{ "article": { "LEGIARTI000021708723": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L6221-7", "ETAT": "VIGUEUR", "TYPE": "AUTONOME", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2010-01-16" } }, "META_COMMUN": { "ID": "LEGIARTI000021708723", "URL": "article/LEGI/ARTI/00/00/21/70/87/LEGIARTI000021708723.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "NOTA": { "CONTENU": "

Par décision du Conseil d'Etat n° 337396 du 23 décembre 2010 l'ordonnance du 13 janvier 2010 est annulée en tant qu'elle n'interdit ni aux professionnels de santé qui ne sont pas autorisés à prescrire des examens de biologie médicale, ni aux établissements de santé, sociaux et médico-sociaux de droit privé, de participer directement ou indirectement au capital d'une société exploitant un laboratoire de biologie médicale.

" }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000021684172", "@num": "1", "#text": "Ordonnance n°2010-49\n du 13 janvier 2010 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000021683301", "@nortexte": "SASX0927179R", "@numtexte": "2010-49", "@typelien": "MODIFIE", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2010-01-13" }, { "@id": "LEGIARTI000006686103", "@num": "L1221-13", "#text": "Code de la santé publique - art. L1221-13", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690305", "@num": "L5212-1", "#text": "Code de la santé publique - art. L5212-1", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690330", "@num": "L5222-3", "#text": "Code de la santé publique - art. L5222-3", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006691271", "@num": "L6221-6", "#text": "Code de la santé publique - art. L6221-6", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000036508442", "@num": "L6224-2", "#text": "Code de la santé publique - art. L6224-2 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000031930803", "@num": "L6241-1", "#text": "Code de la santé publique - art. L6241-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694502", "@num": "L761-7", "#text": "Code de la santé publique - art. L761-7 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006171486", "@fin": "2010-01-16", "#text": "Chapitre Ier : Conditions d'exercice.", "@debut": "2000-06-22" }, { "@id": "LEGISCTA000021708748", "@fin": "2999-01-01", "#text": "Chapitre Ier : Accréditation et contrôle de qualité", "@debut": "2010-01-16" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006155113", "@fin": "2010-01-16", "#text": "Titre II : Directeurs des laboratoires", "@debut": "2000-06-22" }, { "@id": "LEGISCTA000021708750", "@fin": "2999-01-01", "#text": "Titre II : Organisation", "@debut": "2010-01-16" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006140637", "@fin": "2010-01-16", "#text": "Livre II : Laboratoires d'analyses de biologie médicale", "@debut": "2000-06-22" }, { "@id": "LEGISCTA000021708789", "@fin": "2999-01-01", "#text": "Livre II : Biologie médicale", "@debut": "2010-01-16" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006125350", "@fin": "2999-01-01", "#text": "Sixième partie : Etablissements et services de santé", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006103419", "@fin": "2999-01-01", "#text": "Partie législative", "@debut": "2000-06-22" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006691272", "@fin": "2010-01-16", "@num": "L6221-7", "@etat": "MODIFIE", "@debut": "2000-06-22", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000021708723", "@fin": "2999-01-01", "@num": "L6221-7", "@etat": "VIGUEUR", "@debut": "2010-01-16", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

Sans préjudice des dispositions des articles L. 1221-13, L. 5212-1, L. 5222-3 et L. 5232-4, le biologiste-responsable du laboratoire de biologie médicale déclare immédiatement aux organismes mentionnés à l'article L. 6221-6 tout événement affectant son fonctionnement et susceptible d'entraîner un risque majeur pour la santé des patients.

