Acupuncture Needle Puncture

Acupuncture needle puncture testing is essential for ensuring the safety, reliability, and effectiveness of acupuncture needles. This process focuses on assessing the intensity oraz sharpness of the needle tips, and puncture performance, following guidelines like ISO 17218, to guarantee product quality and meet industry standards.

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Importance of Acupuncture Needle Puncture Testing

Acupuncture is a medical practice that requires utmost precision. A poorly manufactured needle can cause patient discomfort, injury, or ineffective therapy. Therefore, acupuncture needle puncture tests are performed to ensure:

  • The needle tip resists bending or breaking (intensity).
  • The needle pierces materials with minimal force (sharpness).
    Testing both properties not only meets regulatory demands but also reflects the manufacturer’s commitment to quality and patient safety.

Understanding the Intensity and Sharpness Test (ISO 17218 Requirements)

ISO 17218 provides a standardized approach for evaluating acupuncture needles. Specifically, it describes detailed methods for testing both intensity (resistance to breakage) and sharpness (piercing force).

Test for Intensity

  • The needle tip is positioned vertically against a smooth steel block.
  • A controlled force is gradually applied until reaching a full load (≤ 1.2 N) at a very slow speed (≤ 0.1 mm/s).
  • After applying force, the needle is inspected under ×5 magnification.
  • No bends, hooks, or fiber-catching ability on cotton must be observed.

Test for Sharpness

  • Without removing the needle, a thin aluminium foil is clamped beneath it.
  • Force is steadily increased until the needle pierces through the foil.
  • The piercing force is recorded, with apparatus precision not exceeding 0.01 N.

These methods provide a clear, quantitative assessment of acupuncture needle quality.

Key Equipment for Acupuncture Needle Puncture Testing

Accurate acupuncture needle puncture testing depends heavily on reliable and standardized testing apparatus. According to ISO 17218, the apparatus must feature:

  • High sensitivity (detecting forces as low as 0.01 N).

  • Auto-correction and anti-shock capabilities.

  • Stable and precise needle clamping systems.

  • Smooth aluminium foil clamping with a 5 mm aperture.

Cell Instruments’ Needle Tip Tester perfectly matches these stringent demands. Our advanced device ensures high accuracy, reliable data processing, and easy compliance with ISO 17218, helping manufacturers streamline their quality assurance processes.

Testing Processes for Acupuncture Needle Puncture Based on ISO 17218

Test TypePurposeMaterialKey Notes
Intensity TestStrength of tipSteel BlockNo bending or hooking allowed
Sharpness TestPiercing force measurementAluminium FoilForce recorded at piercing moment
Qualitative Puncture TestQuick sharpness checkSurgical Glove MembraneDent size and resistance evaluated
Quantitative Puncture TestPrecise piercing forcePolyurethane FilmForce-displacement curve analysis

Intensity Test of Needle Tip

1. Mount the sample acupuncture needle onto the testing apparatus, exposing 5 mm of the needle tip.

2. Position the needle vertically over a smooth, rust-free steel block.

3. Apply a gradually increasing load at a speed ≤ 0.1 mm/s until the required force (according to ISO 17218 Section 5.3.5.2) is reached.

4. Maintain the load for 5 to 10 seconds, then remove the load.

5. Examine the needle tip under 5× magnification:

  • The tip must show no bends, hooks, or deformation.
  • When dragged across cotton, it should not snag any fibers.

Quantitative Puncture Test

1. Condition the polyurethane film (thickness 0.35 ± 0.05 mm, Shore Hardness 85 ± 10 A) at 22 ± 2°C for 24 hours.

2. Mount the film vertically on the testing apparatus without excess tension.

3. Install the acupuncture needle onto the holder so that it is prostopadły to the film surface.

4. Set the movement speed to 100 mm/min.

5. Start the apparatus and record the force-displacement curve.

6. Measure and record the peak puncture forces.

7. Ensure that each puncture happens in fresh film areas to avoid weakening effects from prior tests.

Sharpness Test of Needle Tip

1. After completing the intensity test, keep the needle sample mounted on the apparatus.

2. Install clean, smooth aluminium foil (thickness 0.05 ± 0.002 mm, purity ≥ 99.5%) onto the foil clamping device.

3. Gradually increase force at a controlled speed.

4. The needle tip pierces the foil once the applied force exceeds the resistance of the aluminium.

5. The force reading at the moment of piercing is recorded as the puncture force.

6. Reset the apparatus pointer to its original position.

7. After each puncture, move the foil so that new test points are at least three times the diameter away from previous punctures.

Qualitative Puncture Test

1. Stretch a surgical rubber glove membrane (per ISO 10282) over a 100 mm diameter cup oraz secure it with a rubber band.

2. Puncture the membrane perpendicularly with the acupuncture needle.

3. Observe the piercing behavior:

  • Small dent + low resistance = Sharp tip.
  • Large dent + high resistance = Blunt tip.

This is a comparative and non-quantitative method, suitable for quick evaluations or cross-verification between manufacturers and purchasers.

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