ASTM-F623 Standard Performance Specification for Foley Catheter

ASTM-F623 - 1999 R13 EDITION - CURRENT
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Standard Performance Specification for Foley Catheter
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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 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 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.

1.3 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.

Keywords

balloon catheter; bladder drainage; urology; ICS Number Code 11.040.20 (Transfusion, Infusion)

To find similar documents by ASTM Volume:

13.01 (Medical and Surgical Materials and Devices)

To find similar documents by classification:

11.040.20 (Transfusion, infusion and injection equipment Including blood packs Syringes, needles and catheters, see 11.040.25)

To find similar documents by Federal Supply Class Code:

FSC 6515 (Medical and Surgical Instruments, Equipment, and Supplies)

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Document Number

ASTM-F623-99(2013)

Revision Level

1999 R13 EDITION

Status

Current

Modification Type

Reapproval

Publication Date

Oct. 15, 2013

Document Type

Specification

Page Count

8 pages

Committee Number

F04.34