{ "article": { "LEGIARTI000026831622": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5214-2", "ETAT": "VIGUEUR", "TYPE": "AUTONOME", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2012-12-27" } }, "META_COMMUN": { "ID": "LEGIARTI000026831622", "URL": "article/LEGI/ARTI/00/00/26/83/16/LEGIARTI000026831622.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000026831578", "@num": "3", "#text": "LOI n°2012-1442\n du 24 décembre 2012 - art. 3", "@sens": "cible", "@cidtexte": "JORFTEXT000026830015", "@nortexte": "AFSX1240700L", "@numtexte": "2012-1442", "@typelien": "CREE", "@naturetexte": "LOI", "@datesignatexte": "2012-12-24" }, { "@id": "LEGIARTI000006690281", "@num": "L5211-1", "#text": "Code de la santé publique - art. L5211-1", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000026831618", "@fin": "2999-01-01", "#text": "Chapitre IV : Interdiction de certains matériaux dans les dispositifs médicaux", "@debut": "2012-12-27" } ] }, "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": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000026831622", "@fin": "2999-01-01", "@num": "L5214-2", "@etat": "VIGUEUR", "@debut": "2012-12-27", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "Est interdite l'utilisation des biberons comportant du bisphénol A et répondant à la définition des dispositifs médicaux mentionnée à l'article L. 5211-1." } }, "LEGIARTI000006690281": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5211-1", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2001-03-03", "DATE_DEBUT": "2000-06-22" } }, "META_COMMUN": { "ID": "LEGIARTI000006690281", "URL": "article/LEGI/ARTI/00/00/06/69/02/LEGIARTI000006690281.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPANXXXXXXX1X5211L01XXAA" } }, "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": "LEGIARTI000006684513", "@num": "25", "#text": "Décret n°2003-1010 du 22 octobre 2003 - art. 25 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000610356", "@nortexte": "SOCA0323026D", "@numtexte": "2003-1010", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2003-10-22" }, { "@id": "LEGIARTI000020350738", "@num": "3", "#text": "Arrêté du 16 août 2006 - art. 3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000640165", "@nortexte": "SANP0623371A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000020317472", "@num": "3", "#text": "Arrêté du 16 août 2006 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000639975", "@nortexte": "SANP0623370A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000022916144", "#text": "Arrêté du 15 septembre 2010 - art. 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R165-65 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006171392", "@fin": "2001-03-03", "#text": "Chapitre Ier : Régime juridique des dispositifs médicaux.", "@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": "LEGIARTI000006690281", "@fin": "2001-03-03", "@num": "L5211-1", "@etat": "MODIFIE", "@debut": "2000-06-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690282", "@fin": "2010-03-21", "@num": "L5211-1", "@etat": "MODIFIE", "@debut": "2001-03-03", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000021964486", "@fin": "2022-04-22", "@num": "L5211-1", "@etat": "MODIFIE", "@debut": "2010-03-21", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000045630295", "@fin": "2022-07-31", "@num": "L5211-1", "@etat": "MODIFIE", "@debut": "2022-04-22", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000046126069", "@fin": "2999-01-01", "@num": "L5211-1", "@etat": "VIGUEUR", "@debut": "2022-07-31", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
On entend par dispositif médical tout instrument, appareil, équipement, matière, produit, à l'exception des produits d'origine humaine, ou autre article utilisé seul ou en association, y compris les accessoires et logiciels intervenant dans son fonctionnement, destiné par le fabricant à être utilisé chez l'homme à des fins médicales et dont l'action principale voulue n'est pas obtenue par des moyens pharmacologiques ou immunologiques ni par métabolisme, mais dont la fonction peut être assistée par de tels moyens.
\n
Les dispositifs médicaux qui sont conçus pour être implantés en totalité ou en partie dans le corps humain ou placés dans un orifice naturel, et qui dépendent pour leur bon fonctionnement d'une source d'énergie électrique ou de toute source d'énergie autre que celle qui est générée directement par le corps humain ou la pesanteur, sont dénommés dispositifs médicaux implantables actifs.
