duringmanufacturingandassemblywithStandardCareisunlikelytosignificantlyaffecttheproduct'pliancetogovernmentalregulations,fitorfunction.-?AFit/FunctionCharacteristicrequiresAdditionalCaretoensurethatreasonablyanticipatedvariationduringmanufactureandassemblyisunlikelytosignificantlyaffecttheproduct'sfit,functionortheabilitytoprocessorbuildtheproduct.-?plianceCharacteristicrequiresSpecialCaretoensurethatreasonablyanticipatedvariationduringmanufactureandassemblyisveryunlikelytosignificantlyaffecttheproduct'pliancetogovernmentalregulations.plianceandfit/functionKPCs.-?Thepossibleeffectofmanufacturingvariationisrelatedtosafetyand/plianceratherthanfitand/orfunction.-?urrence(“...couldsignificantlyaffect”pliancevs.“...islikelytosignificantlyaffect”forFit/Function)isusedintheclassificationdecision.