{ "article": { "LEGIARTI000046118730": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "2", "TYPE": "ENTIEREMENT_MODIF", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2999-01-01" } }, "META_COMMUN": { "ID": "LEGIARTI000046118730", "URL": "article/LEGI/ARTI/00/00/46/11/87/LEGIARTI000046118730.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000046125993", "@num": "L1221-4", "#text": "Code de la santé publique - art. L1221-4 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000046125982", "@num": "L1221-8", "#text": "Code de la santé publique - art. L1221-8 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "@cid": "JORFTEXT000046113837", "@nor": "SPRP2217455R", "@num": "2022-1086", "@nature": "ORDONNANCE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Ordonnance n° 2022-1086 du 29 juillet 2022 portant adaptation du droit français au règlement (UE) 2017/746 du Parlement européen et du Conseil du 5 avril 2017 relatif aux dispositifs médicaux de diagnostic in vitro", "@debut": "2999-01-01", "@id_txt": "JORFTEXT000046113837", "@c_titre_court": "Ordonnance n°2022-1086 du 29 juillet 2022" }, { "@fin": "2999-01-01", "#text": "Ordonnance n° 2022-1086 du 29 juillet 2022 portant adaptation du droit français au règlement (UE) 2017/746 du Parlement européen et du Conseil du 5 avril 2017 relatif aux dispositifs médicaux de diagnostic in vitro", "@debut": "2022-07-31", "@id_txt": "LEGITEXT000046118709", "@c_titre_court": "Ordonnance n°2022-1086 du 29 juillet 2022" } ], "@ministere": "Ministère de la santé et de la prévention", "@date_publi": "2022-07-30", "@date_signature": "2022-07-29", "@num_parution_jo": "0175" } }, "VERSIONS": { "VERSION": [ { "LIEN_ART": { "@id": "LEGIARTI000046118730", "@fin": "2999-01-01", "@num": "2", "@debut": "2999-01-01", "@origine": "LEGI" } }, { "LIEN_ART": { "@id": "JORFARTI000046113839", "@fin": "2999-01-01", "@num": "2", "@debut": "2999-01-01", "@origine": "JORF" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
A modifié les dispositions suivantes :

