Technisch reglement tot vaststelling van de dosisbeperkingen voor personen die deelnemen aan experimenten op de menselijke persoon die een medische blootstelling inhouden en waarbij geen direct medisch voordeel van deze blootstellingen wordt verwacht, de 30 mars 2020
HOOFDSTUK 1. - Algemene bepalingen
Artikel 1. Dit reglement is van toepassing op personen die deelnemen aan experimenten op de menselijke persoon die een medische blootstelling inhouden en waarbij geen direct medisch voordeel van deze blootstellingen wordt verwacht.
HOOFDSTUK 2. - Vaststelling van dosisbeperkingen
Art. 2. Voor een volwassene van 50 jaar of jonger die deelneemt aan experimenten op de menselijke persoon, wordt de waarde van de dosisbeperking vastgesteld op:
* 0,1 mSv voor een experiment waarvan het verwachte voordeel voor de samenleving gering is en dat uitsluitend betrekking heeft op het verwerven van wetenschappelijke kennis;
* 1 mSv voor een experiment waarvan het verwachte voordeel voor de samenleving intermediair is, wat overeenkomt met het verwerven van wetenschappelijke kennis die leidt tot een algemeen voordeel voor de gezondheid;
* 10 mSv voor een experiment met een matig verwacht voordeel voor de samenleving en rechtstreeks gericht op de diagnose, behandeling of preventie van ziekten;
* - 20 mSv voor een experiment met een aanzienlijk verwacht voordeel voor de samenleving en rechtstreeks gericht op het redden van levens of het voorkomen of onderdrukken van ernstige ziekten.
Art. 3. Voor een...
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