{"id":6661,"date":"2025-05-12T11:00:20","date_gmt":"2025-05-12T03:00:20","guid":{"rendered":"https:\/\/www.qualitester.com\/?page_id=6661"},"modified":"2025-05-12T11:27:11","modified_gmt":"2025-05-12T03:27:11","slug":"iso-9626","status":"publish","type":"page","link":"https:\/\/www.qualitester.com\/nb\/standards\/iso-9626\/","title":{"rendered":"ISO 9626"},"content":{"rendered":"<h1 style=\"text-align: center;\" data-start=\"553\" data-end=\"1074\">ISO 9626<br \/>\n<small>Syringe Needle Tubing Test<\/small><\/h1>\n<p class=\"\" data-start=\"553\" data-end=\"1074\"><a href=\"https:\/\/www.qualitester.com\/nb\/standards\/iso-9626\/\"><em data-start=\"553\" data-end=\"563\">ISO 9626<\/em><\/a> defines the international standard for <strong data-start=\"603\" data-end=\"636\">stainless steel needle tubing<\/strong> used in the manufacture of medical devices such as hypodermic needles. Developed to ensure safety, consistency, and performance, ISO 9626 provides rigorous specifications for tubing dimensions and mechanical properties ranging from 3.4 mm (10 Gauge) to 0.18 mm (34 Gauge). It applies strictly to <em data-start=\"933\" data-end=\"940\">rigid<\/em> stainless steel tubing\u2014excluding flexible variants\u2014making it essential for syringe needle manufacturers and medical device producers.<\/p>\n<p class=\"\" data-start=\"1076\" data-end=\"1420\">For quality control professionals and medical device manufacturers, understanding ISO 9626 is crucial. This standard not only governs the design of medical tubing but also prescribes specific tests such as the <strong data-start=\"1286\" data-end=\"1316\">syringe needle tubing test<\/strong>, <strong data-start=\"1318\" data-end=\"1343\">needle stiffness test<\/strong>, <strong data-start=\"1345\" data-end=\"1377\">tubing break resistance test<\/strong>, og <strong data-start=\"1383\" data-end=\"1419\">needle corrosion resistance test<\/strong>.<\/p>\n<p class=\"\" data-start=\"1422\" data-end=\"1601\">Let\u2019s explore the key testing methods required by ISO 9626 and how manufacturers can ensure compliance using specialized equipment like Cell Instruments&#8217; <strong data-start=\"1576\" data-end=\"1585\">TS-01<\/strong> og <strong data-start=\"1590\" data-end=\"1600\">NTT-01<\/strong>.<\/p>\n<hr class=\"\" data-start=\"1603\" data-end=\"1606\" \/>\n<h2 data-start=\"1608\" data-end=\"1666\">Syringe Needle Tubing Test Requirements Under ISO 9626<\/h2>\n<p class=\"\" data-start=\"1668\" data-end=\"1815\">To ensure a stainless steel needle tube meets this standard, manufacturers must evaluate it against several critical performance metrics. These include:<\/p>\n<ul>\n<li data-start=\"1819\" data-end=\"1843\"><strong data-start=\"1819\" data-end=\"1843\">Dimensional accuracy<\/strong><\/li>\n<li data-start=\"1846\" data-end=\"1892\"><strong data-start=\"1846\" data-end=\"1873\">Wall thickness category<\/strong> (RW, TW, ETW, UTW)<\/li>\n<li data-start=\"1895\" data-end=\"1930\"><strong data-start=\"1895\" data-end=\"1930\">Material strength and integrity<\/strong><\/li>\n<li data-start=\"1933\" data-end=\"1976\"><strong data-start=\"1933\" data-end=\"1976\">Resistance to deformation and corrosion<\/strong><\/li>\n<\/ul>\n<p class=\"\" data-start=\"1978\" data-end=\"2143\">Each metric is associated with standardized testing procedures to ensure tubing quality throughout production and prior to use in syringes and other medical devices.<\/p>\n<h3 data-start=\"2150\" data-end=\"2194\"><strong data-start=\"2150\" data-end=\"2194\">1. Needle Stiffness Test &#8211; ISO 9626 Annex B<\/strong><\/h3>\n<p class=\"\" data-start=\"2196\" data-end=\"2468\">Den <strong data-start=\"2200\" data-end=\"2225\">needle stiffness test<\/strong> evaluates the tubing\u2019s ability to resist deflection under an applied force. According to Annex B of this standard, a plunger applies up to 60 N force to the center of a needle tube supported at both ends. The deflection is then precisely measured.