" } }, "LEGIARTI000006686103": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L1221-13", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2004-08-11", "DATE_DEBUT": "2000-06-22" } }, "META_COMMUN": { "ID": "LEGIARTI000006686103", "URL": "article/LEGI/ARTI/00/00/06/68/61/LEGIARTI000006686103.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPANXXXXXXX1X1221L13XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000217229", "#text": "Ordonnance 2000-548 2000-06-15", "@sens": "source", "@cidtexte": "JORFTEXT000000217229", "@nortexte": "MESX0000036P", "@typelien": "CODIFICATION", "@naturetexte": "RAPPORT", "@datesignatexte": "2999-01-01" }, { "@id": "JORFTEXT000000227015", "#text": "Loi 2002-303 2002-03-04 art. 92 JORF 5 mars 2002", "@sens": "source", "@cidtexte": "JORFTEXT000000227015", "@nortexte": "MESX0100092L", "@numtexte": "2002-303", "@typelien": "CODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2002-03-04" }, { "@id": "LEGIARTI000034152829", "@num": "1", "#text": "Arrêté du 27 février 2017 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000034150863", "@nortexte": "AFSP1706243A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2017-02-27" }, { "@id": "LEGIARTI000006417944", "@num": "226-13", "#text": "Code pénal - art. 226-13 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006070719", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006417946", "@num": "226-14", "#text": "Code pénal - art. 226-14 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006070719", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000021708723", "@num": "L6221-7", "#text": "Code de la santé publique - art. L6221-7 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000027480644", "@num": "L6221-9", "#text": "Code de la santé publique - art. L6221-9 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694212", "@num": "L666-12", "#text": "Code de la santé publique - art. L666-12 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694210", "@num": "L666-12", "#text": "Code de la santé publique - art. L666-12 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000039459172", "@num": "R1413-61-1", "#text": "Code de la santé publique - art. R1413-61-1 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000034687007", "@num": "R1413-68", "#text": "Code de la santé publique - art. R1413-68 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000034686956", "@num": "R1413-79", "#text": "Code de la santé publique - art. R1413-79 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000034682983", "@num": "R1524-5", "#text": "Code de la santé publique - art. R1524-5 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000034687243", "@num": "R1524-6", "#text": "Code de la santé publique - art. R1524-6 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006802537", "@num": "R711-1-11", "#text": "Code de la santé publique - art. R711-1-11 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006171018", "@fin": "2999-01-01", "#text": "Chapitre Ier : Collecte, préparation et conservation du sang, de ses composants et des produits sanguins labiles.", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006154985", "@fin": "2999-01-01", "#text": "Titre II : Sang humain", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006140604", "@fin": "2999-01-01", "#text": "Livre II : Don et utilisation des éléments et produits du corps humain", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006125345", "@fin": "2999-01-01", "#text": "Première partie : Protection générale de la santé", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006103419", "@fin": "2999-01-01", "#text": "Partie législative", "@debut": "2000-06-22" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006686103", "@fin": "2004-08-11", "@num": "L1221-13", "@etat": "MODIFIE", "@debut": "2000-06-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006686104", "@fin": "2005-09-02", "@num": "L1221-13", "@etat": "MODIFIE", "@debut": "2004-08-11", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006686105", "@fin": "2012-05-01", "@num": "L1221-13", "@etat": "MODIFIE", "@debut": "2005-09-02", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000025139304", "@fin": "2014-12-25", "@num": "L1221-13", "@etat": "MODIFIE", "@debut": "2012-05-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000029962861", "@fin": "2016-01-28", "@num": "L1221-13", "@etat": "MODIFIE", "@debut": "2014-12-25", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000031931400", "@fin": "2017-07-01", "@num": "L1221-13", "@etat": "MODIFIE", "@debut": "2016-01-28", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000033897135", "@fin": "2999-01-01", "@num": "L1221-13", "@etat": "VIGUEUR", "@debut": "2017-07-01", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
On entend par hémovigilance l'ensemble des procédures de surveillance organisées depuis la collecte du sang et de ses composants jusqu'au suivi des receveurs, en vue de recueillir et d'évaluer les informations sur les effets inattendus ou indésirables résultant de l'utilisation thérapeutique des produits sanguins labiles et d'en prévenir l'apparition.
\n
Les personnes qui ont à connaître de ces informations sont tenues au secret professionnel dans les conditions et sous les peines prévues aux articles 226-13 et 226-14 du code pénal.
\n
Un décret en Conseil d'Etat, pris après avis de l'Agence française de sécurité sanitaire des produits de santé, fixe les règles d'hémovigilance, et notamment la nature des informations nécessaires à la surveillance des effets de l'utilisation des produits sanguins labiles que les praticiens sont tenus de fournir, ainsi que les conditions d'exercice de cette surveillance.
" } }, "LEGIARTI000006686104": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L1221-13", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2005-09-02", "DATE_DEBUT": "2004-08-11" } }, "META_COMMUN": { "ID": "LEGIARTI000006686104", "URL": "article/LEGI/ARTI/00/00/06/68/61/LEGIARTI000006686104.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPANXXXXXXX1X1221L13XXAB" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000217229", "#text": "Ordonnance 2000-548 2000-06-15", "@sens": "source", "@cidtexte": "JORFTEXT000000217229", "@nortexte": "MESX0000036P", "@typelien": "CODIFICATION", "@naturetexte": "RAPPORT", "@datesignatexte": "2999-01-01" }, { "@id": "JORFTEXT000000227015", "#text": "Loi 2002-303 2002-03-04 art. 92 JORF 5 mars 2002", "@sens": "source", "@cidtexte": "JORFTEXT000000227015", "@nortexte": "MESX0100092L", "@numtexte": "2002-303", "@typelien": "CODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2002-03-04" }, { "@id": "LEGIARTI000006697740", "@num": "116", "#text": "Loi n°2004-806 du 9 août 2004 - art. 116 () JORF 11 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787078", "@nortexte": "SANX0300055L", "@numtexte": "2004-806", "@typelien": "MODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2004-08-09" }, { "@id": "LEGIARTI000034152829", "@num": "1", "#text": "Arrêté du 27 février 2017 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000034150863", "@nortexte": "AFSP1706243A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2017-02-27" }, { "@id": "LEGIARTI000006417944", "@num": "226-13", "#text": "Code pénal - art. 226-13 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006070719", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006417946", "@num": "226-14", "#text": "Code pénal - art. 226-14 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006070719", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000021708723", "@num": "L6221-7", "#text": "Code de la santé publique - art. 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R1413-61-1 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000034687007", "@num": "R1413-68", "#text": "Code de la santé publique - art. R1413-68 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000034686956", "@num": "R1413-79", "#text": "Code de la santé publique - art. R1413-79 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000034682983", "@num": "R1524-5", "#text": "Code de la santé publique - art. R1524-5 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000034687243", "@num": "R1524-6", "#text": "Code de la santé publique - art. R1524-6 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006802537", "@num": "R711-1-11", "#text": "Code de la santé publique - art. R711-1-11 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006171018", "@fin": "2999-01-01", "#text": "Chapitre Ier : Collecte, préparation et conservation du sang, de ses composants et des produits sanguins labiles.", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006154985", "@fin": "2999-01-01", "#text": "Titre II : Sang humain", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006140604", "@fin": "2999-01-01", "#text": "Livre II : Don et utilisation des éléments et produits du corps humain", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006125345", "@fin": "2999-01-01", "#text": "Première partie : Protection générale de la santé", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006103419", "@fin": "2999-01-01", "#text": "Partie législative", "@debut": "2000-06-22" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006686103", "@fin": "2004-08-11", "@num": "L1221-13", "@etat": "MODIFIE", "@debut": "2000-06-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006686104", "@fin": "2005-09-02", "@num": "L1221-13", "@etat": "MODIFIE", "@debut": "2004-08-11", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006686105", "@fin": "2012-05-01", "@num": "L1221-13", "@etat": "MODIFIE", "@debut": "2005-09-02", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000025139304", "@fin": "2014-12-25", "@num": "L1221-13", "@etat": "MODIFIE", "@debut": "2012-05-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000029962861", "@fin": "2016-01-28", "@num": "L1221-13", "@etat": "MODIFIE", "@debut": "2014-12-25", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000031931400", "@fin": "2017-07-01", "@num": "L1221-13", "@etat": "MODIFIE", "@debut": "2016-01-28", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000033897135", "@fin": "2999-01-01", "@num": "L1221-13", "@etat": "VIGUEUR", "@debut": "2017-07-01", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
On entend par hémovigilance l'ensemble des procédures de surveillance organisées depuis la collecte du sang et de ses composants jusqu'au suivi des receveurs, en vue de recueillir et d'évaluer les informations sur les effets inattendus ou indésirables résultant de l'utilisation thérapeutique des produits sanguins labiles en vue d'en prévenir l'apparition, ainsi que les informations sur les incidents graves ou inattendus survenus chez les donneurs. L'hémovigilance comprend également le suivi épidémiologique des donneurs.
\n
Les personnes qui ont à connaître de ces informations sont tenues au secret professionnel dans les conditions et sous les peines prévues aux articles 226-13 et 226-14 du code pénal.
\n
Un décret en Conseil d'Etat, pris après avis de l'Agence française de sécurité sanitaire des produits de santé, fixe les règles d'hémovigilance, et notamment la nature des informations nécessaires à la surveillance des effets de l'utilisation des produits sanguins labiles que les praticiens sont tenus de fournir, ainsi que les conditions d'exercice de cette surveillance.
" } }, "LEGIARTI000006686105": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L1221-13", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2012-05-01", "DATE_DEBUT": "2005-09-02" } }, "META_COMMUN": { "ID": "LEGIARTI000006686105", "URL": "article/LEGI/ARTI/00/00/06/68/61/LEGIARTI000006686105.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPANXXXXXXX1X1221L13XXAC" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000217229", "#text": "Ordonnance 2000-548 2000-06-15", "@sens": "source", "@cidtexte": "JORFTEXT000000217229", "@nortexte": "MESX0000036P", "@typelien": "CODIFICATION", "@naturetexte": "RAPPORT", "@datesignatexte": "2999-01-01" }, { "@id": "JORFTEXT000000227015", "#text": "Loi 2002-303 2002-03-04 art. 92 JORF 5 mars 2002", "@sens": "source", "@cidtexte": "JORFTEXT000000227015", "@nortexte": "MESX0100092L", "@numtexte": "2002-303", "@typelien": "CODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2002-03-04" }, { "@id": "LEGIARTI000006698394", "@num": "10", "#text": "Ordonnance n°2005-1087 du 1 septembre 2005 - art. 10 () JORF 2 septembre 2005", "@sens": "source", "@cidtexte": "JORFTEXT000000261711", "@nortexte": "SANX0500159R", "@numtexte": "2005-1087", "@typelien": "MODIFICATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2005-09-01" }, { "@id": "LEGIARTI000034152829", "@num": "1", "#text": "Arrêté du 27 février 2017 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000034150863", "@nortexte": "AFSP1706243A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2017-02-27" }, { "@id": "LEGIARTI000006417944", "@num": "226-13", "#text": "Code pénal - art. 226-13 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006070719", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006417946", "@num": "226-14", "#text": "Code pénal - art. 226-14 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006070719", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000021708723", "@num": "L6221-7", "#text": "Code de la santé publique - art. L6221-7 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000027480644", "@num": "L6221-9", "#text": "Code de la santé publique - art. L6221-9 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694212", "@num": "L666-12", "#text": "Code de la santé publique - art. L666-12 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694210", "@num": "L666-12", "#text": "Code de la santé publique - art. L666-12 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000039459172", "@num": "R1413-61-1", "#text": "Code de la santé publique - art. R1413-61-1 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000034687007", "@num": "R1413-68", "#text": "Code de la santé publique - art. R1413-68 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000034686956", "@num": "R1413-79", "#text": "Code de la santé publique - art. R1413-79 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000034682983", "@num": "R1524-5", "#text": "Code de la santé publique - art. R1524-5 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000034687243", "@num": "R1524-6", "#text": "Code de la santé publique - art. R1524-6 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006802537", "@num": "R711-1-11", "#text": "Code de la santé publique - art. R711-1-11 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006171018", "@fin": "2999-01-01", "#text": "Chapitre Ier : Collecte, préparation et conservation du sang, de ses composants et des produits sanguins labiles.", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006154985", "@fin": "2999-01-01", "#text": "Titre II : Sang humain", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006140604", "@fin": "2999-01-01", "#text": "Livre II : Don et utilisation des éléments et produits du corps humain", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006125345", "@fin": "2999-01-01", "#text": "Première partie : Protection générale de la santé", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006103419", "@fin": "2999-01-01", "#text": "Partie législative", "@debut": "2000-06-22" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006686103", "@fin": "2004-08-11", "@num": "L1221-13", "@etat": "MODIFIE", "@debut": "2000-06-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006686104", "@fin": "2005-09-02", "@num": "L1221-13", "@etat": "MODIFIE", "@debut": "2004-08-11", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006686105", "@fin": "2012-05-01", "@num": "L1221-13", "@etat": "MODIFIE", "@debut": "2005-09-02", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000025139304", "@fin": "2014-12-25", "@num": "L1221-13", "@etat": "MODIFIE", "@debut": "2012-05-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000029962861", "@fin": "2016-01-28", "@num": "L1221-13", "@etat": "MODIFIE", "@debut": "2014-12-25", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000031931400", "@fin": "2017-07-01", "@num": "L1221-13", "@etat": "MODIFIE", "@debut": "2016-01-28", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000033897135", "@fin": "2999-01-01", "@num": "L1221-13", "@etat": "VIGUEUR", "@debut": "2017-07-01", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
L'hémovigilance a pour objet l'ensemble des procédures de surveillance et d'évaluation des incidents, ainsi que des effets indésirables survenant chez les donneurs ou les receveurs de produits sanguins labiles. Elle porte sur l'ensemble de la chaîne transfusionnelle allant de la collecte des produits sanguins labiles jusqu'au suivi des receveurs. L'hémovigilance comprend également le suivi épidémiologique des donneurs.
\n
Les personnes qui ont à connaître de ces informations sont tenues au secret professionnel dans les conditions et sous les peines prévues aux articles 226-13 et 226-14 du code pénal.
\n
Un décret en Conseil d'Etat, pris après avis de l'Agence française de sécurité sanitaire des produits de santé, fixe les règles d'hémovigilance, et notamment la nature des informations nécessaires à la surveillance des effets de l'utilisation des produits sanguins labiles que les praticiens sont tenus de fournir, ainsi que les conditions d'exercice de cette surveillance.
" } }, "LEGIARTI000006690305": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5212-1", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2001-03-03", "DATE_DEBUT": "2000-06-22" } }, "META_COMMUN": { "ID": "LEGIARTI000006690305", "URL": "article/LEGI/ARTI/00/00/06/69/03/LEGIARTI000006690305.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPANXXXXXXX1X5212L01XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000217229", "#text": "Ordonnance 2000-548 2000-06-15", "@sens": "source", "@cidtexte": "JORFTEXT000000217229", "@nortexte": "MESX0000036P", "@typelien": "CODIFICATION", "@naturetexte": "RAPPORT", "@datesignatexte": "2999-01-01" }, { "@id": "JORFTEXT000000227015", "#text": "Loi 2002-303 2002-03-04 art. 92 JORF 5 mars 2002", "@sens": "source", "@cidtexte": "JORFTEXT000000227015", "@nortexte": "MESX0100092L", "@numtexte": "2002-303", "@typelien": "CODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2002-03-04" }, { "@id": "LEGITEXT000024478563", "#text": "Décret n°2011-968\n du 16 août 2011 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000024476540", "@nortexte": "ETSP1110434D", "@numtexte": "2011-968", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2011-08-16" }, { "@id": "LEGIARTI000038533524", "#text": "Arrêté du 23 mai 2019 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000038529178", "@nortexte": "SSAP1915191A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2019-05-23" }, { "@id": "LEGIARTI000043969385", "@num": "R2661-4", "#text": "Code de la commande publique - art. R2661-4 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000037701019", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000041587839", "@num": "L123-6", "#text": "Code de la construction et de l'habitation. - art. L123-6 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006074096", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006691660", "@num": "D665-5-3", "#text": "Code de la santé publique - art. D665-5-3 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000049573024", "@num": "L1333-30", "#text": "Code de la santé publique - art. L1333-30 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690286", "@num": "L5211-3", "#text": "Code de la santé publique - art. L5211-3 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000028352333", "@num": "L5461-5", "#text": "Code de la santé publique - art. L5461-5 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000047291570", "@num": "L5461-9", "#text": "Code de la santé publique - art. L5461-9 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000047084082", "@num": "L5522-1", "#text": "Code de la santé publique - art. L5522-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690832", "@num": "L6122-11", "#text": "Code de la santé publique - art. L6122-11 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690837", "@num": "L6122-13", "#text": "Code de la santé publique - art. L6122-13 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000021708723", "@num": "L6221-7", "#text": "Code de la santé publique - art. L6221-7 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694043", "@num": "L665-5", "#text": "Code de la santé publique - art. L665-5 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694042", "@num": "L665-5", "#text": "Code de la santé publique - art. L665-5 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006910095", "@num": "R1333-43", "#text": "Code de la santé publique - art. R1333-43 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006910150", "@num": "R1333-59", "#text": "Code de la santé publique - art. R1333-59 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006910178", "@num": "R1333-68", "#text": "Code de la santé publique - art. R1333-68 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000037017220", "@num": "R1333-78", "#text": "Code de la santé publique - art. R1333-78 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006798535", "@num": "R43-38", "#text": "Code de la santé publique - art. R43-38 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006798554", "@num": "R43-54", "#text": "Code de la santé publique - art. R43-54 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006798564", "@num": "R43-63", "#text": "Code de la santé publique - art. R43-63 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000037011280", "@num": "R5212-26", "#text": "Code de la santé publique - art. R5212-26 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000024479878", "@num": "R5212-35-1", "#text": "Code de la santé publique - art. R5212-35-1 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006806746", "@num": "R231-84", "#text": "Code du travail - art. R231-84 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072050", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006171393", "@fin": "2001-03-03", "#text": "Chapitre II : Matériovigilance.", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006155088", "@fin": "2001-03-03", "#text": "Titre Ier : Dispositifs médicaux", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006140631", "@fin": "2001-03-03", "#text": "Livre II : Dispositifs médicaux et autres produits et objets réglementés dans l'intérêt de la santé publique", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006125349", "@fin": "2999-01-01", "#text": "Cinquième partie : Produits de santé", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006103419", "@fin": "2999-01-01", "#text": "Partie législative", "@debut": "2000-06-22" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690305", "@fin": "2001-03-03", "@num": "L5212-1", "@etat": "MODIFIE", "@debut": "2000-06-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690306", "@fin": "2004-08-11", "@num": "L5212-1", "@etat": "MODIFIE", "@debut": "2001-03-03", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690307", "@fin": "2011-03-24", "@num": "L5212-1", "@etat": "MODIFIE", "@debut": "2004-08-11", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000023754995", "@fin": "2011-12-31", "@num": "L5212-1", "@etat": "MODIFIE", "@debut": "2011-03-24", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000026500017", "@fin": "2012-05-01", "@num": "L5212-1", "@etat": "MODIFIE", "@debut": "2011-12-31", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000025104429", "@fin": "2016-07-17", "@num": "L5212-1", "@etat": "MODIFIE", "@debut": "2012-05-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000032906183", "@fin": "2022-04-22", "@num": "L5212-1", "@etat": "MODIFIE", "@debut": "2016-07-17", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000045630348", "@fin": "2999-01-01", "@num": "L5212-1", "@etat": "VIGUEUR", "@debut": "2022-04-22", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Pour les dispositifs médicaux dont la liste est fixée par le ministre chargé de la santé après avis de l'Agence française de sécurité sanitaire des produits de santé, l'exploitant est tenu de s'assurer du maintien de ces performances et de la maintenance du dispositif médical.
\n
Cette obligation donne lieu, le cas échéant, à un contrôle de qualité dont les modalités sont définies par décret et dont le coût est pris en charge par les exploitants des dispositifs.
\n
Pour les dispositifs médicaux dont la liste est fixée par le ministre chargé de la santé après avis de l'Agence française de sécurité sanitaire des produits de santé, la personne morale ou physique responsable d'une nouvelle mise sur le marché fait établir préalablement une attestation technique, dont les modalités sont définies par décret, garantissant que le dispositif médical concerné est toujours conforme aux exigences essentielles prévues au premier alinéa de l'article L. 5211-3.
\n
Le non-respect des dispositions du présent article peut entraîner la mise hors service provisoire ou définitive du dispositif médical, prononcée par l'Agence française de sécurité sanitaire des produits de santé, ainsi que, le cas échéant, le retrait ou la suspension de l'autorisation de l'installation dans les conditions prévues aux articles L. 6122-11 et L. 6122-13.
