Designation:F2065−00(Reapproved2010)StandardPracticeforTestingforAlternativePathwayComplementActivationinSerumbySolidMaterials1ThisstandardisissuedunderthefixeddesignationF2065;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thispracticeprovidesaprotocolforrapid,invitroscreeningforalternativepathwaycomplementactivatingprop-ertiesofsolidmaterialsusedinthefabricationofmedicaldevicesthatwillcontactblood.1.2Thispracticeisintendedtoevaluatetheacuteinvitroalternativepathwaycomplementactivatingpropertiesofsolidmaterialsintendedforuseincontactwithblood.Forthispractice,“serum”issynonymouswith“complement.”1.3Thispracticeconsistsoftwoproceduralparts.Proce-dureAdescribesexposureofsolidmaterialstoastandardlotofC4-deficientguineapigserum[C4(-)GPS],using0.1-mLserumper13×100-mmdisposableglasstesttubes.Sepharose2CL-4Bisusedasanexampleoftestmaterials.ProcedureBdescribesassayingtheexposedserumforsignificantfunctionalalternativepathwaycomplementdepletionascomparedtocontrolsamples.TheendpointinprocedureBislysisofrabbitRBCinbuffercontainingEGTAandexcessMg++.1.4Thispracticedoesnotaddressfunction,elaboration,ordepletionofindividualcomplementcomponentsexceptasoptionaladditionalconfirmatoryinformationthatcanbeac-quiredusinghumanserumasthecomplementsource.Thispracticedoesnotaddresstheuseofplasmaasasourceofcomplement.1.5Thispracticeisoneofseveraldevelopedfortheassessmentofthebiocompatibilityofmaterials.PracticeF748mayprovideguidancefortheselectionofappropriatemethodsfortestingmaterialsforotheraspectsofbiocompatibility.PracticeF1984providesguidancefortestingsolidmaterialsforwholecomplementactivationinhumanserum,butdoesnotdiscriminatebetweentheclassicaloralternativepathwayofactivation.1.6ThevaluesstatedinSIunitsaretoberegardedasstandard.Nootherunitsofmeasurementareinclude...
