Designation:F1830−97(Reapproved2013)StandardPracticeforSelectionofBloodforinvitroEvaluationofBloodPumps1ThisstandardisissuedunderthefixeddesignationF1830;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thispracticecoversbloodthatwillbeusedforinvitroperformanceassessmentsofbloodpumps.Theseassessmentsincludethehemolyticpropertiesofthedevices.1.2Thispracticecoverstheutilizationofbloodfortheinvitroevaluationofthefollowingdevices:1.2.1Continuousflowrotarybloodpumps(rollerpumps,centrifugalpumps,axialflowpumps,andsoforth)(seePracticeF1841).1.2.2Pulsatilebloodpumps(pneumaticallydriven,electro-mechanicallydriven,andsoforth).1.3Thesourceofbloodutilizedforinvitroevaluationofbloodtrauma(thatis,hemolysiscausedbythebloodpumps,duetothepumpdesign,construction,andmaterialsused)substantiallyinfluencestheresultsoftheperformanceofthesedevices.Thus,astandardizedbloodsourceisrequired.1.4ThevaluesstatedinSIunitsaretoberegardedasstandard.Nootherunitsofmeasurementareincludedinthisstandard.2.ReferencedDocuments2.1ASTMStandards:2F1841PracticeforAssessmentofHemolysisinContinuousFlowBloodPumps3.Terminology3.1DefinitionsofTermsSpecifictoThisStandard:3.1.1continuousflowpump—abloodpumpthatproducescontinuousbloodflowduetoitsrotarymotion.3.1.2hemolysis—oneoftheparametersofblooddamagecausedbyabloodpump.Thiscanbeobservedbyachangeintheplasmacolorandcanbemeasuredasanincreaseoffreeplasmahemoglobinconcentration.3.1.3pulsatilepump—abloodpumpthatproducesbloodflowtomimicanaturalheart.4.SummaryofPractice4.1Fortheexperimentalevaluationofbloodpumpdesignsandmaterials,aninvitrohemolysistestisrecommendedusingfreshbovineorporcineblood.Thedonoranimalsshouldhavenormalbodytemperature,nophysicalsignsofdisease,includ-ingdiarrheaandrhinorrhea,andanacceptablenormalrangeofhematologicalprofiles.Thebloo...
