{"id":2022,"date":"2025-04-09T05:01:05","date_gmt":"2025-04-09T05:01:05","guid":{"rendered":"https:\/\/www.pharmacopoeiatest.com\/?p=2022"},"modified":"2025-04-11T06:36:55","modified_gmt":"2025-04-11T06:36:55","slug":"needle-bonding-strength-test-iso-11040-4","status":"publish","type":"post","link":"https:\/\/www.pharmacopoeiatest.com\/es\/needle-bonding-strength-test-iso-11040-4\/","title":{"rendered":"Ensayo de resistencia a la adherencia por aguja ISO 11040-4 Anexo G1"},"content":{"rendered":"<div data-elementor-type=\"wp-post\" data-elementor-id=\"2022\" class=\"elementor elementor-2022\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-88e81b0 e-flex e-con-boxed e-con e-parent\" data-id=\"88e81b0\" 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-15151de elementor-widget elementor-widget-heading\" data-id=\"15151de\" 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\">Ensayo de adherencia con aguja<\/h1>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3dc2194 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"3dc2194\" 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-d585eff elementor-widget elementor-widget-heading\" data-id=\"d585eff\" 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 G1<\/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-10ec79b e-flex e-con-boxed e-con e-parent\" data-id=\"10ec79b\" 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-7045eb5 elementor-widget elementor-widget-text-editor\" data-id=\"7045eb5\" 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 class=\"\" data-start=\"372\" data-end=\"916\">En la industria de productos sanitarios, especialmente en el caso de las jeringuillas precargadas con agujas estacadas, la <em data-start=\"482\" data-end=\"505\">fuerza de extracci\u00f3n de la aguja<\/em> es esencial para verificar la integridad de la uni\u00f3n entre la aguja y la jeringa. Seg\u00fan <strong data-start=\"609\" data-end=\"633\">ISO 11040-4 Anexo G1<\/strong>Esta prueba mec\u00e1nica es fundamental para evaluar la seguridad, la fiabilidad y el cumplimiento normativo de los sistemas de jeringuillas. La correcta realizaci\u00f3n de esta prueba garantiza que las agujas no se desprendan en condiciones de uso normales o de estr\u00e9s, lo cual es crucial tanto para el uso cl\u00ednico como para la seguridad del paciente.<\/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-53f39ac elementor-widget elementor-widget-heading\" data-id=\"53f39ac\" 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\">Importancia de la fuerza de extracci\u00f3n de la aguja<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-232a548 elementor-widget elementor-widget-text-editor\" data-id=\"232a548\" 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 class=\"\" data-start=\"982\" data-end=\"1259\"><em data-start=\"982\" data-end=\"1005\">Fuerza de extracci\u00f3n de la aguja<\/em> se refiere a la fuerza axial m\u00e1xima necesaria para desprender la aguja de una jeringa. Una uni\u00f3n deficiente entre la aguja y el buje podr\u00eda provocar el desprendimiento durante la inyecci\u00f3n, lo que podr\u00eda causar lesiones, errores de dosificaci\u00f3n o contaminaci\u00f3n. Esta prueba desempe\u00f1a un papel importante en la validaci\u00f3n de la <strong data-start=\"1139\" data-end=\"1166\">fuerza de adhesi\u00f3n de la aguja<\/strong> durante la producci\u00f3n, garantizando que cumple las normas de rendimiento predefinidas bajo <strong data-start=\"1243\" data-end=\"1258\">ISO 11040-4<\/strong>.<\/p>\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-8452827 e-flex e-con-boxed e-con e-parent\" data-id=\"8452827\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-570817b e-con-full e-flex e-con e-child\" data-id=\"570817b\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-413bd47 elementor-widget elementor-widget-heading\" data-id=\"413bd47\" 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\">M\u00e9todos de ensayo en ISO 11040-4 Anexo G1<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-fcd29af elementor-widget elementor-widget-text-editor\" data-id=\"fcd29af\" 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 class=\"\" data-start=\"1587\" data-end=\"1757\">Para llevar a cabo la <em data-start=\"1604\" data-end=\"1627\">fuerza de extracci\u00f3n de la aguja<\/em> correctamente, los fabricantes deben seguir las <strong data-start=\"1673\" data-end=\"1697\">ISO 11040-4 Anexo G1<\/strong> procedimiento. A continuaci\u00f3n se desglosa el m\u00e9todo normalizado.