{"id":734,"date":"2026-01-15T00:43:19","date_gmt":"2026-01-15T00:43:19","guid":{"rendered":"https:\/\/www.syringetest.com\/?page_id=734"},"modified":"2026-01-15T01:06:56","modified_gmt":"2026-01-15T01:06:56","slug":"iso-7864","status":"publish","type":"page","link":"https:\/\/www.syringetest.com\/es\/standards\/iso-7864","title":{"rendered":"ISO 7864"},"content":{"rendered":"<div data-elementor-type=\"wp-page\" data-elementor-id=\"734\" class=\"elementor elementor-734\" 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\">ISO 7864 and Quality Control of Hypodermic Needles<\/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 data-start=\"463\" data-end=\"847\"><strong data-start=\"463\" data-end=\"475\">ISO 7864<\/strong> is the core international standard governing sterile hypodermic needles for single use. It defines both performance requirements and verified test methods to ensure safety, consistency, and functionality in clinical use. From a quality and regulatory perspective, ISO 7864 connects product design, material selection, and mechanical performance through objective testing.<\/p><p data-start=\"849\" data-end=\"1181\">For manufacturers, medical device laboratories, and inspection agencies, ISO 7864 provides a structured framework to evaluate needle strength, penetration behavior, bonding reliability, and fluid delivery performance. These parameters directly affect user safety, patient comfort, and compliance with global regulatory expectations.<\/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-ad68bc6 e-flex e-con-boxed e-con e-parent\" data-id=\"ad68bc6\" 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\">Hypodermic Needle Testing Under ISO 7864<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-343a570 e-n-tabs-mobile elementor-invisible elementor-widget elementor-widget-n-tabs\" data-id=\"343a570\" 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=\"54764912\" aria-label=\"\u0639\u0644\u0627\u0645\u0627\u062a \u0627\u0644\u062a\u0628\u0648\u064a\u0628. \u0627\u0641\u062a\u062d \u0627\u0644\u0639\u0646\u0627\u0635\u0631 \u0628\u0627\u0633\u062a\u062e\u062f\u0627\u0645 Enter \u0623\u0648 \u0627\u0644\u0645\u0633\u0627\u0641\u0629\u060c \u0648\u0623\u063a\u0644\u0642\u0647\u0627 \u0628\u0627\u0633\u062a\u062e\u062f\u0627\u0645 Escape \u0648\u062a\u0646\u0642\u0644 \u0628\u0627\u0633\u062a\u062e\u062f\u0627\u0645 \u0645\u0641\u0627\u062a\u064a\u062d \u0627\u0644\u0623\u0633\u0647\u0645.\" 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-547649121\" class=\"e-n-tab-title\" aria-selected=\"true\" data-tab-index=\"1\" role=\"tab\" tabindex=\"0\" aria-controls=\"e-n-tab-content-547649121\" style=\"--n-tabs-title-order: 1;\">\n\t\t\t\t\t\t<span class=\"e-n-tab-title-text\">\n\t\t\t\thypodermic needle testing Scope and Significance\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-547649121\" role=\"tabpanel\" aria-labelledby=\"e-n-tab-title-547649121\" data-tab-index=\"1\" style=\"--n-tabs-title-order: 1;\" class=\"e-active elementor-element elementor-element-482d0a3 e-flex e-con-boxed e-con e-child\" data-id=\"482d0a3\" 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-76d83fe elementor-widget elementor-widget-text-editor\" data-id=\"76d83fe\" 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 data-start=\"1287\" data-end=\"1679\">Within <strong data-start=\"1294\" data-end=\"1323\">hypodermic needle testing<\/strong>, ISO 7864 emphasizes mechanical integrity and functional performance. The standard addresses how a needle penetrates tissue-like substrates, how securely it bonds to the hub, and how effectively it delivers fluids. Each test targets a specific risk associated with needle use, such as excessive insertion pain, detachment from the hub, or restricted flow.<\/p><p data-start=\"1681\" data-end=\"1877\">Testing according to ISO 7864 ensures that hypodermic needles perform consistently across batches and manufacturing sites, which is especially important for high-volume disposable medical devices.