" } }, "LEGIARTI000006690306": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5212-1", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2004-08-11", "DATE_DEBUT": "2001-03-03" } }, "META_COMMUN": { "ID": "LEGIARTI000006690306", "URL": "article/LEGI/ARTI/00/00/06/69/03/LEGIARTI000006690306.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPANXXXXXXX1X5212L01XXAB" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000217229", "#text": "Ordonnance 2000-548 2000-06-15", "@sens": "source", "@cidtexte": "JORFTEXT000000217229", "@nortexte": "MESX0000036P", "@typelien": "CODIFICATION", "@naturetexte": "RAPPORT", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006698239", "@num": "1", "#text": "n°2001-198 du 1 mars 2001 - art. 1 () JORF 3 mars 2001", "@sens": "source", "@cidtexte": "JORFTEXT000000588097", "@nortexte": "MESX0100017R", "@numtexte": "2001-198", "@typelien": "MODIFICATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2001-03-01" }, { "@id": "JORFTEXT000000227015", "#text": "Loi 2002-303 2002-03-04 art. 92 JORF 5 mars 2002", "@sens": "source", "@cidtexte": "JORFTEXT000000227015", "@nortexte": "MESX0100092L", "@numtexte": "2002-303", "@typelien": "CODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2002-03-04" }, { "@id": "LEGITEXT000024478563", "#text": "Décret n°2011-968\n du 16 août 2011 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000024476540", "@nortexte": "ETSP1110434D", "@numtexte": "2011-968", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2011-08-16" }, { "@id": "LEGIARTI000038533524", "#text": "Arrêté du 23 mai 2019 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000038529178", "@nortexte": "SSAP1915191A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2019-05-23" }, { "@id": "LEGIARTI000043969385", "@num": "R2661-4", "#text": "Code de la commande publique - art. R2661-4 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000037701019", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000041587839", "@num": "L123-6", "#text": "Code de la construction et de l'habitation. - art. L123-6 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006074096", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006691660", "@num": "D665-5-3", "#text": "Code de la santé publique - art. D665-5-3 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000049573024", "@num": "L1333-30", "#text": "Code de la santé publique - art. L1333-30 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690286", "@num": "L5211-3", "#text": "Code de la santé publique - art. L5211-3 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000028352333", "@num": "L5461-5", "#text": "Code de la santé publique - art. L5461-5 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000047291570", "@num": "L5461-9", "#text": "Code de la santé publique - art. L5461-9 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000047084082", "@num": "L5522-1", "#text": "Code de la santé publique - art. L5522-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690832", "@num": "L6122-11", "#text": "Code de la santé publique - art. L6122-11 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690837", "@num": "L6122-13", "#text": "Code de la santé publique - art. L6122-13 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000021708723", "@num": "L6221-7", "#text": "Code de la santé publique - art. L6221-7 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694043", "@num": "L665-5", "#text": "Code de la santé publique - art. L665-5 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694042", "@num": "L665-5", "#text": "Code de la santé publique - art. L665-5 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006910095", "@num": "R1333-43", "#text": "Code de la santé publique - art. R1333-43 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006910150", "@num": "R1333-59", "#text": "Code de la santé publique - art. R1333-59 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006910178", "@num": "R1333-68", "#text": "Code de la santé publique - art. R1333-68 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000037017220", "@num": "R1333-78", "#text": "Code de la santé publique - art. R1333-78 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006798535", "@num": "R43-38", "#text": "Code de la santé publique - art. R43-38 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006798554", "@num": "R43-54", "#text": "Code de la santé publique - art. R43-54 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006798564", "@num": "R43-63", "#text": "Code de la santé publique - art. R43-63 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000037011280", "@num": "R5212-26", "#text": "Code de la santé publique - art. R5212-26 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000024479878", "@num": "R5212-35-1", "#text": "Code de la santé publique - art. R5212-35-1 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006806746", "@num": "R231-84", "#text": "Code du travail - art. R231-84 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072050", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006171396", "@fin": "2999-01-01", "#text": "Chapitre II : Matériovigilance.", "@debut": "2001-03-03" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006155090", "@fin": "2999-01-01", "#text": "Titre Ier : Dispositifs médicaux", "@debut": "2001-03-03" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006140632", "@fin": "2999-01-01", "#text": "Livre II : Dispositifs médicaux, dispositifs médicaux de diagnostic in vitro et autres produits et objets réglementés dans l'intérêt de la santé publique", "@debut": "2001-03-03" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006125349", "@fin": "2999-01-01", "#text": "Cinquième partie : Produits de santé", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006103419", "@fin": "2999-01-01", "#text": "Partie législative", "@debut": "2000-06-22" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690305", "@fin": "2001-03-03", "@num": "L5212-1", "@etat": "MODIFIE", "@debut": "2000-06-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690306", "@fin": "2004-08-11", "@num": "L5212-1", "@etat": "MODIFIE", "@debut": "2001-03-03", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690307", "@fin": "2011-03-24", "@num": "L5212-1", "@etat": "MODIFIE", "@debut": "2004-08-11", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000023754995", "@fin": "2011-12-31", "@num": "L5212-1", "@etat": "MODIFIE", "@debut": "2011-03-24", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000026500017", "@fin": "2012-05-01", "@num": "L5212-1", "@etat": "MODIFIE", "@debut": "2011-12-31", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000025104429", "@fin": "2016-07-17", "@num": "L5212-1", "@etat": "MODIFIE", "@debut": "2012-05-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000032906183", "@fin": "2022-04-22", "@num": "L5212-1", "@etat": "MODIFIE", "@debut": "2016-07-17", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000045630348", "@fin": "2999-01-01", "@num": "L5212-1", "@etat": "VIGUEUR", "@debut": "2022-04-22", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Pour les dispositifs médicaux dont la liste est fixée par le ministre chargé de la santé après avis de l'Agence française de sécurité sanitaire des produits de santé, l'exploitant est tenu de s'assurer du maintien de ces performances et de la maintenance du dispositif médical.
\n
Cette obligation donne lieu, le cas échéant, à un contrôle de qualité dont les modalités sont définies par décret et dont le coût est pris en charge par les exploitants des dispositifs.
\n
Pour les dispositifs médicaux dont la liste est fixée par le ministre chargé de la santé après avis de l'Agence française de sécurité sanitaire des produits de santé, la personne morale ou physique responsable d'une nouvelle mise sur le marché fait établir préalablement une attestation technique, dont les modalités sont définies par décret, garantissant que le dispositif médical concerné est toujours conforme aux exigences essentielles prévues au premier alinéa de l'article L. 5211-3.
\n
Le non-respect des dispositions du présent article peut entraîner la mise hors service provisoire ou définitive du dispositif médical, prononcée par l'Agence française de sécurité sanitaire des produits de santé, ainsi que, le cas échéant, le retrait ou la suspension de l'autorisation de l'installation dans les conditions prévues aux articles L. 6122-11 et L. 6122-13.
" } }, "LEGIARTI000006690307": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5212-1", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2011-03-24", "DATE_DEBUT": "2004-08-11" } }, "META_COMMUN": { "ID": "LEGIARTI000006690307", "URL": "article/LEGI/ARTI/00/00/06/69/03/LEGIARTI000006690307.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPANXXXXXXX1X5212L01XXAC" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000217229", "#text": "Ordonnance 2000-548 2000-06-15", "@sens": "source", "@cidtexte": "JORFTEXT000000217229", "@nortexte": "MESX0000036P", "@typelien": "CODIFICATION", "@naturetexte": "RAPPORT", "@datesignatexte": "2999-01-01" }, { "@id": "JORFTEXT000000227015", "#text": "Loi 2002-303 2002-03-04 art. 92 JORF 5 mars 2002", "@sens": "source", "@cidtexte": "JORFTEXT000000227015", "@nortexte": "MESX0100092L", "@numtexte": "2002-303", "@typelien": "CODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2002-03-04" }, { "@id": "LEGIARTI000006697765", "@num": "140", "#text": "Loi n°2004-806 du 9 août 2004 - art. 140 () JORF 11 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787078", "@nortexte": "SANX0300055L", "@numtexte": "2004-806", "@typelien": "MODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2004-08-09" }, { "@id": "LEGITEXT000024478563", "#text": "Décret n°2011-968\n du 16 août 2011 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000024476540", "@nortexte": "ETSP1110434D", "@numtexte": "2011-968", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2011-08-16" }, { "@id": "LEGIARTI000038533524", "#text": "Arrêté du 23 mai 2019 - art. 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Pour les dispositifs médicaux dont la liste est fixée par le ministre chargé de la santé après avis de l'Agence française de sécurité sanitaire des produits de santé, l'exploitant est tenu de s'assurer du maintien de ces performances et de la maintenance du dispositif médical.
\n
Cette obligation donne lieu, le cas échéant, à un contrôle de qualité dont les modalités sont définies par décret et dont le coût est pris en charge par les exploitants des dispositifs.
\n
La personne physique ou morale responsable de la revente d'un dispositif médical d'occasion figurant sur une liste fixée par arrêté du ministre chargé de la santé, pris sur proposition du directeur général de l'Agence française de sécurité sanitaire des produits de santé, fait établir préalablement par un organisme agréé à cet effet par décision du directeur général de l'Agence française de sécurité sanitaire des produits de santé une attestation technique justifiant d'une maintenance régulière et du maintien des performances du dispositif médical concerné. Les modalités de l'agrément des organismes et de l'attestation technique sont définies par décret.
\n
Le non-respect des dispositions du présent article peut entraîner la mise hors service provisoire ou définitive du dispositif médical, prononcée par l'Agence française de sécurité sanitaire des produits de santé, ainsi que, le cas échéant, le retrait ou la suspension de l'autorisation de l'installation dans les conditions prévues aux articles L. 6122-11 et L. 6122-13.
" } }, "LEGIARTI000006690330": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5222-3", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2012-05-01", "DATE_DEBUT": "2001-03-03" } }, "META_COMMUN": { "ID": "LEGIARTI000006690330", "URL": "article/LEGI/ARTI/00/00/06/69/03/LEGIARTI000006690330.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPANXXXXXXX1X5222L03XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000217229", "#text": "Ordonnance 2000-548 2000-06-15", "@sens": "source", "@cidtexte": "JORFTEXT000000217229", "@nortexte": "MESX0000036P", "@typelien": "CODIFICATION", "@naturetexte": "RAPPORT", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006698241", "@num": "3", "#text": "n°2001-198 du 1 mars 2001 - art. 3 () JORF 3 mars 2001", "@sens": "source", "@cidtexte": "JORFTEXT000000588097", "@nortexte": "MESX0100017R", "@numtexte": "2001-198", "@typelien": "CREATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2001-03-01" }, { "@id": "JORFTEXT000000227015", "#text": "Loi 2002-303 2002-03-04 art. 92 JORF 5 mars 2002", "@sens": "source", "@cidtexte": "JORFTEXT000000227015", "@nortexte": "MESX0100092L", "@numtexte": "2002-303", "@typelien": "CODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2002-03-04" }, { "@id": "LEGIARTI000023097035", "@num": "Annexe II", "#text": "Arrêté du 9 novembre 2010 - art. 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Annexe IV (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000032967651", "@nortexte": "AFSP1622318A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-08-01" }, { "@id": "LEGIARTI000034152829", "@num": "1", "#text": "Arrêté du 27 février 2017 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000034150863", "@nortexte": "AFSP1706243A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2017-02-27" }, { "@id": "LEGIARTI000041898595", "@num": "10-3-1", "#text": "Arrêté du 23 mars 2020 - art. 10-3-1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041746744", "@nortexte": "SSAX2007864A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-03-23" }, { "@id": "LEGIARTI000041890409", "@num": "1", "#text": "Arrêté du 18 mai 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000041889362", "@nortexte": "SSAZ2011564A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-05-18" }, { "@id": "LEGIARTI000041898504", "@num": "1", "#text": "Arrêté du 20 mai 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000041897919", "@nortexte": "SSAZ2012596A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-05-20" }, { "@id": "LEGIARTI000043298218", "@num": "25", "#text": "Arrêté du 10 juillet 2020 - art. 25 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000042106233", "@nortexte": "SSAZ2018110A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-07-10" }, { "@id": "LEGIARTI000042609739", "@num": "26", "#text": "Arrêté du 10 juillet 2020 - art. 26 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000042106233", "@nortexte": "SSAZ2018110A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-07-10" }, { "@id": "LEGIARTI000043298194", "@num": "26-1", "#text": "Arrêté du 10 juillet 2020 - art. 26-1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000042106233", "@nortexte": "SSAZ2018110A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-07-10" }, { "@id": "LEGIARTI000043351359", "@num": "26-2", "#text": "Arrêté du 10 juillet 2020 - art. 26-2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000042106233", "@nortexte": "SSAZ2018110A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-07-10" }, { "@id": "LEGIARTI000042608596", "@num": "1", "#text": "Arrêté du 3 décembre 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000042607794", "@nortexte": "SSAZ2033724A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-12-03" }, { "@id": "LEGIARTI000043298023", "@num": "1", "#text": "Arrêté du 26 mars 2021 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000043294845", "@nortexte": "SSAZ2109865A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-03-26" }, { "@id": "LEGIARTI000047779186", "@num": "25", "#text": "Arrêté du 1 juin 2021 - art. 25 (M)", "@sens": "cible", "@cidtexte": "JORFTEXT000043575801", "@nortexte": "SSAZ2116944A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-06-01" }, { "@id": "LEGIARTI000047779165", "@num": "28", "#text": "Arrêté du 1 juin 2021 - art. 28 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000043575801", "@nortexte": "SSAZ2116944A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-06-01" }, { "@id": "LEGIARTI000043770220", "@num": "27", "#text": "Arrêté du 1er juin 2021 - art. 27 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000043575801", "@nortexte": "SSAZ2116944A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-06-01" }, { "@id": "LEGIARTI000044808700", "@num": "29", "#text": "Arrêté du 1er juin 2021 - art. 29 (M)", "@sens": "cible", "@cidtexte": "JORFTEXT000043575801", "@nortexte": "SSAZ2116944A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-06-01" }, { "@id": "LEGIARTI000043685770", "@num": "ANNEXE VI", "#text": "Arrêté du 16 juin 2021 - art. ANNEXE VI (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000043684636", "@nortexte": "SSAP2116553A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-06-16" }, { "@id": "LEGIARTI000043779691", "@num": "1", "#text": "Arrêté du 9 juillet 2021 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000043776706", "@nortexte": "SSAZ2121615A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-07-09" }, { "@id": "LEGITEXT000049305911", "#text": "Arrêté du 19 mars 2024 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000049304036", "@nortexte": "TSSP2405697A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2024-03-19" }, { "@id": "LEGIARTI000031937850", "@num": "D6211-10", "#text": "Code de la santé publique - art. D6211-10 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000046126105", "@num": "L5222-4", "#text": "Code de la santé publique - art. L5222-4 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690591", "@num": "L5462-2", "#text": "Code de la santé publique - art. L5462-2 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000021708723", "@num": "L6221-7", "#text": "Code de la santé publique - art. L6221-7 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000039459172", "@num": "R1413-61-1", "#text": "Code de la santé publique - art. R1413-61-1 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000034687007", "@num": "R1413-68", "#text": "Code de la santé publique - art. R1413-68 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000034686956", "@num": "R1413-79", "#text": "Code de la santé publique - art. R1413-79 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000034687243", "@num": "R1524-6", "#text": "Code de la santé publique - art. R1524-6 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025786997", "@num": "R5462-2", "#text": "Code de la santé publique - art. R5462-2 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006171398", "@fin": "2999-01-01", "#text": "Chapitre II : Mesures de vigilance.", "@debut": "2001-03-03" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006155091", "@fin": "2999-01-01", "#text": "Titre II : Dispositifs médicaux de diagnostic in vitro", "@debut": "2001-03-03" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006140632", "@fin": "2999-01-01", "#text": "Livre II : Dispositifs médicaux, dispositifs médicaux de diagnostic in vitro et autres produits et objets réglementés dans l'intérêt de la santé publique", "@debut": "2001-03-03" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006125349", "@fin": "2999-01-01", "#text": "Cinquième partie : Produits de santé", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006103419", "@fin": "2999-01-01", "#text": "Partie législative", "@debut": "2000-06-22" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690330", "@fin": "2012-05-01", "@num": "L5222-3", "@etat": "MODIFIE", "@debut": "2001-03-03", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000025104704", "@fin": "2022-07-31", "@num": "L5222-3", "@etat": "MODIFIE", "@debut": "2012-05-01", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000046126072", "@fin": "2999-01-01", "@num": "L5222-3", "@etat": "VIGUEUR", "@debut": "2022-07-31", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Le fabricant ou son mandataire, l'importateur, le distributeur, les professionnels de santé utilisateurs sont tenus de signaler sans délai à l'Agence française de sécurité sanitaire des produits de santé toute défaillance ou altération d'un dispositif médical de diagnostic in vitro susceptible d'entraîner des effets néfastes pour la santé des personnes. Le fabricant ou son mandataire est tenu d'informer l'Agence française de sécurité sanitaire des produits de santé de tout rappel de dispositifs médicaux de diagnostic in vitro, et de lui communiquer, à sa demande, toute information utile à la mise en oeuvre de mesures de protection sanitaire à l'égard des patients.
\n
Le fabricant ou son mandataire, l'importateur et le distributeur sont tenus de conserver toutes les informations nécessaires au rappel éventuel de dispositifs médicaux de diagnostic in vitro mentionné à l'alinéa précédent.
" } }, "LEGIARTI000006691271": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L6221-6", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2010-01-16", "DATE_DEBUT": "2000-06-22" } }, "META_COMMUN": { "ID": "LEGIARTI000006691271", "URL": "article/LEGI/ARTI/00/00/06/69/12/LEGIARTI000006691271.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPANXXXXXXX1X6221L06XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000217229", "#text": "Ordonnance 2000-548 2000-06-15", "@sens": "source", "@cidtexte": "JORFTEXT000000217229", "@nortexte": "MESX0000036P", "@typelien": "CODIFICATION", "@naturetexte": "RAPPORT", "@datesignatexte": "2999-01-01" }, { "@id": "JORFTEXT000000227015", "#text": "Loi 2002-303 2002-03-04 art. 92 JORF 5 mars 2002", "@sens": "source", "@cidtexte": "JORFTEXT000000227015", "@nortexte": "MESX0100092L", "@numtexte": "2002-303", "@typelien": "CODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2002-03-04" }, { "@id": "LEGIARTI000006691267", "@num": "L6221-2", "#text": "Code de la santé publique - art. L6221-2 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006691269", "@num": "L6221-4", "#text": "Code de la santé publique - art. L6221-4 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006691270", "@num": "L6221-5", "#text": "Code de la santé publique - art. L6221-5 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000021708723", "@num": "L6221-7", "#text": "Code de la santé publique - art. L6221-7 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000036508435", "@num": "L6224-1", "#text": "Code de la santé publique - art. L6224-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694499", "@num": "L761-6", "#text": "Code de la santé publique - art. L761-6 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694497", "@num": "L761-6", "#text": "Code de la santé publique - art. L761-6 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000031938820", "@num": "R6221-4", "#text": "Code de la santé publique - art. R6221-4 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006171486", "@fin": "2010-01-16", "#text": "Chapitre Ier : Conditions d'exercice.", "@debut": "2000-06-22" }, { "@id": "LEGISCTA000021708748", "@fin": "2999-01-01", "#text": "Chapitre Ier : Accréditation et contrôle de qualité", "@debut": "2010-01-16" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006155113", "@fin": "2010-01-16", "#text": "Titre II : Directeurs des laboratoires", "@debut": "2000-06-22" }, { "@id": "LEGISCTA000021708750", "@fin": "2999-01-01", "#text": "Titre II : Organisation", "@debut": "2010-01-16" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006140637", "@fin": "2010-01-16", "#text": "Livre II : Laboratoires d'analyses de biologie médicale", "@debut": "2000-06-22" }, { "@id": "LEGISCTA000021708789", "@fin": "2999-01-01", "#text": "Livre II : Biologie médicale", "@debut": "2010-01-16" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006125350", "@fin": "2999-01-01", "#text": "Sixième partie : Etablissements et services de santé", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006103419", "@fin": "2999-01-01", "#text": "Partie législative", "@debut": "2000-06-22" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006691271", "@fin": "2010-01-16", "@num": "L6221-6", "@etat": "MODIFIE", "@debut": "2000-06-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000021708729", "@fin": "2012-05-01", "@num": "L6221-6", "@etat": "MODIFIE", "@debut": "2010-01-16", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000025104594", "@fin": "2999-01-01", "@num": "L6221-6", "@etat": "VIGUEUR", "@debut": "2012-05-01", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Les dispositions des articles L. 6221-4 et L. 6221-5 sont applicables aux bénéficiaires de l'autorisation prévue à l'article L. 6221-2 qui doivent effectuer les communications prévues par lesdits articles au ministre chargé de la santé.
\n
" } }, "LEGIARTI000021684172": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "1", "TYPE": "ENTIEREMENT_MODIF", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2999-01-01" } }, "META_COMMUN": { "ID": "LEGIARTI000021684172", "URL": "article/LEGI/ARTI/00/00/21/68/41/LEGIARTI000021684172.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000684004", "#text": "Loi n° 47-1775 du 10 septembre 1947", "@sens": "source", "@cidtexte": "JORFTEXT000000684004", "@numtexte": "47-1775", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "1947-09-10" }, { "@id": "JORFTEXT000000692471", "#text": "LOI n° 66-879 du 29 novembre 1966", "@sens": "source", "@cidtexte": "JORFTEXT000000692471", "@numtexte": "66-879", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "1966-11-29" }, { "@id": "JORFTEXT000000718101", "#text": "LOI n° 90-1258 du 31 décembre 1990", "@sens": "source", "@cidtexte": "JORFTEXT000000718101", "@nortexte": "JUSX9000026L", "@numtexte": "90-1258", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "1990-12-31" }, { "@id": "JORFARTI000019284119", "@num": "137", "#text": "LOI n° 2008-776 du 4 août 2008 - art. 137", "@sens": "source", "@cidtexte": "JORFTEXT000019283050", "@nortexte": "ECEX0808477L", "@numtexte": "2008-776", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2008-08-04" }, { "@id": "JORFTEXT000021683301", "#text": "Ordonnance n° 2010-49 du 13 janvier 2010", "@sens": "source", "@cidtexte": "JORFTEXT000021683301", "@nortexte": "SASX0927179R", "@numtexte": "2010-49", "@typelien": "CITATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2010-01-13" }, { "@id": "LEGIARTI000006227107", "@num": "L227-13", "#text": "Code de commerce - art. L227-13", "@sens": "source", "@cidtexte": "LEGITEXT000005634379", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006417202", "@num": "121-2", "#text": "Code pénal - art. 121-2", "@sens": "source", "@cidtexte": "LEGITEXT000006070719", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006417273", "@num": "131-21", "#text": "Code pénal - art. 131-21", "@sens": "source", "@cidtexte": "LEGITEXT000006070719", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006417291", "@num": "131-27", "#text": "Code pénal - art. 131-27", "@sens": "source", "@cidtexte": "LEGITEXT000006070719", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006417308", "@num": "131-35", "#text": "Code pénal - art. 131-35", "@sens": "source", "@cidtexte": "LEGITEXT000006070719", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006417944", "@num": "226-13", "#text": "Code pénal - art. 226-13", "@sens": "source", "@cidtexte": "LEGITEXT000006070719", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006418581", "@num": "433-17", "#text": "Code pénal - art. 433-17", "@sens": "source", "@cidtexte": "LEGITEXT000006070719", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGISCTA000021708837", "#text": "Code de la santé publique - Chapitre II : Laboratoire de biologie médicale (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGISCTA000021708698", "#text": "Code de la santé publique - Chapitre II : Conditions d'ouverture et de fonc... (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGISCTA000021708633", "#text": "Code de la santé publique - Chapitre II : Sanctions pénales (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGISCTA000021708812", "#text": "Code de la santé publique - Chapitre III : Biologiste médical (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGISCTA000021708932", "#text": "Code de la santé publique - Chapitre III : Structures juridiques (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGISCTA000006171485", "#text": "Code de la santé publique - Chapitre IV : Dispositions pénales. 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L6221-7 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000021708719", "@num": "L6221-8", "#text": "Code de la santé publique - art. L6221-8 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000021708715", "@num": "L6221-9", "#text": "Code de la santé publique - art. L6221-9 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000021708695", "@num": "L6222-1", "#text": "Code de la santé publique - art. L6222-1 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000021708692", "@num": "L6222-2", "#text": "Code de la santé publique - art. L6222-2 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000021708690", "@num": "L6222-3", "#text": "Code de la santé publique - art. L6222-3 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000021708687", "@num": "L6222-4", "#text": "Code de la santé publique - art. L6222-4 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000021708685", "@num": "L6222-5", "#text": "Code de la santé publique - art. L6222-5 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000021708938", "@num": "L6222-6", "#text": "Code de la santé publique - art. 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L6223-2 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000021708882", "@num": "L6223-3", "#text": "Code de la santé publique - art. L6223-3 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000021708875", "@num": "L6223-4", "#text": "Code de la santé publique - art. L6223-4 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000021708869", "@num": "L6223-5", "#text": "Code de la santé publique - art. L6223-5 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000021708860", "@num": "L6223-6", "#text": "Code de la santé publique - art. L6223-6 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000021708855", "@num": "L6223-7", "#text": "Code de la santé publique - art. L6223-7 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000021708917", "@num": "L6231-1", "#text": "Code de la santé publique - art. L6231-1 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000021708910", "@num": "L6231-2", "#text": "Code de la santé publique - art. L6231-2 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000021708655", "@num": "L6241-1", "#text": "Code de la santé publique - art. L6241-1 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000021708652", "@num": "L6241-2", "#text": "Code de la santé publique - art. L6241-2 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000021708648", "@num": "L6241-3", "#text": "Code de la santé publique - art. L6241-3 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000021708646", "@num": "L6241-4", "#text": "Code de la santé publique - art. L6241-4 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000021708637", "@num": "L6241-5", "#text": "Code de la santé publique - art. L6241-5 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000021708635", "@num": "L6241-6", "#text": "Code de la santé publique - art. L6241-6 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000021708629", "@num": "L6242-1", "#text": "Code de la santé publique - art. L6242-1 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000021708943", "@num": "L6242-2", "#text": "Code de la santé publique - art. L6242-2 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000021708922", "@num": "L6242-3", "#text": "Code de la santé publique - art. 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A modifié les dispositions suivantes :

