Technisch reglement houdende de vaststelling van het model en de modaliteiten van de studie ter rechtvaardiging voor aanname voor veralgemeend gebruik van een handeling die medische blootstelling met zich meebrengt, de 30 mars 2020
HOOFDSTUK 1. - Definities
Artikel 1. De definities van het koninklijk besluit van 20 juli 2001 houdende algemeen reglement op de bescherming van de bevolking, van de werknemers en het leefmilieu tegen het gevaar van de ioniserende stralingen en het Besluit medische blootstellingen zijn van toepassing op dit technisch reglement.
HOOFDSTUK 2. - Algemene bepalingen
Art. 2. § 1. Het rapport van de studie ter rechtvaardiging volgt het model weergegeven in Bijlage 1.
§ 2. Indien bepaalde elementen niet van toepassing zijn voor de handeling in kwestie, mag dit als zodanig aangegeven worden in het rapport met een korte toelichting.
Art. 3. § 1. De aanvraag wordt geëvalueerd door het FANC.
§ 2. Indien nodig kan er bijkomende informatie opgevraagd worden door het FANC.
Art. 4. Het FANC keurt de aanvraag goed indien de handeling voldoende netto voordeel oplevert wanneer het totale potentiële diagnostische of therapeutische voordeel, waaronder begrepen het directe voordeel voor de gezondheid of de levenskwaliteit van de persoon die de blootstelling ondergaat en het maatschappelijke voordeel, wordt afgewogen tegen de individuele schade welke de persoon die de blootstelling ondergaat, kan ondervinden, rekening houdend met de doeltreffendheid, de voordelen en de risico's van beschikbare alternatieve technieken die hetzelfde oogmerk hebben maar die geen of minder blootstelling aan...
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