ASTM F3014 Suture Needle Penetration Force Testing

ASTM F3014

Suture Needle Penetration Test

ASTM F3014 is a crucial standard for the penetration testing of surgical suture needles. It sets out procedures for evaluating the needle penetration force required when piercing materials during medical procedures. For professionals in surgical device quality assurance, mastering ASTM F3014 ensures product safety, reliability, and performance.

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ASTM F3014 Overview and Importance

ASTM F3014, titled “Standard Test Method for Penetration Testing of Needles Used in Surgical Sutures”, provides standardized guidelines for assessing the performance of sharp and blunt surgical needles. Although Phase 1 of ASTM F3014 does not define a specific test medium, it outlines precise needle penetration test procedures and data collection methods.

The standard applies to both straight and curved needles, quantifying the needle penetration force required to pass through a medium. By simulating clinical conditions, it helps ensure that suture needles can effectively pierce tissue with minimal trauma and maintain consistent performance across multiple uses.

Suture Needle Testing Procedure

For consistent and reliable suture needle testing, ASTM F3014 details a structured approach:

  • Needle Clamping: Secure the needle in a clamping fixture at a uniform gripping location. This setup ensures that the needle remains perpendicular to the test medium during testing.
  • Controlled Motion: Depending on the needle type (straight or curved), either rotational or linear motion is applied. For curved needles, the clamping fixture rotates at a constant 4° ± 2°/s. For straight needles, linear motion occurs at speeds between 10.0 cm/min and 30.5 cm/min.
  • データ収集: As the needle penetrates the medium at a 40° angle, the needle penetration force is continuously measured. This data reveals the needle’s resistance to penetration based on factors like tip geometry and coating.

Needle Penetration Force Test Significance

の needle penetration test described in ASTM F3014 is vital for several reasons:

  • 品質保証: Consistent needle penetration force ensures reliability across production batches.
  • 製品の安全性: Properly tested needles reduce patient trauma during suturing.
  • 規制遵守: Meeting standard ensures that manufacturers comply with recognized standards, enhancing market credibility.

For industries like medical device manufacturing and quality inspection, this standard forms the basis for rigorous performance verification.

Key Equipment for Needle Penetration Testing

Performing this standard-compliant tests requires specialized equipment:

  • Clamping Fixture: Holds the needle securely to prevent slippage during penetration.
  • Data Collection System: Measures and records force data as the needle penetrates the medium.
  • Motion Control System: Ensures constant speed for both rotational and linear movements.

At Cell Instruments, we offer advanced testing solutions tailored for ASTM F3014 compliance. Our automated testing systems ensure precision and repeatability, supporting reliable suture needle testing across diverse applications.

ゴム栓用針入度試験機 ISO 8871-5 2

Contact Us Get ASTM F3014 Testing Solution

As a trusted provider of needle penetration test equipment and suture needle testing solutions, Cell Instruments supports your compliance with ASTM F3014. Our expertise extends beyond instrumentation — we offer customized testing systems and automation solutions to meet your unique needs. Our solutions are suitable for medical, pharmaceutical, and related industries, ensuring that your products meet the highest standards of safety and performance.

よくある質問

It sets the procedures for testing the penetration force of surgical suture needles to ensure safety and performance.

The standard applies to both straight and curved surgical needles, whether sharp or blunt.

A minimum of ten penetrations per needle is required, and at least 30 needles should be tested for statistical reliability.

It measures the force needed for a needle to penetrate the medium, helping ensure minimal patient trauma and consistent needle performance.

We offer advanced testing systems, customization, and automation services to ensure your suture needle testing meets standards.

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