ASTM_D_8389_-_21.pdf

Designation:D838921Standard Performance Specification forUrinary Intermittent Catheters1This standard is issued under the fixed designation D8389;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last revision.A number in parentheses indicates the year of last reapproval.Asuperscript epsilon()indicates an editorial change since the last revision or reapproval.1.Scope1.1 This performance specification establishes performancerequirements for the short-term utilization of a single-use,non-balloon-urinary catheter,French sizes 12 through 30inclusive,used by the medical professions for providing amethod of bladder drainage through the urethra.The product ismanufactured in various sizes and materials such as latex,silicone,rubber,and various polymers(as well as combinationsof these)and is provided non-sterile and sterile for single useonly.The non-sterile catheters should be sterilized.1.2 Catheters whose surface has been chemically treated toeffect biocompatibility or microbial properties may be tested tothis specification.The safety and effectiveness of antimicrobialcoatings or their incorporation into device polymer materialsare not within the scope of this specification.1.3 Catheters whose surface has been chemically treated toenhance their lubricity may be tested to this specification.1.4 Regulatory bodies may require additional information,such as clinical data,to support the subject products of thisstandard.1.5 ExclusionsCatheters for non-urethral catheterization,such as for nephrostomy,suprapubic cystostomy,ureterostomy,gastrostomy,enemas,and so forth,are excluded from the scopeof this specification.1.6 The values stated in SI units are to be regarded as thestandard.The values given in parentheses are for informationonly.1.7 This standard does not purport to address all of thesafety concerns,if any,associated with its use.It is theresponsibility of the user of this standard to establish appro-priate safety,health,and environmental practices and deter-mine the applicability of regulatory limitations prior to use.1.8 This international standard was developed in accor-dance with internationally recognized principles on standard-ization established in the Decision on Principles for theDevelopment of International Standards,Guides and Recom-mendations issued by the World Trade Organization TechnicalBarriers to Trade(TBT)Committee.2.Referenced Documents2.1 ASTM Standards:2D412 Test Methods for Vulcanized Rubber and Thermoplas-tic ElastomersTensionD573 Test Method for RubberDeterioration in an AirOvenD1894 Test Method for Static and Kinetic Coefficients ofFriction of Plastic Film and SheetingF748 Practice for Selecting Generic Biological Test Methodsfor Materials and DevicesF1980 Guide for Accelerated Aging of Sterile Barrier Sys-tems for Medical Devices2.2 ISO Standards:3ISO/AAMI/ANSI 109931 Biological Testing of Medicaland Dental Material and DevicesPart 1:Guidance onSelection of TestsISO 20696(2018)Sterile Urethral Catheters for Single Use3.Terminology3.1 Definitions:3.1.1 distal,nrefers to the funnel end of the catheter,sincewhen in position for clinical use,the funnel is distal or farthestfrom the patient.3.1.2 French size,na scale used for denoting the size ofother tubular instruments and devices,each unit being roughlyequivalent to 0.33 mm in diameter.1This specification is under the jurisdiction ofASTM Committee D11 on Rubberand Rubber-like Materials and is the direct responsibility of Subcommittee D11.40on Consumer Rubber Products.Current edition approved May 1,2021.Published June 2021.DOI:10.1520/D8389-21.2For referenced 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 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 StatesThis international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for theDevelopment of International Standards,Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade(TBT)Committee.13.1.2.1 DiscussionLabel French sizes are as follows:French SizeOutside Diameter,in.(mm)60.078(2.0)80.104(2.6)100.130(3.3)120.157(4.0)130.171(4.3)140.184(4.7)150.197(5.0)160.210(5.3)170.223(5.7)180.236(6.0)190.249(6.3)200.262(6.7)210.276(7.0)220.289(7.3)230.302(7.7)240.315(8.0)250.328(8.3)260.341(8.7)280.354(9.0)300.367(9.3)3.1.3 lumen,nthe channel within a tube.3.1.4 non-balloon urinary catheter,na catheter insertedinto the bladder via the urethra for short-term drainage(equalto or less than 24 h).3.1.4.1 DiscussionA non-balloon urinary or intermittenttype cathet