Public health: protection of individuals against ionizing radiation in medical exposures (repl. Direct. 84/466/Euratom)
1996/0230(CNS)
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).