<\/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-d4835ce e-flex e-con-boxed e-con e-parent\" data-id=\"d4835ce\" 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-ea29382 elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"ea29382\" 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\">Needle Penetration Test and Penetration Force Evaluation<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-55047da e-con-full e-flex e-con e-child\" data-id=\"55047da\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-ae8face e-con-full e-flex elementor-invisible e-con e-child\" data-id=\"ae8face\" data-element_type=\"container\" data-settings=\"{&quot;animation&quot;:&quot;fadeInLeft&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-42248e5 elementor-widget elementor-widget-text-editor\" data-id=\"42248e5\" data-element_type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;none&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 data-start=\"1945\" data-end=\"2214\">One of the most critical procedures described in ISO 7864 is the <strong data-start=\"2010\" data-end=\"2037\">needle penetration test<\/strong>. This method measures the force required for a needle to enter a standardized substrate at a constant speed. The resulting force\u2013displacement curve provides two key indicators:<\/p><ul data-start=\"2216\" data-end=\"2390\"><li data-start=\"2216\" data-end=\"2304\"><p data-start=\"2218\" data-end=\"2304\"><strong data-start=\"2218\" data-end=\"2244\">Fuerza de penetraci\u00f3n m\u00e1xima<\/strong>, representing the maximum resistance during initial entry<\/p><\/li><li data-start=\"2305\" data-end=\"2390\"><p data-start=\"2307\" data-end=\"2390\"><strong data-start=\"2307\" data-end=\"2321\">Fuerza de arrastre<\/strong>, reflecting friction as the needle continues through the substrate<\/p><\/li><\/ul><p data-start=\"2392\" data-end=\"2679\">Controlled measurement of <strong data-start=\"2418\" data-end=\"2439\">fuerza de penetraci\u00f3n<\/strong> helps manufacturers optimize needle geometry, tip sharpness, and surface finish. Excessive penetration force may increase patient discomfort, while insufficient force consistency may indicate variability in grinding or polishing processes.<\/p><p data-start=\"2681\" data-end=\"2949\">A dedicated <strong data-start=\"2693\" data-end=\"2712\">Strength Tester<\/strong> equipped with a high-resolution load cell ensures reliable force measurement and repeatable results. Modern systems allow precise speed control and continuous force recording, which supports both development and routine quality control.<\/p>\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 class=\"elementor-element elementor-element-fda7334 e-con-full e-flex e-con e-child\" data-id=\"fda7334\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-a601c24 elementor-widget__width-initial elementor-invisible elementor-widget elementor-widget-image\" data-id=\"a601c24\" data-element_type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInRight&quot;}\" 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\t<img fetchpriority=\"high\" decoding=\"async\" width=\"284\" height=\"457\" src=\"https:\/\/www.syringetest.com\/wp-content\/uploads\/2026\/01\/ISO-7864-Annex-D.png\" class=\"attachment-large size-large wp-image-736\" alt=\"ISO 7864 Anexo D\" srcset=\"https:\/\/www.syringetest.com\/wp-content\/uploads\/2026\/01\/ISO-7864-Annex-D.png 284w, https:\/\/www.syringetest.com\/wp-content\/uploads\/2026\/01\/ISO-7864-Annex-D-186x300.png 186w, https:\/\/www.syringetest.com\/wp-content\/uploads\/2026\/01\/ISO-7864-Annex-D-7x12.png 7w\" sizes=\"(max-width: 284px) 100vw, 284px\" \/>\t\t\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>\n\t\t<div class=\"elementor-element elementor-element-7ada073 e-con-full e-flex e-con e-child\" data-id=\"7ada073\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-61bbbd2 elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"61bbbd2\" 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<h3 class=\"elementor-heading-title elementor-size-default\"><a href=\"https:\/\/www.syringetest.com\/es\/syringe-liquid-leakage-test-for-closure-system\/\">Fragmentation Test for Medical Needles<\/a><\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0e3eedc elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"0e3eedc\" 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 data-start=\"2999\" data-end=\"3310\">En <strong data-start=\"3003\" data-end=\"3045\">fragmentation test for medical needles<\/strong> focuses on structural safety. During insertion and withdrawal, a needle must remain intact without shedding fragments that could remain in tissue. ISO 7864 includes requirements to verify that the needle maintains its integrity under defined mechanical conditions.