ASTM F623 Standard Performance Specification for Foley Catheter

EUROLAB, with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of ASTM F623 testing. This performance specification specifies performance requirements for short-term use of a disposable, balloon-retained catheter, French sizes 12 to 26 (inclusive), used by medical professionals to provide bladder drainage through the urethra.

The product is manufactured in a variety of sizes and materials such as latex, silicone, rubber and various polymers (and combinations thereof) and is supplied non-sterile for sterilization and sterile for single use only. Catheters whose surface has been chemically treated to affect biocompatibility or microbial properties can be tested to this specification.

Catheters that have been chemically treated to increase their lubricity with a coating can be tested to this specification.

Appendices in this specification contain detailed information for this specification, such as apparatus or materials. The appendices in this specification contain information for guidance only and are not a mandatory part of the specification. Regulators may require additional information, such as clinical data, to support different design features.

Values ​​stated in SI units will be accepted as standard. Values ​​in parentheses are for informational purposes only.

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 such catheters for non-urethral catheterization (such as nephrostomy, suprapubic cystostomy, ureterostomy, gastrostomy, enema, and the like) is outside the scope of this specification.

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, health and environmental 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 issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

EUROLAB assists manufacturers with ASTM F623 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.