{"id":4091,"date":"2025-05-07T16:12:42","date_gmt":"2025-05-07T08:12:42","guid":{"rendered":"https:\/\/www.leakagetester.com\/?p=4091"},"modified":"2025-05-07T16:30:00","modified_gmt":"2025-05-07T08:30:00","slug":"syringe-leak-test-method-liquid-leakage-test","status":"publish","type":"post","link":"https:\/\/www.leakagetester.com\/pt\/syringe-leak-test-method-liquid-leakage-test\/","title":{"rendered":"M\u00e9todo de ensaio de fuga de seringa - Ensaio de fuga de l\u00edquido"},"content":{"rendered":"<p>Garantir a integridade das seringas \u00e9 essencial para a seguran\u00e7a dos doentes e a qualidade dos produtos nas ind\u00fastrias m\u00e9dica e farmac\u00eautica. Um dos procedimentos mais cr\u00edticos para o controlo de qualidade \u00e9 o <strong>m\u00e9todo de ensaio de estanquidade da seringa<\/strong>, que determina se uma seringa pode evitar fugas de l\u00edquido em condi\u00e7\u00f5es espec\u00edficas. Este teste \u00e9 particularmente crucial tanto para seringas descart\u00e1veis operadas manualmente como para seringas pr\u00e9-cheias utilizadas em sistemas de distribui\u00e7\u00e3o automatizados.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Resumo do m\u00e9todo de ensaio de estanquidade da seringa<\/h2>\n\n\n\n<p>O <strong>m\u00e9todo de ensaio de estanquidade da seringa<\/strong> refere-se ao processo de verifica\u00e7\u00e3o da exist\u00eancia de fugas de l\u00edquido do corpo da seringa ou do sistema de fecho quando sujeito a tens\u00e3o mec\u00e2nica ou press\u00e3o interna. As fugas podem comprometer a esterilidade e a exatid\u00e3o da dosagem, colocando s\u00e9rios riscos aos utilizadores.<\/p>\n\n\n\n<p>Existem duas normas principais que regem os testes de estanquidade das seringas:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong><a href=\"https:\/\/www.leakagetester.com\/pt\/standards\/iso-7886-1\/\" target=\"_blank\" rel=\"noreferrer noopener\">Norma ISO 7886-1<\/a><\/strong>: Centra-se em <strong>seringas para uso manual<\/strong>, vulgarmente conhecidas por seringas descart\u00e1veis.<\/li>\n\n\n\n<li><strong>ISO 11040-4<\/strong>: Aplica-se a <strong>recipientes de vidro para seringas pr\u00e9-cheias<\/strong>, especialmente as utilizadas em processos automatizados de enchimento e acabamento.<\/li>\n<\/ul>\n\n\n\n<p>Cada norma define aparelhos, condi\u00e7\u00f5es e par\u00e2metros de ensaio espec\u00edficos para avaliar a resist\u00eancia a fugas de diferentes tipos de seringas.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<div class=\"wp-block-uagb-advanced-heading uagb-block-218a8fd5\"><h2 class=\"uagb-heading-text\">Teste de estanquidade para seringas manuais (ISO 7886-1)<\/h2><\/div>\n\n\n\n<h3 class=\"wp-block-heading\">Ensaio de fuga de l\u00edquido da seringa sob compress\u00e3o<\/h3>\n\n\n\n<p>De acordo com o Anexo D do <strong>Norma ISO 7886-1<\/strong>, o objetivo \u00e9 avaliar as fugas para al\u00e9m do <strong>veda\u00e7\u00e3o da tampa do \u00eambolo<\/strong> quando a for\u00e7a \u00e9 aplicada. As etapas incluem:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Enchimento<\/strong> a seringa com <strong>\u00e1gua destilada<\/strong> acima da sua capacidade nominal.<\/li>\n\n\n\n<li><strong>Expuls\u00e3o de ar<\/strong>, e, em seguida, ajustar a \u00e1gua para o volume nominal.<\/li>\n\n\n\n<li><strong>Veda\u00e7\u00e3o<\/strong> o bico da seringa utilizando um encaixe c\u00f3nico de a\u00e7o de refer\u00eancia em conformidade com a norma ISO 80369-7.<\/li>\n\n\n\n<li>Aplica\u00e7\u00e3o de um <strong>for\u00e7a lateral<\/strong> de 0,25-3 N para induzir o movimento radial do \u00eambolo.<\/li>\n\n\n\n<li>Aplica\u00e7\u00e3o <strong>press\u00e3o axial<\/strong> (200 ou 300 kPa) para o \u00eambolo para <strong>30-35 segundos<\/strong>.<\/li>\n<\/ul>\n\n\n\n<p><strong>Crit\u00e9rios de aprova\u00e7\u00e3o\/reprova\u00e7\u00e3o<\/strong>: N\u00e3o deve haver fugas de \u00e1gua para al\u00e9m do selo da tampa do \u00eambolo. Os resultados devem ser documentados com a capacidade da seringa, observa\u00e7\u00f5es de fugas e data do teste.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Instrumento recomendado:<\/h3>\n\n\n\n<p>Instrumentos celulares\u2019.\u2019 <strong>SPPT-01 Testador de fugas do \u00eambolo da seringa<\/strong> automatiza este processo, garantindo <strong>controlo preciso da for\u00e7a e da press\u00e3o<\/strong>, e, ao mesmo tempo, oferece relat\u00f3rios de testes f\u00e1ceis.