{"id":311,"date":"2025-05-06T07:41:30","date_gmt":"2025-05-06T07:41:30","guid":{"rendered":"https:\/\/www.syringetest.com\/?page_id=311"},"modified":"2025-05-06T08:08:46","modified_gmt":"2025-05-06T08:08:46","slug":"needle-tubing-breakage-resistance-test","status":"publish","type":"page","link":"https:\/\/www.syringetest.com\/es\/needle-tubing-breakage-resistance-test","title":{"rendered":"Ensayo de resistencia a la rotura del tubo de aguja"},"content":{"rendered":"<div data-elementor-type=\"wp-page\" data-elementor-id=\"311\" class=\"elementor elementor-311\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-292be0b e-flex e-con-boxed e-con e-parent\" data-id=\"292be0b\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-0f48abd elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"0f48abd\" data-element_type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Ensayo de resistencia a la rotura del tubo de aguja<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6817f29 elementor-widget__width-initial elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"6817f29\" data-element_type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Comprender <strong>resistencia a la rotura del tubo de aguja<\/strong> es crucial para mantener la seguridad y calidad de los productos sanitarios, especialmente jeringuillas y agujas de infusi\u00f3n. Esta prueba garantiza que el tubo pueda soportar sin fallos el esfuerzo de flexi\u00f3n durante la fabricaci\u00f3n y el uso cl\u00ednico. Para los profesionales que trabajan en el control de calidad, especialmente en las industrias farmac\u00e9utica y de dispositivos m\u00e9dicos, dominar esta prueba no s\u00f3lo es vital para el cumplimiento de la normativa, sino tambi\u00e9n para la seguridad del paciente.<\/p>\t\t\t\t\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<div class=\"elementor-element elementor-element-05adfe7 e-flex e-con-boxed e-con e-parent\" data-id=\"05adfe7\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ecf369e elementor-widget__width-inherit elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"ecf369e\" data-element_type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Importancia de la resistencia a la rotura del tubo de aguja<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f390758 elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"f390758\" data-element_type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Los tubos de las agujas deben ser resistentes, especialmente cuando se manipulan, doblan e insertan repetidamente en tejidos blandos o duros. Si el tubo se rompe, puede causar da\u00f1os graves al paciente y plantear riesgos legales y normativos para el fabricante. Por eso el <strong>resistencia a la rotura del tubo de aguja<\/strong> es esencial, ya que simula la tensi\u00f3n mec\u00e1nica del mundo real y eval\u00faa si el tubo mantiene su integridad estructural tras una flexi\u00f3n c\u00edclica.<\/p><p><strong>Syringetest.com<\/strong> apoya esta necesidad cr\u00edtica proporcionando sistemas de ensayo precisos y repetibles para ayudar a los fabricantes de productos sanitarios a cumplir eficazmente las normas internacionales.<\/p>\t\t\t\t\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<div class=\"elementor-element elementor-element-2b52750 e-flex e-con-boxed e-con e-parent\" data-id=\"2b52750\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-040e55f elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"040e55f\" data-element_type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Comprensi\u00f3n de las normas ISO 9626 e ISO 9626 Anexo C<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ae97939 elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"ae97939\" data-element_type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><a href=\"https:\/\/www.syringetest.com\/es\/standards\/iso-9626\/\">ISO 9626<\/a> es la norma internacional que especifica las propiedades mec\u00e1nicas de los tubos con aguja de acero inoxidable utilizados en la fabricaci\u00f3n de productos sanitarios. <strong>Anexo C de la norma ISO 9626<\/strong> esboza un <strong>m\u00e9todo normativo<\/strong> para comprobar la resistencia de los tubos a la rotura bajo esfuerzos de flexi\u00f3n repetidos.<\/p><p>Seg\u00fan <strong>Anexo C<\/strong>Para ello, el tubo debe doblarse c\u00edclicamente para simular la fatiga mec\u00e1nica y, a continuaci\u00f3n, inspeccionarse visualmente para detectar cualquier signo de fractura. El resultado determina si el tubo cumple los requisitos m\u00ednimos de rendimiento necesarios para un uso m\u00e9dico seguro.