ISO

ISO 10555 - Tensile Testing of Catheter Tubing

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Intravascular catheters are devices used for either diagnostic purposes or to deliver treatments within the vascular system. They are commonly used to treat clogged arteries by moving through the vascular system to access the site of a blockage, where a balloon or stent is placed in order to permanently hold the artery open. Cardiac catheterization is extremely commonplace and helps prevents cardiac arrest in millions of people with high blood pressure and other cardiac risk factors. As with all medical devices, the consequences of catheter failure are severe. Because of this, regulatory bodies maintain strict testing requirements to ensure that all devices are suitable for their intended use. ISO 10555 is a testing standard that defines specifications for single-use intravascular catheters, including mechanical properties, corrosion resistance, and functional properties related to gas and liquid leakage. The various annexes of the standard correspond to various types of vascular catheters. To read the standard in full, purchase ISO 10555.