preventing
excessive medical exposure;                                      Assistants shall receive instruction in the techniques
                                                                 applied and in suitable radiation protection procedures;
Whereas, on the other hand, ionizing radiation has               they shall receive training appropriate to their work.
enabled very great progress to be made in the diagnostic,
therapeutic and preventive aspects of medicine and
whereas, moreover, new techniques are • under
development, notably in nuclear medicine, high energy                                       Article 2
therapy and the use of computer-controlled tomography;
whereas, although it is certainly not desired to raise           (a) No radiological examination shall be carried out for
objections to the proper use of ionizing radiation for                preventive purposes without medical indication.
legitimate reasons and under good radiation protection
conditions, it is nevertheless important to eliminate            (b) Individual or collective preventive radiological
unnecessary radiation exposures;                                      examinations shall be carried out only if they are
                                                                      biologically, clinically or epidemiologically justified.
Whereas measures which make it possible to increase              (c) Radiological examinations carried out at the request
significantly the radiation protection of patients and of             of insurance companies shall depend on a previous
the general public in no way jeopardize the benefits -                medical decision. Such examinations may be refused
whether diagnostic, preventive or therapeutic -                       by the individuals concerned.
obtainable from radiation; whereas, on the contrary,
measures which avoid inappropriate or excessive                  (d) Direct fluoroscopic examinations without the use of
radiation exposure improve the quality and effectiveness              image intensification shall be carried out only when
of medical uses of radiation;                                         justified by exceptional circumstances.
 ---pagebreak---  31. 12. 80                           Official Journal of the European Communities                           No C 350/21
                           Article 3                              criteria of acceptability for radiological installations,
                                                                  without prejudice to the Community provisions on
 Member States shall take the steps necessary to ensure           harmonization relating to medical electroradiological
 that doctors or dentists engaged in radiology referred to        equipment.
 in Article 1 have acquired adequate and effective training
 in radiation protection.                                         All installations in use shall be kept under appropriate
                                                                  surveillance in regard to procedures relevant to
 Training facilities shall also be available for doctors or       radiological protection.
 dentists engaged in radiology already authorized to use
 ionizing radiation but who have not acquired the                 Member States shall implement the necessary measures
 necessary competence in radiation protection.                    with a view to improving inadequate or defective
                                                                  features of installations subject to such surveillance. In
                                                                  extreme cases Member States may require that certain
                          Article 4                               installations be removed from service.
The doctors or dentists engaged in radiology and
assistants referred to in Article 1 and 3 shall make the
necessary arrangements to ensure that exposures                                            Article 7
permitted for diagnostic purposes are kept under control
and as low as reasonably achievable.                              Member States shall determine the actual requirements
                                                                  of the population with a view to optimizing the
                                                                  use of sophisticated departments of radiotherapy,
                                                                  radiodiagnosis and nuclear medicine. A trained specialist
                          Article 5                               in medical physics shall be at any time available to such
                                                                  departments.
(a) Member States shall set up a system allowing any
     practitioner who may be consulted to ascertain what
     previous radiological examinations a patient has
     undergone.                                                                            Article 8
(b) Appropriate measures shall ensure that existing
                                                                 Member States shall take the steps necessary for
     radiological information or records can be made
                                                                 compliance with this Directive before 1 February 1983.
     available quickly and without complex formalities to
     other medical or dental practitioners treating the
                                                                 Member State shall inform the Commission of provisions
     patient.
                                                                 they have made to comply with this Directive.
                          Article 6
                                                                                           Article 9
Member States shall draw up an inventory of medical
and dental radiological equipment and shall establish            This Directive is addressed to the Member States.
              Proposal for
               I. a Council Directive amending Directives Nos 69/169/EEC and 78/1035/EEC - tax-free
                   allowances applied in international travel and to imports of goods in small consignments
                   of a non-commercial character: third countries
                   a third Council Directive amending Directive No 74/651/EEC on the tax reliefs to be
                   allowed on the importation of goods in small consignments of a non-commercial character
                   within the Community
                          (Submitted by the Commission to the Council on 18 December 1980)