Designation:F750−87(Reapproved2012)StandardPracticeforEvaluatingMaterialExtractsbySystemicInjectionintheMouse1ThisstandardisissuedunderthefixeddesignationF750;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thispracticecoversanonspecific,acutetoxicitytestusedfordetectingleachablesfrommaterialsusedinmedicaldevices.1.2TheliquidsinjectedintothemousearethoseobtainedbyPracticeF619wheretheextractionvehiclesaresaline,vegetableoil,orotherliquidssimulatinghumanbodyfluids.1.3Twoproceduresareoutlined:MethodAforintravenousinjectionandMethodBforintraperitonealinjection.1.4Thispracticeisoneofseveraldevelopedfortheassessmentofthebiocompatibilityofmaterials.PracticeF748mayprovideguidancefortheselectionofappropriatemethodsfortestingmaterialsforaspecificapplication.1.5ThevaluesstatedinSIunitsaretoberegardedasstandard.Nootherunitsofmeasurementareincludedinthisstandard.2.ReferencedDocuments2.1ASTMStandards:2F619PracticeforExtractionofMedicalPlasticsF748PracticeforSelectingGenericBiologicalTestMethodsforMaterialsandDevices3.SummaryofPractice3.1TheextractliquidispreparedinaccordancewithPrac-ticeF619.Theextractionvehiclesaresalineandvegetableoil,orotherextractionvehicles,asdescribedinPracticeF619.Theextractliquidisinjectedintomice,andtheanimalsareobservedatregularintervalsfor72hforreactions,survival,etc.4.SignificanceandUse4.1Thispracticeisintendedtohelpassessthebiocompat-ibilityofmaterialsusedinmedicaldevices.Itisanacutetoxicologicaltestdesignedtodetectthepresenceofinjuriousleachablesubstances.4.2Thispracticemaynotbeappropriateforalltypesofimplantapplications.Theuseriscautionedtoconsidertheappropriatenessofthemethodinviewofthematerialsbeingtested,theirpotentialapplications,andtherecommendationscontainedinPracticeF748.4.3Theonlylimitationapplicableistheextractpreparatio...
