{ "article": { "LEGIARTI000031937106": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "D6211-11", "ETAT": "VIGUEUR", "TYPE": "AUTONOME", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2016-01-29" } }, "META_COMMUN": { "ID": "LEGIARTI000031937106", "URL": "article/LEGI/ARTI/00/00/31/93/71/LEGIARTI000031937106.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000031935878", "@num": "1", "#text": "Décret n°2016-46 du 26 janvier 2016 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000031922237", "@nortexte": "AFSP1526854D", "@numtexte": "2016-46", "@typelien": "CREE", "@naturetexte": "DECRET", "@datesignatexte": "2016-01-26" }, { "@id": "LEGIARTI000031937017", "@num": "D6211-9", "#text": "Code de la santé publique - art. D6211-9 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006196835", "@fin": "2016-01-29", "#text": "Sous-section 1 : Dispositions communes.", "@debut": "2005-07-26" }, { "@id": "LEGISCTA000031980318", "@fin": "2999-01-01", "#text": "Sous-section 1 : Cohérence entre les données du dispositif médical ou du dispositif médical de diagnostic in vitro et le résultat de l'examen de biologie médicale", "@debut": "2016-01-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006190894", "@fin": "2016-01-29", "#text": "Section 2 : Règles de fonctionnement", "@debut": "2005-07-26" }, { "@id": "LEGISCTA000031980320", "@fin": "2999-01-01", "#text": "Section 2 : Conditions et modalités de réalisation", "@debut": "2016-01-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006178713", "@fin": "2016-01-29", "#text": "Chapitre Ier : Fonctionnement", "@debut": "2005-07-26" }, { "@id": "LEGISCTA000031980367", "@fin": "2999-01-01", "#text": "Chapitre Ier : Examen de biologie médicale", "@debut": "2016-01-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006161030", "@fin": "2016-01-29", "#text": "Titre Ier : Régime juridique des laboratoires", "@debut": "2005-07-26" }, { "@id": "LEGISCTA000031980369", "@fin": "2999-01-01", "#text": "Titre Ier : Définitions et principes généraux", "@debut": "2016-01-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006145494", "@fin": "2016-01-29", "#text": "Livre II : Laboratoires d'analyses de biologie médicale", "@debut": "2005-07-26" }, { "@id": "LEGISCTA000031980371", "@fin": "2999-01-01", "#text": "Livre II : Biologie médicale", "@debut": "2016-01-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006132400", "@fin": "2999-01-01", "#text": "Sixième partie : Etablissements et services de santé", "@debut": "2005-07-26" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006112927", "@fin": "2999-01-01", "#text": "Partie réglementaire", "@debut": "2000-12-23" } ] }, "@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": "LEGIARTI000031937106", "@fin": "2999-01-01", "@num": "D6211-11", "@etat": "VIGUEUR", "@debut": "2016-01-29", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

Pour les dispositifs médicaux et pour les dispositifs médicaux de diagnostic in vitro autres que ceux mentionnés à l'article D. 6211-9, le contrôle est réalisé, le cas échéant, selon les modalités prévues dans la notice d'instruction du dispositif concerné.

" } }, "LEGIARTI000031935878": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "1", "TYPE": "ENTIEREMENT_MODIF", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2999-01-01" } }, "META_COMMUN": { "ID": "LEGIARTI000031935878", "URL": "article/LEGI/ARTI/00/00/31/93/58/LEGIARTI000031935878.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGISCTA000006196988", "#text": "Code de la santé publique - Sous-section 1 : Actes d'anatomie et de cytolog... (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "ABROGATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGISCTA000006196989", "#text": "Code de la santé publique - Sous-section 2 : Examens biologiques d'interpré... (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "ABROGATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006918994", "@num": "D6211-33", "#text": "Code de la santé publique - art. 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R6213-7 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "ABROGE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000031181862", "@num": "R6213-8", "#text": "Code de la santé publique - art. R6213-8 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "ABROGE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000031181864", "@num": "R6213-9", "#text": "Code de la santé publique - art. R6213-9 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "ABROGE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006741287", "@num": "L161-37", "#text": "Code de la sécurité sociale. - art. L161-37", "@sens": "source", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006740731", "@num": "L162-1-7", "#text": "Code de la sécurité sociale. - art. 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\n
\n
A modifié les dispositions suivantes :

