ASTM D8389-21 - Standard Performance Specification for Urinary Intermittent Catheters

1.1 This performance specification establishes performance requirements for the short-term utilization of a single-use, non-balloon- urinary catheter, French sizes 12 through 30 inclusive, used by the medical professions for providing a method of bladder drainage through 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 and sterile for single use only. The non-sterile catheters should be sterilized.

1.2 Catheters whose surface has been chemically treated to effect biocompatibility or microbial properties may be tested to this specification. The safety and effectiveness of antimicrobial coatings or their incorporation into device polymer materials are not within the scope of this specification.

1.3 Catheters whose surface has been chemically treated to enhance their lubricity may be tested to this specification.

1.4 Regulatory bodies may require additional information, such as clinical data, to support the subject products of this standard.

1.5 Exclusions—Catheters for non-urethral catheterization, such as for nephrostomy, suprapubic cystostomy, ureterostomy, gastrostomy, enemas, and so forth, are excluded from the scope of this specification.

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

1.7 This 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.

1.8 This 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.