<\/p><p data-start=\"3312\" data-end=\"3584\">This test supports risk reduction in clinical use and confirms that material quality, heat treatment, and manufacturing processes meet the expected safety threshold. Fragmentation results also provide valuable feedback during supplier qualification and process validation.<\/p>\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 class=\"elementor-element elementor-element-cb1aef4 e-con-full e-flex e-con e-child\" data-id=\"cb1aef4\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-64a5239 e-con-full e-flex elementor-invisible e-con e-child\" data-id=\"64a5239\" data-element_type=\"container\" data-settings=\"{&quot;animation&quot;:&quot;fadeInLeft&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-c50402d elementor-widget elementor-widget-heading\" data-id=\"c50402d\" 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<h3 class=\"elementor-heading-title elementor-size-default\">Needle Bond and Bonding Strength Verification<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b9b9803 elementor-widget elementor-widget-text-editor\" data-id=\"b9b9803\" data-element_type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;none&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 data-start=\"3641\" data-end=\"3862\"><strong data-start=\"3641\" data-end=\"3656\">Needle Bond<\/strong> strength represents the mechanical connection between the needle tube and the hub. ISO 7864 specifies a tensile test method to confirm that this bond withstands defined loads without separation or failure.<\/p><p data-start=\"3864\" data-end=\"4178\">Using a calibrated tensile <strong data-start=\"3891\" data-end=\"3910\">Strength Tester<\/strong>, the needle is pulled axially at a controlled speed until separation occurs or a maximum force is reached. The recorded value reflects the bonding strength and indicates whether the selected adhesive or bonding process is suitable for the needle size and application.<\/p><p data-start=\"4180\" data-end=\"4324\">Reliable needle bond performance is essential for preventing accidental detachment during injection, which could cause serious safety incidents.<\/p>\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 class=\"elementor-element elementor-element-a4bf01b e-con-full e-flex e-con e-child\" data-id=\"a4bf01b\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-812ae93 elementor-widget__width-initial elementor-invisible elementor-widget elementor-widget-image\" data-id=\"812ae93\" data-element_type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInRight&quot;}\" 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\t<img decoding=\"async\" width=\"600\" height=\"600\" src=\"https:\/\/www.syringetest.com\/wp-content\/uploads\/2026\/01\/ISO-7864-Standard-Guide-for-Hypodermic-Needle-Testing.webp\" class=\"attachment-large size-large wp-image-737\" alt=\"\" srcset=\"https:\/\/www.syringetest.com\/wp-content\/uploads\/2026\/01\/ISO-7864-Standard-Guide-for-Hypodermic-Needle-Testing.webp 600w, https:\/\/www.syringetest.com\/wp-content\/uploads\/2026\/01\/ISO-7864-Standard-Guide-for-Hypodermic-Needle-Testing-300x300.webp 300w, https:\/\/www.syringetest.com\/wp-content\/uploads\/2026\/01\/ISO-7864-Standard-Guide-for-Hypodermic-Needle-Testing-150x150.webp 150w, https:\/\/www.syringetest.com\/wp-content\/uploads\/2026\/01\/ISO-7864-Standard-Guide-for-Hypodermic-Needle-Testing-12x12.webp 12w\" sizes=\"(max-width: 600px) 100vw, 600px\" \/>\t\t\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>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-41ab1d6 e-con-full e-flex e-con e-parent\" data-id=\"41ab1d6\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-48c60fb elementor-widget__width-inherit elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"48c60fb\" 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\">Selecci\u00f3n del equipo de prueba de jeringuillas adecuado<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-57384eb e-con-full e-flex elementor-invisible e-con e-child\" data-id=\"57384eb\" data-element_type=\"container\" data-settings=\"{&quot;animation&quot;:&quot;fadeInUp&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ffb5df1 eael-infobox-content-align--center eael-infobox-shape-square eael-infobox-hover-img-shape-square elementor-widget elementor-widget-eael-info-box\" data-id=\"ffb5df1\" data-element_type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;none&quot;}\" data-widget_type=\"eael-info-box.