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ASTM F 623 : 2019

Current

Current

The latest, up-to-date edition.

Standard Performance Specification for Foley Catheter

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

24-03-2021

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.

1.1This 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 non-sterile 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.

1.2Catheters whose surface has been chemically treated to enhance their lubricity with a coating may be tested to this specification.

1.3The annexes in this specification include detailed information, such as apparatus or materials for this specification.

1.4The appendixes in this specification contain information intended to provide guidance only and are not a mandatory part of the specification.

1.5Regulatory bodies may require additional information, such as clinical data, to support different design features.

1.6The values stated in SI units are to be regarded as the standard. The values given in parentheses are for information only.

1.7Exclusions—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 enhanced for lubricity using liquids or gels.

1.8This standard does not purport to address all of the safety 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.

1.9This 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.

Committee
D 11
DocumentType
Standard
Pages
10
ProductNote
This standard also refer to ISO 10993.
PublisherName
American Society for Testing and Materials
Status
Current
Supersedes

ASTM F 2528 : 2006 : R2014 Standard Test Methods for Enteral Feeding Devices with a Retention Balloon

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ASTM D 4483 : 2005 : REV A Standard Practice for Evaluating Precision for Test Method Standards in the Rubber and Carbon Black Manufacturing Industries
ASTM D 3078 : 1994 Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission
ASTM D 1076 : 2006 Standard Specification for Rubber-Concentrated, Ammonia Preserved, Creamed, and Centrifuged Natural Latex
ASTM D 3078 : 2002 : R2013 Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission
ASTM E 691 : 2020 Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
ASTM D 1076 : 2015 Standard Specification for Rubber—Concentrated, Ammonia Preserved, Creamed, and Centrifuged Natural Latex
ASTM D 412 : 2016 : EDT 1 Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension
ASTM D 1076 : 2014 Standard Specification for Rubber—Concentrated, Ammonia Preserved, Creamed, and Centrifuged Natural Latex
ASTM D 3767 : 2003 : R2014 Standard Practice for Rubber—Measurement of Dimensions
ASTM E 691 : 2019 : EDT 1 Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
ASTM E 691 : 2023 Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
ASTM D 412 : 2016 Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension
ASTM D 3767 : 2003 : R2008 Standard Practice for Rubber<span class='unicode'>—</span>Measurement of Dimensions
ASTM E 691 : 2022 Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
ASTM E 691 : 2009 Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
ASTM D 1076 : 1997 Standard Specification for Rubber-Concentrated, Ammonia Preserved, Creamed, and Centrifuged Natural Latex
ASTM D 3078 : 2002 Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission
ASTM D 1076 : 2023 Standard Specification for Rubber—Concentrated, Ammonia Stabilized, Creamed, and Centrifuged Natural Latex
ASTM E 691 : 2021 Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
ASTM D 4483 : 2005 Standard Practice for Evaluating Precision for Test Method Standards in the Rubber and Carbon Black Manufacturing Industries
ASTM D 3078 : 2002 : R2008 : EDT 1 Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission
ASTM D 3078 : 2002 : R2008 Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission
ASTM D 3767 : 2003 : R2020 Standard Practice for Rubber—Measurement of Dimensions
ASTM D 3767 : 1996 Standard Practice for Rubber-Measurement of Dimensions
ASTM D 4483 : 2014 : REV A Standard Practice for Evaluating Precision for Test Method Standards in the Rubber and Carbon Black Manufacturing Industries
ASTM D 412 : 2016 : R2021 Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension
ASTM D 4483 : 2014 Standard Practice for Evaluating Precision for Test Method Standards in the Rubber and Carbon Black Manufacturing Industries
ASTM D 4483 : 2018 Standard Practice for Evaluating Precision for Test Method Standards in the Rubber and Carbon Black Manufacturing Industries
ASTM D 4483 : 2005 : REV A : R2011 Standard Practice for Evaluating Precision for Test Method Standards in the Rubber and Carbon Black Manufacturing Industries
ASTM D 3767 : 2001 Standard Practice for Rubber-Measurement of Dimensions
ASTM D 1076 : 2010 Standard Specification for Rubber-Concentrated, Ammonia Preserved, Creamed, and Centrifuged Natural Latex
ASTM D 1076 : 2002 Standard Specification for Rubber-Concentrated, Ammonia Preserved, Creamed, and Centrifuged Natural Latex

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