Council Directive 97/43/Euratom (repealed)Show full title

Article 4 Optimization

1. (a) All doses due to medical exposure for radiological purposes except radiotherapeutic procedures referred to in Article 1 (2) shall be kept as low as reasonably achievable consistent with obtaining the required diagnostic information, taking into account economic and social factors.

(b) For all medical exposure of individuals for radio-therapeutic purposes, as mentioned in Article 1 (2) (a), exposures of target volumes shall be individually planned; taking into account that doses of non-target volumes and tissues shall be as low as reasonably achievable and consistent with the intended radiotherapeutic purpose of the exposure.

2. Member States shall:

(a) promote the establishment and the use of diagnostic reference levels for radiodiagnostic examinations, as referred to in Article 1 (2) (a), (b), (c) and (e), and the availability of guidance for this purpose having regard to European diagnostic reference levels where available;

(b) ensure that for each biomedical and medical research project as mentioned in Article 1 (2) (d):

• (b) the individuals concerned shall participate voluntarily,

• these individuals shall be informed about the risks of this exposure,

• a dose constraint is established for individuals for whom no direct medical benefit is expected from this exposure,

• in the case of patients, who voluntarily accept to undergo an experimental diagnostic or therapeutic practice and who are expected to receive a diagnostic or therapeutical benefit from this practice, the target levels of doses shall be planned on an individual basis by the practitioner and/or prescriber,

(c) ensure that special attention be given, to keep the dose arising from the medico-legal exposure referred to in Article 1 (2) (e) as low as reasonably achievable.

3. The optimization process shall include the selection of equipment, the consistent production of adequate diagnostic information or therapeutic outcome as well as the practical aspects, quality assurance including quality control and the assessment and evaluation of patient doses or administered activities, taking into account economic and social factors.

4. Member States shall ensure that:

(a) dose constraints are established for exposure, as referred to in Article 1 (3), of those individuals knowingly and willingly helping (other than as part of their occupation) in the support and comfort of patients undergoing medical diagnosis or treatment where appropriate;

(b) appropriate guidance is established for exposure as referred to in Article 1 (3);

(c) in the case of a patient undergoing a treatment or diagnosis with radionuclides, where appropriate the practitioner or the holder of the radiological installation provides the patient or legal guardian with written instructions, with a view to the restriction of doses to persons in contact with the patient as far as reasonably achievable and to provide information on the risks of ionizing radiation.

These instructions shall be handed out before leaving the hospital or clinic or a similar institution.