{"id":1994,"date":"2025-04-02T06:13:33","date_gmt":"2025-04-02T06:13:33","guid":{"rendered":"https:\/\/www.pharmacopoeiatest.com\/?p=1994"},"modified":"2025-04-02T06:30:46","modified_gmt":"2025-04-02T06:30:46","slug":"syringes-needle-penetration-test-iso-11040-4","status":"publish","type":"post","link":"https:\/\/www.pharmacopoeiatest.com\/pt\/syringes-needle-penetration-test-iso-11040-4\/","title":{"rendered":"Seringas Ensaio de penetra\u00e7\u00e3o de agulha ISO 11040-4 Anexo F"},"content":{"rendered":"<div data-elementor-type=\"wp-post\" data-elementor-id=\"1994\" class=\"elementor elementor-1994\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-d8f0949 e-flex e-con-boxed e-con e-parent\" data-id=\"d8f0949\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-af89456 elementor-widget elementor-widget-heading\" data-id=\"af89456\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Teste de penetra\u00e7\u00e3o com agulhas<\/h1>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-75ecf40 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"75ecf40\" data-element_type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-20ce2df elementor-widget elementor-widget-heading\" data-id=\"20ce2df\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">ISO 11040-4 Anexo F<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-c9ca423 e-flex e-con-boxed e-con e-parent\" data-id=\"c9ca423\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-41f75ef e-con-full e-flex e-con e-child\" data-id=\"41f75ef\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-5114c7b elementor-widget elementor-widget-text-editor\" data-id=\"5114c7b\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>O <strong>teste de penetra\u00e7\u00e3o com seringas e agulhas<\/strong> \u00e9 um procedimento crucial na ind\u00fastria de dispositivos m\u00e9dicos, que assegura a nitidez e a efic\u00e1cia das agulhas utilizadas em aplica\u00e7\u00f5es m\u00e9dicas. Este teste avalia a <strong>for\u00e7a de penetra\u00e7\u00e3o da agulha<\/strong> necess\u00e1rio para perfurar uma folha de ensaio, reflectindo a facilidade com que uma agulha pode penetrar na pele humana ou noutros materiais.<\/p><p>Para garantir a seguran\u00e7a dos doentes e a fiabilidade dos produtos, s\u00e3o necess\u00e1rias normas internacionais como <strong>ISO 11040-4<\/strong> descrevem metodologias de ensaio precisas para agulhas de seringa. Estas normas ajudam os fabricantes a manter o controlo de qualidade e a conformidade regulamentar.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1c4a1c1 elementor-widget elementor-widget-heading\" data-id=\"1c4a1c1\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Equipamento necess\u00e1rio para o teste de penetra\u00e7\u00e3o de agulhas<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-405b6c1 elementor-widget elementor-widget-text-editor\" data-id=\"405b6c1\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p data-pm-slice=\"1 3 []\">De acordo com <strong>ISO 11040-4<\/strong>O seguinte aparelho \u00e9 indispens\u00e1vel para a realiza\u00e7\u00e3o de uma <a href=\"https:\/\/www.pharmacopoeiatest.com\/pt\/syringe-needle-penetration-test\/\" target=\"_blank\" rel=\"noopener\"><strong>teste de penetra\u00e7\u00e3o de agulhas<\/strong><\/a>:<\/p><ul><li data-pm-slice=\"1 3 []\"><strong>M\u00e1quina universal de ensaio de tra\u00e7\u00e3o e compress\u00e3o<\/strong> com uma gama de medi\u00e7\u00e3o at\u00e9 10 N (ou conforme necess\u00e1rio) e uma velocidade de ensaio entre 20 mm\/min e 200 mm\/min.<\/li><li data-pm-slice=\"1 3 []\"><strong>Suporte de agulha<\/strong> para fixar a agulha durante o teste.<\/li><li data-pm-slice=\"1 3 []\"><strong>Folha de teste<\/strong>A empresa \u00e9 respons\u00e1vel pela gest\u00e3o de projectos, com especifica\u00e7\u00f5es acordadas entre fabricantes e clientes.