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-a860fa6 e-con-full e-flex e-con e-child\" data-id=\"a860fa6\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-996cc40 e-con-full e-flex e-con e-child\" data-id=\"996cc40\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2456c08 elementor-widget elementor-widget-heading\" data-id=\"2456c08\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Configuraci\u00f3n de la prueba y requisitos del equipo<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b295a09 elementor-widget elementor-widget-text-editor\" data-id=\"b295a09\" 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 class=\"\" data-start=\"1807\" data-end=\"1924\">El equipamiento b\u00e1sico incluye un <strong data-start=\"1837\" data-end=\"1890\">m\u00e1quina universal de ensayos de tracci\u00f3n y compresi\u00f3n<\/strong> cumpliendo las siguientes condiciones:<\/p><ul data-start=\"1926\" data-end=\"2220\"><li class=\"\" data-start=\"1926\" data-end=\"1996\"><p class=\"\" data-start=\"1928\" data-end=\"1996\"><strong data-start=\"1928\" data-end=\"1942\">C\u00e9lula de carga:<\/strong> M\u00e1x. 500 N (o el valor adecuado en funci\u00f3n de la resistencia de la muestra)<\/p><\/li><li class=\"\" data-start=\"1997\" data-end=\"2048\"><p class=\"\" data-start=\"1999\" data-end=\"2048\"><strong data-start=\"1999\" data-end=\"2014\">Velocidad de prueba:<\/strong> 50 mm\/min (valor predeterminado recomendado)<\/p><\/li><li class=\"\" data-start=\"2049\" data-end=\"2097\"><p class=\"\" data-start=\"2051\" data-end=\"2097\"><strong data-start=\"2051\" data-end=\"2069\">Frecuencia de muestreo:<\/strong> \u2265500 Hz para precisi\u00f3n de pico<\/p><\/li><li class=\"\" data-start=\"2098\" data-end=\"2157\"><p class=\"\" data-start=\"2100\" data-end=\"2157\"><strong data-start=\"2100\" data-end=\"2126\">Dispositivo de sujeci\u00f3n de agujas:<\/strong> Agarre seguro sin deslizamiento<\/p><\/li><li class=\"\" data-start=\"2158\" data-end=\"2220\"><p class=\"\" data-start=\"2160\" data-end=\"2220\"><strong data-start=\"2160\" data-end=\"2179\">Soporte para jeringuillas:<\/strong> Sujeta la jeringa por la brida o el hombro<\/p><\/li><\/ul><p class=\"\" data-start=\"2222\" data-end=\"2499\">Instrumentos celulares <strong data-start=\"2240\" data-end=\"2275\">MPT-01 Comprobador de envases m\u00e9dicos<\/strong> es una soluci\u00f3n excelente para este fin. Dise\u00f1ada para pruebas de envases y dispositivos m\u00e9dicos, ofrece velocidad de prueba ajustable, precisi\u00f3n controlada por PLC y pinzas configurables a medida para evaluaciones de jeringas y agujas.<\/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<div class=\"elementor-element elementor-element-d9546da elementor-widget elementor-widget-image\" data-id=\"d9546da\" 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\/es\/category\/product\/syringe-test\/\">\n\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"442\" height=\"1024\" src=\"https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2025\/04\/Needle-Bonding-Strength-Testing-ISO-11040-4-Annex-G1-442x1024.webp\" class=\"attachment-large size-large wp-image-2024\" alt=\"Ensayo de resistencia a la adherencia por aguja ISO 11040-4 Anexo G1\" srcset=\"https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2025\/04\/Needle-Bonding-Strength-Testing-ISO-11040-4-Annex-G1-442x1024.webp 442w, https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2025\/04\/Needle-Bonding-Strength-Testing-ISO-11040-4-Annex-G1-130x300.webp 130w, https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2025\/04\/Needle-Bonding-Strength-Testing-ISO-11040-4-Annex-G1-768x1779.webp 768w, https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2025\/04\/Needle-Bonding-Strength-Testing-ISO-11040-4-Annex-G1-663x1536.webp 663w, https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2025\/04\/Needle-Bonding-Strength-Testing-ISO-11040-4-Annex-G1-884x2048.webp 884w, https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2025\/04\/Needle-Bonding-Strength-Testing-ISO-11040-4-Annex-G1-scaled.webp 1105w\" sizes=\"(max-width: 442px) 100vw, 442px\" \/>\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>\n\t\t\t\t<div class=\"elementor-element elementor-element-27af015 elementor-widget elementor-widget-heading\" data-id=\"27af015\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Preparaci\u00f3n y manipulaci\u00f3n de muestras<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f39f978 elementor-widget elementor-widget-text-editor\" data-id=\"f39f978\" 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<ul><li class=\"\" data-start=\"2543\" data-end=\"2625\"><p class=\"\" data-start=\"2545\" data-end=\"2625\">Utilice <strong data-start=\"2549\" data-end=\"2585\">jeringas subensambladas esterilizadas<\/strong> listo para ser llenado con una aguja estacada.