-Code de la santé publique
\nSct. Livre II : Biologie médicale, Sct. Titre Ier : Définition et principes généraux, Sct. Chapitre Ier : Examen de biologie médicale, Sct. Section 1 : Définitions et champ d'application, Art. L6211-1, Art. L6211-2, Art. L6211-3, Art. L6211-4, Art. L6211-5\n, Art L6211-6, \nArt. L6211-2-1, Art. L6211-6, Sct. Section 2 : Conditions et modalités de réalisation, Art. L6211-7, Art. L6211-8, Art. L6211-9, Art. L6213-6, Sct. Titre II : Organisation, Sct. Chapitre Ier : Accréditation et contrôle de qualité, Art. L6221-1, Art. L6221-2, Art. L6221-2-1, Art. L6221-3, Art. L6221-4, Art. L6221-5, Art. L6221-6, Art. L6221-7, Art. L6221-8, Art. L6221-9, Art. L6221-10, Art. L6221-11, Art. L6221-11-1, Art. L6221-12, Art. L6221-13, Sct. Chapitre II : Conditions d'ouverture et de fonctionnement, Art. L6222-1, Art. L6222-2, Art. L6222-3, Art. L6222-4, Art. L6222-5, Sct. Titre IV : Sanctions, Sct. Chapitre Ier : Sanctions administratives et disciplinaires, Sct. Section 1 : Sanctions administratives, Art. L6241-1, Art. L6241-2, Art. L6241-3, Art. L6241-4, Sct. Section 2 : Sanctions disciplinaires, Art. L6241-5, Art. L6241-6, Sct. Chapitre II : Sanctions pénales, Art. L6242-1
\n

