 |
|
The modular platform enables realistic testing under clinical conditions. It complies with international standards including ISO 10555, DIN EN ISO 25539, and ASTM F623 |
|
Even during long tests, the feed and holding mechanism ensures highly precise measurement results (Images source: ZwickRoell)  |
ZwickRoell's new horizontal testing system for catheters provides manufacturers and development departments of interventional medical devices with a powerful tool for optimising their testing processes: The modular platform enables realistic testing under clinical-like conditions. And it complies with international standards (including ISO 10555, DIN EN ISO 25539, ASTM F623) – a decisive advantage for companies that value quality, efficiency, and regulatory compliance.
To ensure patient safety, interventional medical devices such as catheters, guide wires or insertion systems for heart valve implants must be tested under realistic conditions. Thanks to the horizontal testing system, clinical use can be simulated by combined forward and rotational movements, such as trackability, crossability, withdrawability and pushability.
The advantages: manufacturers obtain reliable, reproducible test results that shorten development cycles, accelerate validation and simplify regulatory documentation – all of which add up to clear competitive advantages in a dynamic market environment.
Modularity and ergonomics for maximum efficiency in laboratory operations
The test platform offers flexible test conditions – whether in a salt-resistant media bath, with individual anatomical models or in a fluid-flowing hose system. The height-adjustable test level enables ergonomic working and quick setup. System-controlled processes minimise operating errors and increase process reliability. And thanks to its modular architecture, the system can be easily expanded – for example, with additional sensors, actuators or customer-specific requirements. This allows the test solution to grow with the requirements of companies and remain usable in the long term. The precise feeding of test samples allows cyclical test requirements to be implemented accurately within anatomical models or individual test setups. Even with long samples, the feed and holding mechanism ensures high-precision measurement results. At the same time, the elimination of forces caused by friction/gravity allows data to be collected reliably. Submersible grippers with integrated catheter centring and individually
Compliant, auditable and robust in regulatory terms
The testing system meets all relevant international standards (ISO 10555, DIN EN ISO 25539, ASTM F623, etc.) and can be adapted to customer-specific requirements.
Time-synchronised video recording – above and below water – and direct display of results in testXpert enable transparent documentation and also allow retrospective detailed analysis of complex issues in the anatomical model and regulatory approvals. The holding/feed unit neutralises friction and weight influences of the test specimen and ensures accurate force measurement data – a decisive factor for the validation of complex product designs.
Cost-effectiveness and investment security
In addition to its technical performance, the system also offers impressive economic benefits: the salt-resistant materials guarantee durability, while the lightweight pegboard system with numbered rows and columns enables reproducible setups, quick cleaning and reduced downtime. The high availability of the system increases productivity in the laboratory and reduces operating costs in the long term.
Clinical testing redefined
The horizontal testing system is more than just a testing machine – it is a strategic tool for research and development, quality assurance, innovation promotion and efficiency enhancement. It combines technical intelligence, clinical relevance and economic scalability in a compact system.