- Code de la santé publique
\n Art. L1221-4, Art. L1221-8\n
\n

\n
" } }, "LEGIARTI000046125982": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L1221-8", "ETAT": "VIGUEUR", "TYPE": "AUTONOME", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2022-07-31" } }, "META_COMMUN": { "ID": "LEGIARTI000046125982", "URL": "article/LEGI/ARTI/00/00/46/12/59/LEGIARTI000046125982.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000020330078", "@num": "3", "#text": "Arrêté du 13 novembre 2006 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000463112", "@nortexte": "SANP0624638A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-11-13" }, { "@id": "LEGIARTI000006816377", "@num": "1", "#text": "Arrêté du 30 octobre 2007 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000523747", "@nortexte": "SJSP0770001A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2007-10-30" }, { "@id": "LEGIARTI000027699119", "@num": "1", "#text": "Arrêté du 17 juin 2013 - art. 1 (VD)", "@sens": "cible", "@cidtexte": "JORFTEXT000027697076", "@nortexte": "AFSP1301854A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-06-17" }, { "@id": "LEGIARTI000030186616", "@num": "7", "#text": "DÉCRET n°2015-100 du 2 février 2015 - art. 7 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000030185960", "@nortexte": "AFSP1431045D", "@numtexte": "2015-100", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2015-02-02" }, { "@id": "LEGIARTI000034392999", "@num": "1", "#text": "Décret n°2017-500 du 6 avril 2017 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000034390458", "@nortexte": "AFSH1702718D", "@numtexte": "2017-500", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2017-04-06" }, { "@id": "LEGIARTI000044295877", "@num": "1", "#text": "Arrêté du 25 octobre 2021 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000044294321", "@nortexte": "SSAP2132119A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-10-25" }, { "@id": "LEGIARTI000044295871", "@num": "4", "#text": "Arrêté du 25 octobre 2021 - art. 4 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000044294321", "@nortexte": "SSAP2132119A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-10-25" }, { "@id": "LEGIARTI000046118730", "@num": "2", "#text": "Ordonnance n°2022-1086 du 29 juillet 2022 - art. 2", "@sens": "cible", "@cidtexte": "JORFTEXT000046113837", "@nortexte": "SPRP2217455R", "@numtexte": "2022-1086", "@typelien": "MODIFIE", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2022-07-29" }, { "@id": "LEGIARTI000006908791", "@num": "D1221-56", "#text": "Code de la santé publique - art. D1221-56 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000029962879", "@num": "L1221-10", "#text": "Code de la santé publique - art. L1221-10 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000029962870", "@num": "L1221-10-2", "#text": "Code de la santé publique - art. L1221-10-2 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033281970", "@num": "L1221-11", "#text": "Code de la santé publique - art. L1221-11 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000031931400", "@num": "L1221-13", "#text": "Code de la santé publique - art. L1221-13 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006686077", "@num": "L1221-3", "#text": "Code de la santé publique - art. L1221-3", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006686083", "@num": "L1221-6", "#text": "Code de la santé publique - art. L1221-6", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025139315", "@num": "L1221-8-2", "#text": "Code de la santé publique - art. L1221-8-2 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000031931436", "@num": "L1221-9", "#text": "Code de la santé publique - art. L1221-9 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000048687865", "@num": "L1222-8", "#text": "Code de la santé publique - art. L1222-8 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000029962838", "@num": "L1223-1", "#text": "Code de la santé publique - art. L1223-1 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033282106", "@num": "L1223-2", "#text": "Code de la santé publique - art. L1223-2 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033282099", "@num": "L1223-3", "#text": "Code de la santé publique - art. L1223-3 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033282082", "@num": "L1223-4", "#text": "Code de la santé publique - art. L1223-4 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006686207", "@num": "L1242-1", "#text": "Code de la santé publique - art. L1242-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006686213", "@num": "L1243-1", "#text": "Code de la santé publique - art. L1243-1", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000046479737", "@num": "L1271-8", "#text": "Code de la santé publique - art. L1271-8 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025453948", "@num": "L1525-4", "#text": "Code de la santé publique - art. L1525-4 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025453939", "@num": "L1543-3", "#text": "Code de la santé publique - art. L1543-3 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000029957675", "@num": "L5126-5-2", "#text": "Code de la santé publique - art. L5126-5-2 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690352", "@num": "L5311-2", "#text": "Code de la santé publique - art. L5311-2", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694197", "@num": "L666-8", "#text": "Code de la santé publique - art. L666-8 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694194", "@num": "L666-8", "#text": "Code de la santé publique - art. L666-8 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000049986712", "@num": "R1121-2", "#text": "Code de la santé publique - art. R1121-2 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006908658", "@num": "R1211-1", "#text": "Code de la santé publique - art. R1211-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006908670", "@num": "R1211-12", "#text": "Code de la santé publique - art. R1211-12 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000035321590", "@num": "R1222-40", "#text": "Code de la santé publique - art. R1222-40 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000035333823", "@num": "R1223-1", "#text": "Code de la santé publique - art. R1223-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000035333612", "@num": "R1223-10", "#text": "Code de la santé publique - art. R1223-10 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000029460476", "@num": "R1223-14", "#text": "Code de la santé publique - art. R1223-14 (T)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000035333818", "@num": "R1223-2", "#text": "Code de la santé publique - art. R1223-2 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006746639", "@num": "R162-31", "#text": "Code de la sécurité sociale. - art. R162-31 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025111890", "@num": "R162-31-1", "#text": "Code de la sécurité sociale. - art. R162-31-1 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000044131997", "@num": "R162-31-2", "#text": "Code de la sécurité sociale. - art. R162-31-2 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000048639454", "@num": "38", "#text": "Code des douanes - art. 38 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006071570", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000044983676", "@num": "281 octies", "#text": "Code général des impôts, CGI. - art. 281 octies (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006069577", "@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": "LEGIARTI000006686087", "@fin": "2003-12-08", "@num": "L1221-8", "@etat": "MODIFIE", "@debut": "2000-06-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006686088", "@fin": "2004-08-07", "@num": "L1221-8", "@etat": "MODIFIE", "@debut": "2003-12-08", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006686089", "@fin": "2005-09-02", "@num": "L1221-8", "@etat": "MODIFIE", "@debut": "2004-08-07", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006686090", "@fin": "2010-01-16", "@num": "L1221-8", "@etat": "MODIFIE", "@debut": "2005-09-02", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000022104902", "@fin": "2012-05-01", "@num": "L1221-8", "@etat": "MODIFIE", "@debut": "2010-01-16", "@origine": "LEGI" } }, { "@etat": "MODIFIE_MORT_NE", "LIEN_ART": { "@id": "LEGIARTI000025104443", "@fin": "2012-03-07", "@num": "L1221-8", "@etat": "MODIFIE_MORT_NE", "@debut": "2012-05-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000025454345", "@fin": "2014-12-25", "@num": "L1221-8", "@etat": "MODIFIE", "@debut": "2012-03-07", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000029962891", "@fin": "2016-01-28", "@num": "L1221-8", "@etat": "MODIFIE", "@debut": "2014-12-25", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000031931228", "@fin": "2016-10-22", "@num": "L1221-8", "@etat": "MODIFIE", "@debut": "2016-01-28", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000033282002", "@fin": "2022-07-31", "@num": "L1221-8", "@etat": "MODIFIE", "@debut": "2016-10-22", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000046125982", "@fin": "2999-01-01", "@num": "L1221-8", "@etat": "VIGUEUR", "@debut": "2022-07-31", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

