{"id":13293,"date":"2023-07-31T11:31:06","date_gmt":"2023-07-31T11:31:06","guid":{"rendered":"https:\/\/www.icemedics.com\/regulamento-de-dispositivos-medicos-ue-2017-745\/"},"modified":"2023-10-10T07:26:11","modified_gmt":"2023-10-10T07:26:11","slug":"regulamento-de-dispositivos-medicos-ue-2017-745","status":"publish","type":"page","link":"https:\/\/www.icemedics.com\/pt-pt\/regulamento-de-dispositivos-medicos-ue-2017-745\/","title":{"rendered":"Regulamento de Dispositivos M\u00e9dicos UE 2017\/745"},"content":{"rendered":"

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Regulamento<\/h1>\n

de Dispositivos<\/h1>\n

M\u00e9dicos<\/h1>\n

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

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Este regulamento se aplica a dispositivos m\u00e9dicos e seus acess\u00f3rios.<\/h2>\n

Para fins de aplica\u00e7\u00e3o do Regulamento UE 2017\/745, um dispositivo m\u00e9dico \u00e9 entendido como qualquer instrumento, aparelho, equipamento, material ou outro artigo, usado sozinho ou em combina\u00e7\u00e3o, incluindo software, destinado pelo fabricante a ser usado em seres humanos.<\/p>\n

Considerando o risco que representam para o paciente, os dispositivos m\u00e9dicos s\u00e3o classificados em quatro classes de risco:<\/p>\n

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

    Os produtos da Classe I correspondem ao menor risco, enquanto os da Classe III correspondem ao maior risco.<\/p>\n

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

    Esta norma europeia especifica os requisitos e m\u00e9todos de teste para determinar as propriedades f\u00edsicas de luvas m\u00e9dicas de uso \u00fanico, a fim de garantir que elas forne\u00e7am e mantenham um n\u00edvel adequado de prote\u00e7\u00e3o contra a contamina\u00e7\u00e3o cruzada, tanto para o paciente quanto para o usu\u00e1rio durante o uso.<\/p>\n

    Requisitos e testes para determinar:<\/p>\n

      \n
    • EN 455-1:2001 Sem furos Verifica\u00e7\u00e3o de AQL (<=1.5)<\/strong><\/li>\n
    • EN 455-2:2015 Propriedades F\u00edsicas<\/li>\n
    • EN 455-3:2015 Avalia\u00e7\u00e3o Biol\u00f3gica<\/li>\n
    • EN 455-4:2010 Determina\u00e7\u00e3o da Vida \u00datil<\/li>\n<\/ul>\n

      Dispositivo M\u00e9dico (DM) \/<\/strong>
      Produto M\u00e9dico (PM)<\/strong><\/p>\n

      Luvas m\u00e9dicas de uso \u00fanico Classe I (n\u00e3o est\u00e9reis)<\/strong><\/p>\n

      EN 455-1: Sem furos<\/h3>\n

      Este regulamento se aplica a dispositivos m\u00e9dicos e seus acess\u00f3rios. AQL <=1.5<\/strong><\/p>\n

      O \u00edndice AQL determina o grau de porosidade da luva. Para qualificar como um produto m\u00e9dico, o \u00edndice de AQL deve ser <= 1.5 .<\/p>\n

      Para determinar o grau de porosidade da luva, s\u00e3o realizados dois testes:<\/p>\n

        \n
      • Testes de ar<\/li>\n
      • Testes de \u00e1gua<\/li>\n<\/ul>\n

        EN 455-2: Propriedades F\u00edsicas<\/h3>\n<\/div>\n<\/div>\n<\/div>\n

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        \n
        \n
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        EN 455-3: Avalia\u00e7\u00e3o Biol\u00f3gica<\/h3>\n

        Os testes de avalia\u00e7\u00e3o biol\u00f3gica s\u00e3o importantes para determinar a adequa\u00e7\u00e3o. Desta forma, s\u00e3o obtidas informa\u00e7\u00f5es precisas sobre os efeitos dos diversos materiais utilizados na produ\u00e7\u00e3o. Dessa forma, s\u00e3o identificadas negatividades nos processos de design e desenvolvimento, e desvios s\u00e3o evitados.<\/p>\n

          \n
        • Prote\u00ednas de l\u00e1tex extra\u00edveis (obrigat\u00f3rias se a luva for de l\u00e1tex)<\/li>\n
        • Endotoxinas bacterianas (se a luva for rotulada como est\u00e9ril com “baixo teor de endotoxinas”)<\/li>\n
        • Conte\u00fado de p\u00f3<\/li>\n<\/ul>\n

          EN 455-4: Determina\u00e7\u00e3o da Vida \u00datil<\/h3>\n

          \u00c9 importante testar a vida \u00fatil dos produtos para fornecer uma data de validade eficaz. Isso d\u00e1 aos usu\u00e1rios a confian\u00e7a de que a luva ser\u00e1 de boa qualidade enquanto estiver atualizada.<\/p>\n

          Todas as luvas t\u00eam uma determinada vida \u00fatil. Durante esse per\u00edodo, essas luvas devem ser capazes de atender \u00e0s tr\u00eas primeiras partes do padr\u00e3o relevante. Portanto, o padr\u00e3o TS EN 455-4 explica como testar a vida \u00fatil de uma luva e como rotul\u00e1-la.<\/p>\n<\/div>\n<\/div>\n<\/div>\n

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          Regulamento de Dispositivos M\u00e9dicos UE 2017\/745 Este regulamento se aplica a dispositivos m\u00e9dicos e seus acess\u00f3rios. Para fins de aplica\u00e7\u00e3o do Regulamento UE 2017\/745, um dispositivo m\u00e9dico \u00e9 entendido como qualquer instrumento, aparelho, equipamento, material ou outro artigo, usado sozinho ou em combina\u00e7\u00e3o, incluindo software, destinado pelo fabricante a ser usado em seres humanos. Considerando […]<\/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-13293","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.icemedics.com\/pt-pt\/wp-json\/wp\/v2\/pages\/13293","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.icemedics.com\/pt-pt\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.icemedics.com\/pt-pt\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.icemedics.com\/pt-pt\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.icemedics.com\/pt-pt\/wp-json\/wp\/v2\/comments?post=13293"}],"version-history":[{"count":0,"href":"https:\/\/www.icemedics.com\/pt-pt\/wp-json\/wp\/v2\/pages\/13293\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.icemedics.com\/pt-pt\/wp-json\/wp\/v2\/media?parent=13293"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}