" } }, "LEGIARTI000006690282": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5211-1", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2010-03-21", "DATE_DEBUT": "2001-03-03" } }, "META_COMMUN": { "ID": "LEGIARTI000006690282", "URL": "article/LEGI/ARTI/00/00/06/69/02/LEGIARTI000006690282.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPANXXXXXXX1X5211L01XXAB" } }, "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": "LEGIARTI000006684513", "@num": "25", "#text": "Décret n°2003-1010 du 22 octobre 2003 - art. 25 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000610356", "@nortexte": "SOCA0323026D", "@numtexte": "2003-1010", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2003-10-22" }, { "@id": "LEGIARTI000020350738", "@num": "3", "#text": "Arrêté du 16 août 2006 - art. 3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000640165", "@nortexte": "SANP0623371A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000020317472", "@num": "3", "#text": "Arrêté du 16 août 2006 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000639975", "@nortexte": "SANP0623370A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000022916144", "#text": "Arrêté du 15 septembre 2010 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000022915397", "@nortexte": "SASP1023783A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-09-15" }, { "@id": "LEGITEXT000030258990", "#text": "DÉCRET n°2015-188 du 18 février 2015 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000030258165", "@nortexte": "AFSS1414563D", "@numtexte": "2015-188", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2015-02-18" }, { "@id": "LEGIARTI000030909420", "@num": "5", "#text": "DÉCRET n°2015-881 du 17 juillet 2015 - art. 5 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000030907542", "@nortexte": "AFSH1506845D", "@numtexte": "2015-881", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2015-07-17" }, { "@id": "LEGIARTI000034155211", "@num": "5", "#text": "Décret n°2017-291 du 6 mars 2017 - art. 5", "@sens": "cible", "@cidtexte": "JORFTEXT000034154540", "@nortexte": "DEVL1702157D", "@numtexte": "2017-291", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2017-03-06" }, { "@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": "LEGIARTI000050090741", "@num": "2", "#text": "Arrêté du 15 juin 2021 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000043673283", "@nortexte": "SSAH2116294A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-06-15" }, { "@id": "LEGIARTI000047690229", "@num": "1", "#text": "Arrêté du 12 juin 2023 - art. 1 (VD)", "@sens": "cible", "@cidtexte": "JORFTEXT000047689131", "@nortexte": "SPRS2316031A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2023-06-12" }, { "@id": "LEGITEXT000051060847", "#text": "Décret n°2025-80 du 28 janvier 2025 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000051058924", "@nortexte": "TSSH2431602D", "@numtexte": "2025-80", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2025-01-28" }, { "@id": "LEGIARTI000051060858", "@num": "1", "#text": "Décret n°2025-80 du 28 janvier 2025 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000051058924", "@nortexte": "TSSH2431602D", "@numtexte": "2025-80", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2025-01-28" }, { "@id": "LEGIARTI000031829279", "@num": "R314-168", "#text": "Code de l'action sociale et des familles - art. R314-168 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006074069", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033700163", "@num": "R314-26", "#text": "Code de l'action sociale et des familles - art. R314-26 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006074069", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000032775739", "@num": "D543-259", "#text": "Code de l'environnement - art. D543-259 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006074220", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000034155479", "@num": "D543-296-2", "#text": "Code de l'environnement - art. D543-296-2 (T)", "@sens": "cible", "@cidtexte": "LEGITEXT000006074220", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025021487", "@num": "L522-1", "#text": "Code de l'environnement - art. L522-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006074220", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000037556713", "@num": "L541-10-5", "#text": "Code de l'environnement - art. L541-10-5 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006074220", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000051561876", "@num": "L541-15-10", "#text": "Code de l'environnement - art. L541-15-10 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006074220", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000051061049", "@num": "R541-339", "#text": "Code de l'environnement - art. R541-339 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006074220", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000039695081", "@num": "R543-171-2", "#text": "Code de l'environnement - art. R543-171-2 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006074220", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000050750828", "@num": "R543-360", "#text": "Code de l'environnement - art. R543-360 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006074220", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000043841624", "@num": "R557-9-2", "#text": "Code de l'environnement - art. R557-9-2 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006074220", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000021964481", "@num": "L1111-3", "#text": "Code de la santé publique - art. L1111-3 