ISO 10555 - Tensile Testing of Catheter Tubing

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.

ISO 10555 requires a universal testing machine to evaluate the tensile properties of the catheter body as well as the joint strength of the connectors and hubs attached to the catheter. Because this test primarily measures maximum force, a basic system such as Instron's 3400 Series is appropriate, though labs with multiple testing applications may require the advanced features found in Instron's high-tier 6800 Series. No extensometry is required by the standard, but some customers will use either a long travel contacting extensometer or video extensomter for extensometry measurements.

Catheters undergoing tensile testing usually elongate significantly during testing and experience extrusion from the grip faces. As such, they generally require pneumatic gripping solutions, as manual grips will result in slippage once elongation reaches a certain point. Catheters diameter is another factor to consider, with very small diameter catheters often being tested on pneumatic cord and yarn grips.

ISO 10555 requires specimens to be conditioned at 37 degrees Celsius to mimic body temperature. Instron's Biobox encloses the entire system in a controlled environment at 37 C in order to simplify the conditioning and testing process.