{"id":13460,"date":"2023-07-31T11:31:06","date_gmt":"2023-07-31T11:31:06","guid":{"rendered":"https:\/\/www.icemedics.com\/reglement-ue-2017-745\/"},"modified":"2023-10-16T07:59:58","modified_gmt":"2023-10-16T07:59:58","slug":"reglement-ue-2017-745","status":"publish","type":"page","link":"https:\/\/www.icemedics.com\/fr\/reglement-ue-2017-745\/","title":{"rendered":"R\u00e8glement UE 2017\/745"},"content":{"rendered":"

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R\u00e8glement<\/h1>\n

sur les dispositifs<\/h1>\n

m\u00e9dicaux<\/h1>\n

UE 2017\/745<\/h1>\n<\/div>\n<\/div>\n<\/div>\n

[\/et_pb_text][\/et_pb_column_inner][et_pb_column_inner type=\u00a0\u00bb1_2″ saved_specialty_column_type=\u00a0\u00bb3_4″ _builder_version=\u00a0\u00bb4.18.0″ _module_preset=\u00a0\u00bbdefault\u00a0\u00bb global_colors_info=\u00a0\u00bb{}\u00a0\u00bb][et_pb_image src=\u00a0\u00bbhttps:\/\/www.icemedics.com\/wp-content\/uploads\/2023\/08\/MD.png\u00a0\u00bb title_text=\u00a0\u00bbMD\u00a0\u00bb _builder_version=\u00a0\u00bb4.18.0″ _module_preset=\u00a0\u00bbdefault\u00a0\u00bb width=\u00a0\u00bb80%\u00a0\u00bb custom_margin=\u00a0\u00bb10px||||false|false\u00a0\u00bb global_colors_info=\u00a0\u00bb{}\u00a0\u00bb][\/et_pb_image][\/et_pb_column_inner][\/et_pb_row_inner][et_pb_row_inner _builder_version=\u00a0\u00bb4.18.0″ _module_preset=\u00a0\u00bbdefault\u00a0\u00bb custom_margin=\u00a0\u00bb||||false|false\u00a0\u00bb global_colors_info=\u00a0\u00bb{}\u00a0\u00bb][et_pb_column_inner saved_specialty_column_type=\u00a0\u00bb3_4″ _builder_version=\u00a0\u00bb4.18.0″ _module_preset=\u00a0\u00bbdefault\u00a0\u00bb global_colors_info=\u00a0\u00bb{}\u00a0\u00bb][et_pb_text _builder_version=\u00a0\u00bb4.18.0″ _module_preset=\u00a0\u00bb973a289d-d11c-43e2-9475-6c39c832f592″ text_font=\u00a0\u00bbSource Sans Pro||||||||\u00a0\u00bb text_text_color=\u00a0\u00bb#000000″ text_font_size=\u00a0\u00bb16px\u00a0\u00bb header_font=\u00a0\u00bbHeebo|700|||||||\u00a0\u00bb header_text_align=\u00a0\u00bbleft\u00a0\u00bb header_text_color=\u00a0\u00bb#ff9900″ header_font_size=\u00a0\u00bb45px\u00a0\u00bb header_line_height=\u00a0\u00bb0.5em\u00a0\u00bb header_2_font=\u00a0\u00bbSource Sans Pro|700|||||||\u00a0\u00bb header_2_text_align=\u00a0\u00bbleft\u00a0\u00bb header_2_text_color=\u00a0\u00bb#ff9900″ header_2_font_size=\u00a0\u00bb35px\u00a0\u00bb header_3_font=\u00a0\u00bbSource Sans Pro|600|||||||\u00a0\u00bb header_3_text_color=\u00a0\u00bb#ff9900″ header_3_font_size=\u00a0\u00bb30px\u00a0\u00bb background_enable_color=\u00a0\u00bboff\u00a0\u00bb use_background_color_gradient=\u00a0\u00bboff\u00a0\u00bb text_orientation=\u00a0\u00bbjustified\u00a0\u00bb header_text_shadow_style=\u00a0\u00bbpreset2″ header_text_shadow_horizontal_length=\u00a0\u00bb0.04em\u00a0\u00bb header_text_shadow_vertical_length=\u00a0\u00bb0.03em\u00a0\u00bb header_text_shadow_color=\u00a0\u00bbrgba(10,10,10,0.13)\u00a0\u00bb header_2_text_shadow_style=\u00a0\u00bbpreset2″ header_2_text_shadow_horizontal_length=\u00a0\u00bb0.04em\u00a0\u00bb header_2_text_shadow_vertical_length=\u00a0\u00bb0.03em\u00a0\u00bb header_2_text_shadow_color=\u00a0\u00bbrgba(10,10,10,0.13)\u00a0\u00bb header_3_text_shadow_style=\u00a0\u00bbpreset2″ header_3_text_shadow_horizontal_length=\u00a0\u00bb0.04em\u00a0\u00bb header_3_text_shadow_vertical_length=\u00a0\u00bb0.03em\u00a0\u00bb header_3_text_shadow_color=\u00a0\u00bbrgba(10,10,10,0.13)\u00a0\u00bb global_colors_info=\u00a0\u00bb{}\u00a0\u00bb]<\/p>\n

