Règlement technique fixant les contraintes de dose pour les personnes participant à des expérimentations sur la personne humaine qui impliquent des expositions médicales et pour lesquelles aucun avantage médical direct n'est attendu de ces expositions, de 30 mars 2020
CHAPITRE 1er. - Dispositions générales
Article 1er. Le présent règlement s'applique aux personnes participant à des expérimentations sur la personne humaine qui impliquent des expositions médicales et pour lesquelles aucun avantage médical direct n'est attendu de ces expositions.
CHAPITRE 2. - Fixation des contraintes de dose
Art. 2. Pour un adulte de 50 ans ou moins participant à une expérimentation sur la personne humaine, la valeur de la contrainte de dose est fixée à :
* 0,1 mSv pour une expérimentation dont le bénéfice attendu pour la société est mineur, correspondant uniquement à une acquisition de connaissances scientifiques ;
* 1 mSv pour une expérimentation dont le bénéfice attendu pour la société est intermédiaire, correspondant à une acquisition de connaissances scientifiques menant à un bénéfice général pour la santé ;
* 10 mSv pour une expérimentation dont le bénéfice attendu pour la société est modéré, visant directement au diagnostic, au traitement ou à la prévention de maladies ;
* 20 mSv pour une expérimentation dont le bénéfice attendu pour la société est substantiel, visant directement à sauver des vies ou à prévenir ou atténuer des maladies graves.
Art. 3. Pour un...
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