A créé les dispositions suivantes :

-Code de la santé publique
\nSct. Chapitre III : Structures juridiques, Sct. Titre III : Inspections, Art. L6242-2, Art. L6222-6, Sct. Section 2 : Modalités d'exercice, Art. L6211-10, Art. L6223-1, Art. L6211-11, Art. L6222-7, Art. L6213-7, Art. L6242-3, Art. L6231-1, Art. L6223-2, Art. L6213-8, Art. L6222-8, Art. L6242-4, Art. L6211-12, Art. L6231-2, Art. L6223-3, Art. L6213-9, Art. L6211-13, Art. L6242-5, Art. L6223-4, Art. L6213-10, Art. L6211-14, Art. L6223-5, Art. L6211-15, Art. L6213-11, Art. L6223-6, Art. L6211-16, Art. L6213-12, Art. L6223-7, Art. L6211-17, Art. L6211-18, Art. L6211-19, Art. L6211-20, Art. L6211-21, Art. L6211-22, Art. L6211-23, Sct. Chapitre II : Laboratoire de biologie médicale, Art. L6212-1, Art. L6212-2, Art. L6212-3, Art. L6212-4, Art. L6212-5, Art. L6212-6, Sct. Chapitre III : Biologiste médical, Sct. Section 1 : Conditions d'exercice, Art. L6213-1, Art. L6213-2, Art. L6213-3, Art. L6213-4, Art. L6213-5, Art. L6213-6, Sct. Titre Ier : Définition et principes généraux \n
\n

A abrogé les dispositions suivantes :

-Code de la santé publique
\nSct. Chapitre IV : Dispositions pénales., Art. L6214-1, Art. L6214-2, Art. L6214-3, Art. L6214-4, Art. L6214-5, Art. L6214-6, Art. L6214-7\n
\n

\n
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L'instance nationale d'accréditation transmet sans délai à la Haute Autorité de santé, à l'Agence française de sécurité sanitaire des produits de santé, à l'Agence de la biomédecine et à l'agence régionale de santé les décisions d'accréditation, de suspension ou de retrait d'accréditation des laboratoires de biologie médicale.

\n
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Pour les dispositifs médicaux dont la liste est fixée par le ministre chargé de la santé après avis de l'Agence française de sécurité sanitaire des produits de santé, l'exploitant est tenu de s'assurer du maintien de ces performances et de la maintenance du dispositif médical.

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Cette obligation donne lieu, le cas échéant, à un contrôle de qualité dont les modalités sont définies par décret et dont le coût est pris en charge par les exploitants des dispositifs.

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La personne physique ou morale responsable de la revente d'un dispositif médical d'occasion figurant sur une liste fixée par arrêté du ministre chargé de la santé, pris sur proposition du directeur général de l'Agence française de sécurité sanitaire des produits de santé, établit, selon des modalités fixées par décret en Conseil d'Etat, une attestation justifiant de la maintenance régulière et du maintien des performances du dispositif médical concerné.

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Le non-respect des dispositions du présent article peut entraîner la mise hors service provisoire ou définitive du dispositif médical, prononcée par l'Agence française de sécurité sanitaire des produits de santé, ainsi que, le cas échéant, le retrait ou la suspension de l'autorisation de l'installation dans les conditions prévues aux articles L. 6122-11 et L. 6122-13.

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" } }, "LEGIARTI000025104429": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5212-1", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2016-07-17", "DATE_DEBUT": "2012-05-01" } }, "META_COMMUN": { "ID": "LEGIARTI000025104429", "URL": "article/LEGI/ARTI/00/00/25/10/44/LEGIARTI000025104429.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "NOTA": { "CONTENU": "

Loi n° 2011-2012 du 29 décembre 2011 article 41 III : Les présentes dispositions entrent en vigueur à une date prévue par le décret pris pour leur application et au plus tard le 1er août 2012. Dès cette entrée en vigueur, l'Agence nationale de sécurité du médicament et des produits de santé exerce l'ensemble des droits et supporte l'ensemble des obligations de l'Agence française de sécurité sanitaire des produits de santé. Jusqu'à l'entrée en vigueur de ces dispositions, les compétences et pouvoirs que la présente loi attribue à l'Agence nationale de sécurité du médicament et des produits de santé sont exercés par l'Agence française de sécurité sanitaire des produits de santé.

Le décret n° 2012-597 du 27 avril 2012 est entré en vigueur le 1er mai 2012.

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R231-84 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072050", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006171396", "@fin": "2999-01-01", "#text": "Chapitre II : Matériovigilance.", "@debut": "2001-03-03" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006155090", "@fin": "2999-01-01", "#text": "Titre Ier : Dispositifs médicaux", "@debut": "2001-03-03" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006140632", "@fin": "2999-01-01", "#text": "Livre II : Dispositifs médicaux, dispositifs médicaux de diagnostic in vitro et autres produits et objets réglementés dans l'intérêt de la santé publique", "@debut": "2001-03-03" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006125349", "@fin": "2999-01-01", "#text": "Cinquième partie : Produits de santé", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006103419", "@fin": "2999-01-01", "#text": "Partie législative", "@debut": "2000-06-22" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690305", "@fin": "2001-03-03", "@num": "L5212-1", "@etat": "MODIFIE", "@debut": "2000-06-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690306", "@fin": "2004-08-11", "@num": "L5212-1", "@etat": "MODIFIE", "@debut": "2001-03-03", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690307", "@fin": "2011-03-24", "@num": "L5212-1", "@etat": "MODIFIE", "@debut": "2004-08-11", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000023754995", "@fin": "2011-12-31", "@num": "L5212-1", "@etat": "MODIFIE", "@debut": "2011-03-24", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000026500017", "@fin": "2012-05-01", "@num": "L5212-1", "@etat": "MODIFIE", "@debut": "2011-12-31", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000025104429", "@fin": "2016-07-17", "@num": "L5212-1", "@etat": "MODIFIE", "@debut": "2012-05-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000032906183", "@fin": "2022-04-22", "@num": "L5212-1", "@etat": "MODIFIE", "@debut": "2016-07-17", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000045630348", "@fin": "2999-01-01", "@num": "L5212-1", "@etat": "VIGUEUR", "@debut": "2022-04-22", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

Pour les dispositifs médicaux dont la liste est fixée par le ministre chargé de la santé après avis de l'Agence nationale de sécurité du médicament et des produits de santé, l'exploitant est tenu de s'assurer du maintien de ces performances et de la maintenance du dispositif médical.

Cette obligation donne lieu, le cas échéant, à un contrôle de qualité dont les modalités sont définies par décret et dont le coût est pris en charge par les exploitants des dispositifs.

La personne physique ou morale responsable de la cession à titre onéreux ou à titre gratuit d'un dispositif médical d'occasion figurant sur une liste fixée par arrêté du ministre chargé de la santé, pris sur proposition du directeur général de l'Agence nationale de sécurité du médicament et des produits de santé, établit, selon des modalités fixées par décret en Conseil d'Etat, une attestation justifiant de la maintenance régulière et du maintien des performances du dispositif médical concerné.