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">Ensaio de estanquidade para seringas pr\u00e9-cheias (ISO 11040-4 Anexo G3)<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\">Teste de fugas do sistema de fecho de seringas<\/h3>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:66.66%\">\n<p>Para <strong>seringas pr\u00e9-cheias<\/strong>, Anexo G do <strong>ISO 11040-4<\/strong> descreve um m\u00e9todo para avaliar a integridade da veda\u00e7\u00e3o de <strong>protectores de agulha ou tampas de ponta<\/strong>. Este ensaio simula os picos de press\u00e3o durante o transporte ou o enchimento.<\/p>\n\n\n\n<p><strong>Procedimento<\/strong>:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Que o <strong>sistema de fecho repousar durante 12 horas<\/strong> antes do ensaio para estabilizar.<\/li>\n\n\n\n<li>Encher a seringa at\u00e9 <strong>1\/3-2\/3 da sua capacidade<\/strong> com \u00e1gua destilada.<\/li>\n\n\n\n<li>Colocar a seringa numa <strong>suporte de ensaio<\/strong> e aplicar uma press\u00e3o de <strong>110 kPa<\/strong> para <strong>5 segundos<\/strong> utilizando ar comprimido ou um aparelho de ensaio de tra\u00e7\u00e3o\/compress\u00e3o.<\/li>\n\n\n\n<li><strong>Inspe\u00e7\u00e3o visual<\/strong> para a forma\u00e7\u00e3o de got\u00edculas ou o desprendimento de componentes.<\/li>\n<\/ul>\n\n\n\n<p><strong>Crit\u00e9rios de aceita\u00e7\u00e3o<\/strong>: A seringa passa se n\u00e3o forem observadas got\u00edculas e se o sistema de fecho permanecer intacto.<\/p>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-vertically-aligned-center is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:33.33%\">\n<div class=\"wp-block-uagb-image aligncenter uagb-block-c7693e0f wp-block-uagb-image--layout-default wp-block-uagb-image--effect-static wp-block-uagb-image--align-center\"><figure class=\"wp-block-uagb-image__figure\"><img loading=\"lazy\" decoding=\"async\" srcset=\"https:\/\/www.leakagetester.com\/wp-content\/uploads\/2025\/05\/Syringe-Leak-Test-Method-Liquid-Leakage-Test-ISO-11040-4-nnex-G3.webp ,https:\/\/www.leakagetester.com\/wp-content\/uploads\/2025\/05\/Syringe-Leak-Test-Method-Liquid-Leakage-Test-ISO-11040-4-nnex-G3.webp 780w, https:\/\/www.leakagetester.com\/wp-content\/uploads\/2025\/05\/Syringe-Leak-Test-Method-Liquid-Leakage-Test-ISO-11040-4-nnex-G3.webp 360w\" sizes=\"auto, (max-width: 480px) 150px\" src=\"https:\/\/www.leakagetester.com\/wp-content\/uploads\/2025\/05\/Syringe-Leak-Test-Method-Liquid-Leakage-Test-ISO-11040-4-nnex-G3.webp\" alt=\"M\u00e9todo de ensaio de estanquidade de seringa - Ensaio de fuga de l\u00edquido ISO 11040-4 nnex G3\" class=\"uag-image-4099\" width=\"255\" height=\"279\" title=\"M\u00e9todo de ensaio de estanquidade de seringa - Ensaio de fuga de l\u00edquido ISO 11040-4 nnex G3\" role=\"img\"\/><\/figure><\/div>\n<\/div>\n<\/div>\n\n\n\n<h3 class=\"wp-block-heading\">Instrumento recomendado:<\/h3>\n\n\n\n<p>Instrumentos celulares\u2019.\u2019 <strong>MST-01 Testador de dispositivos m\u00e9dicos<\/strong> oferece op\u00e7\u00f5es de pressuriza\u00e7\u00e3o de ar e compress\u00e3o mec\u00e2nica. Suporta amostragem de alta frequ\u00eancia (\u2265100 Hz), aumentando a <strong>exatid\u00e3o e repetibilidade<\/strong> de resultados.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">Porque \u00e9 que o teste de fugas de seringa \u00e9 importante<\/h2>\n\n\n\n<p>As fugas nas seringas n\u00e3o s\u00f3 provocam perdas de dosagem e contamina\u00e7\u00e3o, como tamb\u00e9m n\u00e3o cumprem a regulamenta\u00e7\u00e3o. Aderir a <strong>Norma ISO 7886-1<\/strong> e <strong>ISO 11040-4<\/strong>:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Melhora <strong>seguran\u00e7a dos doentes<\/strong> e a fiabilidade do produto.<\/li>\n\n\n\n<li>Apoios <strong>garantia de qualidade<\/strong> durante a produ\u00e7\u00e3o.<\/li>\n\n\n\n<li>Assegura <strong>aprova\u00e7\u00e3o regulamentar<\/strong> para os mercados nacional e internacional.<\/li>\n<\/ul>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Selecionando o testador de vazamento de dispositivo m\u00e9dico correto<\/strong><\/h2>\n\n\n\n<p>Escolher a op\u00e7\u00e3o correta <strong>verificador de fugas para dispositivos m\u00e9dicos<\/strong> depende do tipo de seringa, do volume de teste e das necessidades de automatiza\u00e7\u00e3o. Para os fabricantes que lidam com uma grande variedade de seringas - incluindo op\u00e7\u00f5es descart\u00e1veis e pr\u00e9-cheias - \u00e9 vital utilizar instrumentos vers\u00e1teis que possam simular todas as for\u00e7as e press\u00f5es necess\u00e1rias, conforme definido pelas normas.