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Article R1333-48 of the French Public Health Code

In the event of the use of a new technology intended for radiotherapy, radiosurgery, diagnosis or radioguided interventional practices, or of a new type of practice carried out using an existing technology, an order by the Minister for Health, issued after consultation with healthcare professionals and the opinion of the competent bodies, may lay down, on a transitional basis, special provisions for collecting and analysing information concerning the expected benefits…

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Article R1333-49 of the French Public Health Code

At the end of the transitional period mentioned in Article R. 1333-48, the information collected and the results of its analysis are taken into account to update the guide provided for in Article R. 1333-47 and, in the case of diagnostic examinations and radioguided interventional practices, to establish diagnostic reference levels, in accordance with the provisions of Article R. 1333-61.

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Article R1333-50 of the French Public Health Code

The provisions of Article R. 1333-48 apply : 1° To new radiopharmaceutical medicinal products benefiting from a marketing authorisation or an early access authorisation or a compassionate access authorisation mentioned in Article L. 5121-12 and II of Article L. 5121-12-1 ; 2° New radioactive implantable medical devices where this is justified by radiation protection issues.

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Article R1333-51 of the French Public Health Code

Any organised screening programme involving exposure to ionising radiation is authorised by an order of the Minister for Health, issued after consultation with the Haute Autorité de Santé. This order specifies, where applicable, the technique used for this screening.

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Article R1333-52 of the French Public Health Code

Prior to requesting and performing a procedure, the doctor or dental surgeon checks that it is justified on the basis of the guide or documents mentioned in article R. 1333-47. In the event of disagreement between the applicant and the person performing the procedure, the decision rests with the latter.

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Article R1333-53 of the French Public Health Code

No procedure involving exposure to ionising radiation may be performed without a prior written exchange of relevant clinical information between the applicant and the person performing the procedure. The applicant must specify in particular: 1° The reason ; 2° The purpose ; 3° The circumstances of the planned exposure, in particular any pregnancy; 4° Previous examinations or procedures performed; 5° Any information required to comply with the optimisation principle mentioned…

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Article R1333-55 of the French Public Health Code

When an exposure is not justified within the meaning of articles R. 1333-46 and R. 1333-47 but appears necessary for a patient in a particular case, the person requesting the procedure and the person performing the procedure shall mention the relevant clinical information prior to the exposure in their written exchanges and in the procedure report provided for in article R. 1333-66.

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Article R1333-56 of the French Public Health Code

A procedure using ionising radiation on an asymptomatic person to detect a disease at an early stage may be carried out either as part of organised screening for the disease, or after specific justification has been provided by the person carrying out the procedure in conjunction with the person requesting the procedure, taking into account, where appropriate, the recommendations of the Haute Autorité de Santé. The patient is informed of…

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Article R1333-57 of the French Public Health Code

The implementation of the optimisation principle referred to in 2° of Article L. 1333-2 aims to keep the dose of ionising radiation as low as reasonably achievable in order to obtain the medical information sought or to achieve the therapeutic objective of the exposure. Optimisation is implemented when equipment is selected and during the performance of each procedure. It includes the assessment of radiation doses or the activity of radioactive…

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