<\/p>\n<p class=\"\" data-start=\"2470\" data-end=\"2595\">This test ensures the tubing retains structural integrity during insertion into the human body without bending or buckling.<\/p>\n<p class=\"\" data-start=\"2597\" data-end=\"2779\"><strong data-start=\"2597\" data-end=\"2654\">Recommended Instrument: <a href=\"https:\/\/www.qualitester.com\/nb\/produkt-2\/medical-needle-tubing-stiffness-tester\/\" target=\"_blank\" rel=\"noopener\">TS-01 Tubing Stiffness Tester<\/a><\/strong><br data-start=\"2654\" data-end=\"2657\" \/>Cell Instruments\u2019 <strong data-start=\"2675\" data-end=\"2684\">TS-01<\/strong> is specifically designed for stiffness testing in compliance with ISO 9626 Annex B. It offers:<\/p>\n<ul>\n<li data-start=\"2783\" data-end=\"2807\">\u00b10.01 N force accuracy<\/li>\n<li data-start=\"2810\" data-end=\"2853\">0.01 mm deflection measurement resolution<\/li>\n<li data-start=\"2856\" data-end=\"2893\">Variable test speeds (1\u2013500 mm\/min)<\/li>\n<li data-start=\"2896\" data-end=\"2930\">7-inch HMI touchscreen operation<\/li>\n<li data-start=\"2933\" data-end=\"2973\">Automatic return and overload protection<\/li>\n<\/ul>\n<p class=\"\" data-start=\"2975\" data-end=\"3083\">With the <strong data-start=\"2984\" data-end=\"2993\">TS-01<\/strong>, quality control teams can confidently evaluate the mechanical rigidity of needle tubing.<\/p>\n<h3 data-start=\"3090\" data-end=\"3141\">2. Tubing Break Resistance Test &#8211; ISO 9626 Annex C<\/h3>\n<p class=\"\" data-start=\"3143\" data-end=\"3433\">ISO 9626 Annex C defines the <strong data-start=\"3172\" data-end=\"3204\">tubing break resistance test<\/strong>, which assesses the fatigue performance of the tubing through repeated bending cycles. The tubing is fixed at one end and bent to specified angles (25\u00b0, 20\u00b0, or 15\u00b0, depending on wall thickness) for 20 complete cycles at 0.5 Hz.<\/p>\n<p class=\"\" data-start=\"3435\" data-end=\"3542\">This test simulates clinical use and ensures that the tubing can withstand repeated stress without failure.<\/p>\n<p class=\"\" data-start=\"3544\" data-end=\"3746\"><strong data-start=\"3544\" data-end=\"3600\">Recommended Instrument: <a href=\"https:\/\/www.qualitester.com\/nb\/produkt-2\/syringe-needle-break-resistance-testing\/\" target=\"_blank\" rel=\"noopener\">NTT-01 Syringe Needle Break Resistance Tester<\/a><\/strong><br data-start=\"3600\" data-end=\"3603\" \/>Cell Instruments\u2019 <strong data-start=\"3621\" data-end=\"3631\">NTT-01<\/strong> is tailored to execute tubing break resistance testing under the exact parameters of ISO 9626 Annex C. It ensures:<\/p>\n<ul>\n<li>Accurate control of angular displacement<\/li>\n<li>Adjustable force application<\/li>\n<li>Consistent cycling rate for fatigue evaluation<\/li>\n<\/ul>\n<p class=\"\" data-start=\"3878\" data-end=\"3985\">Ved hjelp av <strong data-start=\"3888\" data-end=\"3898\">NTT-01<\/strong> helps manufacturers avoid tubing breakage issues that could compromise patient safety.<\/p>\n<hr class=\"\" data-start=\"3987\" data-end=\"3990\" \/>\n<h3 data-start=\"3992\" data-end=\"4047\">3. Needle Corrosion Resistance Test &#8211; ISO 9626 Annex D<\/h3>\n<p class=\"\" data-start=\"4049\" data-end=\"4339\">Den <strong data-start=\"4053\" data-end=\"4089\">needle corrosion resistance test<\/strong> measures the tubing\u2019s ability to withstand chemical exposure. As per ISO 9626 Annex D, the tubing is partially immersed in a 0.5 mol\/L sodium chloride solution for seven hours at 23\u202f\u00b0C. After immersion, the tubing is inspected for visible corrosion.<\/p>\n<p class=\"\" data-start=\"4341\" data-end=\"4451\">This test is vital for confirming the biocompatibility and long-term durability of the stainless steel needle.<\/p>\n<p class=\"\" data-start=\"4453\" data-end=\"4622\">To support this procedure, Cell Instruments offers corrosion resistance testing setups compatible with ISO 3696 water standards and appropriate reagent handling systems.