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000043895775", "@num": "L1261-1", "#text": "Code de la santé publique - art. L1261-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690183", "@num": "L513-10-1", "#text": "Code de la santé publique - art. L513-10-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690293", "@num": "L5211-5", "#text": "Code de la santé publique - art. L5211-5 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000021941883", "@num": "L5211-5-2", "#text": "Code de la santé publique - art. L5211-5-2 (VT)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025086888", "@num": "L5213-1", "#text": "Code de la santé publique - art. L5213-1 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026831622", "@num": "L5214-2", "#text": "Code de la santé publique - art. L5214-2 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690661", "@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": "LEGIARTI000033621099", "@num": "L6147-3", "#text": "Code de la santé publique - art. L6147-3 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000044841432", "@num": "L6431-4", "#text": "Code de la santé publique - art. L6431-4 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694037", "@num": "L665-3", "#text": "Code de la santé publique - art. L665-3 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694036", "@num": "L665-3", "#text": "Code de la santé publique - art. L665-3 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006909999", "@num": "R1333-17", "#text": "Code de la santé publique - art. R1333-17 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006910857", "@num": "R1414-43", "#text": "Code de la santé publique - art. R1414-43 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006910859", "@num": "R1414-45", "#text": "Code de la santé publique - art. R1414-45 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006910860", "@num": "R1414-46", "#text": "Code de la santé publique - art. R1414-46 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006910861", "@num": "R1414-47", "#text": "Code de la santé publique - art. R1414-47 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006798501", "@num": "R43-12", "#text": "Code de la santé publique - art. R43-12 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000045187722", "@num": "R5121-210", "#text": "Code de la santé publique - art. R5121-210 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916188", "@num": "R5211-1", "#text": "Code de la santé publique - art. R5211-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916264", "@num": "R5212-1", "#text": "Code de la santé publique - art. R5212-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916324", "@num": "R5221-2", "#text": "Code de la santé publique - art. R5221-2 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801750", "@num": "R665-64-2", "#text": "Code de la santé publique - art. R665-64-2 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000038887559", "@num": "L162-1-7-1", "#text": "Code de la sécurité sociale. - art. L162-1-7-1 (VT)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000041396907", "@num": "L162-1-8", "#text": "Code de la sécurité sociale. - art. L162-1-8 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000044628361", "@num": "L165-1-1", "#text": "Code de la sécurité sociale. - art. L165-1-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000037064523", "@num": "L245-5-5-1", "#text": "Code de la sécurité sociale. - art. L245-5-5-1 (VT)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000036636595", "@num": "R162-50-13", "#text": "Code de la sécurité sociale. - art. R162-50-13 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000032886217", "@num": "R165-65", "#text": "Code de la sécurité sociale. - art. R165-65 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006171570", "@fin": "2999-01-01", "#text": "Chapitre Ier : Régime juridique des dispositifs médicaux.", "@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": "LEGIARTI000006690281", "@fin": "2001-03-03", "@num": "L5211-1", "@etat": "MODIFIE", "@debut": "2000-06-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690282", "@fin": "2010-03-21", "@num": "L5211-1", "@etat": "MODIFIE", "@debut": "2001-03-03", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000021964486", "@fin": "2022-04-22", "@num": "L5211-1", "@etat": "MODIFIE", "@debut": "2010-03-21", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000045630295", "@fin": "2022-07-31", "@num": "L5211-1", "@etat": "MODIFIE", "@debut": "2022-04-22", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000046126069", "@fin": "2999-01-01", "@num": "L5211-1", "@etat": "VIGUEUR", "@debut": "2022-07-31", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
On entend par dispositif médical tout instrument, appareil, équipement, matière, produit, à l'exception des produits d'origine humaine, ou autre article utilisé seul ou en association, y compris les accessoires et logiciels intervenant dans son fonctionnement, destiné par le fabricant à être utilisé chez l'homme à des fins médicales et dont l'action principale voulue n'est pas obtenue par des moyens pharmacologiques ou immunologiques ni par métabolisme, mais dont la fonction peut être assistée par de tels moyens.
\n
Les dispositifs médicaux qui sont conçus pour être implantés en totalité ou en partie dans le corps humain ou placés dans un orifice naturel, et qui dépendent pour leur bon fonctionnement d'une source d'énergie électrique ou de toute source d'énergie autre que celle qui est générée directement par le corps humain ou la pesanteur, sont dénommés dispositifs médicaux implantables actifs.
