Designation:F2100−11StandardSpecificationforPerformanceofMaterialsUsedinMedicalFaceMasks1ThisstandardisissuedunderthefixeddesignationF2100;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thisspecificationcoverstestingandrequirementsformaterialsusedintheconstructionofmedicalfacemasksthatareusedinprovidinghealthcareservicessuchassurgeryandpatientcare.1.2Thisspecificationprovidesfortheclassificationofmedicalfacemaskmaterialperformance.Medicalfacemaskmaterialperformanceisbasedontestingforbacterialfiltrationefficiency,differentialpressure,sub-micronparticulatefiltra-tionefficiency,resistancetopenetrationbysyntheticblood,andflammability.1.3Thisspecificationdoesnotaddressallaspectsofmedi-calfacemaskdesignandperformance.Thisspecificationdoesnotspecificallyevaluatetheeffectivenessofmedicalfacemaskdesignsasrelatedtothebarrierandbreathabilityproperties.Thisspecificationdoesnotalsoapplytorespiratoryprotection,whichmaybenecessaryforsomehealthcareservices.1.4ThevaluesstatedinSIunitsaretoberegardedasstandard.Nootherunitsofmeasurementareincludedinthisstandard.1.5Thefollowingprecautionarycaveatpertainsonlytothetestmethodsportion,Section9,ofthisspecification:Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimita-tionspriortouse.2.ReferencedDocuments2.1ASTMStandards:2F1494TerminologyRelatingtoProtectiveClothingF1862TestMethodforResistanceofMedicalFaceMaskstoPenetrationbySyntheticBlood(HorizontalProjectionofFixedVolumeataKnownVelocity)F2101TestMethodforEvaluatingtheBacterialFiltrationEfficiency(BFE)ofMedicalFaceMaskMaterials,UsingaBiologicalAerosolofStaphylococcusaureusF2299TestMethodforDeterminingtheIn...
