{"id":9833,"date":"2026-02-24T15:11:44","date_gmt":"2026-02-24T07:11:44","guid":{"rendered":"https:\/\/www.packqc.com\/standard\/iso-7864\/"},"modified":"2026-04-16T09:54:22","modified_gmt":"2026-04-16T01:54:22","slug":"iso-7864","status":"publish","type":"standard","link":"https:\/\/www.packqc.com\/nn\/standard\/iso-7864\/","title":{"rendered":"ISO 7864"},"content":{"rendered":"<h2 class=\"wp-block-heading\">ISO 7864 for Sterile Hypodermic Needle Test<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\"><strong data-start=\"1102\" data-end=\"1114\">ISO 7864<\/strong>, titled <em data-start=\"1123\" data-end=\"1200\">&#8220;Sterile hypodermic needles for single use \u2014 Requirements and test methods&#8221;<\/em>, defines key mechanical and performance criteria for hypodermic needles. The standard ensures that each needle demonstrates sufficient sharpness, structural integrity, and reliable bonding between the <strong data-start=\"1402\" data-end=\"1425\">needle tube and hub<\/strong>. It also prescribes detailed procedures for both <strong data-start=\"1475\" data-end=\"1504\">penetration force testing<\/strong> and <strong data-start=\"1509\" data-end=\"1534\">bond strength testing<\/strong>, which are essential quality metrics in sterile needle manufacturing.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Needle Penetration Force Test<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">The <strong data-start=\"1671\" data-end=\"1698\">needle penetration test<\/strong> measures how much force is required to insert a needle into a specified substrate at a consistent rate. According to <strong>ISO 7864 Annex D<\/strong>:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>A <strong data-start=\"1839\" data-end=\"1870\">force measurement apparatus<\/strong> (e.g., a load cell-based tester) is used.<\/li>\n\n\n\n<li>The test speed is typically <strong data-start=\"1943\" data-end=\"1957\">100 mm\/min<\/strong>.<\/li>\n\n\n\n<li>Needles must penetrate up to <strong data-start=\"1990\" data-end=\"2021\">80% of their nominal length<\/strong>.<\/li>\n\n\n\n<li>Substrates like natural latex rubber or polyurethane simulate human skin.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Two critical parameters are captured:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong data-start=\"2140\" data-end=\"2166\">Peak Penetration Force<\/strong>: The maximum force required for the needle to pierce the substrate.<\/li>\n\n\n\n<li><strong data-start=\"2237\" data-end=\"2251\">Drag Force<\/strong>: The average frictional resistance during the insertion.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Cell Instruments offers a <strong data-start=\"2513\" data-end=\"2551\">precision penetration force tester<\/strong>, ideal for conducting the <strong data-start=\"2578\" data-end=\"2605\">needle penetration test<\/strong>. Its high-resolution sensors and programmable speed control ensure full compliance with ISO 7864.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Needle Bonding Strength Test<br>&#8211;<small>Between Needle Tube and Hub<\/small><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Annex E<\/strong> of ISO 7864 focuses on the <strong data-start=\"2807\" data-end=\"2839\">needle bonding strength test<\/strong>, which ensures that the bond between the <strong data-start=\"2881\" data-end=\"2904\">needle tube and hub<\/strong> can withstand mechanical stress without detaching.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The procedure includes:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Mounting the needle vertically in a <strong data-start=\"3019\" data-end=\"3047\">universal tensile tester<\/strong>.<\/li>\n\n\n\n<li>Using specialized grips to avoid slippage or deformation.<\/li>\n\n\n\n<li>Applying tensile force at <strong data-start=\"3137\" data-end=\"3150\">50 mm\/min<\/strong> until the bond fails.<\/li>\n\n\n\n<li>Recording the <strong data-start=\"3189\" data-end=\"3214\">maximum tensile force<\/strong> at which failure occurs.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">This test validates the mechanical integrity of the <strong data-start=\"3293\" data-end=\"3318\">needle bonding system<\/strong>, a key requirement to prevent medical mishaps during injections or fluid transfer.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The <strong data-start=\"3436\" data-end=\"3477\">Cell Instruments Bond Strength Tester<\/strong> supports ISO 7864-compliant tensile tests with customizable fixtures for different needle types.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Applications Across Industries<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">The ISO 7864 needle test methods aren\u2019t limited to just medical syringe manufacturers. They also apply to:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong data-start=\"4658\" data-end=\"4686\">Pharmaceutical companies<\/strong> developing injection-based drug delivery systems.<\/li>\n\n\n\n<li><strong data-start=\"4739\" data-end=\"4766\">Packaging manufacturers<\/strong> producing prefilled syringe kits.<\/li>\n\n\n\n<li><strong data-start=\"4803\" data-end=\"4834\">Quality inspection agencies<\/strong> conducting regulatory testing.<\/li>\n\n\n\n<li><strong data-start=\"4868\" data-end=\"4880\">R&amp;D labs<\/strong> studying material compatibility and performance.