Peuvent être préparés à partir du sang ou de ses composants :

1° Des produits sanguins labiles, comprenant notamment le sang total, le plasma dans la production duquel n'intervient pas un processus industriel, quelle que soit sa finalité, et les cellules sanguines d'origine humaine. A l'exception des produits sanguins labiles destinés à des recherches impliquant la personne humaine, seuls peuvent être distribués ou délivrés à des fins thérapeutiques, les produits sanguins labiles dont la liste et les caractéristiques sont fixées par décision de l'Agence nationale de sécurité du médicament et des produits de santé, après avis du président de l'Etablissement français du sang et du directeur du centre de transfusion sanguine des armées, et publiée au Journal officiel de la République française.

2° Des pâtes plasmatiques ;

2° bis Du plasma à finalité transfusionnelle dans la production duquel intervient un processus industriel, régi par le livre Ier de la cinquième partie ;

3° Des médicaments issus du fractionnement du plasma régis par le même livre Ier ;

4° Des dispositifs médicaux de diagnostic in vitro et leurs accessoires régis par le règlement (UE) 2017/746 du Parlement européen et du Conseil du 5 avril 2017 et le titre II du livre II de la cinquième partie ;

5° Des produits cellulaires à finalité thérapeutique mentionnés à l'article L. 1243-1 ; \n

6° (Abrogé) ;

7° Des excipients à usage pharmaceutique et des substances utilisées lors de la fabrication d'un médicament mais n'entrant pas dans sa composition.

Le sang et ses composants, qu'ils aient ou non été prélevés au sein de l'Etablissement français du sang, peuvent également être utilisés pour effectuer les contrôles de qualité des examens de biologie médicale ainsi que pour la réalisation et le contrôle des dispositifs médicaux de diagnostic in vitro et leurs accessoires, ou pour effectuer sur les produits préparés à partir du sang ou de ses composants les expertises et les contrôles techniques réalisés par l'Agence nationale de sécurité du médicament et des produits de santé en application du 1° de l'article L. 5311-2. Les principes mentionnés aux articles L. 1221-3, L. 1221-4 et L. 1221-6 sont également applicables dans ce cas.

\n
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Le sang, ses composants et leurs dérivés ne peuvent pas être distribués, délivrés, utilisés sans qu'aient été faits des examens biologiques et des tests de dépistage de maladies transmissibles.

Le sang, ses composants et leurs dérivés peuvent être distribués et utilisés à des fins de recherche, de contrôle des examens de biologie médicale ou de contrôle des dispositifs médicaux de diagnostic in vitro et leurs accessoires, à l'exclusion de toute administration à l'homme, avant l'obtention des résultats des examens biologiques et des tests de dépistage prévus au premier alinéa.

Les conditions d'application du présent article sont fixées par décret.

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Article 2 ENTIEREMENT_MODIF (Ordonnance n° 2022-1086 du 29 juillet 2022 portant adaptation du droit français au règlement (UE) 2017/746 du Parlement européen et du Conseil du 5 avril 2017 relatif aux dispositifs médicaux de diagnostic in vitro)