Règlement technique établissant le modèle et les modalités de l'étude de justification en faveur de l'adoption pour utilisation généralisée d'une pratique impliquant une exposition à des fins médicales, de 30 mars 2020
CHAPITRE 1er. - Définitions
Article 1er. Les définitions de l'arrêté royal du 20 juillet 2001 portant règlement général de la protection de la population, des travailleurs et de l'environnement contre le danger des rayonnements ionisants et de l'Arrêté expositions médicales s'appliquent au présent règlement technique.
CHAPITRE 2. - Dispositions générales
Art. 2. § 1. Le rapport de l'étude de justification respecte le modèle figurant à l'Annexe 1.
§ 2. Si certains éléments ne s'appliquent pas à la pratique en question, il convient de l'indiquer dans le rapport en fournissant une brève explication.
Art. 3. § 1. La demande est évaluée par l'AFCN.
§ 2. Des renseignements complémentaires peuvent, le cas échéant, être demandés par l'AFCN.
Art. 4. L'AFCN approuve la demande si la pratique présente un avantage net suffisant, lorsqu'on compare les avantages diagnostiques ou thérapeutiques potentiels globaux qu'elle procure, y compris les avantages directs pour la santé et la qualité de vie de la personne concernée et les avantages pour la société par rapport au préjudice individuel qu'une exposition pourrait provoquer, en tenant compte de l'efficacité ainsi que des avantages et des risques d'autres techniques disponibles ayant le même objectif mais n'impliquant aucune exposition ou une exposition moindre aux rayonnements...
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