<\/li><\/ul>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3315f97 elementor-widget elementor-widget-image\" data-id=\"3315f97\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<a href=\"https:\/\/www.pharmacopoeiatest.com\/pt\/syringe-needle-penetration-test\/\">\n\t\t\t\t\t\t\t<img decoding=\"async\" src=\"https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/elementor\/thumbs\/ISO-11040-4-syringes-needle-penetration-test-equipment-r3r52op9pahd5s2kzyk3xzbhif0hy69cozbct55ytk.webp\" title=\"ISO 11040-4 seringas equipamento de ensaio de penetra\u00e7\u00e3o de agulhas\" alt=\"ISO 11040-4 seringas equipamento de ensaio de penetra\u00e7\u00e3o de agulhas\" loading=\"lazy\" \/>\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ff15e94 elementor-widget elementor-widget-heading\" data-id=\"ff15e94\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Seringas M\u00e9todo de ensaio de penetra\u00e7\u00e3o de agulha Procedimento<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-fe76308 elementor-widget elementor-widget-text-editor\" data-id=\"fe76308\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ol><li>Fixar a folha de teste num suporte sem tens\u00e3o.<\/li><li>Fixar a agulha perpendicularmente no suporte, alinhando a sua ponta com o centro geom\u00e9trico da folha de teste.<\/li><li>Iniciar o teste e deixar a agulha penetrar na folha de alum\u00ednio a uma velocidade controlada.<\/li><li>Registar a curva for\u00e7a-deslocamento para analisar as carater\u00edsticas de penetra\u00e7\u00e3o.<\/li><li>Repetir o teste com uma nova sec\u00e7\u00e3o de folha de alum\u00ednio para cada medi\u00e7\u00e3o.<\/li><\/ol><p>Taxas de amostragem mais elevadas, como 500 Hz, aumentam a precis\u00e3o da medi\u00e7\u00e3o ao registar valores de for\u00e7a de pico.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-60ebd0c elementor-widget elementor-widget-heading\" data-id=\"60ebd0c\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Par\u00e2metros-chave da for\u00e7a de penetra\u00e7\u00e3o da agulha nos ensaios<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0f1cf32 elementor-widget elementor-widget-text-editor\" data-id=\"0f1cf32\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p data-pm-slice=\"1 1 []\">A for\u00e7a exercida durante a penetra\u00e7\u00e3o \u00e9 classificada em diferentes fases:<\/p><ul data-spread=\"false\"><li><strong>For\u00e7a de perfura\u00e7\u00e3o (F<sub>0<\/sub>):<\/strong> A for\u00e7a necess\u00e1ria para passar a ponta da agulha atrav\u00e9s da folha de alum\u00ednio.<\/li><li><strong>For\u00e7a de corte (F<sub>1<\/sub>):<\/strong> A for\u00e7a utilizada pelas arestas de corte.<\/li><li><strong>For\u00e7a no calcanhar (F<sub>2<\/sub>):<\/strong> A for\u00e7a exercida quando a ponta da agulha passa atrav\u00e9s dela.<\/li><li><strong>For\u00e7a de penetra\u00e7\u00e3o de arrasto (F<sub>3<\/sub>):<\/strong> A for\u00e7a de resist\u00eancia ap\u00f3s a penetra\u00e7\u00e3o total.<\/li><\/ul><p>Ao avaliar estes par\u00e2metros, os fabricantes podem garantir que as agulhas cumprem as normas de nitidez e de utiliza\u00e7\u00e3o exigidas.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-84d059d elementor-widget elementor-widget-heading\" data-id=\"84d059d\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Conformidade com a norma ISO 11040-4 para garantia de qualidade<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7a670d9 elementor-widget elementor-widget-text-editor\" data-id=\"7a670d9\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p data-pm-slice=\"1 3 []\">A norma ISO 11040-4 estabelece diretrizes abrangentes para o ensaio de seringas pr\u00e9-cheias, garantindo:<\/p><ul><li data-pm-slice=\"1 3 []\">Normalizado <strong>for\u00e7a de penetra\u00e7\u00e3o da agulha<\/strong> medi\u00e7\u00e3o.<\/li><li data-pm-slice=\"1 3 []\">Consist\u00eancia entre diferentes tipos de agulhas e seringas.<\/li><li data-pm-slice=\"1 3 []\">Conformidade com os requisitos globais de seguran\u00e7a m\u00e9dica.<\/li><li data-pm-slice=\"1 3 []\">Redu\u00e7\u00e3o dos riscos associados a uma penetra\u00e7\u00e3o incorrecta da agulha.<\/li><\/ul>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5e1f022 elementor-widget elementor-widget-heading\" data-id=\"5e1f022\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Equipamento de ensaio de penetra\u00e7\u00e3o de agulhas NPT-01<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-53d8fee elementor-widget elementor-widget-text-editor\" data-id=\"53d8fee\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p data-pm-slice=\"1 3 []\">O <strong>Equipamento de ensaio de penetra\u00e7\u00e3o de agulhas NPT-01<\/strong> foi concebido para satisfazer <strong>ISO 11040-4<\/strong> conformidade, oferecendo simultaneamente solu\u00e7\u00f5es de teste precisas. Possui as seguintes carater\u00edsticas<\/p><ul><li data-pm-slice=\"1 3 []\"><strong>Controlo PLC e ecr\u00e3 t\u00e1til HMI de 7 polegadas<\/strong> para um funcionamento f\u00e1cil.