" } }, "LEGIARTI000021964486": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5211-1", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2022-04-22", "DATE_DEBUT": "2010-03-21" } }, "META_COMMUN": { "ID": "LEGIARTI000021964486", "URL": "article/LEGI/ARTI/00/00/21/96/44/LEGIARTI000021964486.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000006684513", "@num": "25", "#text": "Décret n°2003-1010 du 22 octobre 2003 - art. 25 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000610356", "@nortexte": "SOCA0323026D", "@numtexte": "2003-1010", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2003-10-22" }, { "@id": "LEGIARTI000020350738", "@num": "3", "#text": "Arrêté du 16 août 2006 - art. 3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000640165", "@nortexte": "SANP0623371A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000020317472", "@num": "3", "#text": "Arrêté du 16 août 2006 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000639975", "@nortexte": "SANP0623370A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000021961833", "@num": "2", "#text": "Ordonnance n°2010-250\n du 11 mars 2010 - art. 2", "@sens": "cible", "@cidtexte": "JORFTEXT000021961300", "@nortexte": "SASX1001341R", "@numtexte": "2010-250", "@typelien": "MODIFIE", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2010-03-11" }, { "@id": "LEGIARTI000022916144", "#text": "Arrêté du 15 septembre 2010 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000022915397", "@nortexte": "SASP1023783A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-09-15" }, { "@id": "LEGITEXT000030258990", "#text": "DÉCRET n°2015-188 du 18 février 2015 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000030258165", "@nortexte": "AFSS1414563D", "@numtexte": "2015-188", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2015-02-18" }, { "@id": "LEGIARTI000030909420", "@num": "5", "#text": "DÉCRET n°2015-881 du 17 juillet 2015 - art. 5 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000030907542", "@nortexte": "AFSH1506845D", "@numtexte": "2015-881", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2015-07-17" }, { "@id": "LEGIARTI000034155211", "@num": "5", "#text": "Décret n°2017-291 du 6 mars 2017 - art. 5", "@sens": "cible", "@cidtexte": "JORFTEXT000034154540", "@nortexte": "DEVL1702157D", "@numtexte": "2017-291", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2017-03-06" }, { "@id": "LEGIARTI000038533524", "#text": "Arrêté du 23 mai 2019 - art. 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R541-339 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006074220", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000039695081", "@num": "R543-171-2", "#text": "Code de l'environnement - art. R543-171-2 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006074220", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000050750828", "@num": "R543-360", "#text": "Code de l'environnement - art. R543-360 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006074220", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000043841624", "@num": "R557-9-2", "#text": "Code de l'environnement - art. R557-9-2 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006074220", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000021964481", "@num": "L1111-3", "#text": "Code de la santé publique - art. 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R1414-46 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006910861", "@num": "R1414-47", "#text": "Code de la santé publique - art. R1414-47 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006798501", "@num": "R43-12", "#text": "Code de la santé publique - art. R43-12 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000045187722", "@num": "R5121-210", "#text": "Code de la santé publique - art. R5121-210 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916188", "@num": "R5211-1", "#text": "Code de la santé publique - art. R5211-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916264", "@num": "R5212-1", "#text": "Code de la santé publique - art. R5212-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916324", "@num": "R5221-2", "#text": "Code de la santé publique - art. R5221-2 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801750", "@num": "R665-64-2", "#text": "Code de la santé publique - art. R665-64-2 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000038887559", "@num": "L162-1-7-1", "#text": "Code de la sécurité sociale. - art. L162-1-7-1 (VT)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000041396907", "@num": "L162-1-8", "#text": "Code de la sécurité sociale. - art. L162-1-8 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000044628361", "@num": "L165-1-1", "#text": "Code de la sécurité sociale. - art. 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On entend par dispositif médical tout instrument, appareil, équipement, matière, produit, à l'exception des produits d'origine humaine, ou autre article utilisé seul ou en association, y compris les accessoires et logiciels nécessaires au bon fonctionnement de celui-ci, destiné par le fabricant à être utilisé chez l'homme à des fins médicales et dont l'action principale voulue n'est pas obtenue par des moyens pharmacologiques ou immunologiques ni par métabolisme, mais dont la fonction peut être assistée par de tels moyens. Constitue également un dispositif médical le logiciel destiné par le fabricant à être utilisé spécifiquement à des fins diagnostiques ou thérapeutiques.

