ISO 10555: Tensile Testing of Intravascular Catheters
Standard At A Glance
- ISO 10555
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.
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
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.
Instron 6800 Series Universal Testing Systems provide unparalleled accuracy and reliability. Built on a patent-pending Operator Protect system architecture with an all-new Smart-Close Air Kit and Collision Mitigation features, the 6800 Series makes materials testing simpler, smarter, and safer than ever before.
Bluehill Universal Software is built from the ground-up for touch interaction and an intuitive user experience. Discover simpler and smarter testing with features such as pre-loaded test methods, QuickTest in seconds, enhanced data exporting: and Instron Connect – a new feature that provides a direct communication link to Service. Users of previous versions of software such as Bluehill 2 and Bluehill 3 can easily upgrade to the newest version of Bluehill.
Pneumatic cord and yarn grips provide a convenient method for clamping fiber, cord, yarns and fine wires to reduce the problem associated with testing these materials.
The Instron® model XL (long travel) extensometer is a precise device for measuring strain in highly extensible materials such as elastomers, semi-rigid plastics and films.
The SVE2 is an affordable non-contacting strain measurement solution for high elongation materials. The SVE2 is ideal for elastomers and polymers that have less demanding requirements for measuring strain.