Designation:F1828−97(Reapproved2014)StandardSpecificationforUreteralStents1ThisstandardisissuedunderthefixeddesignationF1828;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.INTRODUCTIONTheobjectiveofthisspecificationistodescribethetestmethodsusedtoevaluatethesafetyandeffectivenessofanindwellingureteralstent,havingretentionmeansatthekidneyandbladderends,usedforurinarydrainageofthekidneytothebladderviatheureter.Thisspecificationincludesrefereetestmethodsthatcanbeusedtoevaluatetheperformancecharacteristicsofureteralstents.Notethatthetestmethodsarenottobeconstruedasproductionmethods,qualitycontroltechniques,ormanufacturer’slotreleasecriteria.TheproductparametersaddressedbythestandardincludethosedeterminedbytheASTMtaskgrouptobepertinenttotheproduct.1.Scope1.1Thisspecificationcoverstherefereetestmethodsforevaluatingtheperformancecharacteristicsofasingle-useureteralstentwithretainingmeansatbothends,duringshorttermusefordrainageofurinefromthekidneytothebladder.Thesestentsaretypicallyavailableindiametersof3.7Frto14.0Fr,andlengthsof8cmto30cm,andaremadeofsilicone,polyurethane,andotherpolymers.Theyareprovidednon-sterileforsterilizationandsterileforsingle-use.1.2Exclusions—Long-termindwellingusage(over30days)isencounteredwiththisproduct,butnotcommonly,andisthereforeconsideredanexceptiontothisspecification.Similarly,theuseofureteralstentsfornon-ureteralapplica-tionssuchasnephrostomyandileostomyisexcludedfromthescopeofthisspecification.Non-sterileureteralstentsarealsoexcludedduetothevariabilityofhospitalsterilizationequip-mentandprocessesandtheresultingeffectsonureteralstentcharacteristics.1.3Thefollowingprecautionarystatementpertainsonlytothetestmethodportion,Section5,ofthisspecification:1.4Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithi...
