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against the dangers of ionizing radiation in relation to medical exposure, and repealing Directive 84/466/Euratom (repealed)
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This is the original version (as it was originally adopted).
1.Medical exposure referred to in Article 1 (2) shall show a sufficient net benefit, weighing the total potential diagnostic or therapeutic benefits it produces, including the direct health benefits to an individual and the benefits to society, against the individual detriment that the exposure might cause, taking into account the efficacy, benefits and risks of available alternative techniques having the same objective but involving no or less exposure to ionizing radiation.
In particular:
(a)all new types of practices involving medical exposure shall be justified in advance before being generally adopted,
existing types of practices involving medical exposure may be reviewed whenever new, important evidence about their efficacy or consequences is acquired.
(b)all individual medical exposures shall be justified in advance taking into account the specific objectives of the exposure and the characteristics of the individual involved.
If a type of practice involving a medical exposure is not justified in general, a specific individual exposure of this type could be justified in special circumstances, to be evaluated on a case-by-case basis.
The prescriber and the practitioner as specified by Member States, shall seek, where practicable, to obtain previous diagnostic information or medical records relevant to the planned exposure and consider these data to avoid unnecessary exposure.
(c)medical exposure for biomedical and medical research shall be examined by an ethics committee, set up in accordance with national procedures and/or by the competent authorities.
(d)special attention shall be given to the justification of those medical exposures where there is no direct health benefit for the person undergoing the exposure and especially for those exposures on medico-legal grounds.
2.Exposure referred to in Article 1 (3) shall show a sufficient net benefit, taking into account also the direct health benefits to a patient, the benefits to individuals referred to in Article 1 (3) and the detriment that the exposure might cause.
3.If an exposure can not be justified, it should be prohibited.
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