<\/p>\n<hr class=\"\" data-start=\"4624\" data-end=\"4627\" \/>\n<h2 data-start=\"4629\" data-end=\"4668\">Benefits of Complying with ISO 9626<\/h2>\n<p class=\"\" data-start=\"4670\" data-end=\"4730\">Compliance with this standard ensures that syringe needle tubing:<\/p>\n<ul>\n<li data-start=\"4734\" data-end=\"4772\">Meets international safety standards<\/li>\n<li data-start=\"4775\" data-end=\"4830\">Minimizes the risk of bending, breakage, or corrosion<\/li>\n<li data-start=\"4833\" data-end=\"4882\">Enhances patient comfort and device reliability<\/li>\n<li data-start=\"4885\" data-end=\"4919\">Streamlines regulatory approvals<\/li>\n<\/ul>\n<p class=\"\" data-start=\"4921\" data-end=\"5071\">Additionally, adherence to ISO 9626 helps build trust with healthcare professionals and end-users while reducing product recalls or clinical failures.<\/p>\n<hr class=\"\" data-start=\"5073\" data-end=\"5076\" \/>\n<h2 data-start=\"5078\" data-end=\"5138\">Partnering with Cell Instruments for ISO 9626 Compliance<\/h2>\n<p class=\"\" data-start=\"5140\" data-end=\"5408\">Cell Instruments is a trusted manufacturer of advanced <strong data-start=\"5195\" data-end=\"5228\">needle tubing testing systems<\/strong>. We offer high-performance equipment tailored to meet this standard\u00a0testing requirements for syringe needle tubing, including stiffness, break resistance, and corrosion resistance.<\/p>\n<p class=\"\" data-start=\"5410\" data-end=\"5619\">Our <strong data-start=\"5414\" data-end=\"5423\">TS-01<\/strong> og <strong data-start=\"5428\" data-end=\"5438\">NTT-01<\/strong> instruments are designed with precision control, high repeatability, and intuitive operation\u2014ideal for quality assurance labs, syringe manufacturers, and medical device developers.<\/p>\n<p><img fetchpriority=\"high\" decoding=\"async\" class=\"alignright wp-image-6666\" src=\"https:\/\/www.qualitester.com\/wp-content\/uploads\/2025\/05\/ISO-9626-300x300.webp\" alt=\"ISO 9626\" width=\"400\" height=\"400\" srcset=\"https:\/\/www.qualitester.com\/wp-content\/uploads\/2025\/05\/ISO-9626-300x300.webp 300w, https:\/\/www.qualitester.com\/wp-content\/uploads\/2025\/05\/ISO-9626-150x150.webp 150w, https:\/\/www.qualitester.com\/wp-content\/uploads\/2025\/05\/ISO-9626-12x12.webp 12w, https:\/\/www.qualitester.com\/wp-content\/uploads\/2025\/05\/ISO-9626-100x100.webp 100w, https:\/\/www.qualitester.com\/wp-content\/uploads\/2025\/05\/ISO-9626.webp 600w\" sizes=\"(max-width: 400px) 100vw, 400px\" \/><\/p>\n<p class=\"\" data-start=\"5621\" data-end=\"5674\">By working with Cell Instruments, you gain access to:<\/p>\n<ul>\n<li data-start=\"5678\" data-end=\"5724\">Equipment designed for strict ISO compliance<\/li>\n<li data-start=\"5727\" data-end=\"5784\">Customizable testing solutions for unique product needs<\/li>\n<li data-start=\"5787\" data-end=\"5839\">Ongoing technical support and calibration services<\/li>\n<\/ul>\n<p class=\"\" data-start=\"5862\" data-end=\"6249\">Understanding and implementing ISO 9626 standards is essential for anyone involved in the design, manufacture, or quality control of medical needle tubing. By performing accurate <strong data-start=\"6041\" data-end=\"6072\">syringe needle tubing tests<\/strong>, including <strong data-start=\"6084\" data-end=\"6104\">needle stiffness<\/strong>, <strong data-start=\"6106\" data-end=\"6133\">tubing break resistance<\/strong>, og <strong data-start=\"6139\" data-end=\"6176\">needle corrosion resistance tests<\/strong>, manufacturers can guarantee performance, safety, and global compliance.<\/p>\n<p class=\"\" data-start=\"6251\" data-end=\"6446\">Cell Instruments is your reliable partner in achieving <a href=\"https:\/\/www.iso.org\/standard\/60480.html\" target=\"_blank\" rel=\"noopener nofollow\">ISO 9626<\/a> testing success. With our expert-grade <strong data-start=\"6354\" data-end=\"6363\">TS-01<\/strong> og <strong data-start=\"6368\" data-end=\"6378\">NTT-01<\/strong> systems, you\u2019ll meet the toughest industry demands with confidence.