<\/li><li data-pm-slice=\"1 3 []\"><strong>Motor passo a passo e fuso de esferas de precis\u00e3o<\/strong> garantindo resultados consistentes.<\/li><li data-pm-slice=\"1 3 []\"><strong>Velocidades de ensaio vari\u00e1veis (1-500mm\/min)<\/strong> para condi\u00e7\u00f5es de ensaio flex\u00edveis.<\/li><li data-pm-slice=\"1 3 []\"><strong>Gabaritos de reten\u00e7\u00e3o de amostras m\u00faltiplas<\/strong> para acomodar v\u00e1rios tipos de agulhas e seringas.<\/li><li data-pm-slice=\"1 3 []\"><strong>Microimpressora incorporada e sa\u00edda RS232<\/strong> para um registo eficiente dos dados.<\/li><\/ul>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f7e5035 elementor-widget elementor-widget-text-editor\" data-id=\"f7e5035\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p data-pm-slice=\"1 1 []\">O <strong>teste de penetra\u00e7\u00e3o com seringas e agulhas<\/strong> \u00e9 vital para garantir a nitidez das agulhas, a seguran\u00e7a dos doentes e a conformidade regulamentar. Ao seguir <strong>ISO 11040-4<\/strong> diretrizes e utilizando equipamento de ensaio avan\u00e7ado como o <strong>NPT-01<\/strong>Com a ajuda de um sistema de gest\u00e3o da qualidade, os fabricantes podem melhorar a qualidade dos produtos e cumprir as normas da ind\u00fastria.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"<p>Ensaio de penetra\u00e7\u00e3o de agulhas ISO 11040-4 Anexo F O ensaio de penetra\u00e7\u00e3o de agulhas em seringas \u00e9 um procedimento crucial na ind\u00fastria de dispositivos m\u00e9dicos, garantindo a nitidez e a efic\u00e1cia das agulhas utilizadas em aplica\u00e7\u00f5es m\u00e9dicas. Este teste avalia a for\u00e7a de penetra\u00e7\u00e3o da agulha necess\u00e1ria para perfurar uma folha de teste, reflectindo a facilidade com que uma agulha pode penetrar em seres humanos [...]<\/p>","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_uag_custom_page_level_css":"","site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"disabled","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""}},"footnotes":""},"categories":[26],"tags":[],"class_list":["post-1994","post","type-post","status-publish","format-standard","hentry","category-blog"],"acf":[],"uagb_featured_image_src":{"full":false,"thumbnail":false,"medium":false,"medium_large":false,"large":false,"1536x1536":false,"2048x2048":false,"trp-custom-language-flag":false},"uagb_author_info":{"display_name":"pharmacopoeiatest","author_link":"https:\/\/www.pharmacopoeiatest.com\/pt\/author\/pharmacopoeiatest\/"},"uagb_comment_info":0,"uagb_excerpt":"Needle Penetration Testing ISO 11040-4 Annex F The syringes needle penetration test is a crucial procedure in the medical device industry, ensuring the sharpness and effectiveness of needles used in medical applications. This test evaluates the needle penetration force required to pierce a test foil, reflecting the ease with which a needle can penetrate human&hellip;","_links":{"self":[{"href":"https:\/\/www.pharmacopoeiatest.com\/pt\/wp-json\/wp\/v2\/posts\/1994","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.pharmacopoeiatest.com\/pt\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.pharmacopoeiatest.com\/pt\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/pt\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/pt\/wp-json\/wp\/v2\/comments?post=1994"}],"version-history":[{"count":5,"href":"https:\/\/www.pharmacopoeiatest.com\/pt\/wp-json\/wp\/v2\/posts\/1994\/revisions"}],"predecessor-version":[{"id":2009,"href":"https:\/\/www.pharmacopoeiatest.com\/pt\/wp-json\/wp\/v2\/posts\/1994\/revisions\/2009"}],"wp:attachment":[{"href":"https:\/\/www.pharmacopoeiatest.com\/pt\/wp-json\/wp\/v2\/media?parent=1994"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/pt\/wp-json\/wp\/v2\/categories?post=1994"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/pt\/wp-json\/wp\/v2\/tags?post=1994"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}