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  • ASTM
    F623-99(2006) Standard Performance Specification for Foley Catheter
    Edition: 2006
    $103.58
    Unlimited Users per year

Description of ASTM-F623 2006

ASTM F623 - 99(2006)

Standard Performance Specification for Foley Catheter

Active Standard ASTM F623 | Developed by Subcommittee: F04.34

Book of Standards Volume: 13.01




ASTM F623

1. 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 nonsterile 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 ExclusionsLong-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-cm 3 balloon and pediatric catheters, and catheters whose surface has been chemically treated to enhance their lubricity have not been tested to this specification and excluded from the scope of this specification and will require separate standard development.

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.


2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.

ASTM Standards

F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices

Other Documents

U.S.PharmacopeiaAvai

Keywords

balloon catheter; bladder drainage; urology;


ICS Code

ICS Number Code 11.040.20 (Transfusion, Infusion)


DOI: 10.1520/F0623-99R06

ASTM International is a member of CrossRef.

ASTM F623

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About ASTM

ASTM International, formerly known as the American Society for Testing and Materials (ASTM), is a globally recognized leader in the development and delivery of international voluntary consensus standards. Today, some 12,000 ASTM standards are used around the world to improve product quality, enhance safety, facilitate market access and trade, and build consumer confidence. ASTM’s leadership in international standards development is driven by the contributions of its members: more than 30,000 of the world’s top technical experts and business professionals representing 150 countries. Working in an open and transparent process and using ASTM’s advanced electronic infrastructure, ASTM members deliver the test methods, specifications, guides, and practices that support industries and governments worldwide.
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