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t        <div class=\"eael-infobox icon-on-top\">\n\t            <div class=\"infobox-icon\">\n\n                            <img decoding=\"async\" src=\"https:\/\/www.syringetest.com\/wp-content\/uploads\/2025\/07\/ISO-7886-1-Annex-B-air-leakage-test-for-syringe.webp\" alt=\"ISO 7886-1 Anexo B ensayo de estanqueidad al aire para jeringa\">\n            \n            \n            \n        <\/div>\n            <div class=\"infobox-content\">\n                    <div class=\"infobox-title-section\">\n                <h3 class=\"title\">SLT-02 Comprobador de fugas en jeringas<\/h3>            <\/div>\n            <div><p data-start=\"0\" data-end=\"483\">Este instrumento aplica con precisi\u00f3n un vac\u00edo controlado a la jeringa, lo que permite una supervisi\u00f3n precisa de los cambios de presi\u00f3n y de la integridad del \u00e9mbolo. Dise\u00f1ado con conexiones compatibles con la norma ISO 80369-7 y mecanismos de sujeci\u00f3n seguros, el SLT-01 garantiza una evaluaci\u00f3n exhaustiva tanto de la estanqueidad del aire como de la retenci\u00f3n del tap\u00f3n del \u00e9mbolo.<\/p><p data-start=\"485\" data-end=\"945\">\u00a0<\/p><\/div>        <\/div>\n            <\/div>\n\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c042898 eael-infobox-content-align--center eael-infobox-shape-square eael-infobox-hover-img-shape-square elementor-widget elementor-widget-eael-info-box\" data-id=\"c042898\" data-element_type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;none&quot;}\" data-widget_type=\"eael-info-box.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t        <div class=\"eael-infobox icon-on-top\">\n\t            <div class=\"infobox-icon\">\n\n                            <img decoding=\"async\" src=\"https:\/\/www.syringetest.com\/wp-content\/uploads\/2025\/07\/ISO-7886-1-Annex-E-syringe-glide-force-tester.webp\" alt=\"Comprobador de la fuerza de deslizamiento de jeringas ISO 7886-1 Anexo E\">\n            \n            \n            \n        <\/div>\n            <div class=\"infobox-content\">\n                    <div class=\"infobox-title-section\">\n                <h2 class=\"title\">MST-01 Comprobador m\u00e9dico de jeringuillas<\/h2>            <\/div>\n            <div><p data-start=\"485\" data-end=\"945\">Utiliza un sistema mec\u00e1nico de alta precisi\u00f3n para medir las fuerzas de desprendimiento y deslizamiento durante la expulsi\u00f3n del fluido. El MST-01 permite a los fabricantes cuantificar la resistencia a la iniciaci\u00f3n y al desplazamiento, proporcionando datos esenciales para garantizar un movimiento suave y uniforme del \u00e9mbolo, lo que es fundamental para garantizar la seguridad y la comodidad.<\/p><p data-start=\"947\" data-end=\"1407\" data-is-last-node=\"\" data-is-only-node=\"\">\u00a0<\/p><\/div>        <\/div>\n            <\/div>\n\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a5ad445 eael-infobox-content-align--center eael-infobox-shape-square eael-infobox-hover-img-shape-square elementor-widget elementor-widget-eael-info-box\" data-id=\"a5ad445\" data-element_type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;none&quot;}\" data-widget_type=\"eael-info-box.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t        <div class=\"eael-infobox icon-on-top\">\n\t            <div class=\"infobox-icon\">\n\n                            <img decoding=\"async\" src=\"https:\/\/www.syringetest.com\/wp-content\/uploads\/2025\/07\/ISO-7886-1-Annex-D-liquid-leakage-at-syringe-plunger-stopper-under-compression.webp\" alt=\"ISO 7886-1 Anexo D fuga de l\u00edquido en el tap\u00f3n del \u00e9mbolo de la jeringa bajo compresi\u00f3n\">\n            \n            \n            \n        <\/div>\n            <div class=\"infobox-content\">\n                    <div class=\"infobox-title-section\">\n                <h2 class=\"title\">SPPT-01 Comprobador de estanqueidad de jeringas<\/h2>            <\/div>\n            <div><p>Este dispositivo simula la presi\u00f3n en el interior de la jeringa al tiempo que aplica cargas laterales y axiales al \u00e9mbolo, reproduciendo fielmente las condiciones de uso cl\u00ednico. El SSPT-01 est\u00e1 dise\u00f1ado para detectar incluso fallos sutiles de sellado, lo que ayuda a los fabricantes a verificar la fiabilidad del producto y el cumplimiento de las estrictas normas de seguridad.