Test Methods for Catheters and Medical Tubing
Medical catheters are typically inserted into canals, vessels, passageways, or body cavities to inject or remove fluids from the body. Applications include drug delivery, urology, neuromodulation, balloon angioplasty, dialysis, and more. Failure of these devices can result in severe patient injury. As a result, mechanical testing is used for research and development purposes, as well as quality control. Mechanical testing is also required by the Food and Drug Administration’s (FDA) guidance documents to demonstrate device safety.
Breaking strength of the tubing is a critical measurement of product quality. In addition, it’s imperative to test the catheter’s frictional forces during insertion and removal from the body. ISO 1055-1 outlines general requirements for testing intravascular catheters.
The challenges of testing catheters and medical tubing are:
- Finding a gripping solution that does not cause jaw breaks
- Testing at body temperature
- Having a low force system with sufficient travel for tensile testing
- Low force load cell for frictional testing
- Flexible software that can conduct both tortuosity tests for friction measurements, as well as standard tensile tests
- Finding a gripping solution that does not cause jaw breaks – Instron offers pneumatic cord and yarn grips that are highly effective at preventing slippage and reducing the clamping stress applied to the specimen. The reduced clamping stress helps prevent jaw breaks.
- Testing at body temperature – For testing at body temperature, Instron offers the BioBox, which can surround a single column 5900 Series or 3300 Series system for testing at 37°C.
- Having a low force system with sufficient travel for tensile testing – The 5944 model is a low force test system that also has sufficient travel for testing high elongation catheters.
- Low force load cell for frictional testing – For tortuosity testing, Instron offers a catheter test system that enables the frictional forces of a catheter or piece of medical tubing to be quantified. The system is a 5900 Series test system, mounted horizontally, that utilizes two low force load cells to average force measurements during testing. The catheter test system enables simulation testing of how a doctor, nurse, or surgeon would insert the catheter into a patient’s body.
- Flexible software that can conduct both tortuosity tests for friction measurements, as well standard tensile tests – Bluehill® Universal software enables users to conduct both standard tensile tests of catheters, as well as frictional tests on catheters using a horizontal test system.
5900 Universal Testing Systems are engineered for precision, built for durability, and offer the flexibility for changing requirements. They are designed with standard and optional features that increase testing efficiency and improve the testing experience for the operator. A wide range of models are available for testing capacities from < 100N up to 600kN.
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Instron 3300 Series Universal Testing Systems for Tensile, Compression, Bend, and other material property tests.
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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.
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The Instron® Catheter Testing System is designed for both tortuosity and tensile testing of catheters. The system can be easily moved from a vertical a to horizontal position to allow for different test setups. The horizontal tortuoisity testing setup uses unique,averagind dual load cell approach to minimize the effects of side-loading, increasing the accuracy of load readings for low-force friction tests.
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Within the medical device industry, regulatory agencies often test internally-based devices and implants in a physiological state. The Instron® BioBox meets the growing trend of testing actual medical devices and biomaterials at body temperature (37°С). For large or long devices, testing in а liquid may not bе practical. As an alternative, testing inside а controlled air environment at body temperature provides а powerful solution. The BioBox can bе incorporated as а standard item on а new single column frame or in selected models already in operation. This bох permits the full travel test of sutures, catheter tubings, latex gloves, and а wide variety of other devices and biomaterials at physiologically relevant temperatures.
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Hospital and surgical products are often consumable and designed for one-time patient use, such as catheters, guide wires, intravenous lines, tubing, and an assortment of wound closure products such as bandages, sutures, and staples that require mechanical testing to ensure product quality.
- 3.0 MB