ISO 10555-4 Intravenous Catheters, Sterile and Disposable Catheters, Part 4: Standard Test for Balloon Dilation Catheters

EUROLAB laboratory provides testing and compliance services within the scope of ISO 10555-4 standard. ISO 10555-4 specifies requirements for balloon dilatation catheters supplied in sterile condition and intended for single use.

Unless otherwise specified in this part of ISO 10555, balloon dilation catheters shall comply with ISO 10555-1. The position of the balloon should be radio detectable when the catheter is inserted into the body.

The nominal size of the catheter will be indicated as follows;

• Diameters of inflated balloons, expressed in millimeters, or diameter of each segment at the recommended pressure for multi-diameter balloons;
• The effective length of the balloon at the recommended pressure;
• The diameter of the largest guidewire that can be used with the catheter, if any.

Balloon Dilatation Catheter test requirements;

• Radio detectability
• Nominal size designation
• Balloon-grade burst pressure (RBP)
• balloon fatigue
• Balloon deflating time
• From balloon diameter to inflation pressure

EUROLAB assists manufacturers with ISO 10555-4 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.