Les dispositifs médicaux qui sont conçus pour être implantés en totalité ou en partie dans le corps humain ou placés dans un orifice naturel, et qui dépendent pour leur bon fonctionnement d'une source d'énergie électrique ou de toute source d'énergie autre que celle qui est générée directement par le corps humain ou la pesanteur, sont dénommés dispositifs médicaux implantables actifs.

" } }, "LEGIARTI000026831578": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "3", "TYPE": "ENTIEREMENT_MODIF", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2999-01-01" } }, "META_COMMUN": { "ID": "LEGIARTI000026831578", "URL": "article/LEGI/ARTI/00/00/26/83/15/LEGIARTI000026831578.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGISCTA000026831618", "#text": "Code de la santé publique - Chapitre IV : Interdiction de certains matériau... (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026831620", "@num": "L5214-1", "#text": "Code de la santé publique - art. L5214-1 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026831622", "@num": "L5214-2", "#text": "Code de la santé publique - art. L5214-2 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "@cid": "JORFTEXT000026830015", "@nor": "AFSX1240700L", "@num": "2012-1442", "@nature": "LOI", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "LOI n° 2012-1442 du 24 décembre 2012 visant à la suspension de la fabrication, de l'importation, de l'exportation et de la mise sur le marché de tout conditionnement à vocation alimentaire contenant du bisphénol A (1)", "@debut": "2999-01-01", "@id_txt": "JORFTEXT000026830015", "@c_titre_court": "LOI n°2012-1442 du 24 décembre 2012" }, { "@fin": "2999-01-01", "#text": "LOI n° 2012-1442 du 24 décembre 2012 visant à la suspension de la fabrication, de l'importation, de l'exportation et de la mise sur le marché de tout conditionnement à vocation alimentaire contenant du bisphénol A (1)", "@debut": "2012-12-27", "@id_txt": "LEGITEXT000026831573", "@c_titre_court": "LOI n°2012-1442 du 24 décembre 2012" } ], "@date_publi": "2012-12-26", "@date_signature": "2012-12-24" } }, "VERSIONS": { "VERSION": [ { "LIEN_ART": { "@id": "LEGIARTI000026831578", "@fin": "2999-01-01", "@num": "3", "@debut": "2999-01-01", "@origine": "LEGI" } }, { "LIEN_ART": { "@id": "JORFARTI000026830029", "@fin": "2999-01-01", "@num": "3", "@debut": "2999-01-01", "@origine": "JORF" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
A créé les dispositions suivantes :

- Code de la santé publique
\n Sct. Chapitre IV : Interdiction de certains matériaux dans les dispositifs médicaux, Art. L5214-1, Art. L5214-2\n
\n

\n
" } }, "LEGIARTI000045630295": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5211-1", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2022-07-31", "DATE_DEBUT": "2022-04-22" } }, "META_COMMUN": { "ID": "LEGIARTI000045630295", "URL": "article/LEGI/ARTI/00/00/45/63/02/LEGIARTI000045630295.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.

