Council Directive 2013/59/EuratomShow full title

Article 55 U.K. Justification

1. Medical exposure shall show a sufficient net benefit, weighing the total potential diagnostic or therapeutic benefits it produces, including the direct benefits to health of 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 ionising radiation.

2. Member States shall ensure that the principle defined in paragraph 1 is applied and in particular that:

(a) new types of practices involving medical exposure are justified in advance before being generally adopted;

(b) all individual medical exposures are justified in advance taking into account the specific objectives of the exposure and the characteristics of the individual involved.

(c) if a type of practice involving medical exposure is not justified in general, a specific individual exposure of this type can be justified, where appropriate, in special circumstances, to be evaluated on a case-by-case basis and documented.

(d) the referrer and the practitioner, as specified by Member States, seek, where practicable, to obtain previous diagnostic information or medical records relevant to the planned exposure and consider these data to avoid unnecessary exposure.

(e) medical exposure for medical or biomedical research are examined by an ethics committee, set up in accordance with national procedures and/or by the competent authority;

(f) specific justification for medical radiological procedures to be performed as part of a health screening programme are carried out by the competent authority in conjunction with appropriate medical scientific societies or relevant bodies.

(g) the exposure of carers and comforters show a sufficient net benefit, taking into account the direct health benefits to a patient, the possible benefits to the carer / comforter and the detriment that the exposure might cause.

(h) any medical radiological procedure on an asymptomatic individual, to be performed for the early detection of disease, is part of a health screening programme, or requires specific documented justification for that individual by the practitioner, in consultation with the referrer, following guidelines from relevant medical scientific societies and the competent authority. Special attention shall be given to the provision of information to the individual subject to medical exposure, as required by point (d) of Article 57(1).