Medical Fluid connectors cover photo of luer locks. catheters, and mandrels

Catheters, Medical Fluid Connectors, Luer Fittings Mechanical Testing Solutions

Medical fluid connectors are utilized within intravascular or hypodermic applications of medical devices/instrumentation to facilitate a leak-free administration of various fluids to a patient through a central line, eliminating the need for multiple needle insertions within a given patient. Catheters, used for cardiovascular, urological, gastrointestinal, neurovascular, and ophthalmic applications, may be inserted into vessels, skin tissue, body cavities or the brain.

As with most devices in the medical industry, medical fluid connectors and catheters must adhere to strict manufacturing and testing protocols. ADMET testing systems are trusted by leading medical device manufacturers, universities, and research laboratories to determine the mechanical properties and endurance limits of medical devices, luer fittings, catheters, and biomaterials. Our systems meet FDA 21 CFR part 11 requirements and are capable of performing tension, compression, flexural, adhesive, torsion, axial-torsion and planar biaxial tests according to ASTM and ISO standards. Our ability to design a system to fit specific needs allows ADMET to provide testing solutions for even the most unique and demanding applications.

Common Medical Fluid Connectors that Require Mechanical Testing

intravascular stent

Stents

Intravascular Stents

Also known as endovascular or vascular stents, intravascular stents are synthetic tubular structures intended for permanent implant in native or graft vasculature. These stents provide mechanical radial support after deployment to enhance vessel patency over the life of the device. In order to maintain vessel patency, the device must deform within the in-vivo loading environment without a flow-limiting loss in lumen area. Mechanical testing provides information on properties such as kink resistance and durability.

Balloon Expandable Stents

Balloon expandable stents are stents that expand once they reach the intended location by a balloon catheter. The stent remains expanded after the deflation of the balloon. Balloons must withstand multiple inflations during clinical use to avoid inducing device failure or vessel damage. Mechanical testing results provide information on balloon cycle fatigue, balloon-rated burst pressure, and more.

Self-Expanding Stents

A self-expanding stent’s diameter increases from its pre-deployed size to its post-deployed size in the absence of balloon inflation or other mechanical assistance. The self-expanding quality can result from material properties or geometry or both. Raw material mechanical testing results are required for the device to work as intended.

Luer Lock

Luer Fittings

Luer fittings or luer-lock fittings are intended to connect two medical devices in a liquid-leak-proof and mechanically secure manner. Applications for these male and female tapered, interlocking fittings include but are not limited to, syringes, needles, stopcocks, IV sets, and diagnostic and therapeutic catheters. Mechanical testing of luer fittings is performed to ensure they do not misconnect with other fluid connectors, and they safely and securely connect with their mating half.

catheter

Catheters and Tubing

Catheters and tubing are medical devices designed to be inserted into the body to treat diseases or perform surgical procedures. They serve various functions such as draining fluids, administering drugs, and gaining access to surgical sites. The design and mechanical properties of catheters vary based on their intended application, ranging from cardiovascular and urological to neurovascular uses. Mechanical testing is crucial to ensure their safety, durability, and efficacy, particularly because any failure could lead to significant medical complications.

Syringes

Syringes or hypodermic needles are intended for use to inject the drug substances into the bloodstream. Mechanical testing of hypodermic needle quality testing provides information on gauging, leakage, and needle insertion/penetration to ensure the end product is safe and efficacious.

Talk to our Engineers

Work with our engineers to design a testing solution for your application.

We are happy to help!
Talk to our Engineers

Common Medical Fluid Connector Test Types & Standards:

Axial-torsion testing on luer locks vertical

Axial-Torsion Testing

ISO 80369-7:2021 is the current test standard to test small-bore connectors intended to be used for connections in intravascular applications or hypodermic connections in hypodermic applications of medical devices and accessories.  The standard is categorized into annexes, eight of which are applicable for mechanical testing performed to evaluate the performance requirements of the medical connectors. These annexes include:

three point bend test performed in a small material testing machine

Bend Testing

Bend testing provides information on the ability of catheters to bend in order to accommodate a predetermined clinically relevant radius or angle during access and delivery. Bending flexibility of a stent system may be a factor in its ability to track through the vascular anatomy, and may be a factor in vascular trauma along the delivery pathway distal to the guide catheter. Bending flexibility of a deployed stent may be one measure of its ability to flex with a vessel, or to conform to the natural curvature of a vessel. 

Bend test setup includes a universal testing machine equipped with a bend fixture where the test specimen is placed on two lower supports. The force is then applied through a loading nose. The results of bend testing provide information on a catheter’s flexural properties as well as kink resistance and rigidity.