ASTM F 623 : 2025

1.1This performance specification establishes performance requirements for the short-term (>24 h and <30 days) utilization of a single-use, balloon-retention catheter, French sizes 12 through 26 inclusive, used by the medical professionals for providing a means of bladder drainage by means of the urethra. The product is manufactured in various sizes and materials such as latex, silicone, rubber, and various polymers (as well as combinations of these) and is provided non-sterile for sterilization and sterile for single use only.

1.2Catheters whose surface has been chemically treated to effect biocompatibility or microbial properties may be tested to this specification. This standard does not comprehensively cover these types of catheters.

1.3Catheters whose surface has been chemically treated to enhance their lubricity with a coating may be tested to this specification. This standard does not comprehensively cover these types of catheters.

1.4The annexes in this specification include detailed information, such as apparatus or materials for this specification.

1.5The appendixes in this specification contain information intended to provide guidance only and are not a mandatory part of the specification.

1.6Regulatory bodies may require additional information, including clinical data, to support marketing authorization.

1.7The values stated in SI units are to be regarded as the standard. The values given in parentheses are for information only.

1.8Exclusions—Long-term indwelling usage (over 30 days) is encountered with this product, but not commonly, and is therefore considered an exception to this specification. Similarly, the use of such catheters for nonurethral catheterization (such as for nephrostomy, suprapubic cystostomy, ureterostomy, gastrostomy, enemas, and so forth) is excluded from the scope of this specification. Likewise, three lumen catheters, 30 mL balloon and pediatric catheters, and catheters whose surface has been enhanced for lubricity using liquids or gels.

1.9This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

1.10This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.