ايزو 7864
Sterile Hypodermic Needle Testing
Penetration and Drag Force & Needle Bonding Strength

ايزو 7864 defines the requirements and test methods for sterile hypodermic needles for single use. This international standard ensures that medical needles used for injection or fluid withdrawal meet stringent safety, sharpness, and performance requirements.

في Cell Instruments Co., Ltd., 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.

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Understanding ISO 7864 and Its Importance

ايزو 7864 establishes uniform specifications to ensure the sterility, integrity, and mechanical strength 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.

The standard outlines detailed procedures for various hypodermic needle testing parameters, such as needle sharpness, penetrability, bonding strength, و dimensional accuracy. Each of these tests helps evaluate how effectively a needle can perform during clinical use.

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Key ISO 7864 Testing Methods

Annex D – Hypodermic Needle Sharpness Testing and Penetrability Testing

One of the most important performance factors in hypodermic needle testing is its sharpness. Hypodermic needle sharpness testing evaluates the penetration force and drag force during needle insertion into a standardized substrate.

According to ISO 7864 Annex D, the اختبار قابلية اختراق الإبرة is performed by inserting the needle into a substrate (often latex or polyurethane film) at a constant speed of 100 مم/دقيقة. Two parameters are measured:

• Peak penetration force – the maximum force required to pierce the substrate.
• Drag force – the average frictional resistance as the needle moves through the substrate.

These values are plotted in a force–displacement curve, representing both the initial puncture and the frictional forces acting on the needle.

To perform this test accurately, أجهزة الخلية جهاز اختبار اختراق الإبرة وقوة السحب NPD-01 offers high-precision measurement of penetration and drag forces, enabling users to assess needle performance in compliance with ISO 7864 Annex D.

Annex E – Needle Bonding Strength Test

Another critical part of iso 7864 testing is evaluating the mechanical connection between the needle tube و needle hub. The needle bonding strength test (Annex E) ensures that the needle can withstand the tensile forces encountered during use without detachment.

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 until the hub separates or the needle breaks. The maximum force recorded represents the bonding strength.

For reliable and repeatable results, Cell Instruments’ NBS-01 Needle Bonding Strength Tester 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.

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Syringe Functionality and Hypodermic Syringe Testing

While ISO 7864 focuses on needles, it is often used alongside ايزو 7886-1, which covers hypodermic syringes for single use. Syringe functionality testing examines the ease of operation, plunger force, and leakage prevention—ensuring the complete injection system functions reliably.

When combined with hypodermic syringe testing, ISO 7864 testing provides a full evaluation of the needle-syringe assembly, confirming that both components work seamlessly together.

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Why Choose Cell Instruments for ISO 7864 Testing

With years of expertise in material and medical device testing, أدوات الخلية provides advanced, automated solutions that meet international standards such as ISO 7864 and ISO 9626.

Our جهاز اختبار اختراق الإبرة وقوة السحب NPD-01 و NBS-01 Needle Bonding Strength Tester deliver:

• High accuracy load cells for force measurement.
• Programmable test speeds and penetration depths.
• Automated data recording and analysis.
• User-friendly interfaces for efficient testing workflows.

These systems are ideal for hypodermic needle manufacturers, syringe producers, medical laboratories, و quality control agencies seeking ISO-compliant testing capabilities.

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ايزو 7864 plays a vital role in ensuring the safety, performance, and reliability of sterile hypodermic needles. Through standardized needle sharpness tests, penetrability assessments, and bonding strength evaluations, manufacturers can deliver products that meet both regulatory and user expectations.

By using advanced testing instruments like NPD-01 و NBS-01 من أدوات الخلية, laboratories can achieve precise, repeatable results fully aligned with ISO 7864 requirements—enhancing both quality assurance و customer trust in every needle produced.