Op Cell Instruments Co.<\/strong><\/a>, we provide advanced solutions for testing the mechanical properties and functionality of medical needles and syringes in accordance with ISO 7864. Our instruments are widely used in medical device quality control, research, and compliance testing.<\/p>\n ISO 7864<\/strong> establishes uniform specifications to ensure the sterility, integrity, and mechanical strength<\/em> of hypodermic needles. These standards are critical for maintaining patient safety by minimizing insertion pain, preventing breakage, and ensuring proper bonding between the needle and hub.<\/p>\n The standard outlines detailed procedures for various hypodermic needle testing<\/strong> parameters, such as needle sharpness, penetrability, bonding strength,<\/em> en dimensional accuracy.<\/em> Each of these tests helps evaluate how effectively a needle can perform during clinical use.<\/p>\n One of the most important performance factors in hypodermic needle testing<\/strong> is its sharpness. Hypodermic needle sharpness testing<\/strong> evaluates the penetration force and drag force<\/em> during needle insertion into a standardized substrate.<\/p>\n According to ISO 7864 Annex D, the needle penetrability testing<\/strong> is performed by inserting the needle into a substrate (often latex or polyurethane film) at a constant speed of 100 mm\/min<\/strong>. Two parameters are measured:<\/p>\n These values are plotted in a force\u2013displacement curve, representing both the initial puncture and the frictional forces acting on the needle.<\/p>\n To perform this test accurately, Cel-instrumenten\u2019 NPD-01 Naaldpenetratie- en sleepkrachttester<\/a><\/strong>\u00a0offers high-precision measurement of penetration and drag forces, enabling users to assess needle performance in compliance with ISO 7864 Annex D.<\/p>\n Another critical part of iso 7864 testing<\/strong> is evaluating the mechanical connection between the needle tube<\/em> en needle hub<\/em>. De needle bonding strength test<\/strong> (Annex E) ensures that the needle can withstand the tensile forces encountered during use without detachment.<\/p>\n In this test, the needle is mounted vertically on a tensile testing machine. The load cell is set to zero, and the sample is pulled at a speed of 50 mm\/min<\/strong> until the hub separates or the needle breaks. The maximum force recorded<\/strong> represents the bonding strength.<\/p>\n For reliable and repeatable results, Cell Instruments\u2019 NBS-01 Needle Bonding Strength Tester<\/strong> provides accurate force measurement and high sampling precision. This instrument is designed specifically to evaluate bonding strength according to ISO 7864 and related standards like ISO 9626.<\/p>\n While ISO 7864 focuses on needles, it is often used alongside ISO 7886-1<\/strong><\/a>, which covers hypodermic syringes for single use<\/em>. Syringe functionality testing<\/strong> examines the ease of operation, plunger force, and leakage prevention\u2014ensuring the complete injection system functions reliably.<\/p>\n When combined with hypodermic syringe testing<\/strong>, ISO 7864 testing provides a full evaluation of the needle-syringe assembly<\/em>, confirming that both components work seamlessly together.<\/p>\n With years of expertise in material and medical device testing, Cel Instrumenten<\/strong> provides advanced, automated solutions that meet international standards such as ISO 7864 and ISO 9626.<\/p>\n Our NPD-01 Naaldpenetratie- en sleepkrachttester<\/strong>\u00a0en NBS-01 Needle Bonding Strength Tester<\/strong> deliver:<\/p>\n These systems are ideal for hypodermic needle manufacturers, syringe producers, medical laboratories,<\/strong> en quality control agencies<\/strong> seeking ISO-compliant testing capabilities.<\/p>\n
\nUnderstanding ISO 7864 and Its Importance<\/h2>\n
\nKey ISO 7864 Testing Methods<\/h2>\n
Annex D – Hypodermic Needle Sharpness Testing and Penetrability Testing<\/h3>\n
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Annex E – Needle Bonding Strength Test<\/h3>\n
\nSyringe Functionality and Hypodermic Syringe Testing<\/h2>\n
\nWhy Choose Cell Instruments for ISO 7864 Testing<\/h2>\n
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