Designation:F2151–01StandardPracticeforAssessmentofWhiteBloodCellMorphologyAfterContactwithMaterials1ThisstandardisissuedunderthefixeddesignationF2151;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(e)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thispracticeprovidesaprotocolfortheassessmentoftheeffectofmaterialsusedinthefabricationofmedicaldevices,thatwillcontactblood,onthemorphologyofwhitebloodcells.1.2Thispracticeisintendedtoevaluatetheacuteinvitroeffectsofmaterialsintendedforuseincontactwithblood.1.3Thispracticeusesdirectcontactofthematerialwithblood,andextractsofthematerialarenotused.1.4Thispracticeisoneofseveraldevelopedfortheassessmentofthebiocompatibilityofmaterials.PracticeF748providesgeneralguidancefortheselectionofappropriatemethodsfortestingmaterialsforaspecificapplication.1.5Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappro-priatesafetyandhealthpracticesanddeterminetheapplica-bilityofregulatorylimitationspriortouse.1.6Identificationofasupplierofmaterialsorreagentsisfortheconvenienceoftheuseranddoesnotimplysinglesource.Appropriatematerialsandreagentsmaybeobtainedfrommanycommercialsupplyhouses.2.ReferencedDocuments2.1ASTMStandards:F619PracticeForExtractionOfMedicalPlastics2F748PracticeForSelectingGenericBiologicalTestMeth-odsForMaterialsAndDevices2F756PracticeforAssessmentofHemolyticPropertiesofMaterials23.Terminology3.1Definitions:3.1.1controlmaterial,n—amaterialsuchaslowdensitypolyethylene(LDPE)whichisexpectedtohaveminimaleffectonthemorphologyofwhitebloodcells.3.1.2nucleardamage,n—forthewhitebloodcellmorphol-ogytest,thistermususedtodescribethenucleusofawhitebloodcellappearstobecondensed,fragmentedorlysed;fortheWhiteBloodCellMorphologyTest.Thisincludesnucleardamagethatmightbeclassifiedas...
