{"id":743,"date":"2026-01-21T01:54:08","date_gmt":"2026-01-21T01:54:08","guid":{"rendered":"https:\/\/www.syringetest.com\/?page_id=743"},"modified":"2026-01-21T02:15:30","modified_gmt":"2026-01-21T02:15:30","slug":"iso-9626","status":"publish","type":"page","link":"https:\/\/www.syringetest.com\/pt\/standards\/iso-9626","title":{"rendered":"ISO 9626"},"content":{"rendered":"
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ISO 9626 Needle Tubing Stiffness Test and Resistance Testing for Medical Devices<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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ISO 9626<\/strong> provides critical guidelines for testing stainless steel needle tubing used in medical devices, such as hypodermic needles. These tests, including the ensaio de rigidez de tubos de agulhas<\/strong><\/a> and breakage resistance, ensure that the tubing maintains mechanical integrity under various conditions, contributing to the safety and effectiveness of medical devices. This article explains the key aspects of ISO 9626<\/strong>, o ensaio de rigidez de tubos de agulhas<\/strong>, and related tests such as corrosion resistance<\/strong> e resist\u00eancia \u00e0 rutura do tubo da agulha<\/strong>.<\/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

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The Importance of ISO 9626 in Needle Tubing Testing<\/h2>

ISO 9626:2016<\/strong> specifies the requirements for rigid stainless steel needle tubing<\/strong> used in the production of medical devices, primarily for human use. The standard applies to tubing of various metric sizes, ranging from 3.4 mm (10 Gauge)<\/strong> to 0.18 mm (34 Gauge)<\/strong>. It covers mechanical properties such as needle tubing stiffness<\/strong>, breakage resistance, and corrosion resistance, which are crucial for ensuring the safety and reliability of medical devices.<\/p>

ISO 9626 outlines the testing methods for determining the physical properties of needle tubing, including tensile strength<\/strong>, stiffness<\/strong>e breakage resistance<\/strong>. These tests are essential for manufacturers to comply with industry standards and provide high-quality, durable products.<\/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\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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Needle Tubing Stiffness Test According to ISO 9626<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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O ensaio de rigidez de tubos de agulhas<\/strong> is an integral part of ISO 9626. This test evaluates the ability of the tubing to resist bending under force. To perform the test, a specified force is applied to the center of a given length of tubing, which is supported at both ends. The amount of deflection is then measured.<\/p>

Equipment for the Stiffness Test<\/h3>

The stiffness test requires a stiffness testing apparatus<\/strong> capable of applying a downward force of up to 60 N<\/strong>. This apparatus should have a plunger with a blunt wedge at the bottom, and the force applied should be measured with accuracy of \u00b10.1 N<\/strong>. The deflection of the tubing should be measured to the nearest 0,01 mm<\/strong>.<\/p>

The test provides important data for understanding how a needle’s tubing will perform during use, including its flexibility<\/strong> and ability to withstand external forces without failure. Manufacturers rely on the stiffness test<\/strong> to ensure that their products meet the necessary mechanical standards.<\/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

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Needle Tubing Breakage Resistance: Ensuring Durability<\/a><\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Another key test specified in ISO 9626<\/strong> is the needle tubing breakage resistance test<\/strong>.<\/a> This test evaluates the ability of needle tubing to withstand repeated bending without breaking, which is critical in applications where the needle may be subjected to stress during insertion.<\/p>

The test involves applying a force to the tubing, bending it through a specified angle and repeating the bending cycles. The tubing must withstand 20 cycles<\/strong> of bending in both directions without breaking. This test simulates the forces the tubing might encounter during routine use and ensures that the needle will not fail under normal condition<\/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

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Corrosion Resistance Test for Needle Tubing<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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O corrosion resistance<\/strong> of needle tubing is another crucial property, particularly for medical devices exposed to various chemicals and sterilization processes. ISO 9626 outlines a method for testing corrosion resistance by immersing the tubing in a sodium chloride solution<\/strong> and observing the effects after a set period.<\/p>

The test involves immersing the tubing in a 0.5 mol\/l sodium chloride solution<\/strong> at 23 \u00b1 2\u00b0C<\/strong> para 7 hours<\/strong>. After the immersion period, the tubing is inspected for any signs of corrosion. Corrosion resistance is essential for ensuring the longevity and integrity of the needle tubing, particularly in environments where it is exposed to saline solutions or sterilizing agents.<\/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\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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Selecting the Right Syringe Testing Equipment<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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TS-01 Tubing Stiffness Tester<\/h3> <\/div>\n

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NTT-01 Needle Toughness<\/h2> <\/div>\n

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The Role of the Syringe Tube Stiffness Tester<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Para efetuar uma needle tubing stiffness tests<\/strong>, it is essential to use the correct equipment. The Syringe Tube Stiffness Tester<\/strong> foi concebido para medir o bending resistance<\/strong> of needle tubing, ensuring that the product meets the necessary standards for use in medical applications. This instrument can measure the deflection of the tubing under varying loads, allowing manufacturers to assess the quality of the tubing and ensure its durability.<\/p>

The Syringe Tube Stiffness Tester is highly accurate and provides reliable data for manufacturers to ensure compliance with ISO 9626<\/strong> standards. Using this equipment helps guarantee that needle tubing is stiff enough to maintain its shape and integrity during use but flexible enough to be inserted easily.<\/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

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Porqu\u00ea escolher Syringetest.com?<\/b><\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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By following ISO 9626<\/strong> and using appropriate testing equipment, manufacturers can produce durable and high-quality needle tubing that ensures the safety of patients and the efficacy of medical devices.<\/p>

Syringetest.com<\/strong> fornece servi\u00e7os avan\u00e7ados equipamento de teste de seringas<\/strong> designed to support complete compliance and streamlined QC workflows. If you’re looking to upgrade your syringe validation process or improve test accuracy, contact us to learn how our instruments can help meet your standards.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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ISO 9626 Needle Tubing Stiffness Test and Resistance Testing for Medical Devices ISO 9626 provides critical guidelines for testing stainless steel needle tubing used in medical devices, such as hypodermic needles. These tests, including the needle tubing stiffness test and breakage resistance, ensure that the tubing maintains mechanical integrity under various conditions, contributing to the […]<\/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-743","page","type-page","status-publish","hentry"],"yoast_head":"\nISO 9626 Needle Tubing Stiffness Test and Breakage Resistance<\/title>\n<meta name=\"description\" content=\"Learn about ISO 9626 and its role in testing needle tubing stiffness. 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