Introduction to Syringe Needle Break Resistance Testing

Syringe needle break resistance testing plays a crucial role in ensuring the safety and effectiveness of hypodermic needles. Needles must withstand the mechanical stresses encountered during medical procedures, including insertion and withdrawal. A needle that breaks during use can lead to serious health risks such as injury or contamination, making the testing of needle break resistance a vital part of the quality control process.

One of the most widely recognized standards for syringe needle testing is ISO 9626. This international standard outlines the requirements for the materials, dimensions, and mechanical properties of hypodermic needles, including specific testing methods to evaluate their resistance to breakage. By adhering to ISO 9626, manufacturers ensure that their needles meet safety standards and are fit for medical use.

Understanding ISO 9626 and Syringe Needle Testing

ISO 9626 Overview

ISO 9626:2016 is an international standard that provides specifications for the dimensions, materials, and performance of hypodermic needles. The standard ensures that needles are manufactured to precise tolerances, using materials that can endure the forces encountered during typical medical procedures.

In particular, ISO 9626 specifies test methods for the resistance of needles to breakage, which are critical to ensuring the durability of needles under normal operational conditions. These tests help identify any structural weaknesses that could lead to needle failure, thereby preventing potential injuries or complications during use.

ISO 9626: Annex C (Test Method for Resistance to Breakage)

The test method for resistance to breakage described in Annex C of ISO 9626 is focused on simulating the mechanical stresses that hypodermic needles experience during medical procedures. This test involves bending the needle tubing at specified angles to determine its resistance to breakage under repeated stress cycles.

Test Principle

The test begins by fixing one end of the needle tubing and applying a bending force to the opposite end at a certain distance. The force causes the needle tubing to bend at an angle, either in one direction or both directions, with the tubing being subjected to multiple cycles of bending. The test helps determine whether the needle can withstand the mechanical stress without breaking.

Test Parameters

The key parameters for the test include:

Bending Angle: Needles are bent at an angle of 25° for regular-walled tubing, 20° for thin-walled tubing, and 15° for extra-thin-walled or ultra-thin-walled tubing.
Test Frequency: The bending process is repeated at a rate of 0.5 Hz, simulating the stresses experienced during use.

The test is conducted over 20 complete cycles, and any visible signs of breakage are recorded. This helps identify weak points in the needle that could lead to failure in real-world medical applications.

NTT-01 Needle Toughness Tester: Features and Benefits

The NTT-01 Needle Toughness Tester is designed to perform syringe needle break resistance tests in strict accordance with ISO 9626. This instrument is crucial for evaluating the mechanical durability of hypodermic needles and ensuring they can withstand the bending forces encountered during use.

Working Mechanism

The NTT-01 Needle Toughness Tester works by fixing one end of the needle tubing in place while applying a force at a specified distance to bend the tubing. This force is applied in both directions, simulating the conditions the needle would encounter during insertion and withdrawal. The test is performed in cycles to measure the needle’s ability to endure repetitive stresses without breaking.

Test Modes

The NTT-01 provides flexibility in testing by offering both one-way and two-way bending modes. This allows for a comprehensive evaluation of needle durability under different conditions, which is essential for meeting ISO 9626’s requirements.

Key Features

PLC-Controlled System: The NTT-01 is equipped with a programmable logic controller (PLC) and a 7-inch HMI touchscreen, making it easy to operate and control the test parameters.
Variable Test Speed: The instrument allows for precise control of the test speed, which can be adjusted according to the specific needs of the test.
Automatic Return: In case of power failure, the system automatically returns to its previous position, ensuring continuity in testing.
Compliance with ISO 9626: The NTT-01 complies with ISO 9626 Annex C, making it a reliable tool for performing syringe needle break resistance tests.

Benefits of Syringe Needle Break Resistance Testing

Enhanced Product Safety

By conducting syringe needle break resistance testing, manufacturers can ensure that their needles are durable enough to withstand the stresses of medical procedures. This reduces the risk of needle breakage, which could result in injuries to patients or healthcare professionals.

Quality Assurance

Syringe needle break resistance testing helps manufacturers meet regulatory requirements and quality standards, such as ISO 9626. By adhering to these standards, manufacturers can ensure that their products are consistent, reliable, and safe for use in medical settings.

Cost Savings

Testing for break resistance can help manufacturers avoid costly recalls or legal issues by identifying potential defects before the needles reach the market. This proactive approach saves money in the long run by ensuring the release of high-quality, durable products.

Key Standards for Syringe Needle Break Resistance Testing

In addition to ISO 9626, there are other relevant standards that govern syringe needle testing, including:

GB/T 18457: A Chinese standard for testing the resistance of needles to breakage, which aligns closely with ISO 9626.
ASTM F2922: A standard for the testing of the mechanical properties of needles, including resistance to breakage.

These standards help establish a benchmark for the performance of hypodermic needles and ensure that they meet the required specifications for safety and reliability.

Conclusion

Syringe needle break resistance testing is a vital process for ensuring the durability and safety of hypodermic needles. By adhering to ISO 9626 and using tools like the NTT-01 Needle Toughness Tester, manufacturers can ensure that their needles meet the highest safety standards and perform reliably during medical procedures. This testing not only protects patients but also ensures that manufacturers remain compliant with industry regulations.

For more information on the NTT-01 Needle Toughness Tester and how it can help improve the quality of your syringe needles, contact us today.

FAQ Section

What is syringe needle break resistance testing?
- Syringe needle break resistance testing evaluates the needle’s ability to withstand mechanical stress during insertion and withdrawal to prevent breakage.
How does ISO 9626 relate to syringe needle testing?
- ISO 9626 sets the standard for the dimensions, materials, and mechanical properties of hypodermic needles, including the testing methods for break resistance.
What is the NTT-01 Needle Toughness Tester?
- The NTT-01 Needle Toughness Tester is a machine used to perform the bending test required by ISO 9626, ensuring the break resistance of hypodermic needles.
How do you perform the syringe needle break resistance test?
- The test involves bending the needle tubing at a specified angle and frequency, in one or two directions, to evaluate its durability under stress.
What are the benefits of syringe needle break resistance testing?
- The test ensures needle safety, prevents injuries, and helps manufacturers meet industry standards and regulatory requirements.

NTT-01 Syringe Needle Break Resistance Testing Equipment