{"id":19263,"date":"2015-09-29T11:10:16","date_gmt":"2015-09-29T09:10:16","guid":{"rendered":"https:\/\/ionclinics.com\/blog\/o-que-e-um-certificado-ce-sanitario-epte\/"},"modified":"2025-05-20T14:51:23","modified_gmt":"2025-05-20T12:51:23","slug":"o-que-e-um-certificado-ce-sanitario-epte","status":"publish","type":"post","link":"https:\/\/ionclinics.com\/pt-br\/blog\/o-que-e-um-certificado-ce-sanitario-epte\/","title":{"rendered":"O que \u00e9 um certificado CE sanit\u00e1rio? &#8211; EPTE\u00ae"},"content":{"rendered":"<p><strong>O certificado\u00a0CE\u00a0<\/strong><b>sanit\u00e1rio<\/b>\u00a0de conformidade \u00e9 um\u00a0requisito obrigat\u00f3rio para comercializar\u00a0produtos sanit\u00e1rios na\u00a0Europa.\u00a0Um produto com certificado CE sanit\u00e1rio \u00e9\u00a0facilmente identificado atrav\u00e9s\u00a0de uma etiqueta\u00a0e instru\u00e7\u00f5es de uso mediante o\u00a0s\u00edmbolo CE + n\u00famero de organismo notificado. Exemplo:<\/p>\n<figure id=\"attachment_9465\" aria-describedby=\"caption-attachment-9465\" style=\"width: 300px\" class=\"wp-caption aligncenter\"><a href=\"https:\/\/ionclinics.com\/wp-content\/uploads\/2023\/01\/CE-sanitario-TUV-producto-sanitario.png\"><img loading=\"lazy\" decoding=\"async\" class=\"wp-image-9465 size-medium\" src=\"https:\/\/ionclinics.com\/wp-content\/uploads\/2023\/01\/CE-sanitario-TUV-producto-sanitario.png\" alt=\"CE sanitario y n\u00famero notificado\" width=\"300\" height=\"178\" \/><\/a><figcaption id=\"caption-attachment-9465\" class=\"wp-caption-text\">CE de produto sanit\u00e1rio<\/figcaption><\/figure>\n<p>No caso de que na evolu\u00e7\u00e3o de conformidade\u00a0participe um\u00a0<strong>Organismo Notificado<\/strong>, o\u00a0CE sanit\u00e1rio vem com\u00a0o n\u00famero de identifica\u00e7\u00e3o do mesmo. (Na\u00a0figura: 1936 \u00e9 o\u00a0n\u00ba de identifica\u00e7\u00e3o do\u00a0Organismo Notificado T\u00dcV).<\/p>\n<p>No\u00a0marcado, o CE sanit\u00e1rio indica que o produto est\u00e1 em\u00a0conformidade com\u00a0as directivas e\u00a0legisla\u00e7\u00e3o que lhe s\u00e3o\u00a0recomendadas. Na<strong>\u00a0Europa \u00e9\u00a0ilegal a comercializa\u00e7\u00e3o\u00a0e\u00a0posterior utiliza\u00e7\u00e3o de produtos que n\u00e3o tenham\u00a0este certificado, al\u00e9m dos perigos que representam para a sa\u00fade<\/strong>. Todos os produtos sanit\u00e1rios devem contar com o\u00a0certificado sanit\u00e1rio e coloc\u00e1-lo \u00e0 disposi\u00e7\u00e3o dos seus clientes.<!--more leer mas--><\/p>\n<h2>Certificado CE sanit\u00e1rio como garantia<\/h2>\n<p>As\u00a0directivas exigem uns <strong>requisitos m\u00ednimos<\/strong>\u00a0<strong>CE sanit\u00e1rio<\/strong> para a\u00a0correcta avalia\u00e7\u00e3o e\u00a0certifica\u00e7\u00e3o de produtos.\u00a0A\u00a0lei obriga todos os fabricantes a prestar\u00a0as seguintes garantias:<\/p>\n<ul>\n<li><strong>Garantia\u00a0da informa\u00e7\u00e3o<\/strong>: Deve ser estabelecida uma documenta\u00e7\u00e3o t\u00e9cnica do produto denominado\u00a0<strong>Technical File<\/strong>. Este inclui especifica\u00e7\u00f5es, planos, manual de usu\u00e1rio, manuais de servi\u00e7os de assist\u00eancia t\u00e9cnica, etiquetagem\u00a0e\u00a0documenta\u00e7\u00e3o de acompanhamento.