Injection Needle Rigidity Tester

The Medical Injection Needle Rigidity Tester is designed to evaluate the mechanical rigidity of medical injection needles. It measures deflection and load under controlled conditions, ensuring that needles meet required standards for patient safety, comfort, and performance. The instrument supports a wide range of needle specifications and wall types, providing precise, repeatable results for manufacturers, laboratories, and regulatory testing.
Application
The tester is suitable for rigidity testing of medical injection needles in the following industries and products:
(1) Medical Device Manufacturing: Quality control of single-use, sterile injection needles.
(2) Research & Development: Testing new needle designs, wall thicknesses, and mechanical properties.
(3) Regulatory & Certification Labs: Compliance testing according to national and international standards.
(4) Third-Party Testing Organizations: Verification of needle rigidity for certification and reporting.
(5) Educational & Training Institutions: Demonstration and training on needle testing protocols.
Standards
The instrument is compliant with the following standards, including relevant international regulations:
(1) GB 18457-2001 – Medical Injection Needle Rigidity Performance Testing Standard
(2) ISO 7864:2016 – Sterile Hypodermic Needles for Single Use – Requirements and Test Methods
(3) ASTM F899-16 – Standard Test Method for Determining Needle Rigidity and Flexibility
(4) EN ISO 9626:2016 – Stainless Steel Needles for Medical Use – Mechanical Requirements
Features
(1) Precision compliance: engineered to meet global medical standards
(2) High accuracy: deflection measurement ±0.01 mm, load control ±0.1 N
(3) Versatile: supports needle diameters 0.3–3.4 mm and wall types (normal, thin, ultra-thin)
(4) User-friendly: automated testing, simplified setup
(5) Durable construction: compact, robust design (25 kg) with lifetime standard upgrades
(6) Adjustable span distance: 0–55 mm with ±0.5 mm accuracy
(7) Controlled loading speed: 1 mm/min ±0.1 mm/min
(8) Ergonomic design: compact footprint (460 × 340 × 400 mm) for laboratory efficiency
Technical Parameters
| Parameter | Specification |
|---|---|
| Deflection Measurement | 0–5 mm, Accuracy ±0.01 mm |
| Load Capacity | 5.5–60 N, Accuracy ±0.1 N |
| Span Adjustment | 0–55 mm, Accuracy ±0.5 mm |
| Needle Compatibility | 0.3–3.4 mm (Normal/Thin/Ultra-Thin Wall) |
| Loading Speed | 1 mm/min ±0.1 mm/min |
| Dimensions (L×W×H) | 460 × 340 × 400 mm |
| Weight | 25 kg |
| Power Supply | AC 220 V / 50 Hz or Customized |
| Warranty | 1 Year + Lifetime Standard Upgrades |
Accessories
(1) Main testing unit
(2) Calibration weights
(3) Specialized needle jigs and clamps
(4) Onboard thermal printer for instant data documentation
(5) User manual and calibration certificate
Test Procedures
(1) Mount the needle sample on the specified jig
(2) Set the span distance (0–55 mm) and loading speed (1 mm/min ±0.1 mm/min) on the controller
(3) Start the automated test to apply vertical force at the center of the span
(4) Measure deflection and load in real time via the integrated sensor
(5) Record results automatically or print via onboard thermal printer
(6) Compare measurements against standard thresholds for rigidity qualification
(7) Repeat for additional needle samples as required
Maintenance Information
(1) Keep the instrument clean and free from dust or debris
(2) Inspect clamps, sensors, and load cells regularly for wear or damage
(3) Calibrate the force transducer periodically to maintain measurement accuracy
(4) Avoid exposure to liquids, extreme temperatures, or mechanical shocks
(5) Ensure proper grounding of the power supply to protect electronic components
(6) Maintain logs of calibration, testing, and maintenance for compliance purposes
FAQ
1. What is the core advantage of this product?
The core advantage of the Medical Injection Needle Rigidity Tester is its ability to accurately measure needle deflection and applied load under controlled conditions. With high measurement accuracy and adjustable span settings, it enables consistent evaluation of needle rigidity across a wide range of needle diameters and wall types.
2. Are the test results reliable?
Yes. The tester uses precision sensors for both load and deflection measurement, combined with controlled loading speed and automated test procedures. Regular calibration and standardized fixtures ensure repeatable and dependable test results.
3. Which international or industry standards does it comply with?
The instrument complies with GB 18457-2001 for injection needle rigidity testing, ISO 7864:2016 for sterile hypodermic needles, ASTM F899-16 for needle rigidity and flexibility testing, and EN ISO 9626:2016 for mechanical requirements of medical stainless steel needles.
4. Why is this product important?
Needle rigidity directly affects insertion performance, patient comfort, and clinical safety. Reliable rigidity testing helps ensure that medical injection needles meet mechanical requirements, reducing the risk of bending, deformation, or failure during use.
5. Which fields is this product suitable for?
The tester is suitable for medical device manufacturing, research and development laboratories, regulatory and certification testing institutions, third-party testing organizations, and educational or training facilities involved in medical needle evaluation.
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