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Medical Needle Toughness Tester

Medical Needle Toughness Tester

The Medical Needle Toughness Tester is designed to evaluate the mechanical strength and flexibility of medical needles under bending stress. It features a 5.7-inch LCD touch display (120 × 90 mm) and supports testing of three types of needle walls: normal, thin, and ultra-thin. The device is manufactured in compliance with GB18457 (“Stainless steel needle for medical equipment manufacturing”), GB15811 (“Sterile disposable injection needle”), and ISO 9626 standards.

This tester is ideal for R&D, quality control, and production verification of disposable medical needles.

Application

(1) Medical disposable injection needles – evaluating bending durability before packaging.

(2) Insulin pen needles – testing ultra-thin walls for high flexibility without fracture.

(3) Vacutainer blood collection needles – ensuring mechanical reliability during insertion.

(4) IV infusion needles and cannulas – verifying structural integrity under repeated bending stress.

(5) Specialty surgical needles – quality assurance for orthopedic or microsurgical applications.

Standards

The device meets and supports testing according to the following international and national standards:

(1) GB15811 – Sterile disposable injection needle

(2) GB18457 – Stainless steel needle for medical equipment manufacturing

(3) ISO 9626 – Stainless steel needle for medical use

Features

(1) High-precision touch LCD interface for intuitive operation.

(2) Adjustable bending angles for normal, thin, and ultra-thin needle walls.

(3) Automatic bi-directional bending for standardized toughness testing.

(4) High-brightness 4-digit LED display for accurate parameter monitoring.

(5) Supports multiple syringe diameters (0.2–3.4 mm).

(6) Compact and robust design with net weight of 10 kg.

(7) Free perpetual upgrades according to national standards.

(8) Complete accessory kit included for immediate testing.

Test Procedure

(1) Fix one end of the needle tube firmly in the jig.

(2) Adjust the span according to needle wall type:

Normal wall: 25° bending

Thin wall: 20° bending

Ultra-thin wall: 15° bending

(3) Apply force at the specified span position, bi-directionally, 20 times at a frequency of 0.5 Hz.

(4) Observe the needle for breakage, deformation, or failure.

Principle: One end of the needle is fixed. A force is applied from the fixed point to the prescribed span, bending in one direction and then in the opposite direction, repeated for the defined number of cycles.

Technical Parameters

Parameter Specification
Syringe nominal specifications 0.2 – 3.4 mm
Test frequency 0.5 Hz
Rocker arm bending angle 15°, 20°, 25° (switch selectable, displayed on high-brightness 4-digit LED)
Bending distance 6 – 95 mm, accuracy ±0.1 mm (10 selectable spans)
Number of experiments Bi-directional force 20 times
Net weight 10 kg
Overall dimensions (L × W × H) 300 × 240 × 240 mm
Standards GB15811, GB18457, ISO 9626
Control & Display 5.7-inch LCD touch menu (120 × 90 mm)
Upgrade Free perpetual upgrade according to national standards
Power supply AC 220 V, 50 Hz
Part List Host (1 set), Printing paper (1 roll), Fixture (1 set), Weight (1 set), Operating Instructions

Accessories

(1) Printing paper (1 roll)

(2) Needle fixture (1 set)

(3) Weight set for bending calibration

(4) Operating instructions in English/Chinese

Maintenance Information

(1) Keep the device clean and dry; wipe with a soft cloth after use.

(2) Check the calibration of bending angles and LED display periodically.

(3) Avoid impact or vibration to ensure precise mechanical performance.

(4) Follow local electrical safety standards for power supply and grounding.

FAQ

1. What is the core advantage of this product?

The core advantage of the Medical Needle Toughness Tester is its standardized bi-directional bending test capability, which accurately evaluates the toughness and flexibility of medical needles. It supports normal, thin, and ultra-thin needle walls, ensuring consistent assessment across different needle structures.

2. Are the test results reliable?

Yes. The tester applies controlled bending angles, fixed test frequency, and a defined number of bi-directional cycles in accordance with relevant standards. Combined with stable mechanical structure and clear digital display, it provides repeatable and dependable test results.

3. Which international or industry standards does it comply with?

The device complies with GB15811 for sterile disposable injection needles, GB18457 for stainless steel medical needles, and ISO 9626 for stainless steel needles for medical use.

4. Why is this product important?

Needle toughness is critical to prevent fracture or excessive deformation during clinical use. By verifying bending durability before packaging and distribution, this tester helps ensure patient safety, product reliability, and compliance with regulatory requirements.

5. Which fields is this product suitable for?

The tester is suitable for medical disposable injection needle manufacturing, insulin pen needle production, blood collection needle testing, IV infusion needle verification, and research and quality control activities in medical device laboratories and production facilities.


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