<\/p><\/li><li class=\"\" data-start=\"2626\" data-end=\"2718\"><p class=\"\" data-start=\"2628\" data-end=\"2718\">Garantizar que las muestras de ensayo reflejen las condiciones reales de producci\u00f3n para mantener la relevancia de los resultados.<\/p><\/li><li class=\"\" data-start=\"2719\" data-end=\"2827\"><p class=\"\" data-start=\"2721\" data-end=\"2827\">Evite las precargas antes de iniciar la medici\u00f3n - ajuste la c\u00e9lula de carga a <em data-start=\"2792\" data-end=\"2798\">cero<\/em> sin presi\u00f3n adicional.<\/p><\/li><\/ul>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-c6fdd34 e-con-full e-flex e-con e-child\" data-id=\"c6fdd34\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-793e953 e-con-full e-flex e-con e-child\" data-id=\"793e953\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-b7b4771 elementor-widget elementor-widget-heading\" data-id=\"b7b4771\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Procedimiento de prueba de resistencia a la adhesi\u00f3n con aguja<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6e44f24 elementor-widget elementor-widget-text-editor\" data-id=\"6e44f24\" 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 class=\"\" data-start=\"2870\" data-end=\"2924\"><p class=\"\" data-start=\"2873\" data-end=\"2924\">Monte la jeringa verticalmente en el banco de pruebas.<\/p><\/li><li class=\"\" data-start=\"2925\" data-end=\"2975\"><p class=\"\" data-start=\"2928\" data-end=\"2975\">Sujete firmemente la aguja para evitar que resbale.<\/p><\/li><li class=\"\" data-start=\"2976\" data-end=\"3028\"><p class=\"\" data-start=\"2979\" data-end=\"3028\">Ponga a cero la c\u00e9lula de carga antes de aplicar la carga.<\/p><\/li><li class=\"\" data-start=\"3029\" data-end=\"3071\"><p class=\"\" data-start=\"3032\" data-end=\"3071\">Inicie la prueba de extracci\u00f3n a 50 mm\/min.<\/p><\/li><li class=\"\" data-start=\"3072\" data-end=\"3122\"><p class=\"\" data-start=\"3075\" data-end=\"3122\">Contin\u00fae hasta que la aguja se desprenda o se rompa.<\/p><\/li><li class=\"\" data-start=\"3123\" data-end=\"3172\"><p class=\"\" data-start=\"3126\" data-end=\"3172\">Registre el <strong data-start=\"3137\" data-end=\"3169\">curva fuerza\/desplazamiento<\/strong>.<\/p><\/li><li class=\"\" data-start=\"3173\" data-end=\"3256\"><p class=\"\" data-start=\"3176\" data-end=\"3256\">Tenga en cuenta la <strong data-start=\"3185\" data-end=\"3207\">fuerza m\u00e1xima m\u00e1xima<\/strong>que representa el <em data-start=\"3230\" data-end=\"3253\">fuerza de extracci\u00f3n de la aguja<\/em>.<\/p><\/li><\/ol>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-9c468e4 e-con-full e-flex e-con e-child\" data-id=\"9c468e4\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-4f65822 elementor-widget elementor-widget-heading\" data-id=\"4f65822\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Comunicaci\u00f3n de resultados<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d2e072e elementor-widget elementor-widget-text-editor\" data-id=\"d2e072e\" 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 class=\"\" data-start=\"3290\" data-end=\"3357\">Seg\u00fan la norma ISO 11040-4 Anexo G1, el informe de la prueba debe incluir:<\/p><ul data-start=\"3359\" data-end=\"3509\"><li class=\"\" data-start=\"3359\" data-end=\"3385\"><p class=\"\" data-start=\"3361\" data-end=\"3385\">Fuerza m\u00e1xima pico (N)<\/p><\/li><li class=\"\" data-start=\"3386\" data-end=\"3418\"><p class=\"\" data-start=\"3388\" data-end=\"3418\">Gr\u00e1fico de fuerza frente a desplazamiento<\/p><\/li><li class=\"\" data-start=\"3419\" data-end=\"3442\"><p class=\"\" data-start=\"3421\" data-end=\"3442\">Velocidad de ensayo (mm\/min)<\/p><\/li><li class=\"\" data-start=\"3443\" data-end=\"3462\"><p class=\"\" data-start=\"3445\" data-end=\"3462\">Cantidad de muestras<\/p><\/li><li class=\"\" data-start=\"3463\" data-end=\"3509\"><p class=\"\" data-start=\"3465\" data-end=\"3509\">Cualquier desviaci\u00f3n, observaci\u00f3n o anomal\u00eda<\/p><\/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-753fbcc elementor-widget elementor-widget-text-editor\" data-id=\"753fbcc\" 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>Para el tratamiento avanzado de datos, el <strong data-start=\"3545\" data-end=\"3555\">MPT-01<\/strong> admite la visualizaci\u00f3n de resultados, la presentaci\u00f3n en tiempo real y la salida RS232 opcional o la integraci\u00f3n de una microimpresora.<\/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<\/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-61b109f e-flex e-con-boxed e-con e-parent\" data-id=\"61b109f\" 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-1ddd053 elementor-widget elementor-widget-heading\" data-id=\"1ddd053\" 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\">Nuestro medidor de fuerza de adherencia de agujas?<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-17dbcca elementor-widget elementor-widget-text-editor\" data-id=\"17dbcca\" 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 class=\"\" data-start=\"4323\" data-end=\"4503\">Con experiencia en ensayos de productos sanitarios y envases, <strong data-start=\"4379\" data-end=\"4409\">Cell Instruments Co.<\/strong> ofrece soluciones a medida para <em data-start=\"4440\" data-end=\"4463\">fuerza de extracci\u00f3n de la aguja<\/em> evaluaciones. Nuestro comprobador MPT-01 permite:<\/p><ul data-start=\"4505\" data-end=\"4762\"><li class=\"\" data-start=\"4505\" data-end=\"4534\"><p class=\"\" data-start=\"4507\" data-end=\"4534\">Alta precisi\u00f3n (0,5% F.S.)<\/p><\/li><li class=\"\" data-start=\"4535\" data-end=\"4592\"><p class=\"\" data-start=\"4537\" data-end=\"4592\">Multifuncionalidad para pruebas de tracci\u00f3n y compresi\u00f3n<\/p><\/li><li class=\"\" data-start=\"4593\" data-end=\"4657\"><p class=\"\" data-start=\"4595\" data-end=\"4657\">Dise\u00f1os de fijaci\u00f3n personalizados para configuraciones de jeringuillas y agujas<\/p><\/li><li class=\"\" data-start=\"4658\" data-end=\"4701\"><p class=\"\" data-start=\"4660\" data-end=\"4701\">Protocolos de prueba programables y repetibles<\/p><\/li><li class=\"\" data-start=\"4702\" data-end=\"4762\"><p class=\"\" data-start=\"4704\" data-end=\"4762\">Cumplimiento de <a href=\"https:\/\/www.iso.org\/standard\/82222.html\" target=\"_blank\" rel=\"noopener\">ISO 11040-4<\/a> y otras normas pertinentes<\/p><\/li><\/ul><p class=\"\" data-start=\"4764\" data-end=\"4917\">Tanto si es un fabricante de jeringuillas como un especialista en control de calidad, respaldamos sus necesidades normativas y retos de ensayo con soluciones fiables.<\/p>\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-de82dd4 e-flex e-con-boxed e-con e-parent\" data-id=\"de82dd4\" 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-cd205c0 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"cd205c0\" 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-a40b489 elementor-widget elementor-widget-heading\" data-id=\"a40b489\" 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\">Preguntas frecuentes<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c0c3e38 elementor-widget elementor-widget-toggle\" data-id=\"c0c3e38\" data-element_type=\"widget\" data-widget_type=\"toggle.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-toggle\">\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-2021\" class=\"elementor-tab-title\" data-tab=\"1\" role=\"button\" aria-controls=\"elementor-tab-content-2021\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon elementor-toggle-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-closed\"><svg class=\"e-font-icon-svg e-fas-caret-right\" viewbox=\"0 0 192 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M0 384.662V127.338c0-17.818 21.543-26.741 34.142-14.142l128.662 128.662c7.81 7.81 7.81 20.474 0 28.284L34.142 398.804C21.543 411.404 0 402.48 0 384.662z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-opened\"><svg class=\"elementor-toggle-icon-opened e-font-icon-svg e-fas-caret-up\" viewbox=\"0 0 320 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M288.662 352H31.338c-17.818 0-26.741-21.543-14.142-34.142l128.662-128.662c7.81-7.81 20.474-7.81 28.284 0l128.662 128.662c12.6 12.599 3.676 34.142-14.142 34.142z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">1. \u00bfCu\u00e1l es la importancia de la prueba de fuerza de extracci\u00f3n de la aguja?