<\/li>\n<li><strong>Garantia\u00a0de seguran\u00e7a<\/strong>: Deve ser feita uma demonstra\u00e7\u00e3o do produto para verificar se est\u00e1 de acordo com a\u00a0normativa que lhe seja aplicada,\u00a0segundo a sua classifica\u00e7\u00e3o.<\/li>\n<li><strong>Garantia\u00a0de cumprimento das especifica\u00e7\u00f5es e devida\u00a0<\/strong><b>efic\u00e1cia<\/b>: Avalia\u00e7\u00e3o\u00a0cl\u00ednica e, no caso da EPTE<i class=\"_4ay8\">\u00ae<\/i> eletr\u00f3lise percut\u00e2nea terap\u00eautica, Investiga\u00e7\u00e3o cl\u00ednica, para a devida\u00a0avalia\u00e7\u00e3o\u00a0da seguran\u00e7a\u00a0e cumprimento\u00a0das especifica\u00e7\u00f5es\u00a0do\u00a0produto.<\/li>\n<li><strong>Garantia\u00a0de qualidade<\/strong>: A\u00a0empresa deve implantar um sistema de assegure a qualidade\u00a0segundo\u00a0<strong><a href=\"http:\/\/www.aenor.es\/aenor\/normas\/normas\/fichanorma.asp?tipo=N&amp;codigo=N0049409#.Vgppv2TtlHw\" target=\"_blank\" rel=\"noopener\">ISO 13485<\/a><\/strong> com\u00a0o seguimento correspondente e que garanta a sua correcta implementa\u00e7\u00e3o.<\/li>\n<\/ul>\n<h3><strong>Processo de Reconhecimento\u00a0<\/strong><strong>Certificado CE\u00a0sanit\u00e1rio<\/strong><\/h3>\n<p><strong>Adquirir um Certificado CE sanit\u00e1rio<\/strong>\u00a0n\u00e3o est\u00e1 ao alcance de qualquer\u00a0produto que se queira comercializar. Um <strong>produto\u00a0sanit\u00e1rio<\/strong> para obter este tipo de certificados de <strong>seguran\u00e7a e efectividade de funcionamento<\/strong> deve seguir um<b>\u00a0<\/b>processo para ser reconhecido como realmente merece\u00a0obtendo o\u00a0certificado CE sanit\u00e1rio para que possa ser\u00a0posteriormente comercializado:<\/p>\n<figure id=\"attachment_9467\" aria-describedby=\"caption-attachment-9467\" style=\"width: 285px\" class=\"wp-caption aligncenter\"><a href=\"https:\/\/ionclinics.com\/wp-content\/uploads\/2023\/01\/ce-sanitario-proceso-ensayo-laboratorio.jpg\"><img loading=\"lazy\" decoding=\"async\" class=\"size-medium wp-image-9467\" src=\"https:\/\/ionclinics.com\/wp-content\/uploads\/2023\/01\/ce-sanitario-proceso-ensayo-laboratorio.jpg\" alt=\"CE-sanitario-proceso\" width=\"285\" height=\"300\" \/><\/a><figcaption id=\"caption-attachment-9467\" class=\"wp-caption-text\">Processo para a obten\u00e7\u00e3o do reconhecimento\u00a0CE sanit\u00e1rio de um produto<\/figcaption><\/figure>\n<p>Ap\u00f3s o desenho do produto, \u00e9 necess\u00e1rio criar\u00a0uma documenta\u00e7\u00e3o que garanta\u00a0o\u00a0cumprimento de todas as leis\u00a0vigentes (Technical File), cujo o grau de exig\u00eancia depende\u00a0da sua classifica\u00e7\u00e3o. A lei\u00a0aplicada \u00e9 a <strong>UNE -EN \u2013 60601 \u2013 1:2008. + Correc\u00e7\u00e3o: 2010<\/strong> para aparelhos\u00a0electrom\u00e9dicos ou o seu equivalente internacional que \u00e9\u00a0<strong>IEC 60601 \u2013 1 :2005+ corr: 2006<\/strong>.