<\/p><\/div>        <\/div>\n            <\/div>\n\n\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<div class=\"elementor-element elementor-element-ad468be e-flex e-con-boxed e-con e-parent\" data-id=\"ad468be\" 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-edb7717 elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"edb7717\" 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\">Flow Rate Through the Needle Test<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5810d33 elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"5810d33\" 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 data-start=\"4369\" data-end=\"4614\">In addition to mechanical strength, ISO 7864 addresses functional performance through the <strong data-start=\"4459\" data-end=\"4496\">flow rate through the needle test<\/strong>. This evaluation confirms that the internal lumen allows fluids to pass at an expected rate under defined conditions.<\/p><p data-start=\"4616\" data-end=\"4869\">Flow rate results relate closely to inner diameter consistency, surface finish, and cleanliness. A stable and predictable flow rate ensures accurate dosing and smooth injection, particularly in applications involving viscous pharmaceutical formulations.<\/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-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\">Test Equipment and Automation Advantages<\/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 data-start=\"4921\" data-end=\"5328\">To meet ISO 7864 efficiently, laboratories increasingly rely on integrated testing platforms. A modern<a href=\"https:\/\/www.qualitester.com\/product\/medical-needle-puncture-tester\/\" target=\"_blank\" rel=\"noopener\"> <strong data-start=\"5024\" data-end=\"5068\">Needle Penetration and Drag Force Tester<\/strong><\/a> from <strong data-start=\"5074\" data-end=\"5094\">Instrumentos celulares<\/strong> combines penetration force measurement, drag force analysis, and flexible fixture design in a single system. Such solutions support standardized testing while allowing customization for specific needle types or customer requirements.<\/p><p data-start=\"5330\" data-end=\"5548\">Automation options further improve repeatability, reduce operator influence, and support high-throughput testing environments. These advantages align well with ISO 7864 objectives and modern quality management systems.<\/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<div class=\"elementor-element elementor-element-88a448a e-flex e-con-boxed e-con e-parent\" data-id=\"88a448a\" 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-6e2733d elementor-widget elementor-widget-text-editor\" data-id=\"6e2733d\" 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 data-start=\"5570\" data-end=\"5981\"><strong data-start=\"5570\" data-end=\"5582\">ISO 7864<\/strong> establishes a comprehensive technical foundation for evaluating sterile hypodermic needles. Through structured hypodermic needle testing, including needle penetration test procedures, penetration force analysis, Needle Bond strength verification, fragmentation test for medical needles, and flow rate through the needle test, manufacturers can ensure safety, performance, and regulatory compliance.<\/p><p data-start=\"5983\" data-end=\"6242\" data-is-last-node=\"\" data-is-only-node=\"\">By adopting advanced testing solutions such as the <a href=\"https:\/\/www.qualitester.com\/\" target=\"_blank\" rel=\"noopener\">Instrumentos celulares<\/a> Needle Penetration and Drag Force Tester, organizations can improve data reliability, streamline quality control, and confidently meet ISO 7864 requirements across the full product lifecycle.<\/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<\/div>","protected":false},"excerpt":{"rendered":"<p>ISO 7864 and Quality Control of Hypodermic Needles ISO 7864 is the core international standard governing sterile hypodermic needles for single use. It defines both performance requirements and verified test methods to ensure safety, consistency, and functionality in clinical use. From a quality and regulatory perspective, ISO 7864 connects product design, material selection, and mechanical [&hellip;]<\/p>","protected":false},"author":4,"featured_media":0,"parent":603,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"footnotes":""},"class_list":["post-734","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>ISO 7864 Standard Guide for Hypodermic Needle Testing<\/title>\n<meta name=\"description\" content=\"This article explains ISO 7864 requirements for sterile hypodermic needles, covering hypodermic needle testing, penetration force, bonding strength, and compliant test methods.