{"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\/uk\/needle-tubing-breakage-resistance-test","title":{"rendered":"\u0412\u0438\u043f\u0440\u043e\u0431\u0443\u0432\u0430\u043d\u043d\u044f \u043d\u0430 \u0441\u0442\u0456\u0439\u043a\u0456\u0441\u0442\u044c \u0434\u043e \u0440\u043e\u0437\u0440\u0438\u0432\u0443 \u0433\u043e\u043b\u0447\u0430\u0441\u0442\u0438\u0445 \u0442\u0440\u0443\u0431\u043e\u043a"},"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\">\u0412\u0438\u043f\u0440\u043e\u0431\u0443\u0432\u0430\u043d\u043d\u044f \u043d\u0430 \u0441\u0442\u0456\u0439\u043a\u0456\u0441\u0442\u044c \u0434\u043e \u0440\u043e\u0437\u0440\u0438\u0432\u0443 \u0433\u043e\u043b\u0447\u0430\u0441\u0442\u0438\u0445 \u0442\u0440\u0443\u0431\u043e\u043a<\/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>\u0420\u043e\u0437\u0443\u043c\u0456\u043d\u043d\u044f <strong>needle tubing breakage resistance<\/strong> 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 industries, mastering this test is not only vital for compliance but also for patient safety.<\/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\">Importance of Needle Tubing Breakage Resistance<\/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>Needle tubing must be resilient, especially during repeated handling, bending, and insertion into soft or hard tissues. If the tubing fractures, it could cause serious harm to the patient and pose legal and regulatory risks for the manufacturer. That\u2019s why the <strong>needle tubing breakage resistance<\/strong> test is essential \u2014 it simulates real-world mechanical stress and evaluates whether the tubing maintains its structural integrity after cyclic bending.<\/p><p><strong>Syringetest.com<\/strong> supports this critical need by providing accurate and repeatable testing systems to help medical device manufacturers meet international standards efficiently.<\/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\">Understanding ISO 9626 and ISO 9626 Annex 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\/uk\/standards\/iso-9626\/\">ISO 9626<\/a> is the international standard specifying the mechanical properties of stainless-steel needle tubing used in the manufacture of medical devices. <strong>Annex C of ISO 9626<\/strong> outlines a <strong>normative method<\/strong> for testing the tubing&#8217;s resistance to breakage under repeated bending stress.<\/p><p>\u0417\u0430 \u0434\u0430\u043d\u0438\u043c\u0438 <strong>Annex C<\/strong>, the tubing must be bent cyclically to simulate mechanical fatigue, and then visually inspected for any signs of fracture. The outcome determines whether the tubing meets the minimum performance requirements necessary for safe medical use.<\/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\">Test Method for Needle Tubing Breakage Resistance<\/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>The breakage resistance test involves precise procedures, which ensure repeatability and compliance. Here\u2019s a breakdown of the method, as referenced in <strong>ISO 9626 Annex 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\tApparatus Requirements\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\t\u041f\u0440\u043e\u0446\u0435\u0434\u0443\u0440\u0430 \u0442\u0435\u0441\u0442\u0443\u0432\u0430\u043d\u043d\u044f\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\tReporting and Documentation Requirements\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>To conduct the test effectively, the following equipment is necessary:<\/p><ul><li><strong>Tubing Fixation Device:<\/strong> To hold one end of the tubing rigidly in place.<\/li><li><strong>Force Application Device:<\/strong> Capable of bending the tubing up to 25\u00b0 depending on wall thickness.<\/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>Secure the Tubing:<\/strong> One end of the needle tubing is rigidly fixed to the support.<\/li><li><strong>Apply Bending Force:<\/strong> At a specified distance from the fixed point, bend the tubing in one direction through a defined angle:<ul><li><em>(25 \u00b11)\u00b0<\/em> for regular-walled<\/li><li><em>(20 \u00b11)\u00b0<\/em> for thin-walled<\/li><li><em>(15 \u00b11)\u00b0<\/em> for extra-thin and ultra-thin-walled tubing<\/li><\/ul><\/li><li><strong>Reverse the Force:<\/strong> Bend the tubing in the opposite direction through the same angle.<\/li><li><strong>Repeat the Cycle:<\/strong> Conduct <strong>20 full cycles<\/strong> of reversal at a rate of <strong>0.5 Hz<\/strong>.<\/li><li><strong>Visual Inspection:<\/strong> After cycling, check the tubing for visible signs of <strong>breakage<\/strong> or cracking.<\/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>\u041f\u043e\u0432\u043d\u0438\u0439 \u0437\u0432\u0456\u0442 \u043f\u0440\u043e \u0432\u0438\u043f\u0440\u043e\u0431\u0443\u0432\u0430\u043d\u043d\u044f \u043f\u043e\u0432\u0438\u043d\u0435\u043d \u043c\u0456\u0441\u0442\u0438\u0442\u0438:<\/p><ul><li><strong>\u0420\u043e\u0437\u043c\u0456\u0440 \u0442\u0430 \u0456\u0434\u0435\u043d\u0442\u0438\u0444\u0456\u043a\u0430\u0446\u0456\u044f \u041d\u041a\u0422<\/strong><\/li><li><strong>Wall type classification<\/strong> (regular, thin, extra-thin, ultra-thin)<\/li><li><strong>Visual results<\/strong> of breakage<\/li><li><strong>Testing date<\/strong><\/li><li><strong>Stainless steel alloy type<\/strong> as specified in Clause 4 of ISO 9626<\/li><\/ul><p>Accurate documentation ensures traceability and facilitates audits or certification processes, which are essential for companies aiming to export or meet stringent regulatory standards.<\/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\">\u0427\u043e\u043c\u0443 \u043c\u0438 \u043e\u0431\u0438\u0440\u0430\u0454\u043c\u043e <b>Syringetest.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>\u0417\u0430 \u0430\u0434\u0440\u0435\u0441\u043e\u044e <strong>Syringetest.com<\/strong>, we specialize in designing high-precision, <strong>automated testing systems<\/strong> that comply with ISO standards, including <strong>ISO 9626 Annex C<\/strong>. Our equipment is widely used in medical device quality control, ensuring consistent test results with minimal human error. Furthermore, we offer <strong>customizable solutions<\/strong> for unique tubing dimensions or wall types and provide <strong>\u043f\u043e\u0441\u043b\u0443\u0433\u0438 \u0437 \u0442\u0440\u0430\u043d\u0441\u0444\u043e\u0440\u043c\u0430\u0446\u0456\u0457 \u0430\u0432\u0442\u043e\u043c\u0430\u0442\u0438\u0437\u0430\u0446\u0456\u0457<\/strong> to integrate this test into production lines seamlessly.<\/p><p>Whether you\u2019re in the pharmaceutical, medical device, or quality inspection sector, our instruments help you maintain compliance while improving operational efficiency.<\/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\">\u0417\u0432'\u044f\u0436\u0456\u0442\u044c\u0441\u044f \u0437 \u043d\u0430\u043c\u0438<\/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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