ISO 10555: Tensile Testing of Intravascular Catheters

ISO 10555 catheter testing

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.

Testing System 

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.




Catheter Test Setup

1) 3400 Series Universal Testing System
2) Bluehill Universal Software
3) 2530 Series Load Cell
4) 2714-005 Pneumatic Cord and Yarn Grips

 

ISO 10555 test setup

Tensile Grips

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.

2712-041
1 kN Model | 2712-041
1 kN Model | 2714-005

Specimen Conditioning 

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.

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