Le non-respect des dispositions du présent article peut entraîner la mise hors service provisoire ou définitive du dispositif médical, prononcée par l'Agence nationale de sécurité du médicament et des produits de santé, ainsi que, le cas échéant, le retrait ou la suspension de l'autorisation de l'installation dans les conditions prévues aux articles L. 6122-11 et L. 6122-13.

" } }, "LEGIARTI000025104594": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L6221-6", "ETAT": "VIGUEUR", "TYPE": "AUTONOME", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2012-05-01" } }, "META_COMMUN": { "ID": "LEGIARTI000025104594", "URL": "article/LEGI/ARTI/00/00/25/10/45/LEGIARTI000025104594.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "NOTA": { "CONTENU": "

Loi n° 2011-2012 du 29 décembre 2011 article 41 III : Les présentes dispositions entrent en vigueur à une date prévue par le décret pris pour leur application et au plus tard le 1er août 2012. Dès cette entrée en vigueur, l'Agence nationale de sécurité du médicament et des produits de santé exerce l'ensemble des droits et supporte l'ensemble des obligations de l'Agence française de sécurité sanitaire des produits de santé. Jusqu'à l'entrée en vigueur mentionnée au premier alinéa du présent III, les compétences et pouvoirs que la présente loi attribue à l'Agence nationale de sécurité du médicament et des produits de santé sont exercés par l'Agence française de sécurité sanitaire des produits de santé.

Le décret n° 2012-597 du 27 avril 2012 est entré en vigueur le 1er mai 2012.

" }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000025071134", "@num": "5", "#text": "LOI n°2011-2012\n du 29 décembre 2011 - art. 5", "@sens": "cible", "@cidtexte": "JORFTEXT000025053440", "@nortexte": "ETSX1119227L", "@numtexte": "2011-2012", "@typelien": "MODIFIE", "@naturetexte": "LOI", "@datesignatexte": "2011-12-29" }, { "@id": "LEGIARTI000021708723", "@num": "L6221-7", "#text": "Code de la santé publique - art. L6221-7 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000036508435", "@num": "L6224-1", "#text": "Code de la santé publique - art. L6224-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694499", "@num": "L761-6", "#text": "Code de la santé publique - art. L761-6 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000031938820", "@num": "R6221-4", "#text": "Code de la santé publique - art. R6221-4 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006171486", "@fin": "2010-01-16", "#text": "Chapitre Ier : Conditions d'exercice.", "@debut": "2000-06-22" }, { "@id": "LEGISCTA000021708748", "@fin": "2999-01-01", "#text": "Chapitre Ier : Accréditation et contrôle de qualité", "@debut": "2010-01-16" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006155113", "@fin": "2010-01-16", "#text": "Titre II : Directeurs des laboratoires", "@debut": "2000-06-22" }, { "@id": "LEGISCTA000021708750", "@fin": "2999-01-01", "#text": "Titre II : Organisation", "@debut": "2010-01-16" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006140637", "@fin": "2010-01-16", "#text": "Livre II : Laboratoires d'analyses de biologie médicale", "@debut": "2000-06-22" }, { "@id": "LEGISCTA000021708789", "@fin": "2999-01-01", "#text": "Livre II : Biologie médicale", "@debut": "2010-01-16" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006125350", "@fin": "2999-01-01", "#text": "Sixième partie : Etablissements et services de santé", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006103419", "@fin": "2999-01-01", "#text": "Partie législative", "@debut": "2000-06-22" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006691271", "@fin": "2010-01-16", "@num": "L6221-6", "@etat": "MODIFIE", "@debut": "2000-06-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000021708729", "@fin": "2012-05-01", "@num": "L6221-6", "@etat": "MODIFIE", "@debut": "2010-01-16", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000025104594", "@fin": "2999-01-01", "@num": "L6221-6", "@etat": "VIGUEUR", "@debut": "2012-05-01", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

L'instance nationale d'accréditation transmet sans délai à la Haute Autorité de santé, à l'Agence nationale de sécurité du médicament et des produits de santé, à l'Agence de la biomédecine et à l'agence régionale de santé les décisions d'accréditation, de suspension ou de retrait d'accréditation des laboratoires de biologie médicale.

\n
" } }, "LEGIARTI000025104704": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5222-3", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2022-07-31", "DATE_DEBUT": "2012-05-01" } }, "META_COMMUN": { "ID": "LEGIARTI000025104704", "URL": "article/LEGI/ARTI/00/00/25/10/47/LEGIARTI000025104704.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "NOTA": { "CONTENU": "

Loi n° 2011-2012 du 29 décembre 2011 article 41 III : Les présentes dispositions entrent en vigueur à une date prévue par le décret pris pour leur application et au plus tard le 1er août 2012. Dès cette entrée en vigueur, l'Agence nationale de sécurité du médicament et des produits de santé exerce l'ensemble des droits et supporte l'ensemble des obligations de l'Agence française de sécurité sanitaire des produits de santé. Jusqu'à l'entrée en vigueur mentionnée au premier alinéa du présent III, les compétences et pouvoirs que la présente loi attribue à l'Agence nationale de sécurité du médicament et des produits de santé sont exercés par l'Agence française de sécurité sanitaire des produits de santé.

Le décret n° 2012-597 du 27 avril 2012 est entré en vigueur le 1er mai 2012.

" }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000217229", "#text": "Rapport relatif à l'ordonnance n° 2000-548 du 15 juin 2000", "@sens": "source", "@cidtexte": "JORFTEXT000000217229", "@nortexte": "MESX0000036P", "@typelien": "CODIFICATION", "@naturetexte": "RAPPORT", "@datesignatexte": "2999-01-01" }, { "@id": "JORFTEXT000000227015", "#text": "Loi n°2002-303 du 4 mars 2002", "@sens": "source", "@cidtexte": "JORFTEXT000000227015", "@nortexte": "MESX0100092L", "@numtexte": "2002-303", "@typelien": "CODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2002-03-04" }, { "@id": "LEGIARTI000023097035", "@num": "Annexe II", "#text": "Arrêté du 9 novembre 2010 - art. 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Annexe IV (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000032967651", "@nortexte": "AFSP1622318A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-08-01" }, { "@id": "LEGIARTI000034152829", "@num": "1", "#text": "Arrêté du 27 février 2017 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000034150863", "@nortexte": "AFSP1706243A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2017-02-27" }, { "@id": "LEGIARTI000041898595", "@num": "10-3-1", "#text": "Arrêté du 23 mars 2020 - art. 10-3-1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041746744", "@nortexte": "SSAX2007864A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-03-23" }, { "@id": "LEGIARTI000041890409", "@num": "1", "#text": "Arrêté du 18 mai 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000041889362", "@nortexte": "SSAZ2011564A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-05-18" }, { "@id": "LEGIARTI000041898504", "@num": "1", "#text": "Arrêté du 20 mai 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000041897919", "@nortexte": "SSAZ2012596A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-05-20" }, { "@id": "LEGIARTI000043298218", "@num": "25", "#text": "Arrêté du 10 juillet 2020 - art. 25 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000042106233", "@nortexte": "SSAZ2018110A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-07-10" }, { "@id": "LEGIARTI000042609739", "@num": "26", "#text": "Arrêté du 10 juillet 2020 - art. 26 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000042106233", "@nortexte": "SSAZ2018110A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-07-10" }, { "@id": "LEGIARTI000043298194", "@num": "26-1", "#text": "Arrêté du 10 juillet 2020 - art. 26-1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000042106233", "@nortexte": "SSAZ2018110A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-07-10" }, { "@id": "LEGIARTI000043351359", "@num": "26-2", "#text": "Arrêté du 10 juillet 2020 - art. 26-2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000042106233", "@nortexte": "SSAZ2018110A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-07-10" }, { "@id": "LEGIARTI000042608596", "@num": "1", "#text": "Arrêté du 3 décembre 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000042607794", "@nortexte": "SSAZ2033724A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-12-03" }, { "@id": "LEGIARTI000043298023", "@num": "1", "#text": "Arrêté du 26 mars 2021 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000043294845", "@nortexte": "SSAZ2109865A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-03-26" }, { "@id": "LEGIARTI000047779186", "@num": "25", "#text": "Arrêté du 1 juin 2021 - art. 25 (M)", "@sens": "cible", "@cidtexte": "JORFTEXT000043575801", "@nortexte": "SSAZ2116944A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-06-01" }, { "@id": "LEGIARTI000047779165", "@num": "28", "#text": "Arrêté du 1 juin 2021 - art. 28 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000043575801", "@nortexte": "SSAZ2116944A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-06-01" }, { "@id": "LEGIARTI000043770220", "@num": "27", "#text": "Arrêté du 1er juin 2021 - art. 27 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000043575801", "@nortexte": "SSAZ2116944A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-06-01" }, { "@id": "LEGIARTI000044808700", "@num": "29", "#text": "Arrêté du 1er juin 2021 - art. 29 (M)", "@sens": "cible", "@cidtexte": "JORFTEXT000043575801", "@nortexte": "SSAZ2116944A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-06-01" }, { "@id": "LEGIARTI000043685770", "@num": "ANNEXE VI", "#text": "Arrêté du 16 juin 2021 - art. 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D6211-10 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000046126105", "@num": "L5222-4", "#text": "Code de la santé publique - art. L5222-4 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690591", "@num": "L5462-2", "#text": "Code de la santé publique - art. L5462-2 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000021708723", "@num": "L6221-7", "#text": "Code de la santé publique - art. L6221-7 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000039459172", "@num": "R1413-61-1", "#text": "Code de la santé publique - art. R1413-61-1 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000034687007", "@num": "R1413-68", "#text": "Code de la santé publique - art. R1413-68 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000034686956", "@num": "R1413-79", "#text": "Code de la santé publique - art. R1413-79 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000034687243", "@num": "R1524-6", "#text": "Code de la santé publique - art. R1524-6 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025786997", "@num": "R5462-2", "#text": "Code de la santé publique - art. R5462-2 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006171398", "@fin": "2999-01-01", "#text": "Chapitre II : Mesures de vigilance.", "@debut": "2001-03-03" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006155091", "@fin": "2999-01-01", "#text": "Titre II : Dispositifs médicaux de diagnostic in vitro", "@debut": "2001-03-03" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006140632", "@fin": "2999-01-01", "#text": "Livre II : Dispositifs médicaux, dispositifs médicaux de diagnostic in vitro et autres produits et objets réglementés dans l'intérêt de la santé publique", "@debut": "2001-03-03" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006125349", "@fin": "2999-01-01", "#text": "Cinquième partie : Produits de santé", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006103419", "@fin": "2999-01-01", "#text": "Partie législative", "@debut": "2000-06-22" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690330", "@fin": "2012-05-01", "@num": "L5222-3", "@etat": "MODIFIE", "@debut": "2001-03-03", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000025104704", "@fin": "2022-07-31", "@num": "L5222-3", "@etat": "MODIFIE", "@debut": "2012-05-01", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000046126072", "@fin": "2999-01-01", "@num": "L5222-3", "@etat": "VIGUEUR", "@debut": "2022-07-31", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Le fabricant ou son mandataire, l'importateur, le distributeur, les professionnels de santé utilisateurs sont tenus de signaler sans délai à l'Agence nationale de sécurité du médicament et des produits de santé toute défaillance ou altération d'un dispositif médical de diagnostic in vitro susceptible d'entraîner des effets néfastes pour la santé des personnes. Le fabricant ou son mandataire est tenu d'informer l'Agence nationale de sécurité du médicament et des produits de santé de tout rappel de dispositifs médicaux de diagnostic in vitro, et de lui communiquer, à sa demande, toute information utile à la mise en oeuvre de mesures de protection sanitaire à l'égard des patients.
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Le fabricant ou son mandataire, l'importateur et le distributeur sont tenus de conserver toutes les informations nécessaires au rappel éventuel de dispositifs médicaux de diagnostic in vitro mentionné à l'alinéa précédent.
" } }, "LEGIARTI000025139304": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L1221-13", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2014-12-25", "DATE_DEBUT": "2012-05-01" } }, "META_COMMUN": { "ID": "LEGIARTI000025139304", "URL": "article/LEGI/ARTI/00/00/25/13/93/LEGIARTI000025139304.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "NOTA": { "CONTENU": "

Loi n° 2011-2012 du 29 décembre 2011 article 41 III : Les présentes dispositions entrent en vigueur à une date prévue par le décret pris pour leur application et au plus tard le 1er août 2012. Dès cette entrée en vigueur, l'Agence nationale de sécurité du médicament et des produits de santé exerce l'ensemble des droits et supporte l'ensemble des obligations de l'Agence française de sécurité sanitaire des produits de santé. Jusqu'à l'entrée en vigueur mentionnée au premier alinéa du présent III, les compétences et pouvoirs que la présente loi attribue à l'Agence nationale de sécurité du médicament et des produits de santé sont exercés par l'Agence française de sécurité sanitaire des produits de santé.