" }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000006684513", "@num": "25", "#text": "Décret n°2003-1010 du 22 octobre 2003 - art. 25 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000610356", "@nortexte": "SOCA0323026D", "@numtexte": "2003-1010", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2003-10-22" }, { "@id": "LEGIARTI000020350738", "@num": "3", "#text": "Arrêté du 16 août 2006 - art. 3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000640165", "@nortexte": "SANP0623371A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000020317472", "@num": "3", "#text": "Arrêté du 16 août 2006 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000639975", "@nortexte": "SANP0623370A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000022916144", "#text": "Arrêté du 15 septembre 2010 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000022915397", "@nortexte": "SASP1023783A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-09-15" }, { "@id": "LEGITEXT000030258990", "#text": "DÉCRET n°2015-188 du 18 février 2015 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000030258165", "@nortexte": "AFSS1414563D", "@numtexte": "2015-188", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2015-02-18" }, { "@id": "LEGIARTI000030909420", "@num": "5", "#text": "DÉCRET n°2015-881 du 17 juillet 2015 - art. 5 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000030907542", "@nortexte": "AFSH1506845D", "@numtexte": "2015-881", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2015-07-17" }, { "@id": "LEGIARTI000034155211", "@num": "5", "#text": "Décret n°2017-291 du 6 mars 2017 - art. 5", "@sens": "cible", "@cidtexte": "JORFTEXT000034154540", "@nortexte": "DEVL1702157D", "@numtexte": "2017-291", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2017-03-06" }, { "@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": "LEGIARTI000050090741", "@num": "2", "#text": "Arrêté du 15 juin 2021 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000043673283", "@nortexte": "SSAH2116294A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-06-15" }, { "@id": "LEGIARTI000045615379", "@num": "10", "#text": "Ordonnance n°2022-582 du 20 avril 2022 - art. 10", "@sens": "cible", "@cidtexte": "JORFTEXT000045614779", "@nortexte": "SSAP2205263R", "@numtexte": "2022-582", "@typelien": "MODIFIE", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2022-04-20" }, { "@id": "LEGIARTI000047690229", "@num": "1", "#text": "Arrêté du 12 juin 2023 - art. 1 (VD)", "@sens": "cible", "@cidtexte": "JORFTEXT000047689131", "@nortexte": "SPRS2316031A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2023-06-12" }, { "@id": "LEGITEXT000051060847", "#text": "Décret n°2025-80 du 28 janvier 2025 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000051058924", "@nortexte": "TSSH2431602D", "@numtexte": "2025-80", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2025-01-28" }, { "@id": "LEGIARTI000051060858", "@num": "1", "#text": "Décret n°2025-80 du 28 janvier 2025 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000051058924", "@nortexte": "TSSH2431602D", "@numtexte": "2025-80", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2025-01-28" }, { "@id": "LEGIARTI000031829279", "@num": "R314-168", "#text": "Code de l'action sociale et des familles - art. R314-168 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006074069", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033700163", "@num": "R314-26", "#text": "Code de l'action sociale et des familles - art. R314-26 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006074069", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000032775739", "@num": "D543-259", "#text": "Code de l'environnement - art. D543-259 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006074220", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000034155479", "@num": "D543-296-2", "#text": "Code de l'environnement - art. D543-296-2 (T)", "@sens": "cible", "@cidtexte": "LEGITEXT000006074220", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025021487", "@num": "L522-1", "#text": "Code de l'environnement - art. L522-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006074220", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000037556713", "@num": "L541-10-5", "#text": "Code de l'environnement - art. L541-10-5 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006074220", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000051561876", "@num": "L541-15-10", "#text": "Code de l'environnement - art. L541-15-10 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006074220", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000051061049", "@num": "R541-339", "#text": "Code de l'environnement - art. R541-339 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006074220", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000039695081", "@num": "R543-171-2", "#text": "Code de l'environnement - art. R543-171-2 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006074220", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000050750828", "@num": "R543-360", "#text": "Code de l'environnement - art. R543-360 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006074220", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000043841624", "@num": "R557-9-2", "#text": "Code de l'environnement - art. R557-9-2 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006074220", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000021964481", "@num": "L1111-3", "#text": "Code de la santé publique - art. L1111-3 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000043895775", "@num": "L1261-1", "#text": "Code de la santé publique - art. L1261-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690183", "@num": "L513-10-1", "#text": "Code de la santé publique - art. L513-10-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690293", "@num": "L5211-5", "#text": "Code