Product Specification

NTT-01 Needle Toughness Tester

Introduction to the Needle Toughness Tester

The Needle Toughness Tester (NTT-01) is a high-performance testing instrument designed to evaluate the mechanical integrity of hypodermic needles. By simulating the stress experienced during insertion and withdrawal, this tester ensures that needles maintain their structural integrity under typical operational conditions. The Needle Toughness Tester complies with ISO 9626:2016 (Annex C) standards and is an essential tool for quality control in the production of medical needles, providing critical insights into their resistance to breakage and failure.
Manufacturers in the medical and pharmaceutical industries rely on this precise testing method to guarantee that their products meet stringent quality requirements. With a user-friendly interface and robust technical features, the NTT-01 is an indispensable tool for any laboratory focused on ensuring the reliability of hypodermic needles.

Applications of the Needle Toughness Tester

The Needle Toughness Tester is primarily used for testing the toughness and bending resistance of hypodermic needles, particularly in the context of:

• Medical Device Quality Assurance: Ensuring the durability of needles used in medical procedures.
• Pharmaceutical Manufacturing: Verifying the mechanical integrity of needles before they are used in packaging for injection systems.
• Regulatory Compliance: Meeting industry standards such as ISO 9626 and GB/T 18457, which require detailed testing of the mechanical properties of medical needles.
• Lab Research and Development: Providing a reliable method for testing new needle designs and materials.

By assessing the ability of needles to withstand mechanical forces during insertion and withdrawal, this tester ensures that needles can perform their function safely without failure or damage.

Working Principle of the NTT-01 Needle Toughness Tester

The Needle Toughness Tester operates by applying a controlled bending force to a hypodermic needle or tubing. The tester applies a force at a specified distance from the needle’s base, bending it in one direction through a precise angle (25 ± 1° for regular-walled, 20 ± 1° for thin-walled, and 15 ± 1° for extra-thin-walled and ultra-thin-walled tubing). This test simulates the mechanical stresses encountered during needle insertion and withdrawal, and the force is applied in both directions, ensuring comprehensive testing.
Test Cycle Details:

• Two-way Bending: The needle is bent first in one direction, then in the opposite direction, ensuring a thorough evaluation of its toughness and flexibility.
• Frequency Control: The test frequency is precisely controlled to simulate the real-world conditions under which hypodermic needles are used.
• Angle Specification: Depending on the tubing thickness, the tester bends the needle to specified angles, ensuring the test replicates actual usage conditions accurately.

The system is capable of applying a force strong enough to cause bending in both directions, ensuring that the needles do not break or deform under stress. This test is repeated over a specified number of cycles, providing valuable data on the mechanical durability of the needle.

Key Features of the NTT-01 Needle Toughness Tester

The Needle Toughness Tester offers a range of advanced features, making it one of the most reliable and efficient instruments for testing the toughness of hypodermic needles:

• PLC Control with HMI Interface: The tester features a programmable logic controller (PLC) that allows for precise control of all test parameters. The 7-inch HMI touchscreen makes it easy to set up and monitor tests in real time.
• Variable Test Speed and Frequency: The test speed can be adjusted to suit different testing needs, and the frequency of test cycles is highly accurate, enabling precise simulations of needle usage.
• Automatic Bending Mode: The device can perform both two-way and one-way bending, depending on the test requirements.
• Power Failure Protection: In case of a power failure, the Needle Toughness Tester automatically returns to its starting position, preventing any damage to the system.
• Data Output: The system is equipped with a microprinter to output test results in a format that is easy to analyze and document.
• Dwell Time Control: The dwell time between bending cycles is adjustable, providing further flexibility for different testing conditions.

Technical Specifications

• Test Method: Follows ISO 9626 Annex C for needle breakage resistance testing
• Control System: PLC-controlled with 7-inch HMI touchscreen
• Data Output: Microprinter for test result documentation

Compliance with International Standards

The Needle Toughness Tester is fully compliant with ISO 9626:2016 Annex C and GB/T 18457 standards, which define the test methods for evaluating the mechanical properties of medical needles and tubing. Compliance with these standards ensures that the Needle Toughness Tester is a trusted and reliable tool for manufacturers looking to meet the highest quality control standards in the industry.

Related Products

For a comprehensive testing solution, the Needle Toughness Tester can be paired with other testing instruments designed for medical and pharmaceutical packaging, including:

• TS-01 Tubing Stiffness Tester: Measures the stiffness of medical tubing to ensure it meets required mechanical properties.
• MPT-01 Medical Packaging Tester: Assesses the integrity and durability of medical packaging materials under stress.
• MST-01 Medical Syringe Tester: Tests the overall performance and safety of syringes used in medical applications.
• SLT-02 Syringe Leak Tester: Ensures that syringes and other medical devices are free from leaks and can maintain their integrity during use.