<\/p>\t\t\t\t\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<div class=\"elementor-element elementor-element-3f79c0a e-flex e-con-boxed e-con e-parent\" data-id=\"3f79c0a\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ec7f91b elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"ec7f91b\" data-element_type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">M\u00e9todo de ensayo de la resistencia a la rotura del tubo de aguja<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-64203b6 elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"64203b6\" data-element_type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>La prueba de resistencia a la rotura implica procedimientos precisos, que garantizan la repetibilidad y el cumplimiento. He aqu\u00ed un desglose del m\u00e9todo, como se indica en <strong>ISO 9626 Anexo C<\/strong>:<\/p>\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-c66d4c9 e-n-tabs-mobile elementor-invisible elementor-widget elementor-widget-n-tabs\" data-id=\"c66d4c9\" data-element_type=\"widget\" data-settings=\"{&quot;tabs_justify_horizontal&quot;:&quot;center&quot;,&quot;_animation&quot;:&quot;fadeInUp&quot;,&quot;horizontal_scroll&quot;:&quot;disable&quot;}\" data-widget_type=\"nested-tabs.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"e-n-tabs\" data-widget-number=\"208065737\" aria-label=\"Sekmeler. Enter ve Space ile \u00f6geleri a\u00e7abilir, Escape ile \u00f6geleri kapatabilir ve Y\u00f6n tu\u015flar\u0131 ile \u00f6geler aras\u0131nda gezinebilirsiniz.\" data-no-translation-aria-label=\"\">\n\t\t\t<div class=\"e-n-tabs-heading\" role=\"tablist\">\n\t\t\t\t\t<button id=\"e-n-tab-title-2080657371\" class=\"e-n-tab-title\" aria-selected=\"true\" data-tab-index=\"1\" role=\"tab\" tabindex=\"0\" aria-controls=\"e-n-tab-content-2080657371\" style=\"--n-tabs-title-order: 1;\">\n\t\t\t\t\t\t<span class=\"e-n-tab-title-text\">\n\t\t\t\tRequisitos de los aparatos\t\t\t<\/span>\n\t\t<\/button>\n\t\t\t\t<button id=\"e-n-tab-title-2080657372\" class=\"e-n-tab-title\" aria-selected=\"false\" data-tab-index=\"2\" role=\"tab\" tabindex=\"-1\" aria-controls=\"e-n-tab-content-2080657372\" style=\"--n-tabs-title-order: 2;\">\n\t\t\t\t\t\t<span class=\"e-n-tab-title-text\">\n\t\t\t\tProcedimiento de ensayo\t\t\t<\/span>\n\t\t<\/button>\n\t\t\t\t<button id=\"e-n-tab-title-2080657373\" class=\"e-n-tab-title\" aria-selected=\"false\" data-tab-index=\"3\" role=\"tab\" tabindex=\"-1\" aria-controls=\"e-n-tab-content-2080657373\" style=\"--n-tabs-title-order: 3;\">\n\t\t\t\t\t\t<span class=\"e-n-tab-title-text\">\n\t\t\t\tRequisitos de informaci\u00f3n y documentaci\u00f3n\t\t\t<\/span>\n\t\t<\/button>\n\t\t\t\t\t<\/div>\n\t\t\t<div class=\"e-n-tabs-content\">\n\t\t\t\t<div id=\"e-n-tab-content-2080657371\" role=\"tabpanel\" aria-labelledby=\"e-n-tab-title-2080657371\" data-tab-index=\"1\" style=\"--n-tabs-title-order: 1;\" class=\"e-active elementor-element elementor-element-661f178 e-con-full e-flex e-con e-child\" data-id=\"661f178\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-45c637c elementor-widget elementor-widget-text-editor\" data-id=\"45c637c\" 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\t\t<p>Para llevar a cabo la prueba con eficacia, es necesario el siguiente equipo:<\/p><ul><li><strong>Dispositivo de fijaci\u00f3n de tubos:<\/strong> Para sujetar r\u00edgidamente un extremo del tubo.<\/li><li><strong>Forzar dispositivo de aplicaci\u00f3n:<\/strong> Capaz de doblar el tubo hasta 25\u00b0 en funci\u00f3n del grosor de la pared.<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div id=\"e-n-tab-content-2080657372\" role=\"tabpanel\" aria-labelledby=\"e-n-tab-title-2080657372\" data-tab-index=\"2\" style=\"--n-tabs-title-order: 2;\" class=\"elementor-element elementor-element-8d83155 e-con-full e-flex e-con e-child\" data-id=\"8d83155\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-1bab19a elementor-widget elementor-widget-text-editor\" data-id=\"1bab19a\" 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\t\t<ol><li><strong>Asegure el tubo:<\/strong> Un extremo del tubo de la aguja est\u00e1 fijado r\u00edgidamente al soporte.<\/li><li><strong>Aplicar fuerza de flexi\u00f3n:<\/strong> A una distancia determinada del punto fijo, doble el tubo en una direcci\u00f3n a trav\u00e9s de un \u00e1ngulo definido:<ul><li><em>(25 \u00b11)\u00b0<\/em> para paredes regulares<\/li><li><em>(20 \u00b11)\u00b0<\/em> para paredes delgadas<\/li><li><em>(15 \u00b11)\u00b0<\/em> para tubos de pared extrafina y ultrafina<\/li><\/ul><\/li><li><strong>Invierte la Fuerza:<\/strong> Doble el tubo en la direcci\u00f3n opuesta con el mismo \u00e1ngulo.<\/li><li><strong>Repite el ciclo:<\/strong> Realice <strong>20 ciclos completos<\/strong> de inversi\u00f3n a un ritmo de <strong>0,5 Hz<\/strong>.<\/li><li><strong>Inspecci\u00f3n visual:<\/strong> Despu\u00e9s del ciclo, compruebe si los tubos presentan signos visibles de <strong>rotura<\/strong> o agrietamiento.