Acupuncture needle puncture testing is essential for ensuring the safety, reliability, and effectiveness of acupuncture needles. This process focuses on assessing the intensitas dan ketajaman of the needle tips, and puncture performance, following guidelines like ISO 17218, to guarantee product quality and meet industry standards.
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:
ISO 17218 provides a standardized approach for evaluating acupuncture needles. Specifically, it describes detailed methods for testing both intensitas (resistance to breakage) and ketajaman (piercing force).
These methods provide a clear, quantitative assessment of acupuncture needle quality.
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.
| Test Type | Purpose | Bahan | Key Notes |
|---|---|---|---|
| Intensity Test | Strength of tip | Steel Block | No bending or hooking allowed |
| Sharpness Test | Piercing force measurement | Aluminium Foil | Force recorded at piercing moment |
| Qualitative Puncture Test | Quick sharpness check | Surgical Glove Membrane | Dent size and resistance evaluated |
| Quantitative Puncture Test | Precise piercing force | Polyurethane Film | Force-displacement curve analysis |
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:
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 tegak lurus 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.
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.
1. Stretch a surgical rubber glove membrane (per ISO 10282) over a 100 mm diameter cup dan secure it with a rubber band.
2. Puncture the membrane perpendicularly with the acupuncture needle.
3. Observe the piercing behavior:
This is a comparative and non-quantitative method, suitable for quick evaluations atau cross-verification between manufacturers and purchasers.
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