ASTM F623-19
Standard Performance Specification for Foley Catheter

Standard No.

ASTM F623-19

Release Date

2019

Published By

American Society for Testing and Materials (ASTM)

Latest

ASTM F623-19

Scope

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. 1.7 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, three lumen catheters, 30-cm3 balloon and pediatric catheters, and catheters whose surface has been enhanced for lubricity using liquids or gels. 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 This performance specification is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee F04.34 on Urological Materials and Devices. Current edition approved March 1, 2019. Published March 2019. Originally approved in 1981. Last previous edition approved in 2013 as F623–99(2013). DOI: 10.1520/F0623-19. Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States 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. 1 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.

ASTM F623-19 Referenced Document

• ASTM D1076 Standard Specification for Rubber-Concentrated, Ammonia Preserved, Creamed, and Centrifuged Natural Latex
• ASTM D3078 Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission
• ASTM D3767 Standard Practice for Rubber-Measurement of Dimensions
• ASTM D412 Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers8212;Tension
• ASTM D4483 Standard Practice for Determining Precision for Test Method Standards in the Rubber and Carbon Black Industries
• ASTM D573 Standard Test Method for Rubber-Deterioration in an Air Oven
• ASTM E691 Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
• ASTM F748 Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
• ISO 10993 Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products*， 2019-11-26 Update

ASTM F623-19 history

• 2019 ASTM F623-19 Standard Performance Specification for Foley Catheter
• 1999 ASTM F623-99(2013) Standard Performance Specification for Foley Catheter
• 1999 ASTM F623-99(2006) Standard Performance Specification for Foley Catheter
• 1999 ASTM F623-99e1 Standard Performance Specification for Foley Catheter
• 1999 ASTM F623-99 Standard Performance Specification for Foley Catheter