de la santé publique - art. L5211-5 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000021941883", "@num": "L5211-5-2", "#text": "Code de la santé publique - art. L5211-5-2 (VT)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025086888", "@num": "L5213-1", "#text": "Code de la santé publique - art. L5213-1 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026831622", "@num": "L5214-2", "#text": "Code de la santé publique - art. L5214-2 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690661", "@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": "LEGIARTI000033621099", "@num": "L6147-3", "#text": "Code de la santé publique - art. L6147-3 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000044841432", "@num": "L6431-4", "#text": "Code de la santé publique - art. L6431-4 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694037", "@num": "L665-3", "#text": "Code de la santé publique - art. L665-3 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694036", "@num": "L665-3", "#text": "Code de la santé publique - art. L665-3 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006909999", "@num": "R1333-17", "#text": "Code de la santé publique - art. R1333-17 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006910857", "@num": "R1414-43", "#text": "Code de la santé publique - art. R1414-43 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006910859", "@num": "R1414-45", "#text": "Code de la santé publique - art. R1414-45 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006910860", "@num": "R1414-46", "#text": "Code de la santé publique - art. R1414-46 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006910861", "@num": "R1414-47", "#text": "Code de la santé publique - art. R1414-47 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006798501", "@num": "R43-12", "#text": "Code de la santé publique - art. R43-12 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000045187722", "@num": "R5121-210", "#text": "Code de la santé publique - art. R5121-210 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916188", "@num": "R5211-1", "#text": "Code de la santé publique - art. R5211-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916264", "@num": "R5212-1", "#text": "Code de la santé publique - art. R5212-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916324", "@num": "R5221-2", "#text": "Code de la santé publique - art. R5221-2 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801750", "@num": "R665-64-2", "#text": "Code de la santé publique - art. R665-64-2 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000038887559", "@num": "L162-1-7-1", "#text": "Code de la sécurité sociale. - art. L162-1-7-1 (VT)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000041396907", "@num": "L162-1-8", "#text": "Code de la sécurité sociale. - art. L162-1-8 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000044628361", "@num": "L165-1-1", "#text": "Code de la sécurité sociale. - art. L165-1-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000037064523", "@num": "L245-5-5-1", "#text": "Code de la sécurité sociale. - art. L245-5-5-1 (VT)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000036636595", "@num": "R162-50-13", "#text": "Code de la sécurité sociale. - art. R162-50-13 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000032886217", "@num": "R165-65", "#text": "Code de la sécurité sociale. - art. R165-65 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006171570", "@fin": "2999-01-01", "#text": "Chapitre Ier : Régime juridique des dispositifs médicaux.", "@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": "LEGIARTI000006690281", "@fin": "2001-03-03", "@num": "L5211-1", "@etat": "MODIFIE", "@debut": "2000-06-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690282", "@fin": "2010-03-21", "@num": "L5211-1", "@etat": "MODIFIE", "@debut": "2001-03-03", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000021964486", "@fin": "2022-04-22", "@num": "L5211-1", "@etat": "MODIFIE", "@debut": "2010-03-21", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000045630295", "@fin": "2022-07-31", "@num": "L5211-1", "@etat": "MODIFIE", "@debut": "2022-04-22", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000046126069", "@fin": "2999-01-01", "@num": "L5211-1", "@etat": "VIGUEUR", "@debut": "2022-07-31", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

I.-La mise sur le marché, la mise en service et la mise à disposition sur le marché des dispositifs médicaux et de leurs accessoires satisfont aux dispositions du règlement (UE) 2017/745 du Parlement européen et du Conseil du 5 avril 2017 et aux dispositions du présent titre.
\n
\n Ces dispositions sont également applicables aux groupes de produits n'ayant pas de destination médicale dont la liste figure à l'annexe XVI du même règlement.
\n
\n II.-On entend par dispositif médical : tout instrument, appareil, équipement, logiciel, implant, réactif, matière ou autre article, destiné par le fabricant à être utilisé, seul ou en association, chez l'homme pour l'une ou plusieurs des fins médicales mentionnées ci-après et dont l'action principale voulue dans ou sur le corps humain n'est pas obtenue par des moyens pharmacologiques ou immunologiques ni par métabolisme, mais dont la fonction peut être assistée par de tels moyens :
\n
\n 1° Diagnostic, prévention, contrôle, prédiction, pronostic, traitement ou atténuation d'une maladie ;
\n
\n 2° Diagnostic, contrôle, traitement, atténuation d'une blessure ou d'un handicap ou compensation de ceux-ci ;
\n
\n 3° Investigation, remplacement ou modification d'une structure ou fonction anatomique ou d'un processus ou état physiologique ou pathologique ;
\n
\n 4° Communication d'informations au moyen d'un examen in vitro d'échantillons provenant du corps humain, y compris les dons d'organes, de sang et de tissus.
