Designation:F2459−12StandardTestMethodforExtractingResiduefromMetallicMedicalComponentsandQuantifyingviaGravimetricAnalysis1ThisstandardisissuedunderthefixeddesignationF2459;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thistestmethodcoversthequantitativeassessmentoftheamountofresidueobtainedfrommetallicmedicalcompo-nentswhenextractedwithaqueousororganicsolvents.1.2Thistestmethoddoesnotadvocateanacceptablelevelofcleanliness.Itidentifiesonetechniquetoquantifyextract-ableresidueonmetallicmedicalcomponents.Inaddition,itisrecognizedthatthistestmethodmaynotbetheonlymethodtodetermineandquantifyextractables.1.3Althoughthesemethodsmaygivetheinvestigatorameanstocomparetherelativelevelsofcomponentcleanliness,itisrecognizedthatsomeformsofcomponentresiduemaynotbeaccountedforbythesemethods.1.4Theapplicabilityofthesegeneralgravimetricmethodshavebeendemonstratedbymanyliteraturereports;however,thespecificsuitabilityforapplicationstoall-metalmedicalcomponentswillbevalidatedbyanInterlaboratoryStudy(ILS)conductedaccordingtoPracticeE691.1.5Thistestmethodisnotintendedtoevaluatetheresiduelevelinmedicalcomponentsthathavebeencleanedforreuse.Thistestmethodisalsonotintendedtoextractresidueforuseinbiocompatibilitytesting.NOTE1—Forextractionofsamplesintendedforthebiologicalevalu-ationofdevicesormaterials,refertoISO10993–12.1.6ThevaluesstatedinSIunitsaretoberegardedasstandard.Nootherunitsofmeasurementareincludedinthisstandard.1.7Thisstandardmayinvolvehazardousorenvironmentally-restrictedmaterials,operations,andequip-ment.Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappro-priatesafetyandhealthpracticesanddeterminetheapplica-bilityofregulatorylimitationspriortouse.2.ReferencedDocu...