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Ce r\u00e8glement concerne les dispositifs m\u00e9dicaux et leurs accessoires.<\/h2>\n

Selon le R\u00e8glement UE 2017\/745, un dispositif m\u00e9dical est d\u00e9fini comme tout instrument, appareil, \u00e9quipement, mat\u00e9riau ou autre article, utilis\u00e9 seul ou en combinaison, y compris les logiciels, et destin\u00e9 par le fabricant \u00e0 \u00eatre employ\u00e9 par des individus.<\/p>\n

Les dispositifs m\u00e9dicaux sont class\u00e9s en quatre cat\u00e9gories de risque en fonction du danger qu’ils repr\u00e9sentent pour les patients :<\/p>\n

    \n
  • Classe I<\/li>\n
  • Classe IIa<\/li>\n
  • Classe IIb<\/li>\n
  • Classe III<\/li>\n<\/ul>\n

    Les produits de Classe I comportent le risque le plus bas, tandis que ceux de Classe III sont associ\u00e9s au risque le plus \u00e9lev\u00e9.<\/p>\n

    EN 455-1-2-3-4<\/h2>\n

    Cette norme europ\u00e9enne \u00e9tablit les exigences et les proc\u00e9dures d’essai n\u00e9cessaires pour \u00e9valuer les caract\u00e9ristiques physiques des gants m\u00e9dicaux \u00e0 usage unique, garantissant ainsi un niveau de protection appropri\u00e9 contre la contamination crois\u00e9e, tant pour le patient que pour l’utilisateur.<\/p>\n

    Exigences et tests pour d\u00e9terminer :<\/p>\n

      \n
    • EN 455-1: Absence de perforations – Verificaci\u00f3n AQL (<=1.5)<\/strong><\/li>\n
    • EN 455-2:2015 – Propri\u00e9t\u00e9s physiques<\/li>\n
    • EN 455-3:2015 – \u00c9valuation biologique<\/li>\n
    • EN 455-4:2010 – D\u00e9termination de la dur\u00e9e de conservation<\/li>\n<\/ul>\n

      Dispositif M\u00e9dical (DM) \/<\/strong>
      Produit Sanitaire (PS)<\/strong><\/p>\n

      Gants m\u00e9dicaux \u00e0 usage unique de Classe I (non st\u00e9riles)<\/strong><\/p>\n

      EN 455-1 : exempt de trous<\/h3>\n

      Ce r\u00e8glement concerne les dispositifs m\u00e9dicaux et leurs accessoires. AQL <=1.5<\/strong><\/p>\n