\" \/>\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.syringetest.com\/es\/standards\/iso-7864\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"ISO 7864 Standard Guide for Hypodermic Needle Testing\" \/>\n<meta property=\"og:description\" content=\"This article explains ISO 7864 requirements for sterile hypodermic needles, covering hypodermic needle testing, penetration force, bonding strength, and compliant test methods.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.syringetest.com\/es\/standards\/iso-7864\/\" \/>\n<meta property=\"og:site_name\" content=\"Syringe and Needle Testing\" \/>\n<meta property=\"article:modified_time\" content=\"2026-01-15T01:06:56+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.syringetest.com\/wp-content\/uploads\/2026\/01\/ISO-7864-Annex-D.png\" \/>\n\t<meta property=\"og:image:width\" content=\"284\" \/>\n\t<meta property=\"og:image:height\" content=\"457\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Tiempo de lectura\" \/>\n\t<meta name=\"twitter:data1\" content=\"6 minutos\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.syringetest.com\/standards\/iso-7864\",\"url\":\"https:\/\/www.syringetest.com\/standards\/iso-7864\",\"name\":\"ISO 7864 Standard Guide for Hypodermic Needle Testing\",\"isPartOf\":{\"@id\":\"https:\/\/www.syringetest.com\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\/\/www.syringetest.com\/standards\/iso-7864#primaryimage\"},\"image\":{\"@id\":\"https:\/\/www.syringetest.com\/standards\/iso-7864#primaryimage\"},\"thumbnailUrl\":\"https:\/\/www.syringetest.com\/wp-content\/uploads\/2026\/01\/ISO-7864-Annex-D.png\",\"datePublished\":\"2026-01-15T00:43:19+00:00\",\"dateModified\":\"2026-01-15T01:06:56+00:00\",\"description\":\"This article explains ISO 7864 requirements for sterile hypodermic needles, covering hypodermic needle testing, penetration force, bonding strength, and compliant test methods.\",\"breadcrumb\":{\"@id\":\"https:\/\/www.syringetest.com\/standards\/iso-7864#breadcrumb\"},\"inLanguage\":\"es\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/www.syringetest.com\/standards\/iso-7864\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"es\",\"@id\":\"https:\/\/www.syringetest.com\/standards\/iso-7864#primaryimage\",\"url\":\"https:\/\/www.syringetest.com\/wp-content\/uploads\/2026\/01\/ISO-7864-Annex-D.png\",\"contentUrl\":\"https:\/\/www.syringetest.com\/wp-content\/uploads\/2026\/01\/ISO-7864-Annex-D.png\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/www.syringetest.com\/standards\/iso-7864#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\/\/www.syringetest.com\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Standards\",\"item\":\"https:\/\/www.syringetest.com\/standards\"},{\"@type\":\"ListItem\",\"position\":3,\"name\":\"ISO 7864\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/www.syringetest.com\/#website\",\"url\":\"https:\/\/www.syringetest.com\/\",\"name\":\"Syringe and Needle Testing\",\"description\":\"Syringe and Needle Test Solutions\",\"publisher\":{\"@id\":\"https:\/\/www.syringetest.com\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/www.syringetest.com\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"es\"},{\"@type\":\"Organization\",\"@id\":\"https:\/\/www.syringetest.com\/#organization\",\"name\":\"Syringe and Needle Testing\",\"url\":\"https:\/\/www.syringetest.com\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"es\",\"@id\":\"https:\/\/www.syringetest.com\/#\/schema\/logo\/image\/\",\"url\":\"https:\/\/www.syringetest.com\/wp-content\/uploads\/2025\/04\/syringetest.webp\",\"contentUrl\":\"https:\/\/www.syringetest.com\/wp-content\/uploads\/2025\/04\/syringetest.webp\",\"width\":512,\"height\":512,\"caption\":\"Syringe and Needle Testing\"},\"image\":{\"@id\":\"https:\/\/www.syringetest.com\/#\/schema\/logo\/image\/\"}}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"ISO 7864 Standard Guide for Hypodermic Needle Testing","description":"This article explains ISO 7864 requirements for sterile hypodermic needles, covering hypodermic needle testing, penetration force, bonding strength, and compliant test methods.