EUROLAB, with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of ASTM F1828 testing. This specification covers referee testing methods for evaluating the performance characteristics of a disposable ureteral stent with retention devices at both ends during short-term use for kidney-to-bladder drainage of urine.
These stents are typically available in diameters of 3,7 Fr to 14,0 Fr and lengths from 8 cm to 30 cm and are made of silicone, polyurethane and other polymers. They are supplied non-sterile for sterilization and sterile for single use.
Long-term persistent use (more than 30 days) is encountered with this product, but is not common and therefore considered an exception to this specification. Similarly, the use of ureteral stents for non-ureteral applications such as nephrostomy and ileostomy is outside the scope of this specification. Non-sterile ureteral stents were also excluded because of the variability of hospital sterilization equipment and procedures and the consequent impact on ureteral stent properties.
This standard does not purport to address all, if any, safety concerns associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and to determine the applicability of regulatory restrictions prior to use.
This international standard has been developed in accordance with the internationally accepted principles of standardization set out in the Resolution on Principles for the development of international standards, guidelines and recommendations published by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
EUROLAB assists manufacturers with ASTM F1828 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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