Décision du 22 août 2013 portant agrément d'un organisme chargé du contrôle de qualité externe des installations de radiothérapie externe prévu par la décision du 27 juillet 2007 fixant les modalités du contrôle de qualité externe des installations de radiothérapie externe
Jurisdiction | France |
Enactment Date | 22 août 2013 |
ELI | https://www.legifrance.gouv.fr/eli/decision/2013/8/22/AFSM1300166S/jo/texte |
Date de publication | 26 septembre 2013 |
Publication au Gazette officiel | JORF n°0224 du 26 septembre 2013 |
Court | Ministère des affaires sociales et de la santé |
Record Number | JORFTEXT000027991341 |
Le directeur général de l'Agence nationale de sécurité du médicament et des produits de santé,
Vu le code de la santé publique, notamment ses articles L. 5212-1 et R. 5212-25 à R. 5212-35 ;
Vu l'arrêté du 3 mars 2003 fixant les listes des dispositifs médicaux soumis à l'obligation de maintenance et au contrôle de qualité mentionnés aux articles L. 5212-1 et R. 5212-26 du code de la santé publique ;
Vu l'arrêté du 20 novembre 2007 relatif à l'agrément des organismes de contrôle de qualité externe des dispositifs médicaux prévu à l'article R. 5212-29 du code de la santé publique ;
Vu la décision du 27 juillet 2007 fixant les modalités du contrôle de qualité externe des installations de radiothérapie externe ;
Vu l'accréditation n° 3-0681 rév.8 délivrée à la société CIBIO par le COFRAC au titre de son programme d'accréditation INS REF 14 pour le contrôle de qualité externe des dispositifs médicaux, prenant effet à compter du 15 juillet 2013 ;
Vu la demande d'agrément présentée par la société CIBIO le 12 juillet 2013 et l'instruction qui en a été faite...
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