1、Designation:F62399(Reapproved 2013)Standard Performance Specification forFoley Catheter1This standard is issued under the fixed designation F623;the number immediately following the designation indicates the year of originaladoption or,in the case of revision,the year of last revision.Anumber in par
2、entheses indicates the year of last reapproval.Asuperscriptepsilon()indicates an editorial change since the last revision or reapproval.INTRODUCTIONThe objective of this specification is to describe those product requirements and associated testmethods that will ensure the safety and effectiveness o
3、f a disposable,5-cm3(mL)balloon,retention-type catheter used in urinary bladder drainage.This specification includes referee test methods that can be used to determine compliance with thestated performance requirements.Note that the test methods are not to be construed as productionmethods,quality c
4、ontrol techniques,or manufacturers lot release criteria.The product parametersaddressed by the standard include those determined by the FDA Panel on Review ofGastroenterological-Urological Devices to be pertinent to the proposed classification of the Foleycatheter to FDA Class II standards,plus othe
5、r parameters determined by the ASTM task force to bepertinent to the product.This specification represents the state of the art at this time and is a minimum performancespecification.It is recognized that the document must remain dynamic;suggestions for revision areencouraged,and should be directed
6、to Committee F04 Staff Manager,ASTM,100 Barr Harbor Dr.,POBox C700,West Conshohocken,PA 194282959.1.Scope1.1 This performance specification establishes performancerequirements for the short-term utilization of a single-use,balloon-retention catheter,French sizes 12 through 26inclusive,used by the me
7、dical professions for providing ameans of bladder drainage by means of the urethra.Theproduct is manufactured in various sizes and materials such aslatex,silicone,rubber,and various polymers(as well ascombinations of these)and is provided nonsterile for steriliza-tion and sterile for single use only
8、.Catheters whose surface hasbeen chemically treated to effect biocompatibility or microbialproperties may be tested to this specification.1.2 ExclusionsLong-term indwelling usage(over 30 days)is encountered with this product,but not commonly,and istherefore considered an exception to this specificat
9、ion.Similarly,the use of such catheters for nonurethral catheter-ization(such as for nephrostomy,suprapubic cystostomy,ureterostomy,gastrostomy,enemas,and so forth)is excludedfrom the scope of this specification.Likewise,three lumencatheters,30-cm3balloon and pediatric catheters,and catheterswhose s
10、urface has been chemically treated to enhance theirlubricity have not been tested to this specification and excludedfrom the scope of this specification and will require separatestandard development.1.3 This standard may involve hazardous materials,operations,and equipment.This standard does not pur
11、port toaddress all of the safety concerns associated with its use.It isthe responsibility of the user of this standard to establishappropriate safety and health practices and determine theapplicability of regulatory limitations prior to use.2.Referenced Documents2.1 ASTM Standards:2F748 Practice for
12、 Selecting Generic Biological Test Methodsfor Materials and Devices2.2 Other Documents:ISO/AAMI/ANSI 109931 Biological Testing of Medicaland Dental Material and Devices Part 1:Guidance onSelection of Tests31This performance specification is under the jurisdiction of ASTM CommitteeF04 on Medical and
13、Surgical Materials and Devices and is the direct responsibilityof Subcommittee F04.34 on Urological Materials and Devices.Current edition approved Oct.1,2013.Published October 2013.Originallyapproved in 1981.Last previous edition approved in 2006 as F623 99(2006).DOI:10.1520/F0623-99R13.2For referen
14、ced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Service at serviceastm.org.For Annual Book of ASTMStandards volume information,refer to the standards Document Summary page onthe ASTM website.3Available from American National Standards Institute(ANSI),25 W.43rd St.,4th
15、Floor,New York,NY 10036,http:/www.ansi.org.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 U.S.Pharmacopeia43.Terminology3.1 Definitions:3.1.1 balloon(Foley)catheteran indwelling catheter re-tained in the bladder by a balloon that is infl
16、ated with liquid.3.1.1.1 DiscussionA two-way balloon catheter has adrainage lumen and inflation lumen(see Fig.1).Commonballoon inflation sizes are 5 cm3with the 5-cm3balloon beingused to hold the catheter in place for normal usage,and 30 cm3where so designated when a larger balloon is used.Athree-wayballoon catheter is used for continuous bladder irrigation andfeatures both a drainage lumen and an irrigation lumen(but asnoted above is excluded from consideration in this specifica-tion).3.1.2 FDA