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.syringetest.com\/es\/standards\/iso-7864\/","og_locale":"es_ES","og_type":"article","og_title":"ISO 7864 Standard Guide for Hypodermic Needle Testing","og_description":"This article explains ISO 7864 requirements for sterile hypodermic needles, covering hypodermic needle testing, penetration force, bonding strength, and compliant test methods.","og_url":"https:\/\/www.syringetest.com\/es\/standards\/iso-7864\/","og_site_name":"Syringe and Needle Testing","article_modified_time":"2026-01-15T01:06:56+00:00","og_image":[{"width":284,"height":457,"url":"https:\/\/www.syringetest.com\/wp-content\/uploads\/2026\/01\/ISO-7864-Annex-D.png","type":"image\/png"}],"twitter_card":"summary_large_image","twitter_misc":{"Tiempo de lectura":"6 minutos"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/www.syringetest.com\/standards\/iso-7864","url":"https:\/\/www.syringetest.com\/standards\/iso-7864","name":"ISO 7864 Standard Guide for Hypodermic Needle Testing","isPartOf":{"@id":"https:\/\/www.syringetest.com\/#website"},"primaryImageOfPage":{"@id":"https:\/\/www.syringetest.com\/standards\/iso-7864#primaryimage"},"image":{"@id":"https:\/\/www.syringetest.com\/standards\/iso-7864#primaryimage"},"thumbnailUrl":"https:\/\/www.syringetest.com\/wp-content\/uploads\/2026\/01\/ISO-7864-Annex-D.png","datePublished":"2026-01-15T00:43:19+00:00","dateModified":"2026-01-15T01:06:56+00:00","description":"This article explains ISO 7864 requirements for sterile hypodermic needles, covering hypodermic needle testing, penetration force, bonding strength, and compliant test methods.","breadcrumb":{"@id":"https:\/\/www.syringetest.com\/standards\/iso-7864#breadcrumb"},"inLanguage":"es","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.syringetest.com\/standards\/iso-7864"]}]},{"@type":"ImageObject","inLanguage":"es","@id":"https:\/\/www.syringetest.com\/standards\/iso-7864#primaryimage","url":"https:\/\/www.syringetest.com\/wp-content\/uploads\/2026\/01\/ISO-7864-Annex-D.png","contentUrl":"https:\/\/www.syringetest.com\/wp-content\/uploads\/2026\/01\/ISO-7864-Annex-D.png"},{"@type":"BreadcrumbList","@id":"https:\/\/www.syringetest.com\/standards\/iso-7864#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/www.syringetest.com\/"},{"@type":"ListItem","position":2,"name":"Standards","item":"https:\/\/www.syringetest.com\/standards"},{"@type":"ListItem","position":3,"name":"ISO 7864"}]},{"@type":"WebSite","@id":"https:\/\/www.syringetest.com\/#website","url":"https:\/\/www.syringetest.com\/","name":"Syringe and Needle Testing","description":"Syringe and Needle Test Solutions","publisher":{"@id":"https:\/\/www.syringetest.com\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.syringetest.com\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"es"},{"@type":"Organization","@id":"https:\/\/www.syringetest.com\/#organization","name":"Syringe and Needle Testing","url":"https:\/\/www.syringetest.com\/","logo":{"@type":"ImageObject","inLanguage":"es","@id":"https:\/\/www.syringetest.com\/#\/schema\/logo\/image\/","url":"https:\/\/www.syringetest.com\/wp-content\/uploads\/2025\/04\/syringetest.webp","contentUrl":"https:\/\/www.syringetest.com\/wp-content\/uploads\/2025\/04\/syringetest.webp","width":512,"height":512,"caption":"Syringe and Needle Testing"},"image":{"@id":"https:\/\/www.syringetest.com\/#\/schema\/logo\/image\/"}}]}},"_links":{"self":[{"href":"https:\/\/www.syringetest.com\/es\/wp-json\/wp\/v2\/pages\/734","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.syringetest.com\/es\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.syringetest.com\/es\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.syringetest.com\/es\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/www.syringetest.com\/es\/wp-json\/wp\/v2\/comments?post=734"}],"version-history":[{"count":4,"href":"https:\/\/www.syringetest.com\/es\/wp-json\/wp\/v2\/pages\/734\/revisions"}],"predecessor-version":[{"id":740,"href":"https:\/\/www.syringetest.com\/es\/wp-json\/wp\/v2\/pages\/734\/revisions\/740"}],"up":[{"embeddable":true,"href":"https:\/\/www.syringetest.com\/es\/wp-json\/wp\/v2\/pages\/603"}],"wp:attachment":[{"href":"https:\/\/www.syringetest.com\/es\/wp-json\/wp\/v2\/media?parent=734"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}