Le décret n° 2012-597 du 27 avril 2012 est entré en vigueur le 1er mai 2012.

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" }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000217229", "#text": "Rapport relatif à l'ordonnance n° 2000-548 du 15 juin 2000", "@sens": "source", "@cidtexte": "JORFTEXT000000217229", "@nortexte": "MESX0000036P", "@typelien": "CODIFICATION", "@naturetexte": "RAPPORT", "@datesignatexte": "2999-01-01" }, { "@id": "JORFTEXT000000227015", "#text": "Loi n°2002-303 du 4 mars 2002", "@sens": "source", "@cidtexte": "JORFTEXT000000227015", "@nortexte": "MESX0100092L", "@numtexte": "2002-303", "@typelien": "CODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2002-03-04" }, { "@id": "LEGIARTI000025071134", "@num": "5", "#text": "LOI n°2011-2012\n du 29 décembre 2011 - art. 5", "@sens": "cible", "@cidtexte": "JORFTEXT000025053440", "@nortexte": "ETSX1119227L", "@numtexte": "2011-2012", "@typelien": "MODIFIE", "@naturetexte": "LOI", "@datesignatexte": "2011-12-29" }, { "@id": "LEGIARTI000034152829", "@num": "1", "#text": "Arrêté du 27 février 2017 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000034150863", "@nortexte": "AFSP1706243A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2017-02-27" }, { "@id": "LEGIARTI000006417944", "@num": "226-13", "#text": "Code pénal - art. 226-13 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006070719", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000021708723", "@num": "L6221-7", "#text": "Code de la santé publique - art. L6221-7 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000027480644", "@num": "L6221-9", "#text": "Code de la santé publique - art. L6221-9 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694212", "@num": "L666-12", "#text": "Code de la santé publique - art. L666-12 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694210", "@num": "L666-12", "#text": "Code de la santé publique - art. L666-12 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000039459172", "@num": "R1413-61-1", "#text": "Code de la santé publique - art. R1413-61-1 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000034687007", "@num": "R1413-68", "#text": "Code de la santé publique - art. R1413-68 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000034686956", "@num": "R1413-79", "#text": "Code de la santé publique - art. R1413-79 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000034682983", "@num": "R1524-5", "#text": "Code de la santé publique - art. R1524-5 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000034687243", "@num": "R1524-6", "#text": "Code de la santé publique - art. R1524-6 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006802537", "@num": "R711-1-11", "#text": "Code de la santé publique - art. R711-1-11 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006171018", "@fin": "2999-01-01", "#text": "Chapitre Ier : Collecte, préparation et conservation du sang, de ses composants et des produits sanguins labiles.", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006154985", "@fin": "2999-01-01", "#text": "Titre II : Sang humain", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006140604", "@fin": "2999-01-01", "#text": "Livre II : Don et utilisation des éléments et produits du corps humain", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006125345", "@fin": "2999-01-01", "#text": "Première partie : Protection générale de la santé", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006103419", "@fin": "2999-01-01", "#text": "Partie législative", "@debut": "2000-06-22" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006686103", "@fin": "2004-08-11", "@num": "L1221-13", "@etat": "MODIFIE", "@debut": "2000-06-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006686104", "@fin": "2005-09-02", "@num": "L1221-13", "@etat": "MODIFIE", "@debut": "2004-08-11", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006686105", "@fin": "2012-05-01", "@num": "L1221-13", "@etat": "MODIFIE", "@debut": "2005-09-02", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000025139304", "@fin": "2014-12-25", "@num": "L1221-13", "@etat": "MODIFIE", "@debut": "2012-05-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000029962861", "@fin": "2016-01-28", "@num": "L1221-13", "@etat": "MODIFIE", "@debut": "2014-12-25", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000031931400", "@fin": "2017-07-01", "@num": "L1221-13", "@etat": "MODIFIE", "@debut": "2016-01-28", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000033897135", "@fin": "2999-01-01", "@num": "L1221-13", "@etat": "VIGUEUR", "@debut": "2017-07-01", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
L'hémovigilance a pour objet l'ensemble des procédures de surveillance et d'évaluation des incidents, ainsi que des effets indésirables survenant chez les donneurs ou les receveurs de produits sanguins labiles. Elle porte sur l'ensemble de la chaîne transfusionnelle allant de la collecte des produits sanguins labiles jusqu'au suivi des receveurs. L'hémovigilance comprend également le suivi épidémiologique des donneurs.
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Les personnes qui ont à connaître de ces informations sont tenues au secret professionnel dans les conditions et sous les peines prévues aux articles 226-13 et 226-14 du code pénal.
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Un décret en Conseil d'Etat, pris après avis de l'Agence nationale de sécurité du médicament et des produits de santé , fixe les règles d'hémovigilance, et notamment la nature des informations nécessaires à la surveillance des effets de l'utilisation des produits sanguins labiles que les praticiens sont tenus de fournir, ainsi que les conditions d'exercice de cette surveillance.
" } }, "LEGIARTI000026500017": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5212-1", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2012-05-01", "DATE_DEBUT": "2011-12-31" } }, "META_COMMUN": { "ID": "LEGIARTI000026500017", "URL": "article/LEGI/ARTI/00/00/26/50/00/LEGIARTI000026500017.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGITEXT000024478563", "#text": "Décret n°2011-968\n du 16 août 2011 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000024476540", "@nortexte": "ETSP1110434D", "@numtexte": "2011-968", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2011-08-16" }, { "@id": "LEGIARTI000025071059", "@num": "34", "#text": "LOI n°2011-2012 du 29 décembre 2011 - art. 34", "@sens": "cible", "@cidtexte": "JORFTEXT000025053440", "@nortexte": "ETSX1119227L", "@numtexte": "2011-2012", "@typelien": "MODIFIE", "@naturetexte": "LOI", "@datesignatexte": "2011-12-29" }, { "@id": "LEGIARTI000038533524", "#text": "Arrêté du 23 mai 2019 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000038529178", "@nortexte": "SSAP1915191A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2019-05-23" }, { "@id": "LEGIARTI000043969385", "@num": "R2661-4", "#text": "Code de la commande publique - art. R2661-4 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000037701019", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000041587839", "@num": "L123-6", "#text": "Code de la construction et de l'habitation. - art. L123-6 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006074096", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006691660", "@num": "D665-5-3", "#text": "Code de la santé publique - art. D665-5-3 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000049573024", "@num": "L1333-30", "#text": "Code de la santé publique - art. L1333-30 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000028352333", "@num": "L5461-5", "#text": "Code de la santé publique - art. L5461-5 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000047291570", "@num": "L5461-9", "#text": "Code de la santé publique - art. L5461-9 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000047084082", "@num": "L5522-1", "#text": "Code de la santé publique - art. L5522-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690832", "@num": "L6122-11", "#text": "Code de la santé publique - art. L6122-11", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690837", "@num": "L6122-13", "#text": "Code de la santé publique - art. L6122-13", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000021708723", "@num": "L6221-7", "#text": "Code de la santé publique - art. L6221-7 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694043", "@num": "L665-5", "#text": "Code de la santé publique - art. L665-5 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694042", "@num": "L665-5", "#text": "Code de la santé publique - art. L665-5 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006910095", "@num": "R1333-43", "#text": "Code de la santé publique - art. R1333-43 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006910150", "@num": "R1333-59", "#text": "Code de la santé publique - art. R1333-59 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006910178", "@num": "R1333-68", "#text": "Code de la santé publique - art. R1333-68 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000037017220", "@num": "R1333-78", "#text": "Code de la santé publique - art. R1333-78 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006798535", "@num": "R43-38", "#text": "Code de la santé publique - art. R43-38 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006798554", "@num": "R43-54", "#text": "Code de la santé publique - art. R43-54 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006798564", "@num": "R43-63", "#text": "Code de la santé publique - art. R43-63 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000037011280", "@num": "R5212-26", "#text": "Code de la santé publique - art. R5212-26 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000024479878", "@num": "R5212-35-1", "#text": "Code de la santé publique - art. R5212-35-1 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006806746", "@num": "R231-84", "#text": "Code du travail - art. 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Cette obligation donne lieu, le cas échéant, à un contrôle de qualité dont les modalités sont définies par décret et dont le coût est pris en charge par les exploitants des dispositifs.

La personne physique ou morale responsable de la cession à titre onéreux ou à titre gratuit d'un dispositif médical d'occasion figurant sur une liste fixée par arrêté du ministre chargé de la santé, pris sur proposition du directeur général de l'Agence française de sécurité sanitaire des produits de santé, établit, selon des modalités fixées par décret en Conseil d'Etat, une attestation justifiant de la maintenance régulière et du maintien des performances du dispositif médical concerné.

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L'hémovigilance a pour objet l'ensemble des procédures de surveillance et d'évaluation des incidents, ainsi que des effets indésirables survenant chez les donneurs ou les receveurs de produits sanguins labiles et de plasma mentionné au 2° bis de l'article L. 1221-8, ce dernier produit demeurant également soumis au chapitre Ier bis du titre II du livre Ier de la cinquième partie. Elle porte sur l'ensemble de la chaîne transfusionnelle allant de la collecte des produits sanguins labiles jusqu'au suivi des receveurs. L'hémovigilance comprend également le suivi épidémiologique des donneurs.

Les personnes qui ont à connaître de ces informations sont tenues au secret professionnel dans les conditions et sous les peines prévues aux articles 226-13 et 226-14 du code pénal.

Un décret en Conseil d'Etat, pris après avis de l'Agence nationale de sécurité du médicament et des produits de santé, fixe les règles d'hémovigilance, et notamment la nature des informations nécessaires à la surveillance des effets de l'utilisation des produits sanguins labiles et du plasma mentionné au 2° bis de l'article L. 1221-8 du présent code que les praticiens sont tenus de fournir, ainsi que les conditions d'exercice de cette surveillance.

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R711-1-11 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006171018", "@fin": "2999-01-01", "#text": "Chapitre Ier : Collecte, préparation et conservation du sang, de ses composants et des produits sanguins labiles.", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006154985", "@fin": "2999-01-01", "#text": "Titre II : Sang humain", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006140604", "@fin": "2999-01-01", "#text": "Livre II : Don et utilisation des éléments et produits du corps humain", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006125345", "@fin": "2999-01-01", "#text": "Première partie : Protection générale de la santé", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006103419", "@fin": "2999-01-01", "#text": "Partie législative", "@debut": "2000-06-22" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006686103", "@fin": "2004-08-11", "@num": "L1221-13", "@etat": "MODIFIE", "@debut": "2000-06-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006686104", "@fin": "2005-09-02", "@num": "L1221-13", "@etat": "MODIFIE", "@debut": "2004-08-11", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006686105", "@fin": "2012-05-01", "@num": "L1221-13", "@etat": "MODIFIE", "@debut": "2005-09-02", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000025139304", "@fin": "2014-12-25", "@num": "L1221-13", "@etat": "MODIFIE", "@debut": "2012-05-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000029962861", "@fin": "2016-01-28", "@num": "L1221-13", "@etat": "MODIFIE", "@debut": "2014-12-25", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000031931400", "@fin": "2017-07-01", "@num": "L1221-13", "@etat": "MODIFIE", "@debut": "2016-01-28", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000033897135", "@fin": "2999-01-01", "@num": "L1221-13", "@etat": "VIGUEUR", "@debut": "2017-07-01", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

L'hémovigilance a pour objet l'ensemble des procédures de surveillance et d'évaluation des incidents, ainsi que des effets indésirables survenant chez les donneurs ou les receveurs de produits sanguins labiles. Elle porte sur l'ensemble de la chaîne transfusionnelle allant de la collecte des produits sanguins labiles jusqu'au suivi des receveurs. L'hémovigilance comprend également le suivi épidémiologique des donneurs.

