EUROLAB, with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of ISO 10555-2 testing. This part of IS0 10555 specifies requirements for angiographic catheters provided in sterile condition and intended for single use.
For the purposes of this section of IS0 10555, the definitions given in IS0 10555-I and the following definitions apply.
Angiographic catheters are intravascular catheters used for the injection or infusion of contrast media or fluids and can be used for pressure measurement and blood sampling.
The nominal size of the catheter should be determined in accordance with IS0 10555-I as well as the diameter of the largest guidewire that can be used with the catheter. If the inside diameter of the catheter is also specified, it should be expressed in millimeters and rounded to the nearest 0,1 mm.
The tip of the distal tip should be flat, rounded, tapered or similarly finished to minimize trauma to the vessels during use.
The catheter is connected to a hydraulic pressure source via its hub or proximal end. Pressure is applied for a fixed period of time and the sample is inspected for rupture and leakage under pressure and for evidence of leakage, damage or deterioration after pressure has been released.
While applying pressure, inspect the catheter for rupture and leakage (ie formation of one or more falling drops of fluid). After the pressure is relieved, disconnect the catheter from the test apparatus and inspect for damage, tears or leaks. Try to pass the ring gauge freely along the test portion of the catheter shaft.
EUROLAB assists manufacturers with ISO 10555-2 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.
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