\u2028 A\u00a0documenta\u00e7\u00e3o\u00a0gerada \u00e9:<\/p>\n<ul>\n<li>Documento\u00a0de <strong>gest\u00e3o de riscos;<\/strong><\/li>\n<li>Documento\u00a0de <strong>valida\u00e7\u00e3o<\/strong>\u00a0de processos como, fabrica\u00e7\u00e3o, aptitude de utiliza\u00e7\u00e3o, verifica\u00e7\u00e3o de software, etc.<\/li>\n<li>Verifica\u00e7\u00e3o de <strong>cumprimento<\/strong> de requisitos essenciais de acordo com a lei em vig\u00eancia.<\/li>\n<\/ul>\n<p>Posto isto, procede-se \u00e0 devida\u00a0<strong>verifica\u00e7\u00e3o\u00a0<\/strong>por um laborat\u00f3rio acreditado para comprovar que o dispositivo\u00a0cumpre todos os requisitos para ser considerado como produto sanit\u00e1rio:<\/p>\n<p>a) Ensaios de\u00a0<b>imunidade:<\/b><\/p>\n<ul>\n<li>Descargas electrost\u00e1ticas;<\/li>\n<li>Imunidade \u00e0s perturba\u00e7\u00f5es conduzidas, induzidas\u00a0pelos campos de r\u00e1dio frequ\u00eancia RF;<\/li>\n<li>Campo magn\u00e9tico a refer\u00eancia industrial.<\/li>\n<\/ul>\n<p>b) Ensaios <strong>emiss\u00e3o\u00a0<\/strong>(Emiss\u00e3o radiada)<\/p>\n<p>c) <strong>Seguran\u00e7a el\u00e9ctrica<\/strong><\/p>\n<ul>\n<li>Identifica\u00e7\u00e3o\u00a0e marca;<\/li>\n<li>Prote\u00e7\u00e3o contra perigos el\u00e9ctricos;<\/li>\n<li>Prote\u00e7\u00e3o contra perigros mec\u00e2nicos;<\/li>\n<li>Prote\u00e7\u00e3o contra perigros de radia\u00e7\u00f5es indesejadas e\u00a0excessivas;<\/li>\n<li>Prote\u00e7\u00e3o contra perigros de temperaturas excessivas e\u00a0outros perigos;<\/li>\n<li>Precis\u00e3o de controlos, instrumentos e\u00a0prote\u00e7\u00e3o contra sa\u00eddas perigosas;<\/li>\n<li>Situa\u00e7\u00f5es perigosas e condi\u00e7\u00f5es de falhas;<\/li>\n<li>Constru\u00e7\u00e3o do produto.<\/li>\n<\/ul>\n<p>Uma vez obtida a conformidade, \u00e9 ent\u00e3o obtido o\u00a0<strong>marco CE sanit\u00e1rio<\/strong>. <strong>Este marco CE sanit\u00e1rio ainda n\u00e3o \u00e9 um CE\u00a0<\/strong><b>sanit\u00e1rio<\/b>. O\u00a0processo para obter o verdadeiro\u00a0CE sanit\u00e1rio seguiria com os seguintes passos:<\/p>\n<h2>Obter CE sanit\u00e1rio: \u00faltimos passos<\/h2>\n<figure id=\"attachment_19042\" aria-describedby=\"caption-attachment-19042\" style=\"width: 4000px\" class=\"wp-caption aligncenter\"><a href=\"http:\/\/www.electrolisisterapeutica.com\/wp-content\/uploads\/2015\/09\/certificado-ce-sanitario-epte-tuv.jpg\"><img loading=\"lazy\" decoding=\"async\" class=\"wp-image-19042 size-full\" src=\"https:\/\/ionclinics.com\/wp-content\/uploads\/2023\/02\/certificado-CE-sanitario-EPTE-System-scaled.jpg\" alt=\"certificado CE sanitario EPTE System\" width=\"4000\" height=\"2836\" \/><\/a><figcaption id=\"caption-attachment-19042\" class=\"wp-caption-text\">Eletr\u00f3lise percut\u00e2nea com certificado CE sanit\u00e1rio<\/figcaption><\/figure>\n<ul>\n<li>Ensaio cl\u00ednico para obter o Certificado CE sanit\u00e1rio;<\/li>\n<li>Aporte de <a href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT02196948\" target=\"_blank\" rel=\"noopener\">ensaios cl\u00ednicos reais<\/a>, com\u00a0uma amostra v\u00e1lida, grupo experimental, grupo de controlo, ensaio autorizado e\u00a0assinado\u00a0por um comit\u00e9 \u00e9tico;<\/li>\n<li>O ensaio\u00a0cl\u00ednico avalia que\u00a0o dispositivo\u00a0tem\u00a0<strong>benef\u00edcios para a sa\u00fade.