<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-2021\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"1\" role=\"region\" aria-labelledby=\"elementor-tab-title-2021\"><p>Esta prueba eval\u00faa la fijaci\u00f3n mec\u00e1nica de la aguja a la jeringa para garantizar que no se desprender\u00e1 durante su uso, manteniendo los est\u00e1ndares de seguridad y rendimiento.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-2022\" class=\"elementor-tab-title\" data-tab=\"2\" role=\"button\" aria-controls=\"elementor-tab-content-2022\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon elementor-toggle-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-closed\"><svg class=\"e-font-icon-svg e-fas-caret-right\" viewbox=\"0 0 192 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M0 384.662V127.338c0-17.818 21.543-26.741 34.142-14.142l128.662 128.662c7.81 7.81 7.81 20.474 0 28.284L34.142 398.804C21.543 411.404 0 402.48 0 384.662z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-opened\"><svg class=\"elementor-toggle-icon-opened e-font-icon-svg e-fas-caret-up\" viewbox=\"0 0 320 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M288.662 352H31.338c-17.818 0-26.741-21.543-14.142-34.142l128.662-128.662c7.81-7.81 20.474-7.81 28.284 0l128.662 128.662c12.6 12.599 3.676 34.142-14.142 34.142z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">2. \u00bfQu\u00e9 norma describe la prueba de resistencia a la adherencia de las agujas?<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-2022\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"2\" role=\"region\" aria-labelledby=\"elementor-tab-title-2022\"><p>La norma ISO 11040-4, concretamente el anexo G1, define la metodolog\u00eda para realizar ensayos de fuerza de extracci\u00f3n de la aguja en jeringas con aguja estacada.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-2023\" class=\"elementor-tab-title\" data-tab=\"3\" role=\"button\" aria-controls=\"elementor-tab-content-2023\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon elementor-toggle-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-closed\"><svg class=\"e-font-icon-svg e-fas-caret-right\" viewbox=\"0 0 192 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M0 384.662V127.338c0-17.818 21.543-26.741 34.142-14.142l128.662 128.662c7.81 7.81 7.81 20.474 0 28.284L34.142 398.804C21.543 411.404 0 402.48 0 384.662z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-opened\"><svg class=\"elementor-toggle-icon-opened e-font-icon-svg e-fas-caret-up\" viewbox=\"0 0 320 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M288.662 352H31.338c-17.818 0-26.741-21.543-14.142-34.142l128.662-128.662c7.81-7.81 20.474-7.81 28.284 0l128.662 128.662c12.6 12.599 3.676 34.142-14.142 34.142z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">3. \u00bfCu\u00e1ntas muestras se necesitan para la prueba de fuerza de extracci\u00f3n de la aguja?<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-2023\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"3\" role=\"region\" aria-labelledby=\"elementor-tab-title-2023\"><p>El n\u00famero depende de sus protocolos internos de validaci\u00f3n y de los acuerdos con el cliente, pero se recomiendan varias muestras para garantizar la fiabilidad estad\u00edstica.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-2024\" class=\"elementor-tab-title\" data-tab=\"4\" role=\"button\" aria-controls=\"elementor-tab-content-2024\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon elementor-toggle-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-closed\"><svg class=\"e-font-icon-svg e-fas-caret-right\" viewbox=\"0 0 192 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M0 384.662V127.338c0-17.818 21.543-26.741 34.142-14.142l128.662 128.662c7.81 7.81 7.81 20.474 0 28.284L34.142 398.804C21.543 411.404 0 402.48 0 384.662z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-opened\"><svg class=\"elementor-toggle-icon-opened e-font-icon-svg e-fas-caret-up\" viewbox=\"0 0 320 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M288.662 352H31.338c-17.818 0-26.741-21.543-14.142-34.142l128.662-128.662c7.81-7.81 20.474-7.81 28.284 0l128.662 128.662c12.6 12.599 3.676 34.142-14.142 34.142z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">4. \u00bfCu\u00e1les son los requisitos de equipamiento para esta prueba?