- Code de la santé publique
\n Sct. Livre II : Biologie médicale, Sct. Titre Ier : Définitions et principes généraux, Sct. Chapitre Ier : Examen de biologie médicale, Sct. Section 1 : Définitions et champ d'application, Sct. Sous-section 1 : Dispositions générales, Art. D6211-1, Art. D6211-2, Art. D6211-3, Art. R6211-1, Art. R6211-2, Art. R6211-3, Art. R6211-4, Art. D6211-5, Art. R6211-5, Art. D6211-6, Sct. Paragraphe 1 : Personnel et équipement., Sct. Sous-section 2 : Examens réalisés en des lieux éloignés de tout laboratoire de biologie médicale, Art. D6211-7, Sct. Section 2 : Conditions et modalités de réalisation, Sct. Sous-section 1 : Cohérence entre les données du dispositif médical ou du dispositif médical de diagnostic in vitro et le résultat de l'examen de biologie médicale, Art. D6211-8, Art. D6211-9, Art. D6211-10, Art. D6211-11, Sct. Sous-section 2 : Prélèvements hors des territoires de santé où sont localisés les laboratoires de biologie médicale, Art. R6211-9, Art. R6211-10, Art. R6211-11, Art. R6211-12, Sct. Sous-section 3 : Activité du laboratoire de biologie médicale, Art. R6211-13, Sct. Paragraphe 2 : Normes applicables à l'installation, à l'équipement et à la bonne exécution des analyses., Art. D6211-13, Sct. Sous-section 3 : Retrait de l'autorisation., Art. D6211-14, Art. R6211-15, Art. R6211-16, Art. R6211-17, Art. D6211-15, Art. D6211-16, Art. D6211-17, Art. R6211-18, Art. R6211-19, Art. R6211-20, Art. R6211-21, Art. R6211-22, Art. R6211-23, Art. R6211-24, Art. R6211-25, Art. R6211-26, Art. R6211-27, Art. R6211-28, Art. R6211-29, Art. R6211-30, Art. R6211-31, Art. R6211-31-1, Sct. Section 3 : Commission nationale permanente de biologie médicale., Sct. Section 4 : Actes et examens biologiques réalisés en dehors des laboratoires, Sct. Section 5 : Régime de déclaration et d'autorisation des laboratoires établis dans un Etat membre de la Communauté européenne ou partie à l'accord sur l'Espace économique européen, Sct. Chapitre II : Laboratoires de biologie médicale, Sct. Section unique : Compatibilité des contrats de coopération avec le schéma régional de l'organisation des soins, Art. R6212-1, Sct. Chapitre III : Biologiste médical, Sct. Section 1 : Conditions d'exercice, Sct. Sous-section 1 : Procédure de reconnaissance d'un domaine de spécialisation\n, Art. R6213-1, Art. R6213-2, Art. R6213-3, Art. R6213-4, Sct. Sous-section 2 : Directeur ou directeur adjoint d'un centre national de référence pour la lutte contre les maladies transmissibles\n, Art. R6213-5, Art. R6213-6, Art. R6213-7, Sct. Sous-section 3 : Médecins et pharmaciens exerçant dans les centres hospitaliers universitaires\n\n, Art. R6213-8, Art. R6213-9, Art. R6213-10, Sct. Sous-section 4 : Conditions d'habilitation à effectuer certains actes de prélèvement, Art. R6213-11, Art. R6213-12, Sct. Section 2 : Modalités d'exercice, Sct. Sous-section 1 : Remplacement à titre temporaire, Art. D6213-13, Art. D6213-14, Sct. Sous-section 2 : Commission nationale de biologie médicale, Art. R6213-15, Art. R6213-16, Art. R6213-17, Art. R6213-18, Art. R6213-19, Art. R6213-20, Art. R6213-21, Art. R6213-22, Art. R6213-23, Art. R6213-24, Art. R6213-25, Art. R6213-26, Art. R6213-27, Art. R6213-28\n
\n

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Pour les dispositifs médicaux de diagnostic in vitro utilisés en ambulatoire, la fréquence de vérification de la cohérence mentionnée à l'article D. 6211-8 est déterminée par les recommandations mentionnées au 2° de l'article L. 161-37 du code de la sécurité sociale ou celles issues des données acquises de la science, ou par les prescriptions figurant dans la notice d'instruction du dispositif médical de diagnostic in vitro concerné si ces dernières sont plus contraignantes. Dans tous les cas, la fréquence de vérification de cette cohérence est au moins annuelle.

Lors de la réalisation du prélèvement pour l'examen de biologie médicale, le patient ou la personne qui effectue habituellement le test réalise celui-ci en présence du biologiste médical ou sous sa responsabilité. Le résultat de la mesure du test est recueilli par le biologiste médical ou sous sa responsabilité.

Ce professionnel de santé rappelle, si nécessaire, au patient ou à la personne qui effectue habituellement le test, les conditions générales d'utilisation des appareils de mesure concernés.

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Article D6211-11 AUTONOME VIGUEUR, en vigueur depuis le 29/01/2016 (Code de la santé publique)