<\/p>\n<hr class=\"\" data-start=\"6448\" data-end=\"6451\" \/>\n<h2 data-start=\"6453\" data-end=\"6492\">VANLIGE SP\u00d8RSM\u00c5L<\/h2>\n<p class=\"\" data-start=\"6494\" data-end=\"6712\"><strong data-start=\"6494\" data-end=\"6558\">1. What types of stainless steel tubing does ISO 9626 cover?<\/strong><br data-start=\"6558\" data-end=\"6561\" \/>This standard applies only to <em data-start=\"6586\" data-end=\"6593\">rigid<\/em> stainless steel tubing used in hypodermic needles and excludes flexible tubing due to different mechanical properties.<\/p>\n<p class=\"\" data-start=\"6714\" data-end=\"6899\"><strong data-start=\"6714\" data-end=\"6764\">2. Why is the needle stiffness test important?<\/strong><br data-start=\"6764\" data-end=\"6767\" \/>It ensures that the tubing resists bending during medical use, which is crucial for safe needle insertion and precise drug delivery.<\/p>\n<p class=\"\" data-start=\"6901\" data-end=\"7104\"><strong data-start=\"6901\" data-end=\"6974\">3. How many bending cycles are required in the break resistance test?<\/strong><br data-start=\"6974\" data-end=\"6977\" \/>ISO 9626 Annex C requires the tubing to undergo <strong data-start=\"7025\" data-end=\"7047\">20 complete cycles<\/strong> of directional bending to evaluate its fatigue strength.<\/p>\n<p class=\"\" data-start=\"7106\" data-end=\"7297\"><strong data-start=\"7106\" data-end=\"7174\">4. What signs indicate failure in the corrosion resistance test?<\/strong><br data-start=\"7174\" data-end=\"7177\" \/>Visible corrosion or discoloration on the immersed portion of the tubing indicates non-compliance with ISO 9626 Annex D.<\/p>\n<p class=\"\" data-start=\"7299\" data-end=\"7540\"><strong data-start=\"7299\" data-end=\"7375\">5. Can Cell Instruments provide customized needle tubing test equipment?<\/strong><br data-start=\"7375\" data-end=\"7378\" \/>Yes, Cell Instruments specializes in <strong data-start=\"7415\" data-end=\"7443\">custom testing solutions<\/strong>, including automation and tailored fixtures, to support specific product and regulatory needs.<\/p>","protected":false},"excerpt":{"rendered":"<p>ISO 9626 Syringe Needle Tubing Test ISO 9626 defines the international standard for stainless steel needle tubing used in the manufacture of medical devices such as hypodermic needles. Developed to ensure safety, consistency, and performance, ISO 9626 provides rigorous specifications for tubing dimensions and mechanical properties ranging from 3.4 mm (10 Gauge) to 0.18 mm &hellip;<\/p>\n<p class=\"read-more\"> <a class=\"\" href=\"https:\/\/www.qualitester.com\/nb\/standards\/iso-9626\/\"> <span class=\"screen-reader-text\">ISO 9626<\/span> Les mer \"<\/a><\/p>","protected":false},"author":4,"featured_media":0,"parent":4948,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"site-sidebar-layout":"default","site-content-layout":"default","ast-global-header-display":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"disabled","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","theme-transparent-header-meta":"default","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","footnotes":""},"class_list":["post-6661","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.qualitester.com\/nb\/wp-json\/wp\/v2\/pages\/6661","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.qualitester.com\/nb\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.qualitester.com\/nb\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.qualitester.com\/nb\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/www.qualitester.com\/nb\/wp-json\/wp\/v2\/comments?post=6661"}],"version-history":[{"count":0,"href":"https:\/\/www.qualitester.com\/nb\/wp-json\/wp\/v2\/pages\/6661\/revisions"}],"up":[{"embeddable":true,"href":"https:\/\/www.qualitester.com\/nb\/wp-json\/wp\/v2\/pages\/4948"}],"wp:attachment":[{"href":"https:\/\/www.qualitester.com\/nb\/wp-json\/wp\/v2\/media?parent=6661"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}