<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-2024\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"4\" role=\"region\" aria-labelledby=\"elementor-tab-title-2024\"><p>Se requiere una m\u00e1quina de ensayos universal con capacidad de 500 N, velocidad de ensayo de 50 mm\/min, pinzas adecuadas y alta frecuencia de muestreo (\u2265500 Hz).<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-2025\" class=\"elementor-tab-title\" data-tab=\"5\" role=\"button\" aria-controls=\"elementor-tab-content-2025\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon elementor-toggle-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-closed\"><svg class=\"e-font-icon-svg e-fas-caret-right\" viewbox=\"0 0 192 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M0 384.662V127.338c0-17.818 21.543-26.741 34.142-14.142l128.662 128.662c7.81 7.81 7.81 20.474 0 28.284L34.142 398.804C21.543 411.404 0 402.48 0 384.662z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-opened\"><svg class=\"elementor-toggle-icon-opened e-font-icon-svg e-fas-caret-up\" viewbox=\"0 0 320 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M288.662 352H31.338c-17.818 0-26.741-21.543-14.142-34.142l128.662-128.662c7.81-7.81 20.474-7.81 28.284 0l128.662 128.662c12.6 12.599 3.676 34.142-14.142 34.142z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">5. \u00bfSe puede personalizar el MPT-01 de Cell Instruments para esta prueba?<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-2025\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"5\" role=\"region\" aria-labelledby=\"elementor-tab-title-2025\"><p>S\u00ed, el MPT-01 ofrece dispositivos personalizables, ajustes programables y funciones de automatizaci\u00f3n adaptadas a la resistencia de la uni\u00f3n de agujas y otros ensayos de dispositivos m\u00e9dicos.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\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>Ensayo de resistencia de la uni\u00f3n de la aguja \u2014 ISO 11040-4, anexo G1 \u2014 En el sector de los productos sanitarios, especialmente en el caso de las jeringas precargadas con agujas fijadas, el ensayo de fuerza de extracci\u00f3n de la aguja es esencial para verificar la integridad de la uni\u00f3n entre la aguja y la jeringa. Seg\u00fan la norma ISO 11040-4, anexo G1, este ensayo mec\u00e1nico es fundamental para evaluar la seguridad, la fiabilidad y [\u2026]<\/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":"","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-2022","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\/es\/author\/pharmacopoeiatest\/"},"uagb_comment_info":0,"uagb_excerpt":"Needle Bonding Strength Test ISO 11040-4 Annex G1 In the medical device industry, especially for prefilled syringes with staked needles, the needle pull-out force test is essential for verifying the bonding integrity between the needle and the syringe. According to ISO 11040-4 Annex G1, this mechanical test is critical to assess the safety, reliability, and&hellip;","_links":{"self":[{"href":"https:\/\/www.pharmacopoeiatest.com\/es\/wp-json\/wp\/v2\/posts\/2022","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.pharmacopoeiatest.com\/es\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.pharmacopoeiatest.com\/es\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/es\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/es\/wp-json\/wp\/v2\/comments?post=2022"}],"version-history":[{"count":5,"href":"https:\/\/www.pharmacopoeiatest.com\/es\/wp-json\/wp\/v2\/posts\/2022\/revisions"}],"predecessor-version":[{"id":2034,"href":"https:\/\/www.pharmacopoeiatest.com\/es\/wp-json\/wp\/v2\/posts\/2022\/revisions\/2034"}],"wp:attachment":[{"href":"https:\/\/www.pharmacopoeiatest.com\/es\/wp-json\/wp\/v2\/media?parent=2022"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/es\/wp-json\/wp\/v2\/categories?post=2022"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/es\/wp-json\/wp\/v2\/tags?post=2022"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}