ISO 10555 Tensile Testing of Sterile Single Use Intravascular Catheters

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ISO 10555 Tensile Testing of Sterile Single Use Intravascular Catheters

Noninvasive surgery is one of the fastest growing areas of medical science. Doctors are using the “cath lab” more often in lieu of traditional surgery, in favor of the reduced risk and shorter recovery times. Innovative medical procedure proposals and incremental technology improvements are driving researchers to turn to International Organization for Standardization and ATSM standards for their product testing. Catheter researchers can look into ISO 10555 for high-quality testing procedures.

ISO 10555 defines tests for intravascular single use catheters. Catheter types that can be tested according to this standard include angiographic catheters, central venous catheters, balloon dilation catheters and over-needle peripheral catheters. ISO 10555 recommends testing for corrosion, force at break, liquid leakage under pressure and air leakage.

Testing procedure

The standard establishes the need to test each portion of the catheter, including each tube, hub, connector and junction. ISO 10555 asks for a measure of tensile force until a break occurs or until a junction separates. Typically, the load requirements are at 15 N (3 lbs) and test speed must be accurately controlled based on the sample length, up to a strain rate of 20 mm/min/mm strain rate.

With advanced experience in the biomedical field, we offer comprehensive solutions to test catheters in accordance to ISO 10555 standards. One of our more popular products used for ISO 10555 include the 220 Series Universal Test Machines. This machine is capable of exerting pressures at or below 5 kN with a relatively high stroke, perfect for elongating samples such as catheters. Another product that can be used to test ISO 10555 is the 100 Series Universal Test Machines. This machine exerts forces up to 10 kN and comes with an array of options for controllers, actuators and accessories. The vice grip has v-jaws meant for better gripping of round samples.

Give one of our experienced application engineers a call today for assistance with your testing plan and budget according to ISO 10555.