Medical Injection Needle Puncture Force Tester
The Medical Injection Needle Puncture Force Tester is a precision instrument designed to evaluate the puncture performance of medical needles. It simulates skin penetration and measures the maximum puncture force, providing reliable data for quality control, research, and production verification. Equipped with a 5.7-inch LCD touch screen, the device offers real-time force/displacement display, automatic data recording, and printing capability for accurate and repeatable measurements.
Application
This tester is suitable for a wide range of medical needle testing scenarios, including:
(1) Disposable medical injection needles – assessing sharpness and penetration performance.
(2) Insulin pen needles – evaluating puncture consistency and patient comfort.
(3) Blood collection needles (Vacutainer) – ensuring safe and reliable blood sampling.
(4) IV infusion needles and cannulas – testing ease of insertion and mechanical performance.
(5) Specialty surgical needles – evaluating microsurgical and orthopedic needle performance.
(6) Veterinary injection needles – verifying puncture efficiency and safety.
(7) Cosmetic or aesthetic needles – assessing penetration force and consistency.
Standards
The instrument complies with domestic and international standards for medical needle testing:
(1) GB15811-2016: Disposable sterile injection needles (China)
(2) ISO 17025: General requirements for the competence of testing and calibration laboratories (International)
(3) EN ISO 7864: Sterile hypodermic needles for single use (International)
(4) ASTM F2878-12: Standard Test Method for Puncture Resistance of Medical Needles (International)
Features
(1) Real-time display of puncture force and peak force for precise evaluation.
(2) 5.7-inch LCD touch screen with intuitive menu for simplified operation.
(3) Automatic data recording, printing, and analysis, including average force and deviation.
(4) Supports a wide range of needle diameters (0.3–1.2 mm) and wall thicknesses.
(5) Compact, portable, and lightweight, suitable for laboratory and production environments.
(6) Accurate simulated skin testing, compliant with GB15811 standards.
(7) Continuous software upgrade capability to align with updated national and international standards.
Parameters
| Parameter | Specification |
|---|---|
| Nominal needle specification | 0.3 – 1.2 mm |
| Test range | 0.10 – 5.00 N, accuracy ±0.01 N |
| Moving speed | 100 mm/min |
| Simulated skin material | Polyurethane membrane, compliant with GB15811 |
| Display | 5.7-inch LCD touch screen (120 × 90 mm) |
| Data output | Printable: 8, 13, or 20 tests per batch; average force and deviation |
| Net weight | 11 kg |
| Dimensions (L × W × H) | 400 × 290 × 240 mm |
| Standards | GB15811-2016, ISO 17025, EN ISO 7864, ASTM F2878-12 |
| Upgrade | Free upgrade according to national standards |
Accessories
(1) Main unit – 1 set
(2) Printing paper – 1 roll
(3) Needle clamp fixture – 1 set
(4) Weight set – 1 set
(5) Operating instructions – 1 set
(6) One-year warranty
(7) Free perpetual upgrade service according to national standards
Test Procedures
(1) Condition the needle and simulated skin at 22°C ± 2°C for at least 24 hours.
(2) Clamp the simulated skin in the fixture, ensuring no stretching or compression.
(3) Mount the needle perpendicular to the surface of the simulated skin, tip centered on the puncture zone.
(4) Set the device moving speed to 100 mm/min.
(5) Start the test. The instrument records maximum puncture force and force/displacement curve in real time.
(6) Print or save test data for analysis, including peak force, F5 peak force, and average deviation.
Maintenance Information
(1) Keep the device and simulated skin clean and free from dust.
(2) Inspect clamps and simulated skin regularly for wear or damage.
(3) Calibrate the force sensor periodically to maintain accuracy.
(4) Store the instrument in a dry, temperature-stable environment.
(5) Follow local electrical safety regulations for proper grounding and operation.
FAQ
1. What is the core advantage of this product?
The core advantage of the Medical Injection Needle Puncture Force Tester lies in its ability to accurately simulate skin penetration and measure real-time puncture force. The combination of precise force sensing, standardized simulated skin, and automated data recording ensures consistent evaluation of needle sharpness and penetration performance.
2. Are the test results reliable?
Yes. The tester uses a controlled test speed, standardized polyurethane simulated skin compliant with GB15811. and high-accuracy force measurement (±0.01 N). Real-time force–displacement monitoring and automatic data analysis further enhance test repeatability and reliability.
3. Which international or industry standards does it comply with?
The instrument complies with GB15811-2016 for disposable sterile injection needles, EN ISO 7864 for sterile hypodermic needles, ASTM F2878-12 for puncture resistance testing, and supports laboratory compliance under ISO 17025 requirements.
4. Why is this product important?
Puncture force directly affects insertion performance, patient comfort, and clinical safety. Reliable puncture force testing helps manufacturers verify needle sharpness, control product consistency, and reduce the risk of excessive penetration force during medical procedures.
5. Which fields is this product suitable for?
The tester is suitable for medical injection needle manufacturing, insulin pen needle production, blood collection and IV infusion device testing, cosmetic and veterinary needle evaluation, as well as quality control, R&D, and regulatory testing laboratories.
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