ASTM-F623 2006

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F623-99(2006) Standard Performance Specification for Foley Catheter

Published By	Publication Date	Number of Pages
ASTM	2006	8

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Categories: 11.040.20 - Transfusion, infusion and injection equipment, ASTM

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Description

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.

PDF Catalog

PDF Pages	PDF Title
1	Scope Referenced Documents
2	Terminology FIG. 1
3	Special Precautions FIG. 2 TABLE 1
4	Test Methods FIG. 3
6	FIG. 4
7	Keywords
8	X1. RATIONALE X1.1 X1.2 X1.3 X2. CHEMICAL COMPOSITION OF ARTIFICIAL URINE X2.1 REFERENCES

Additional information

Standard Title	F623-99(2006) Standard Performance Specification for Foley Catheter
Published Code	ASTM
Publication Date	2006
Pages Count	8
ICS Codes	11.040.20 - Transfusion, infusion and injection equipment

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ASTM-F623 2006

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