Determination of Mechanical Strength in Catheter Tube and Connection Systems

Catheter systems are among the most critical medical products directly affecting patient safety. The mechanical strength of tubes, connectors, and junction components used in these systems is essential to prevent risks such as separation, breakage, or leakage during clinical use. For this reason, catheter systems must be tested in accordance with internationally recognized standards. DIN EN ISO 10555 defines mandatory tensile testing requirements to verify the safety and reliability of catheter system connections.

Main Purpose of the Device

The primary purpose of the tensile testing device used for catheter systems is to measure insertion, retention, and connection forces between catheter tubes and their connectors. The device evaluates the mechanical behavior of the connection up to failure or separation, providing quantitative and repeatable data that reflect real usage conditions.

What Is the DIN EN ISO 10555 Test?

The DIN EN ISO 10555 test is a tensile test applied to evaluate whether the components forming a catheter system are securely connected. During the test, each connection element is subjected to a controlled tensile load until separation, breakage, or failure occurs, and the mechanical response of the connection is analyzed.

Importance and Objective of the Test

The main objective of this test is to verify the safety of catheter systems against tensile forces that may occur during clinical use. Insufficient connection strength can lead to serious complications; therefore, test results are considered a direct indicator of product quality and patient safety.

Scientific Basis of the Test

The tensile test is based on measuring the mechanical behavior of materials and connection systems under tensile stress. The relationship between applied force, elongation, and failure point is evaluated to determine the maximum load capacity and elastic–plastic behavior of the catheter connection.

Use of the Device

During testing, the catheter system is fixed to the device using appropriate fixtures. Tensile force is applied upward at a controlled speed. The test automatically stops when breakage, separation, or a predefined displacement is reached. Force and displacement data are digitally recorded and analyzed.

Technical Information

The device allows stopping based on breakage, fracture, or displacement. Its robust and reliable structure does not require special maintenance. A color touchscreen ensures intuitive operation. The wide speed range enables suitable test conditions for different catheter structures. High force and movement sensitivity improve measurement accuracy. Multiple force units and multilingual interface options support use in international laboratories.

Advantages

Technical Advantages

High force measurement accuracy and precise motion control ensure repeatable and reliable test results. Compatibility with various sample sizes allows testing of catheter systems with different diameters and designs.

Contribution to Quality Control

Tensile testing during production enables early detection of weak or defective connections, supporting consistent product quality and improving manufacturing reliability.

Support for Export and Certification

Tests performed in compliance with DIN EN ISO 10555 facilitate acceptance of products in international markets. They provide essential technical evidence required for certification and regulatory approval processes.

Areas of Application

This test system is widely used by medical device manufacturers, quality control laboratories, R&D centers, and certification bodies. Verifying the reliability of catheter systems is a critical requirement for both manufacturers and end users.

DIN EN ISO 10555

This standard is applied to evaluate the mechanical strength of connection elements in intravascular and similar catheter systems. It covers the measurement of tensile strength between catheter tubes and connectors and aims to ensure safe and reliable use.

Conclusion

The DIN EN ISO 10555 tensile test of catheter systems is an essential evaluation method for ensuring medical product safety. Accurate, reliable, and standard-compliant tensile testing clearly demonstrates the mechanical performance of catheter systems, enhancing product quality and maximizing patient safety.