<\/strong><\/li>\n<\/ul>\n<p>Finalizados todos estes passos\u00a0e\u00a0apresentada toda a documenta\u00e7\u00e3o um\u00a0Organismo Notificado autorizado pela\u00a0Comunidade Europeia para verifica\u00e7\u00e3o\u00a0e\u00a0avalia\u00e7\u00e3o tendo em conta a\u00a0legisla\u00e7\u00e3o\u00a0avaliar\u00e1 o\u00a0processo de fabrica\u00e7\u00e3o, armazenamento e distribui\u00e7\u00e3o de acordo com a norma <strong> ISO 13485<\/strong>\u00a0e far\u00e1 a devida verifica\u00e7\u00e3o da qualidade e efic\u00e1cia do produto em quest\u00e3o (como aconteceu com o dispositivo\u00a0EPTE eletr\u00f3lise percut\u00e2nea terap\u00eautica).<\/p>\n<p>Por \u00faltimo, ap\u00f3s uma\u00a0auditoria favor\u00e1vel do Organismo Notificado, \u00e9 obtido o <strong>Certificado<\/strong>\u00a0<strong>CE\u00a0<\/strong><b>sanit\u00e1rio<\/b>.<\/p>\n<blockquote><p>\u201cApenas poder\u00e3o ser comercializados na Europa produtos sanit\u00e1rios que ostentem o marco de CE sanit\u00e1rio\u201d.<\/p><\/blockquote>\n<p>O Certificado\u00a0CE sanit\u00e1rio \u00e9\u00a0obrigat\u00f3rio\u00a0e<strong>\u00a0as autoridades podem sancionar os incumprimentos relacionados com\u00a0o\u00a0marco CE dos produtos comercializados e que sejam potenciais amea\u00e7as para a\u00a0condi\u00e7\u00e3o f\u00edsica e bem-estar da sa\u00fade humana<\/strong>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>O certificado\u00a0CE\u00a0sanit\u00e1rio\u00a0de conformidade \u00e9 um\u00a0requisito obrigat\u00f3rio para comercializar\u00a0produtos sanit\u00e1rios na\u00a0Europa.\u00a0Um produto com certificado CE sanit\u00e1rio \u00e9\u00a0facilmente identificado atrav\u00e9s\u00a0de uma etiqueta\u00a0e instru\u00e7\u00f5es de uso mediante o\u00a0s\u00edmbolo CE + n\u00famero de organismo notificado. Exemplo: No caso de que na evolu\u00e7\u00e3o de conformidade\u00a0participe um\u00a0Organismo Notificado, o\u00a0CE sanit\u00e1rio vem com\u00a0o n\u00famero de identifica\u00e7\u00e3o do mesmo. (Na\u00a0figura: 1936 \u00e9 o\u00a0n\u00ba [&hellip;]<\/p>\n","protected":false},"author":5,"featured_media":19266,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[1397,1401,1396],"tags":[275,1472,1428,81],"class_list":["post-19263","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-cursos-pt-pt","category-eletrolise-percutanea","category-eletrolise-terapeutica-pt-pt","tag-ce-sanitario","tag-certificado-ce-sanitario","tag-eletrolise-percutanea","tag-epte"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>O que \u00e9 um certificado CE sanit\u00e1rio? - EPTE\u00ae<\/title>\n<meta name=\"description\" content=\"O Certificado CE sanit\u00e1rio \u00e9 obrigat\u00f3rio para todos os produtos sanit\u00e1rios que interfiram com a condi\u00e7\u00e3o e bem-estar da sa\u00fade p\u00fablica.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/ionclinics.com\/pt-br\/blog\/o-que-e-um-certificado-ce-sanitario-epte\/\" \/>\n<meta property=\"og:locale\" content=\"pt_BR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"O que \u00e9 um certificado CE sanit\u00e1rio? 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