<\/p>\n\n\n\n<div class=\"wp-block-uagb-container uagb-block-8ea3bd21 alignfull uagb-is-root-container\"><div class=\"uagb-container-inner-blocks-wrap\"><\/div><\/div>\n\n\n\n<p><strong>Instrumentos de C\u00e9lula<\/strong> oferece solu\u00e7\u00f5es personaliz\u00e1veis e automatizadas como o <strong>SPPT-01<\/strong> e <strong>SLT-01<\/strong>, ideal para ambientes de I&amp;D e de linha de produ\u00e7\u00e3o.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<p>Compreender o <strong>m\u00e9todo de ensaio de estanquidade da seringa<\/strong> \u00e9 crucial para manter a qualidade e a seguran\u00e7a dos dispositivos m\u00e9dicos. Quer esteja a trabalhar com seringas de utiliza\u00e7\u00e3o manual ou com tubos de vidro pr\u00e9-cheios, a conformidade com <strong>Norma ISO 7886-1<\/strong> e <strong>ISO 11040-4<\/strong> garante que cada unidade funciona de forma fi\u00e1vel em condi\u00e7\u00f5es reais. Ao utilizar instrumentos de teste de fugas precisos e conformes da <strong>Instrumentos de C\u00e9lula<\/strong>, Com esta solu\u00e7\u00e3o, os fabricantes podem refor\u00e7ar os seus sistemas de controlo de qualidade e cumprir as normas globais com confian\u00e7a.<\/p>","protected":false},"excerpt":{"rendered":"<p>Garantir a integridade das seringas \u00e9 essencial para a seguran\u00e7a dos doentes e a qualidade dos produtos nas ind\u00fastrias m\u00e9dica e farmac\u00eautica. Um dos procedimentos mais cr\u00edticos para o controlo de qualidade \u00e9 o m\u00e9todo de teste de fugas de seringas, que determina se uma seringa pode evitar fugas de l\u00edquido em condi\u00e7\u00f5es espec\u00edficas. Este teste \u00e9 particularmente crucial tanto para seringas operadas manualmente [...]","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_uag_custom_page_level_css":"","footnotes":""},"categories":[1],"tags":[],"class_list":["post-4091","post","type-post","status-publish","format-standard","hentry","category-test-method"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v25.5 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Syringe Leak Test Method - Liquid Leakage Test - Leakage Tester<\/title>\n<meta name=\"description\" content=\"Syringe leak test method with insights from ISO 7886-1 and ISO 11040-4, including liquid leakage test procedures.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.leakagetester.com\/pt\/syringe-leak-test-method-liquid-leakage-test\/\" \/>\n<meta property=\"og:locale\" content=\"pt_PT\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Syringe Leak Test Method - Liquid Leakage Test - Leakage Tester\" \/>\n<meta property=\"og:description\" content=\"Syringe leak test method with insights from ISO 7886-1 and ISO 11040-4, including liquid leakage test procedures.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.leakagetester.com\/pt\/syringe-leak-test-method-liquid-leakage-test\/\" \/>\n<meta property=\"og:site_name\" content=\"Leakage Tester\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/cellinstruments\/\" \/>\n<meta property=\"article:published_time\" content=\"2025-05-07T08:12:42+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-05-07T08:30:00+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.leakagetester.com\/wp-content\/uploads\/2025\/05\/Syringe-Leak-Test-Method-Liquid-Leakage-Test-ISO-11040-4-nnex-G3.webp\" \/>\n<meta name=\"author\" content=\"leakagetester\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Escrito por\" \/>\n\t<meta name=\"twitter:data1\" content=\"leakagetester\" \/>\n\t<meta name=\"twitter:label2\" content=\"Tempo estimado de leitura\" \/>\n\t<meta name=\"twitter:data2\" content=\"4 minutos\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/www.leakagetester.com\/syringe-leak-test-method-liquid-leakage-test\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/www.leakagetester.com\/syringe-leak-test-method-liquid-leakage-test\/\"},\"author\":{\"name\":\"leakagetester\",\"@id\":\"https:\/\/www.leakagetester.com\/#\/schema\/person\/96aac8c7a484e71f92e270fcd275b658\"},\"headline\":\"Syringe Leak Test Method &#8211; 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