\n
\n Sont réputés être des dispositifs médicaux :

\n
\n-les dispositifs destinés à la maîtrise de la conception ou à l'assistance à celle-ci ;
\n
\n-les produits spécifiquement destinés au nettoyage, à la désinfection ou à la stérilisation des dispositifs médicaux, de leurs accessoires et des groupes de produits n'ayant pas de destination médicale dont la liste figure à l'annexe XVI du règlement (UE) 2017/745 précité.

\n
\n III.-On entend par accessoire de dispositif médical : tout article qui, sans être lui-même un dispositif médical, est destiné par son fabricant à être utilisé avec un dispositif médical donné, ou avec plusieurs d'entre eux, pour permettre une utilisation de ce dispositif médical conforme à sa destination, ou pour contribuer spécifiquement et directement à la fonction médicale du dispositif médical selon sa destination.

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D543-296-2 (T)", "@sens": "cible", "@cidtexte": "LEGITEXT000006074220", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025021487", "@num": "L522-1", "#text": "Code de l'environnement - art. L522-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006074220", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000037556713", "@num": "L541-10-5", "#text": "Code de l'environnement - art. L541-10-5 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006074220", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000051561876", "@num": "L541-15-10", "#text": "Code de l'environnement - art. L541-15-10 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006074220", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000051061049", "@num": "R541-339", "#text": "Code de l'environnement - art. 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R665-64-2 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000038887559", "@num": "L162-1-7-1", "#text": "Code de la sécurité sociale. - art. L162-1-7-1 (VT)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000041396907", "@num": "L162-1-8", "#text": "Code de la sécurité sociale. - art. L162-1-8 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000044628361", "@num": "L165-1-1", "#text": "Code de la sécurité sociale. - art. 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I.-La mise sur le marché, la mise en service et la mise à disposition sur le marché des dispositifs médicaux et de leurs accessoires satisfont aux dispositions du règlement (UE) 2017/745 du Parlement européen et du Conseil du 5 avril 2017 et aux dispositions du présent titre.
\n
\nCes dispositions sont également applicables aux groupes de produits n'ayant pas de destination médicale dont la liste figure à l'annexe XVI du même règlement.
\n
\nII.-On entend par dispositif médical : tout instrument, appareil, équipement, logiciel, implant, réactif, matière ou autre article, destiné par le fabricant à être utilisé, seul ou en association, chez l'homme pour l'une ou plusieurs des fins médicales mentionnées ci-après et dont l'action principale voulue dans ou sur le corps humain n'est pas obtenue par des moyens pharmacologiques ou immunologiques ni par métabolisme, mais dont la fonction peut être assistée par de tels moyens :
\n
\n1° Diagnostic, prévention, surveillance, prédiction, pronostic, traitement ou atténuation d'une maladie ;
\n
\n2° Diagnostic, contrôle, traitement, atténuation d'une blessure ou d'un handicap ou compensation de ceux-ci ;
\n
\n3° Investigation, remplacement ou modification d'une structure ou fonction anatomique ou d'un processus ou état physiologique ou pathologique ;
\n
\n4° Communication d'informations au moyen d'un examen in vitro d'échantillons provenant du corps humain, y compris les dons d'organes, de sang et de tissus.
\n
\nSont réputés être des dispositifs médicaux :

-les dispositifs destinés à la maîtrise de la conception ou à l'assistance à celle-ci ;
\n
\n-les produits spécifiquement destinés au nettoyage, à la désinfection ou à la stérilisation des dispositifs médicaux, de leurs accessoires et des groupes de produits n'ayant pas de destination médicale dont la liste figure à l'annexe XVI du règlement (UE) 2017/745 précité.

\n
\nIII.-On entend par accessoire de dispositif médical : tout article qui, sans être lui-même un dispositif médical, est destiné par son fabricant à être utilisé avec un dispositif médical donné, ou avec plusieurs d'entre eux, pour permettre une utilisation de ce dispositif médical conforme à sa destination, ou pour contribuer spécifiquement et directement à la fonction médicale du dispositif médical selon sa destination.

\n
\n
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Article L5214-2 AUTONOME VIGUEUR, en vigueur depuis le 27/12/2012 (Code de la santé publique)