      L’indice AQL \u00e9value le niveau de porosit\u00e9 du gant. Pour qu’un produit soit qualifi\u00e9 de dispositif m\u00e9dical, son indice AQL doit \u00eatre inf\u00e9rieur ou \u00e9gal \u00e0 <1.5. <\/p>\n

      L’\u00e9valuation de la porosit\u00e9 du gant repose sur deux tests :<\/p>\n

        \n
      • Tests d’air<\/li>\n
      • Tests d’eau<\/li>\n<\/ul>\n

        EN 455-2: caract\u00e9ristiques physiques<\/h3>\n<\/div>\n<\/div>\n<\/div>\n

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        \n
        \n
        \n

        EN 455-3: \u00e9valuation biologique<\/h3>\n

        Les tests d’\u00e9valuation biologique rev\u00eatent une grande importance pour d\u00e9terminer la pertinence des gants. Ils fournissent des informations pr\u00e9cises sur les effets des divers mat\u00e9riaux utilis\u00e9s dans la fabrication, ce qui permet de d\u00e9tecter d’\u00e9ventuelles anomalies dans les processus de conception et de d\u00e9veloppement. Cela comprend :<\/p>\n

          \n
        • Le test des prot\u00e9ines extractibles du latex (obligatoire si le gant est en latex).<\/li>\n
        • Le test des endotoxines bact\u00e9riennes (en cas d’\u00e9tiquetage du gant comme \u00ab\u00a0\u00e0 faible teneur en endotoxines\u00a0\u00bb).<\/li>\n
        • La mesure de la teneur en poudre.<\/li>\n<\/ul>\n

          EN 455-4 : \u00e9valuation de la dur\u00e9e de vie<\/h3>\n

          Il est imp\u00e9ratif de v\u00e9rifier la dur\u00e9e de vie des produits pour pouvoir fournir une date de p\u00e9remption pr\u00e9cise. Cette d\u00e9marche conf\u00e8re aux utilisateurs l’assurance de la qualit\u00e9 constante du gant tant qu’il est valide.<\/p>\n

          Tous les gants poss\u00e8dent une dur\u00e9e de conservation sp\u00e9cifique. Pendant cette p\u00e9riode, elle doit satisfaire aux trois premi\u00e8res parties de la norme pertinente. En cons\u00e9quence, la norme TS EN 455-4 d\u00e9finit la proc\u00e9dure d’\u00e9valuation de la dur\u00e9e de vie des gants et les modalit\u00e9s d’\u00e9tiquetage correspondantes.<\/p>\n<\/div>\n<\/div>\n<\/div>\n

          [\/et_pb_text][\/et_pb_column_inner][\/et_pb_row_inner][\/et_pb_column][\/et_pb_section]<\/p>\n","protected":false},"excerpt":{"rendered":"

          R\u00e8glement sur les dispositifs m\u00e9dicaux UE 2017\/745 Ce r\u00e8glement concerne les dispositifs m\u00e9dicaux et leurs accessoires. Selon le R\u00e8glement UE 2017\/745, un dispositif m\u00e9dical est d\u00e9fini comme tout instrument, appareil, \u00e9quipement, mat\u00e9riau ou autre article, utilis\u00e9 seul ou en combinaison, y compris les logiciels, et destin\u00e9 par le fabricant \u00e0 \u00eatre employ\u00e9 par des individus. […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_et_pb_use_builder":"on","_et_pb_old_content":"","_et_gb_content_width":"","footnotes":""},"class_list":["post-13460","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.icemedics.com\/fr\/wp-json\/wp\/v2\/pages\/13460","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.icemedics.com\/fr\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.icemedics.com\/fr\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.icemedics.com\/fr\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.icemedics.com\/fr\/wp-json\/wp\/v2\/comments?post=13460"}],"version-history":[{"count":0,"href":"https:\/\/www.icemedics.com\/fr\/wp-json\/wp\/v2\/pages\/13460\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.icemedics.com\/fr\/wp-json\/wp\/v2\/media?parent=13460"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}