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Cell Instruments\u2019 equipment is used globally in <strong data-start=\"4981\" data-end=\"5030\">medical, pharmaceutical, adhesives, packaging<\/strong>, and <strong data-start=\"5036\" data-end=\"5063\">quality control sectors<\/strong>, reinforcing our reputation for technical excellence.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Choosing the Right Test Equipment for ISO 7864<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Testing accuracy hinges on using the correct instruments. When selecting <a href=\"https:\/\/www.packqc.com\/nn\/product\/needle-penetration-test-equipment-iso-7864\/\"><strong data-start=\"3777\" data-end=\"3814\">needle penetration test equipment<\/strong><\/a> or a <strong data-start=\"3820\" data-end=\"3844\">bond strength tester<\/strong>, consider the following:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong data-start=\"3873\" data-end=\"3895\">Load Cell Accuracy<\/strong>: Ensure it aligns with the required force range (up to 500 N for bonding tests).<\/li>\n\n\n\n<li><strong data-start=\"3979\" data-end=\"3996\">Speed Control<\/strong>: ISO 7864 mandates exact speeds (e.g., 50 mm\/min, 100 mm\/min).<\/li>\n\n\n\n<li><strong data-start=\"4062\" data-end=\"4084\">Substrate Handling<\/strong>: The substrate holder should provide consistent clamping and penetration area.<\/li>\n\n\n\n<li><strong data-start=\"4166\" data-end=\"4190\">Software Integration<\/strong>: Data collection and analysis features enhance testing transparency and reproducibility.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong data-start=\"4281\" data-end=\"4301\">Cell Instruments<\/strong> specializes in tailor-made testing systems for medical devices, including sterile hypodermic needles. Our automation and customization services allow you to align with ISO 7864 precisely and efficiently.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Frequently Asked Questions<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">1. What is the purpose of the needle penetration test?<br>The needle penetration test measures the force needed for a hypodermic needle to pierce a standard substrate, simulating skin penetration to assess sharpness and ease of use.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">2. How does ISO 7864 define acceptable bonding strength?<br>ISO 7864 specifies minimum bonding force requirements between the needle tube and hub based on needle size. The test ensures that the connection won\u2019t fail during use.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">3. What substrate is used in needle penetration testing?<br>Common substrates include natural latex rubber, polyurethane, silicone rubber, or polyethylene films, all validated for test consistency.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">4. Why should each penetration test use a new substrate site?<br>Reusing substrate sites can affect test accuracy due to deformation or wear, leading to unreliable force measurements.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Contact Us Get ISO 7864 Testing Solution <\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Compliance with <strong data-start=\"5156\" data-end=\"5168\"><a href=\"https:\/\/www.iso.org\/standard\/60481.html\" target=\"_blank\" rel=\"noreferrer noopener nofollow\">ISO 7864<\/a><\/strong> is non-negotiable for any manufacturer of sterile hypodermic needles. Understanding the <strong data-start=\"5257\" data-end=\"5284\">needle penetration test<\/strong>, <strong data-start=\"5286\" data-end=\"5312\">penetration force test<\/strong>, and <strong data-start=\"5318\" data-end=\"5350\">needle bonding strength test<\/strong> ensures that needles meet required safety and performance standards. With advanced, standards-aligned equipment from <strong data-start=\"5468\" data-end=\"5488\">Cell Instruments<\/strong>, testing becomes more precise, reliable, and efficient\u2014helping you deliver products that meet both regulatory and patient expectations.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>","protected":false},"excerpt":{"rendered":"<p>ISO 7864 for Sterile Hypodermic Needle Test ISO 7864, titled &#8220;Sterile hypodermic needles for single use \u2014 Requirements and test methods&#8221;, defines key mechanical and performance criteria for hypodermic needles. The standard ensures that each needle demonstrates sufficient sharpness, structural integrity, and reliable bonding between the needle tube and hub. It also prescribes detailed procedures [&hellip;]<\/p>","protected":false},"featured_media":5505,"parent":0,"template":"","meta":{"_acf_changed":true,"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":""}}},"standard-category":[612],"class_list":["post-9833","standard","type-standard","status-publish","has-post-thumbnail","hentry","standard-category-iso"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.packqc.com\/nn\/wp-json\/wp\/v2\/standard\/9833","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.packqc.com\/nn\/wp-json\/wp\/v2\/standard"}],"about":[{"href":"https:\/\/www.packqc.com\/nn\/wp-json\/wp\/v2\/types\/standard"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.packqc.com\/nn\/wp-json\/wp\/v2\/media\/5505"}],"wp:attachment":[{"href":"https:\/\/www.packqc.com\/nn\/wp-json\/wp\/v2\/media?parent=9833"}],"wp:term":[{"taxonomy":"standard-category","embeddable":true,"href":"https:\/\/www.packqc.com\/nn\/wp-json\/wp\/v2\/standard-category?post=9833"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}