Designation

This standard is issued under the fixed designation F623; the number immediately following the designation indicates the year of original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A superscript epsilon (ε) indicates an editorial change since the last revision or reapproval.

INTRODUCTION

The objective of this specification is to describe those product requirements and associated test methods that will assess the safety and effectiveness of a disposable, 5 mL balloon, retention-type catheter used in urinary bladder drainage.

This specification includes referee test methods that can be used to determine compliance with the stated performance requirements. Note that the test methods are not to be construed as production methods, quality control techniques, or manufacturer’s lot release criteria.

This specification represents the state of the art at this time and is a minimum performance specification. It is recognized that the document must remain dynamic; suggestions for revision are encouraged, and should be directed to ASTM, 100 Barr Harbor Dr., PO Box C700, West Conshohocken, PA 19428-2959.

1. Scope

1.1

This 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.

1.2

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 types of catheters.

1.3

Catheters 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.

1.4

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, three lumen catheters, 30 mL balloon and pediatric catheters, and catheters whose surface has been enhanced for lubricity using liquids or gels.

1.9

This standard does not purport to address all of thesafety 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.

1.10

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.

2. Referenced Documents

2.1

2.2

2.3

3. Terminology

3.1

4. Requirements5

4.1

4.2

4.3

4.4

4.5

4.6

4.7

4.8

5. Special Precautions

5.1

6. Keywords

6.1

ASTM F623 - 25

Standard Performance Specification for Foley Catheter

Current

Published:

1 Jun 2025