Council Directive 97/43/Euratom (repealed)Show full title

Council Directive 97/43/Euratom

of 30 June 1997

on health protection of individuals against the dangers of ionizing radiation in relation to medical exposure, and repealing Directive 84/466/Euratom (repealed)

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Atomic Energy Community, and in particular Article 31 thereof,

Having regard to the proposal from the Commission, drawn up after obtaining the opinion of a group of persons appointed by the Scientific and Technical Committee,

Having regard to the opinion of the European Parliament(1),

Having regard to the opinion of the Economic and Social Committee(2),

(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,

HAS ADOPTED THIS DIRECTIVE:

(1)

OJ No C 167, 2. 6. 1997.

(2)

OJ No C 212, 22. 7. 1996, p. 32.

(3)

OJ No L 159, 29. 6. 1996, p. 1.

(4)

OJ No L 265, 5. 10. 1984, p. 1.

(5)

OJ No L 169, 12. 7. 1993, p. 1.