1.1 This performance specification establishes performance requirements for the short-term (>24 hours and <30 days) utilization of a single-use, three-lumen, 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.
1.2 Catheters 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 devices (e.g. efficacy of surface treatments).
1.3 Catheters whose surface has been chemically treated to enhance their lubricity with a solid or polymer coating may be tested to this specification. This standard does not comprehensively cover these devices (e.g. efficacy of surface treatments).
1.4 The annexes in this specification include detailed information, such as apparatus or materials for this specification.
1.5 The appendixes in this specification contain information intended to provide guidance only and are not a mandatory part of the specification.
1.6 Regulatory bodies may require additional information, including clinical data, to support marketing authorization.
1.7 The values stated in SI units are to be regarded as the standard. The values given in parentheses are for information only.
1.8 Exclusions—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, two-lumen, 30-cm3 balloon and pediatric catheters, and catheters whose surface has been enhanced for lubricity using liquids or gels have not been tested to this specification and are excluded from the scope of this specification and will require separate standard development.
1.9 This standard may involve hazardous materials, operations, and equipment. This standard does not purport to address all of the safety concerns associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
Foley, Catheter, three-way, return flow, 3 way
New standard for catheters with three lumens. No ASTM standard for three-lumen catheters exists.
Medical Device Industry and Testing Labs
The title and scope are in draft form and are under development within this ASTM Committee.
Developed by Subcommittee: D11.40
Staff Manager: Melissa Marcinowski
Date Initiated: 01-07-2022
Technical Contact: Christopher Waddell
Ballot: D11.40 (22-01)
Status: Will Reballot Item