Activites

• 1997/07/09 Final act published in Official Journal
  • Directive 1997/43
  • OJ L 180 09.07.1997, p. 0022
• #2022
• 1997/06/30 Council Meeting
• 1997/06/30 End of procedure in Parliament
• 1997/06/30 Act adopted by Council after consultation of Parliament
• 1997/06/19 Modified legislative proposal published
  • COM(1997)0315 summary

    In its amended proposal, the Commission incorporated 10 of the 12 amendments adopted by the European Parliament in plenary. The amendments incorporated concerned the following points: -the purpose of the Directive is to supplement Directive 96/29/EURATOM on basic safety standards as regards medical exposures, -insertion of a definition of 'potential exposures' and modification of the definition of 'medical physicist', deleting the reference to his responsibilities regarding the protection of workers and the public, -insertion of provisions concerning the optimum quality of the functioning of radiological equipment, -reference to national provisions with regard to the responsibilities of the prescriber and practitioner, -prohibition of exposures without direct health benefit for the person undergoing them, -insertion of a paragraph on taking out of service or replacing equipment and installations which do not comply with acceptability criteria, -strengthening of the role of medical physicists in checking equipment used in radiotherapy, -inclusion of exposures for radiotherapeutic purposes in the article on training of medical and paramedical staff, -improved protection of pregnant women in the case of exposure of the pelvic and abdominal regions. However, the Commission did not accept the amendment seeking to make it possible for every radiological unit to consult a medical physicist. Nor did it accept the amendment concerning the 'examining doctor' (rather than 'practitioner').�

• 1997/05/14 Decision by Parliament, 1st reading/single reading
  • T4-0231/1997 summary

    By adopting the report by Mr Amedeo AMADEO (NI, I) on the dangers of ionizing radiation, the European Parliament approved this proposal for a directive with the following amendments: -the proposed directive should supplement Directive 96/29/Euratom on the basic safety standards as regards medical exposures (rather than 80/836/Euratom), -exposures on medico-legal grounds where there is no direct health benefit for the person undergoing the exposures should be avoided, -every radiological unit must have the possibility of consulting a medical physicist for the necessary advice on the exposure, -the exposures covered by the directive should include exposure resulting from events such as equipment failure or faults or human error and with a probability of occurrence that can be assessed in advance, -Member States should ensure that equipment and installations which do not meet predetermined acceptability criteria are taken out of service or replaced, -a medical physicist should check the suitability of the equipment on the basis of the exposure/diagnostic benefit ratio, laying down the maximum and minimum reference criteria, -quality assurance, as defined in the directive, implies the optimum quality of the equipment (Parliament defines what should be meant by 'optimum quality': in the case of radiodiagnostic procedure, the production of adequate diagnostic information with minimum exposure of patients and workers, and in the case of radiotherapeutic procedures, the optimum exposure of patients and workers), -the prescriber and the examining doctor should have specific responsibilities in accordance with the provisions laid down by the Member State, -pregnant women should not undergo exposure (particularly for medical purposes) affecting the pelvic and abdominal regions (unless their health will otherwise be seriously affected).�

• 1997/05/13 Debate in Parliament
• 1997/04/16 Vote in committee, 1st reading/single reading
  • A4-0146/1997
• 1996/10/23 Committee referral announced in Parliament, 1st reading/single reading
• 1996/09/26 Legislative proposal published
  • COM(1996)0465 summary

    OBJECTIVE: to revise Directive 84/466/Euratom and to specify requirements to be satisfied in order to protect persons who undergo medical examinations or treatment entailing their exposure to ionizing radiation. SUBSTANCE: the Commission proposes the following amendments to the existing directive (84/466/Euratom): - the scope of the directive is more clearly defined with respect to the exposure of individuals as part of medico-legal, insurance or legal procedures. It is extended to include individuals who participate in research as volunteers or who support and comfort patients; - the provisions requiring the application of the principle of justification and optimization to medical exposures have been expanded (specific requirements); - besides requiring that any use of ionizing radiation in medical procedures is effected under the responsibility of a practitioner, the proposal permits practical aspects of the medical procedure to be delegated to other individuals authorized by the competent national authorities. The requirements for the training of the practitioners and other individuals are explicitly set out. In addition, the proposal: - expands the existing requirements on quality control of the installations and requires the establishment of quality assurance programmes which also include assessments of the doses received by the patient; - introduces new requirements concerning paediatric exposures, health screening programmes, procedures involving high doses, the exposure of pregnant and breast-feeding women and the exposure of helpers and volunteers; - introduces the concept of potential exposures and requires their probability and magnitude to be kept as low as reasonably possible; - requests the Member States to ensure the establishment of processes for auditing the implementation of the requirements of the Directive. �

Documents

• Legislative proposal published: COM(1996)0465
• Committee report tabled for plenary, 1st reading/single reading: A4-0146/1997
• Decision by Parliament, 1st reading/single reading: T4-0231/1997
• Modified legislative proposal published: COM(1997)0315
• : Directive 1997/43
• : OJ L 180 09.07.1997, p. 0022

History

(these mark the time of scraping, not the official date of the change)