ASTM International - ASTM F623-19
Standard Performance Specification for Foley Catheter
|Publication Date:||1 March 2019|
|ICS Code (Transfusion, infusion and injection equipment):||11.040.20|
1.1 This performance specification establishes performance requirements for the short-term utilization of a single-use, balloon-retention catheter, French sizes 12 through 26 inclusive, used by the medical professions 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. Catheters whose surface has been chemically treated to effect biocompatibility or microbial properties may be tested to this specification.
1.2 Catheters whose surface has been chemically treated to enhance their lubricity with a coating may be tested to this specification.
1.3 The annexes in this specification include detailed information, such as apparatus or materials for this specification.
1.4 The appendixes in this specification contain information intended to provide guidance only and are not a mandatory part of the specification.
1.5 Regulatory bodies may require additional information, such as clinical data, to support different design features.
1.6 The values stated in SI units are to be regarded as the standard. The values given in parentheses are for information only.
1.8 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.
1.9 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.