ASTM_F_2101_-_14.pdf

Designation:F210114Standard Test Method forEvaluating the Bacterial Filtration Efficiency(BFE)ofMedical Face Mask Materials,Using a Biological Aerosol ofStaphylococcus aureus1This standard is issued under the fixed designation F2101;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last revision.A number in parentheses indicates the year of last reapproval.Asuperscript epsilon()indicates an editorial change since the last revision or reapproval.INTRODUCTIONWorkers,primarily those in the health care profession,involved in treating and caring forindividuals injured or sick,as well as the patient,can be exposed to biological aerosols capable oftransmitting disease.These diseases,which may be caused by a variety of microorganisms,can posesignificant risks to life and health.Since engineering controls can not eliminate all possible exposures,attention is placed on reducing the potential of airborne exposure through the use of medical facemasks.1.Scope1.1 This test method is used to measure the bacterialfiltration efficiency(BFE)of medical face mask materials,employing a ratio of the upstream bacterial challenge todownstream residual concentration to determine filtration effi-ciency of medical face mask materials.1.2 This test method is a quantitative method that allowsfiltration efficiency for medical face mask materials to bedetermined.The maximum filtration efficiency that can bedetermined by this method is 99.9%.1.3 This test method does not apply to all forms or condi-tions of biological aerosol exposure.Users of the test methodshould review modes for worker exposure and assess theappropriateness of the method for their specific applications.1.4 This test method evaluates medical face mask materialsas an item of protective clothing but does not evaluatematerials for regulatory approval as respirators.If respiratoryprotection for the wearer is needed,a NIOSH-certified respi-rator should be used.Relatively high bacterial filtration effi-ciency measurements for a particular medical face maskmaterial does not ensure that the wearer will be protected frombiological aerosols since this test method primarily evaluatesthe performance of the composite materials used in theconstruction of the medical face mask and not its design,fit orfacial sealing properties.1.5 UnitsThe values stated in SI units or inch-pound unitsare to be regarded separately as standard.The values stated ineach system may not be exact equivalents;therefore,eachsystem shall be used independently of the other.Combiningvalues from the two systems may result in nonconformance ofthe standard.1.6 This test method does not address breathability of themedical face mask materials or any other properties affectingthe ease of breathing through the medical face mask material.1.7 This test method may also be used to measure thebacterial filtration efficiency(BFE)of other porous medicalproducts such as surgical gowns,surgical drapes,and sterilebarrier systems.1.8 This standard does not purport to address all of thesafety concerns,if any,associated with its use.It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.2.Referenced Documents2.1 ASTM Standards:2E171 Practice for Conditioning and Testing Flexible BarrierPackagingF1494 Terminology Relating to Protective Clothing1This test method is under the jurisdiction ofASTM Committee F23 on PersonalProtective Clothing and Equipment and is the direct responsibility of SubcommitteeF23.40 on Biological.Current edition approved July 1,2014.Published July 2014.Originally approvedin 2001.Last previous edition approved in 2007 as F2101-07.DOI:10.1520/F2101-14.2For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Service at serviceastm.org.For Annual Book of ASTMStandards volume information,refer to the standards Document Summary page onthe ASTM website.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 2.2 ANSI/ASQC Standard:3ANSI/ASQC Z1.4 Sampling Procedures and Tables for In-spection by Attributes2.3 ISO Standard:4ISO 2859-1 Sampling Plans for Inspection by Attributes2.4 Military Standard:5MIL-STD 36954C(1973)Military Specification:Mask,Surgical,Disposable3.Terminology3.1 Definitions:3.1.1 aerosol,na suspension of solid or liquid particles ina gas.3.1.2 agar,na semi-solid culture medium used to supportthe growth of bacteria and other micro-organisms.3.1.3 airborne exposure pathways,ninhalation routes ofexposure to the medical face mask wearer.3.1.4 bacterial filtration effciency(BFE),nthe effective-ness of a medical face mask material in preventing the passageof aerosolized bacteria;expressed in the percentage of a knownquantity that does not pass the medical face mask material at agiven aerosol flow rate.3.1.5 biological aero