TS-01 Syringe Tube Stiffness Tester

Overview

Den Syringe Tube Stiffness Tester (TS-01) is a high-precision testing device designed to measure the stiffness of medical tubing, particularly hypodermic needles and syringes. As stiffness directly impacts the safety, flexibility, and overall performance of medical tubing, accurate stiffness testing is essential to ensure that tubing maintains the right balance of mechanical strength and flexibility. Overly stiff tubing can increase the risk of breakage or brittle fractures, while overly soft tubing can lead to bending, damage, and potentially unsafe medical procedures.

Den Medical Needle Stiffness Tester is engineered to simulate real-world conditions by applying a specified force to the center of the tubing and measuring its deflection. This ensures that the tubing has the necessary stiffness to perform safely in medical applications, such as injections, infusions, and other critical procedures.

Applications

The TS-01 Syringe Tube Stiffness Tester is used extensively in the medical, pharmaceutical, and packaging industries where precise control over tubing characteristics is vital for product safety. Its primary applications include:

• Syringe Manufacturing: Ensuring that syringes, hypodermic needles, and catheters have the required level of stiffness to minimize risk during insertion and operation.
• Medical Device R&D: Testing new designs and materials used in medical tubing to comply with international safety standards, such as ISO 9626.
• Quality Control: Routine testing of medical packaging materials, such as flexible tubes and injection sites, to ensure they meet regulatory requirements and function as intended during clinical use.
• Medical Packaging: Verifying that tubes used in medical packaging are neither too stiff (which can make them brittle) nor too soft (which can cause flexibility issues during use).
• Pharmaceutical Industry: Ensuring that the drug delivery system is safe and reliable by testing the tubing used in syringes and infusion sets.

Necessity

In the medical industry, tube stiffness is not just a quality feature—it is a critical safety factor. The stiffness of a syringe or hypodermic needle affects its overall performance, and improper stiffness can result in various operational issues, such as difficulty in insertion, breakage, or malfunction during medical procedures. Tubing that is too stiff can become brittle and fail when subjected to stress, leading to catastrophic failure during a procedure.

Conversely, tubing that is too flexible or soft can lead to bending, kinking, or deformation, which can also cause errors in medical procedures or even compromise sterility. The Syringe Tube Stiffness Tester provides an essential tool to measure and verify that the tubing used in these devices is optimized for safety, flexibility, and strength.

Working Principle

The TS-01 Syringe Tube Stiffness Tester operates on a straightforward but highly effective principle. During testing, a specified force (up to 60 N) is applied at the center of the tubing, which is supported at both ends. The tester measures the deflection of the tubing in response to this applied force.

Key Features:

• Force Application: A blunt wedge-shaped plunger, inclined at 60° and with a cylindrical radius of 1 mm, applies a controlled downward force to the tubing.
• Deflection Measurement: The tester measures the deflection of the tubing to an accuracy of ±0.01 mm, which is indicative of the stiffness of the material.
• Force Range: The device is capable of testing tubing with forces ranging from 1 N to 60 N, providing a versatile range of measurements.

The result of this test directly correlates to the stiffness of the tubing and helps manufacturers ensure the product is within the acceptable range for safety and functionality in medical environments.

Technical Specifications

The TS-01 Syringe Tube Stiffness Tester boasts a range of high-precision features that make it an indispensable tool for medical device testing. Here are the key specifications:

• Fixed Force: 60 N (or customizable)
• Test Speed: Adjustable between 1 and 500 mm/min
• Accuracy: ±0.01 mm in deflection measurement
• Power Supply: 110V to 220V AC
• Control System: PLC-controlled with a 7-inch HMI touch screen for ease of operation
• Test Fixture: Multiple fixtures available for downward force tests
• Overload Protection: Built-in overload protection to prevent damage to the device
• Microprinter: For immediate printout of test results

These high-precision capabilities ensure that the stiffness of the syringe tubing is measured accurately and reliably, providing results that manufacturers and regulatory bodies can trust.

Advantages

The TS-01 Syringe Tube Stiffness Tester offers several advantages over traditional stiffness testing methods:

• High Precision: The ±0.01 mm accuracy in deflection measurement ensures highly reliable results for critical applications.
• Wide Range of Application: With adjustable force up to 60 N and variable test speeds, the TS-01 is adaptable to various tubing types and testing requirements.
• Ease of Use: The PLC control system and touch screen operation simplify the testing process, making it user-friendly even for those without extensive technical expertise.
• Durability: With overload protection and automatic returning after each test, the TS-01 ensures longevity and reliability even in high-volume testing environments.
• Compliance with Standards: The tester is designed to comply with ISO 9626 and GB/T18457 standards, ensuring that all measurements meet international safety and performance guidelines.

Configurations and Accessories

Den TS-01 Syringe Tube Stiffness Tester comes with several standard configurations and optional accessories to meet various testing needs:

• Main Machine: Comprising a movable crosshead and test plunger connected to the load cell.
• Test Plunger: Precision plunger with a blunt wedge at the tip, designed to apply the specified force to the tubing.
• Test Pan: A pan to hold the tubing securely during testing.
• Power Cord and Fuse: Essential for operation and safety.

Additional accessories, such as customized fixtures for various test configurations, can be added depending on the tubing being tested.

Standarder

Den TS-01 Syringe Tube Stiffness Tester is designed to meet international standards for medical device testing, including:

• ISO 9626: Defines the required mechanical properties of stainless steel tubing used to make needles. The standard includes methods for evaluating the strength and durability of steel tubing to ensure it meets the requirements of the final product. The force required depends on the needle gauge and wall thickness, two factors that will determine the purpose of the needle. Testing is performed using a three-point bend assembly to determine the stiffness of the material. In addition, a cantilever bend test is performed to evaluate the tubing’s ability to resist fracture. This test is critical to ensure that the needle can withstand the shear forces that may be encountered in a clinical environment.
• GB/T18457: Chinese national standards for the testing of medical devices, including syringes and tubing.

These standards ensure that the TS-01 tester complies with globally recognized safety, quality, and performance requirements, making it ideal for use in regulated environments.

Support and Training

Cell Instruments offers comprehensive support for the TS-01 Syringe Tube Stiffness Tester, including:

• Technical Support: Access to expert assistance for troubleshooting and calibration.
• Training: On-site or online training for staff on how to operate the machine and interpret test results.
• Software Updates: Regular updates to the machine’s software to enhance functionality and ensure compliance with changing industry standards.