Needle Sharpness Testing

Testing Method

Needle sharpness testing is a critical part of quality assurance for medical, surgical, and acupuncture needles. It directly affects patient comfort, injection precision, and safety. This testing involves evaluating the sila prodora of the needle tip and its ability to resist breakage or deformation. Standards such as ASTM F3014, ISO 17218, ISO 11040-4, i ISO 7864 provide rigorous test methods to ensure reliable and reproducible results.

Why Needle Sharpness Testing Matters

Needle sharpness testing ensures that medical and acupuncture needles meet the required performance specifications. Poorly sharpened needles can cause pain, tissue trauma, and complications. High-quality needle testing minimizes these risks and improves patient outcomes. Leading manufacturers, like Stanični instrumenti, offer state-of-the-art testing machines that adhere to international standards.

Key Standards for Needle Sharpness Testing

Understanding the main standards helps ensure accurate and compliant testing processes. Let’s explore the most important guidelines:

ASTM F3014: Surgical Needle Testing

This standard, “Standard Test Method for Penetration Testing of Needles Used in Surgical Sutures”, outlines the procedure for evaluating surgical needle penetration force. It specifies how to secure the needle and the test medium and how to record the data accurately (Sections 4.1, 4.2, 8.1). The test involves:

  • Clamping the needle at the proper location to ensure uniform penetration.
  • Rotating the fixture to pass the needle through the medium at a 40° angle, continuously recording the penetration force.
  • Monitoring for fixturing errors, which can significantly impact the accuracy of the penetration force data.

ISO 7864: Hypodermic Needle Testing

ISO 7864:2016 specifies the requirements and test methods for hypodermic needles. Annex D focuses on measuring both the peak penetration force i sila vuče:

  • The needle penetrates a substrate at a controlled speed (18–28°C, 25–75% RH).
  • The force profile is analyzed to determine the peak and drag forces.
  • Data from multiple samples ensure statistically robust results.

ISO 17218: Acupuncture Needle Testing

For acupuncture needle testing, ISO 17218:2014 (“Sterile acupuncture needles for single use”) provides procedures to evaluate tip sharpness and intensity. According to Annex A:

  • Needle tip sharpness is measured by the force needed to pierce an aluminium foil.
  • Tip intensity is determined by pressing the needle onto a steel block, then examining the tip for damage or deformation.
  • Each test ensures the needle does not bend or hook and does not pull fibres when dragged on cotton.

ISO 11040-4: Syringes Needle Testing

ISO 11040-4 covers prefilled glass syringe barrels and sterilized subassembled syringes. Annex F details the needle penetration test:

  • The test uses a universal tensile and compression testing machine (Section F.2.1) with a recommended sampling rate of 500 Hz for peak measurement accuracy.
  • The needle is fixed perpendicularly to the test foil and driven at controlled speeds (20–200 mm/min).
  • The resulting force-displacement curve represents needle penetration performance.

Best Practices for Needle Sharpness Testing

Here are key practices to ensure accurate testing:

✅ Use properly calibrated instruments – Cell Instruments provides testing machines meeting these standards.
✅ Ensure perpendicular alignment of the needle to the test foil or substrate to avoid skewed data.
✅ Monitor temperature and humidity for consistent testing conditions (ISO 7864).
✅ Replace the test foil or substrate for each new test (ISO 11040-4).
✅ Review and analyze the full force-displacement curve to identify peak forces and drag forces accurately.

Na Stanični instrumenti, we offer advanced testing machines specifically designed for needle sharpness testing. Our systems comply with ASTM F3014, ISO 17218, ISO 11040-4, and ISO 7864, delivering high-resolution data and consistent results. Our experts also provide customized testing solutions to meet your exact needs in medical device manufacturing, pharmaceutical testing, and quality control.

By adhering to these standards and best practices, you can ensure precise, reliable needle sharpness testing and maintain product excellence in critical applications.

Needle Sharpness Testing
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