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Needle Toughness Tester – QualiMed™ NTT

Needle Toughness Tester
Product Categories
Medical Testing Equipment
Standards
ISO 9626 Annex C
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Needle Toughness Tester – QualiMed™ NTT

Needle Toughness Tester – QualiMed™ NTT is a precision mechanical testing system designed to evaluate the flexural durability and toughness of medical needle tubing under controlled cyclic bending conditions.

This Needle Toughness Tester simulates real-world bending stresses encountered during needle insertion and withdrawal, allowing manufacturers and quality laboratories to verify needle integrity, resistance to fracture, and compliance with international safety standards.

Engineered for repeatable, high-accuracy testing, the QualiMed™ NTT supports routine quality control, R&D validation, and regulatory compliance testing for hypodermic needles and related medical tubing.

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Needle Toughness Tester

Needle Toughness Tester – QualiMed™ NTT Applications

The Needle Toughness Tester – QualiMed™ NTT is used across medical device manufacturing and quality assurance environments, including:

  • Hypodermic Needle Manufacturing
    • Verifies bending resistance and toughness of needle tubing to prevent fracture during clinical use.
  • Medical Device Quality Control Laboratories
    • Ensures consistent compliance with needle toughness requirements during batch inspection.
  • Research and Development
    • Supports material selection and design optimization for needle tubing with different wall thicknesses.
  • Regulatory Compliance Testing
    • Performs standardized flex testing required by international medical device standards.
Needle Toughness Tester – QualiMed™ NTTNeedle Toughness Tester – QualiMed™ NTT
Needle Toughness Tester – QualiMed™ NTTNeedle Toughness Tester – QualiMed™ NTT

Right Bending

Left Bending

Needle Toughness Tester – QualiMed™ NTTNeedle Toughness Tester – QualiMed™ NTT

Adjusting Position Height According to Needle Length

Choose the Right Inserting Position

Applicable Standards:

  • ISO 9626 Annex C – Flexural toughness testing of stainless steel needle tubing

Needle Toughness Tester – QualiMed™ NTT Key Features

  • ISO-Compliant Bending Angles
    • Supports standard flex angles of 15°, 20°, and 25° for extra-thin, thin, and regular wall needle tubing.
  • Bi-Directional and Uni-Directional Bending Modes
    • Accurately simulates real-world flexing forces during insertion and withdrawal.
  • High-Precision Angular Control
    • Delivers bending accuracy of ±0.02° for highly repeatable test results.
  • Wide Cycle Range
    • Programmable from 1 to 100,000 cycles to support both standard compliance testing and fatigue studies.
  • PLC Control with 7-Inch HMI Touchscreen
    • Provides intuitive operation, stable performance, and precise parameter control.
  • Integrated Micro-Printer
    • Enables immediate generation of traceable test reports directly at the instrument.
  • Auto-Return Safety Function
    • Automatically restores system position after power interruption to prevent damage or operator error.
  • Adjustable Needle Positioning
    • Accommodates a wide range of needle lengths and tubing sizes with precise alignment control.

Theory and Method

The Needle Toughness Tester operates on a controlled mechanical bending principle in which one end of the needle tubing is rigidly clamped while a mechanical arm applies cyclic angular deflection at a fixed lever distance.

The system bends the needle alternately in forward and reverse directions at specified angles— 25° for regular wall, 20° for thin wall, and 15° for extra-thin wall tubing—at a constant frequency of 0.5 Hz, as defined by ISO 9626 Annex C.After completing the prescribed number of cycles, the needle is visually inspected for cracks, fractures, or structural failure to determine compliance with toughness requirements.

Needle Toughness Tester – QualiMed™ NTT Technical Specifications

ParameterSpecification
ModelQualiMed™ NTT
Product TypeNeedle Toughness Tester
Tubing Wall TypesNormal, thin, extra-thin
Tubing Metric Size0.2 mm – 3.4 mm
Bending Angle Range1° - 45°
Standard Test Angles15°, 20°, 25°
Bending Accuracy±0.02°
Test Frequency0.5 Hz
Number of Cycles1 – 100,000 cycles
Bending ModeTwo-way or one-way
Control SystemPLC
Display7-inch color HMI touchscreen
VoltageAC 110–220 V, 50/60 Hz
Applicable StandardsISO 9626 Annex C

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