<\/li><\/ol>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div id=\"e-n-tab-content-2080657373\" role=\"tabpanel\" aria-labelledby=\"e-n-tab-title-2080657373\" data-tab-index=\"3\" style=\"--n-tabs-title-order: 3;\" class=\"elementor-element elementor-element-bc03100 e-flex e-con-boxed e-con e-child\" data-id=\"bc03100\" 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-5d48674 elementor-widget elementor-widget-text-editor\" data-id=\"5d48674\" 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\t\t<p>Un informe de ensayo completo debe incluir:<\/p><ul><li><strong>Tama\u00f1o e identificaci\u00f3n de los tubos<\/strong><\/li><li><strong>Clasificaci\u00f3n del tipo de pared<\/strong> (normal, fino, extrafino, ultrafino)<\/li><li><strong>Resultados visuales<\/strong> de rotura<\/li><li><strong>Fecha de la prueba<\/strong><\/li><li><strong>Tipo de aleaci\u00f3n de acero inoxidable<\/strong> tal como se especifica en la cl\u00e1usula 4 de la norma ISO 9626<\/li><\/ul><p>Una documentaci\u00f3n precisa garantiza la trazabilidad y facilita las auditor\u00edas o los procesos de certificaci\u00f3n, esenciales para las empresas que pretenden exportar o cumplir normas reglamentarias estrictas.<\/p>\t\t\t\t\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\t<\/div>\n\t\t<\/div>\n\t\t\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<div class=\"elementor-element elementor-element-1b581cc e-con-full e-flex e-con e-parent\" data-id=\"1b581cc\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-61afd37 e-grid e-con-full e-con e-child\" data-id=\"61afd37\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-f8ace73 e-con-full e-flex elementor-invisible e-con e-child\" data-id=\"f8ace73\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;animation&quot;:&quot;fadeInLeft&quot;}\">\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-94cc5ad e-flex e-con-boxed elementor-invisible e-con e-child\" data-id=\"94cc5ad\" data-element_type=\"container\" data-settings=\"{&quot;animation&quot;:&quot;fadeInRight&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-907b713 elementor-widget elementor-widget-heading\" data-id=\"907b713\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Por qu\u00e9 elegir <b>\u00bfSyringetest.com?<\/b><\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-718f32f elementor-widget elementor-widget-text-editor\" data-id=\"718f32f\" 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\t\t<p>En <strong>Syringetest.com<\/strong>Estamos especializados en el dise\u00f1o de alta precisi\u00f3n, <strong>sistemas de pruebas automatizadas<\/strong> que cumplen las normas ISO, incluidas <strong>ISO 9626 Anexo C<\/strong>. Nuestros equipos se utilizan ampliamente en el control de calidad de dispositivos m\u00e9dicos, garantizando resultados de pruebas coherentes con un m\u00ednimo de errores humanos. Adem\u00e1s, ofrecemos <strong>soluciones personalizables<\/strong> para dimensiones de tubo o tipos de pared \u00fanicos y proporcionan <strong>servicios de transformaci\u00f3n de la automatizaci\u00f3n<\/strong> para integrar esta prueba en las l\u00edneas de producci\u00f3n sin problemas.<\/p><p>Tanto si trabaja en el sector farmac\u00e9utico como en el de los dispositivos m\u00e9dicos o la inspecci\u00f3n de calidad, nuestros instrumentos le ayudan a mantener la conformidad al tiempo que mejoran la eficacia operativa.<\/p>\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-f735b94 elementor-widget elementor-widget-eael-creative-button\" data-id=\"f735b94\" data-element_type=\"widget\" data-widget_type=\"eael-creative-button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t        <div class=\"eael-creative-button-wrapper\">\n\n            <a class=\"eael-creative-button eael-creative-button--default\" href=\"#\" data-text=\"Contact Us\">\n\n\t    \n                <div class=\"creative-button-inner\">\n\n                    \n                    <span class=\"cretive-button-text\">Contacte con nosotros<\/span>\n\n                                    <\/div>\n\t                        <\/a>\n        <\/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>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"<p>Needle Tubing Breakage Resistance Test Understanding needle tubing breakage resistance is crucial for maintaining the safety and quality of medical devices, especially syringes and infusion needles. This test ensures that the tubing can endure bending stress during manufacturing and clinical use without failure. For professionals working in quality control, especially in pharmaceutical and medical device [&hellip;]<\/p>","protected":false},"author":2,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"footnotes":""},"class_list":["post-311","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v25.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Needle Tubing Breakage Resistance Test - ISO 9626 Annex C<\/title>\n<meta name=\"description\" content=\"Conduct syringe needle tubing breakage resistance tests in compliance with ISO 9626 and Annex C. 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