ASTM F623-19 PDF

Full title and description

ASTM F623-19 — Standard Performance Specification for Foley Catheter. This specification defines performance, dimensional, and material-related requirements for single-use, balloon‑retention (Foley) urinary catheters (commonly sized French 12–26) intended for short‑term bladder drainage via the urethra.

Abstract

ASTM F623-19 sets out testable performance criteria and exclusions for non‑implantable, single‑use Foley catheters, including balloon retention, lumen patency, dimensional requirements, material and sterility considerations, and guidance in annexes and appendices. It is intended to support manufacturers, test laboratories, and regulatory submissions for short‑term urinary catheters.

General information

• Status: Withdrawn / superseded (replaced by a later revision F623-25).
• Publication date: 1 March 2019 (designation F623-19).
• Publisher: ASTM International (American Society for Testing and Materials).
• ICS / categories: 11.040.20 (transfusion, infusion and injection equipment / urology device category).
• Edition / version: F623-19 (2019 edition).
• Number of pages: 10 pages (document summary / seller listings).

Scope

The specification establishes performance requirements for single‑use, balloon‑retention (Foley) catheters intended for short‑term bladder drainage through the urethra in adult sizes French 12 through 26. Materials covered include latex, silicone, rubber and various polymers (and combinations), and the standard applies to sterile product for single use and products provided non‑sterile for sterilization prior to use. Exclusions include long‑term indwelling use (>30 days), certain pediatric sizes, three‑lumen catheters, 30 cm3 balloons and non‑urethral catheters. Annexes describe apparatus and materials and appendices provide non‑mandatory guidance.

Key topics and requirements

• Balloon retention performance and inflation/deflation characteristics.
• Dimensional and lumen patency requirements for French sizes 12–26.
• Material and construction considerations (latex, silicone, rubber, polymers; coatings and treated surfaces may be addressed).
• Sterility status, packaging, and labeling expectations for single‑use devices.
• Exclusions and limitations (long‑term indwelling, pediatric-specific devices, three‑lumen/irrigation‑type catheters, oversized balloons).
• Reference to annexes/appendices for test apparatus, methods, and non‑mandatory guidance.

Typical use and users

This specification is primarily used by medical device manufacturers (design, production and quality teams), test laboratories performing premarket and routine performance verification, regulatory affairs professionals preparing device submissions, procurement teams specifying product requirements, and clinical engineers or urology clinicians seeking performance benchmarks for Foley catheters. It has also been referenced in regulatory recognition lists for urology/ob‑gyn devices.

Related standards

Standards commonly used alongside or referenced by F623 include the ISO/AAMI/USP biocompatibility and packaging standards (for example ISO 10993 series for biological evaluation), ASTM packaging and aging/transport test methods (as applicable), and other ASTM/AAMI guidance for sterilization, labeling, and device testing. Regulatory recognition lists (such as FDA recognized consensus standards) may list F623 alongside relevant biocompatibility and packaging standards.

Keywords

Foley catheter; urinary catheter; balloon‑retention catheter; single‑use catheter; urology device; catheter performance specification; French size; sterility; biocompatibility.

FAQ

Q: What is this standard?

A: ASTM F623-19 is a performance specification that defines minimum performance, dimensional, material and testing requirements for single‑use balloon‑retention (Foley) urinary catheters intended for short‑term bladder drainage.

Q: What does it cover?

A: It covers adult Foley catheters (French sizes 12–26), including balloon retention tests, lumen patency, dimensional limits, materials (latex, silicone, polymers), sterility/packaging considerations, and lists exclusions such as long‑term indwelling use, pediatric and three‑lumen irrigation catheters. Annexes and appendices provide apparatus details and guidance.

Q: Who typically uses it?

A: Device manufacturers, contract testing laboratories, regulatory and quality professionals, purchasing/procurement teams, and clinical/urology personnel use the standard to specify, test, and evaluate Foley catheters.

Q: Is it current or superseded?

A: The 2019 edition (F623-19) has been withdrawn/superseded and is listed as replaced by a later revision (F623-25). Users should reference the most current ASTM edition (F623-25) for up‑to‑date requirements.

Q: Is it part of a series?

A: F623 is part of ASTM Committee F04 (Medical and Surgical Materials and Devices) outputs and is related by subject matter to other ASTM and international standards addressing biocompatibility, packaging, sterilization and test methods used for urology and single‑use medical devices.

Q: What are the key keywords?

A: Foley catheter, balloon retention, urinary catheter, single‑use, French size, urology, catheter performance.