Les personnes qui ont à connaître de ces informations sont tenues au secret professionnel dans les conditions et sous les peines prévues aux articles 226-13 et 226-14 du code pénal.

Un décret en Conseil d'Etat, pris après avis de l'Agence nationale de sécurité du médicament et des produits de santé, fixe les règles d'hémovigilance, et notamment la nature des informations nécessaires à la surveillance des effets de l'utilisation des produits sanguins labiles que les praticiens sont tenus de fournir, ainsi que les conditions d'exercice de cette surveillance.

" } }, "LEGIARTI000032906183": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5212-1", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2022-04-22", "DATE_DEBUT": "2016-07-17" } }, "META_COMMUN": { "ID": "LEGIARTI000032906183", "URL": "article/LEGI/ARTI/00/00/32/90/61/LEGIARTI000032906183.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "NOTA": { "CONTENU": "

Le décret n° 2012-597 du 27 avril 2012 est entré en vigueur le 1er mai 2012.

" }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000227015", "#text": "Loi n°2002-303 du 4 mars 2002", "@sens": "source", "@cidtexte": "JORFTEXT000000227015", "@nortexte": "MESX0100092L", "@numtexte": "2002-303", "@typelien": "CODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2002-03-04" }, { "@id": "LEGITEXT000024478563", "#text": "Décret n°2011-968\n du 16 août 2011 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000024476540", "@nortexte": "ETSP1110434D", "@numtexte": "2011-968", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2011-08-16" }, { "@id": "LEGIARTI000032896542", "@num": "2", "#text": "Ordonnance n°2016-966 du 15 juillet 2016 - art. 2", "@sens": "cible", "@cidtexte": "JORFTEXT000032894018", "@nortexte": "AFSP1611753R", "@numtexte": "2016-966", "@typelien": "MODIFIE", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2016-07-15" }, { "@id": "LEGIARTI000038533524", "#text": "Arrêté du 23 mai 2019 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000038529178", "@nortexte": "SSAP1915191A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2019-05-23" }, { "@id": "LEGIARTI000043969385", "@num": "R2661-4", "#text": "Code de la commande publique - art. R2661-4 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000037701019", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000041587839", "@num": "L123-6", "#text": "Code de la construction et de l'habitation. - art. L123-6 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006074096", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006691660", "@num": "D665-5-3", "#text": "Code de la santé publique - art. D665-5-3 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000049573024", "@num": "L1333-30", "#text": "Code de la santé publique - art. L1333-30 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000028352333", "@num": "L5461-5", "#text": "Code de la santé publique - art. L5461-5 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000047291570", "@num": "L5461-9", "#text": "Code de la santé publique - art. L5461-9 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000047084082", "@num": "L5522-1", "#text": "Code de la santé publique - art. L5522-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690832", "@num": "L6122-11", "#text": "Code de la santé publique - art. L6122-11", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690837", "@num": "L6122-13", "#text": "Code de la santé publique - art. L6122-13", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000021708723", "@num": "L6221-7", "#text": "Code de la santé publique - art. L6221-7 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694043", "@num": "L665-5", "#text": "Code de la santé publique - art. L665-5 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694042", "@num": "L665-5", "#text": "Code de la santé publique - art. L665-5 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006910095", "@num": "R1333-43", "#text": "Code de la santé publique - art. R1333-43 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006910150", "@num": "R1333-59", "#text": "Code de la santé publique - art. R1333-59 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006910178", "@num": "R1333-68", "#text": "Code de la santé publique - art. R1333-68 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000037017220", "@num": "R1333-78", "#text": "Code de la santé publique - art. R1333-78 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006798535", "@num": "R43-38", "#text": "Code de la santé publique - art. R43-38 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006798554", "@num": "R43-54", "#text": "Code de la santé publique - art. R43-54 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006798564", "@num": "R43-63", "#text": "Code de la santé publique - art. R43-63 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000037011280", "@num": "R5212-26", "#text": "Code de la santé publique - art. R5212-26 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000024479878", "@num": "R5212-35-1", "#text": "Code de la santé publique - art. R5212-35-1 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006806746", "@num": "R231-84", "#text": "Code du travail - art. R231-84 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072050", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006171396", "@fin": "2999-01-01", "#text": "Chapitre II : Matériovigilance.", "@debut": "2001-03-03" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006155090", "@fin": "2999-01-01", "#text": "Titre Ier : Dispositifs médicaux", "@debut": "2001-03-03" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006140632", "@fin": "2999-01-01", "#text": "Livre II : Dispositifs médicaux, dispositifs médicaux de diagnostic in vitro et autres produits et objets réglementés dans l'intérêt de la santé publique", "@debut": "2001-03-03" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006125349", "@fin": "2999-01-01", "#text": "Cinquième partie : Produits de santé", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006103419", "@fin": "2999-01-01", "#text": "Partie législative", "@debut": "2000-06-22" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690305", "@fin": "2001-03-03", "@num": "L5212-1", "@etat": "MODIFIE", "@debut": "2000-06-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690306", "@fin": "2004-08-11", "@num": "L5212-1", "@etat": "MODIFIE", "@debut": "2001-03-03", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690307", "@fin": "2011-03-24", "@num": "L5212-1", "@etat": "MODIFIE", "@debut": "2004-08-11", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000023754995", "@fin": "2011-12-31", "@num": "L5212-1", "@etat": "MODIFIE", "@debut": "2011-03-24", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000026500017", "@fin": "2012-05-01", "@num": "L5212-1", "@etat": "MODIFIE", "@debut": "2011-12-31", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000025104429", "@fin": "2016-07-17", "@num": "L5212-1", "@etat": "MODIFIE", "@debut": "2012-05-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000032906183", "@fin": "2022-04-22", "@num": "L5212-1", "@etat": "MODIFIE", "@debut": "2016-07-17", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000045630348", "@fin": "2999-01-01", "@num": "L5212-1", "@etat": "VIGUEUR", "@debut": "2022-04-22", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

Pour les dispositifs médicaux dont la liste est fixée par décision du directeur général l'Agence nationale de sécurité du médicament et des produits de santé, l'exploitant est tenu de s'assurer du maintien de ces performances et de la maintenance du dispositif médical.

Cette obligation donne lieu, le cas échéant, à un contrôle de qualité dont les modalités sont définies par décret et dont le coût est pris en charge par les exploitants des dispositifs.

La personne physique ou morale responsable de la cession à titre onéreux ou à titre gratuit d'un dispositif médical d'occasion figurant sur une liste fixée par décision du directeur général de l'Agence nationale de sécurité du médicament et des produits de santé, établit, selon des modalités fixées par décret en Conseil d'Etat, une attestation justifiant de la maintenance régulière et du maintien des performances du dispositif médical concerné.

" } }, "LEGIARTI000033897135": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L1221-13", "ETAT": "VIGUEUR", "TYPE": "AUTONOME", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2017-07-01" } }, "META_COMMUN": { "ID": "LEGIARTI000033897135", "URL": "article/LEGI/ARTI/00/00/33/89/71/LEGIARTI000033897135.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "NOTA": { "CONTENU": "

Conformément à l'article 7 de l'ordonnance n° 2017-51 du 19 janvier 2017, les présentes dispositions entrent en application à la date d'entrée en vigueur du décret en Conseil d'Etat pris pour son application, et au plus tard le 1er juillet 2017.
\n

L'hémovigilance a pour objet l'ensemble des procédures de surveillance et d'évaluation des incidents, ainsi que des effets indésirables survenant chez les donneurs ou les receveurs de produits sanguins labiles. Elle porte sur l'ensemble de la chaîne transfusionnelle allant de la collecte des produits sanguins labiles jusqu'au suivi des receveurs. L'hémovigilance comprend également le suivi épidémiologique des donneurs.

\n
\n

\n
Les professionnels de santé, les établissements de transfusion sanguine et les établissements de santé signalent et déclarent les informations relevant de l'hémovigilance. Un décret en Conseil d'Etat détermine les conditions d'application du présent article, notamment les modalités d'organisation du système d'hémovigilance.
" } }, "LEGIARTI000045630348": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5212-1", "ETAT": "VIGUEUR", "TYPE": "AUTONOME", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2022-04-22" } }, "META_COMMUN": { "ID": "LEGIARTI000045630348", "URL": "article/LEGI/ARTI/00/00/45/63/03/LEGIARTI000045630348.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "NOTA": { "CONTENU": "

Se reporter aux modalités d'application prévues aux I, II et III de l'article 17 de l'ordonnance n° 2022-582 du 20 avril 2022.

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Pour les dispositifs mentionnés à l'article premier du règlement (UE) 2017/745 du Parlement européen et du Conseil du 5 avril 2017 dont la liste est fixée par décision du directeur général l'Agence nationale de sécurité du médicament et des produits de santé, l'exploitant est tenu de s'assurer du maintien de ces performances et de la maintenance du dispositif médical.

Cette obligation donne lieu, le cas échéant, à un contrôle de qualité dont les modalités sont définies par décret et dont le coût est pris en charge par les exploitants des dispositifs.

Le non-respect des dispositions du présent article peut entraîner la mise hors service provisoire ou définitive du dispositif, prononcée par l'Agence nationale de sécurité du médicament et des produits de santé, ainsi que, le cas échéant, le retrait ou la suspension de l'autorisation de l'installation dans les conditions prévues aux articles L. 6122-11 et L. 6122-13.

" } }, "LEGIARTI000046126072": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5222-3", "ETAT": "VIGUEUR", "TYPE": "AUTONOME", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2022-07-31" } }, "META_COMMUN": { "ID": "LEGIARTI000046126072", "URL": "article/LEGI/ARTI/00/00/46/12/60/LEGIARTI000046126072.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "NOTA": { "CONTENU": "

Se reporter aux modalités d'application prévues à l'article 15 de l'ordonnance n° 2022-1086 du 29 juillet 2022.

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Les obligations de notification à l'Agence nationale de sécurité du médicament et des produits de santé ou d'information incombant, au titre de la vigilance exercée sur les dispositifs mentionnés à l'article premier du règlement (UE) 2017/746, au fabricant ou, le cas échéant, à son mandataire, à l'importateur et au distributeur, sont définies par ce règlement, notamment à ses articles 10, 13, 14, 82, 83 et 84.
\n
\n En outre, tout professionnel de santé ou tout personnel ayant reçu une formation adaptée et relevant des structures de prévention et associatives ou du service de santé des armées ayant connaissance d'un incident grave le déclare à l'agence. Il peut déclarer, en outre, tous les autres incidents dont il a connaissance, suspectés d'être dus à un dispositif auprès du fabricant afin que celui-ci puisse exercer ses activités de surveillance après commercialisation conformément à l'article 78 du règlement (UE) 2017/746 et élaborer les rapports prévus aux articles 80,81,83 et 84 du même règlement.
\n
\n Tout patient, toute association agréée de patients ou tout utilisateur non professionnel du dispositif peut procéder à la déclaration, auprès de l'agence, de tout incident suspecté d'être dû à un dispositif qu'il utilise.

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Article L6221-7 AUTONOME VIGUEUR, en vigueur depuis le 16/01/2010 (Code de la santé publique)