The CCL-02 Medical Needle Puncture Tester is designed to measure the puncture force of medical needles, injection needles, and needle tubes. By simulating penetration into artificial skin material, the testing system provides accurate, repeatable data for evaluating puncture resistance.
Product Features
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7-inch color touchscreen with graphical user interface (GUI)
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This instrument automatically records the results of both the penetration force and resistance tests.
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Automatic test termination is available with multiple criteria: displacement, force, or time.
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High-precision sensors ensure high accuracy and repeatability of the force measurement system.
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Motion control system with high precision and smooth operation.
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This instrument features automatic data storage and retains memory even after power-off.
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This instrument is equipped with multiple safety features to prevent accidents caused by improper operation during testing, including an emergency stop button and overload protection.
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Equipped with a micro-printer and automatically prints test results upon completion
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Standard USB interface for convenient data transfer
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This instrument features multi-level user permissions, compliant with GMP standards.
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ISP online control and upgrade capabilities enable remote modification of test functions as needed.
Test Principle
The Medical Needle Puncture Tester secures a medical needle and polyurethane film (artificial skin) in its test fixture. The device then drives the needle through the film at a controlled speed, measuring the puncture force. Results are automatically recorded, providing an accurate assessment of needle sharpness and penetration resistance.
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Parameter |
Description |
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Peak Puncture Force |
The maximum load recorded as the needle tip penetrates the test medium—directly correlates with needle sharpness. |
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Mean Puncture Force |
The arithmetic average of forces applied throughout the entire penetration process. |
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Breakthrough Force |
The critical force required at the moment the needle tip passes through the material surface. |
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Sliding Resistance Force |
The continuous resistance encountered as the needle shaft moves through the test medium. |
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Pull Out Force |
The maximum pulling out force required to extract the needle from the test medium. |
Test Standards
This test instrument conforms to many national and international standards:
ISO 7864 – Sterile hypodermic needles for single use (Annex D for penetration force and drag force measurement)
ISO 11608-2 – Needles for single-use syringes (Part 2: Needles for insulin pens)
ISO 8871-5 – Elastomeric components for parenterals and pharmaceutical devices
ASTM F2878 – Standard test method for protective clothing material resistance to hypodermic needle puncture
ASTM F1306 – Standard test method for slow rate penetration resistance of flexible barrier films and laminates
EN 388 – Protective gloves against mechanical risks (puncture resistance)
GB 15811 – Chinese national standard for single-use sterile hypodermic needles
USP <381> – Elastomeric closures for injections
Test Applications
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Basic Applications |
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Disposable sterile injection needles, prefilled syringe needles, infusion needles
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Technical Specifications
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Items |
Specifications |
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Test Range |
0 ~ 20 N (50 N Optional) |
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Resolution |
0.001 N |
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Force Accuracy |
±0.5% FS |
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Loading Speed |
0 ~ 500 mm/min (Adjustable) |
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Speed Accuracy |
±0.5% FS |
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Needle Tubing Size |
0.18 ~ 3.4 mm |
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Specimen |
Polyurethane Film (Artificial Skin) |
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Power Supply |
AC 100-240V 50/60Hz
(can be changed to local requirement) |
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Instrument Dimension |
400 mm (W) x 270 mm (D) x 370 mm (H) |
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Net Weight |
15 kg |
Configurations
Standard Configurations: Instrument, Micro Printer, Polyurethane Film (Artificial Skin)