The guidewire peak tensile tester is designed and manufactured according to the pharmaceutical industry standard of the People's Republic of China, and the instrument conforms to the "YY0450".1-2020 Test requirements in Appendix H of Single-Use Sterile Endovascular Catheter Accessories Part 1: Guiding Devices.
Introduction to the principle of determining the peak tensile force of the guidewire:
The peak tensile force on the guidewire at the critical junction that can lead to failure should be evaluated. Any in vitro connection is not required to perform the tensile tests listed. A tensile force is applied to each test section until failure occurs.
The design and manufacture of the guidewire peak tensile tester conforms to the pharmaceutical industry standards of the People's Republic of China and conforms to the "YY0450".1-2020 Test requirements in Appendix H of Single-Use Sterile Endovascular Catheter Accessories Part 1: Guiding Devices. This instrument is primarily used to determine the peak tensile force of the guidewire, i.e., to evaluate the peak tensile force at the critical junction on the guidewire that may lead to failure. In the process of determining the peak tensile force of the guidewire, it is first necessary to clarify the structure and connection mode of the guidewire. A guidewire is usually made up of multiple segments, which are connected by junctions. These connections can be critical weak points and therefore have a significant impact on guidewire failure. In order to determine the peak tensile force of the guidewire, a tensile test is required. Tensile testing is a commonly used method for testing the mechanical properties of materials by applying tensile forces to observe the deformation and failure behavior of materials. For guidewires, tensile testing is performed at critical junctions of the guidewires until the guidewire fails. During a tensile test, the behavior of the guidewire under different tensile forces needs to be recorded. When the applied tension reaches a certain point, failure may occur at the critical junction of the guidewire. This point is the peak tensile force of the guidewire. The peak tension reflects the strength and stability of the guidewire at critical junctions. By performing a tensile test on the guidewire and recording the peak tensile force, the quality and reliability of the guidewire can be evaluated. If the peak tensile force of the guidewire is lower than the standard requirement, then there may be a quality problem with the guidewire or a weak link in the connection. This can lead to failures in real-world use, which can affect medical outcomes and patient safety. Therefore, it is very important to perform a tensile test on the guidewire using a guidewire peak tension tester and determine the peak tension force. This not only evaluates the quality and reliability of the guidewire, but also provides important data support for medical device manufacturers and regulators to ensure that the performance and safety of medical devices meet the requirements of the standard.