ASTM_F_3502-21.pdf

This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for theDevelopment of International Standards,Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade(TBT)Committee.Designation:F3502-21INTERNATIONALStandard Specification forBarrier Face CoveringsThis standard is issued under the fixed designation F3502: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(8)indicates an editorial change since the last revision or reapproval.INTRODUCTIONThis is the first ASTM standard to address this type of product.The standard was primarilyestablished in response to the global COVID-19 pandemic beginning in 2019 to address a product thatis neither a medical face mask per ASTM Specification F2100 for providing source control,nor arespirator for providing inhalation protection as defined by regulatory requirements specified in theUnited States under 42 CFR Part 84.This specification is intended to establish a national standard baseline for a source control device.This standard brings value by specifying minimum design,performance,and testing requirements andallowing comparison of products by end users where current guidelines have been limited.Evolvingliterature suggests that barrier face coverings could reduce the potential for disease transmission,aswell as offering a reduction of inhalation particulate matter by the wearer.The focus of thisspecification is to identify how the device should perform in terms of source control/protection,comfort,and re-use potential.The level of source control/protection depends on how well particles areblocked from going through the barrier face covering and minimizing the amount of leakage that mayoccur around the perimeter of the barrier face covering.The specific performance property forfiltration efficiency provides a greater challenge than most other particulate filtration tests,includingBFE,based on the use of smaller particles and more rigorous test conditions.Barrier face coveringsmust be comfortable enough for individuals to be willing to wear them for long periods of time.Requirements for breathing resistance were incorporated into the specification.The final performancecriterion was the potential for re-use of the barrier face covering,so the possibility of re-use wasidentified in the specification.Users of this standard are directed to Section I(Scope)and Section 4(Significance and Use)tounderstand the specific areas addressed by this standard and its limitations,along with the reasons forchoice of specific requirements.Users of this standard are further directed to the specific caveats forthis standard that are included in 1.3-1.11.The subcommittee responsible for this standard intendsto further evolve this specification for addressing new knowledge about disease transmission reductionand barrier face covering design,performance,labeling,conformity assessment,and other aspects ofthese productssafety,health,and environmental impact as this information becomes available.1.Scopeoffer a degree of particulate filtration to reduce the amount of1.1 This specification is primarily intended to help ensureinhaled particulate matter by the wearer.barrier face coverings meeting the stated requirements provideNorE 1-The source control/protection provided by barrier face cov-(/a means of source control for individual wearers byerings depends on several factors not considered in this specification,suchreducing the number of expelled droplets and aerosols from theas material degradation from wearer challenges including perspiration,wearers nose and mouth into the air:and(2)to potentiallytalking,sneezing,and the length of time the barrier face covering is worn.Further research is needed to expand the evidence base for the protectiveeffect of face coverings and,in particular,to identify the combinations ofmaterials that maximize both their blocking and filtering effectiveness,asThis specification is under the jurisdiction of ASTM Committee F23 onwell as fit,comfort,durability,and consumer appeal.(https:/Personal Protective Clothing and Equipment and is the direct responsibility ofwww.cde.gov/coronavirus/2019-ncov/more/masking-science-sars-Subcommittee F23.65 on Respiratory.cov2.html.)Current edition approved Feb.15.2021.Published February 2021.DOI:NorE 2-There are currently no established methods for measuring10.1520/F3502-21.outward leakage from a barrier face covering,medical mask,or respirator.Copyright ASTM Intemational,100 Barr Harbor Drive.PO Box C700,West Conshohocken,PA 19428-2959.United StatesCopyright by ASTM Intl(all rights reserved):Tue Feb 2306:36:35 EST 2021Downloaded/printed byF3502-21Nothing in this standard addresses or implies a quantitative assessment of1.3 This specification addresses all barrier face coveringsoutward leakage and no claims can be made about the degree to which aand only barrier face coverings that are intended for either abarrier face covering reduces emission of human-generated particlessingle use(disposable)or multiple uses(reusable).1.2 This specification establishes minimum design,perfor-1.4 This specification does not address the unique additionalmance(testing),labeling,user instruction,reporting andperformance attributes of barrier face coverings that exist forclassification.and conformity assessment requirements forcertain applications,such as flame-resistant apparel used inbarrier face coverings.environments where there are flame,high heat,electrical arc.1.2.1 Design criteria include setting minimum areas of faceor related hazards.but does recommend that barrier facecoverage over the wearers nose and mouth,prohibiting opencoverings also conform to other standards as applicable.vents or valves,requiring a means for retaining the barrier facecovering on the wearers head,and providing a representation1.5 This specification does not address the use of antimi-of product sizing.Manufacturers are further required to per-crobial or antiviral materials.finishes.or mechanisms.form a design analysis for assessing leakage of exhaled airNorE 4-The use of antimicrobial materials,finishes,or mechanisms isfrom the barrier face covering.Manufacturers are permitted togenerally subject to regulatory oversight by government agencies,includ-conduct quantitative testing as specified in this standard toing the U.S.Environmental Protection Agency and U.S.Food and DrugAdministration in the United States,which applies additional safety andsupplement the design analysis.efficacy requirements to these products.See 5.1.2 for the requirement of1.2.2 Performance and testing criteria define minimum bar-nontoxic and non-irritating materials used in the construction of barrierrier face covering filtration efficiency and airflow resistanceface coverings.performance properties.Sub-micron particulate filtration effi-1.6 This specification does not address requirements forciency represents the ability to capture and reduce respirablemedical face masks,which are covered in Specification F2100.droplets and aerosols that potentially contain viruses andbacteria.Airflow resistance represents the wearers ease of1.7 Nothing in this specification is intended to contradict orreplace criteria that are established in 42 CFR Part 84 forbreathing or breathability while wearing the barrier faceair-purifying respirators or requirements for use of respiratorscovering.The impact of repeated cleaning or laundering onin accordance with 29 CFR 1910.134.continued performance is applied for measuring performanceproperties for those barrier face coverings that are intended to1.8 Nothing in this specification is intended to imply thatbe reusable.Manufacturers are permitted to also provide testbarrier face coverings qualify as approved respiratory protec-results for bacterial filtration efficiency(BFE)as supplementaltion devices or have FDA clearance for use in a healthcareinformation to the mandatory performance measurement ofsetting.sub-micron particulate filtration efficiency.1.9 Nothing in this specification is intended to imply thatNorE 3-The principal performance criteria for barrier face coveringbarrier face coverings should be placed on very young childrendetermined by testing are sub-micron particle filtration efficiency and(2 years),anyone who has trouble breathing,or anyone whoairflow resistance.Quantitative leakage assessment testing is optional foris unconscious,incapacitated,or otherwise unable to removeinformation purposes and is not required.This testing is not likely to bebarrier face coverings without assistance.representative of outward leakage from the barrier face covering andshould not be claimed to represent the amount of source control offered by1.10 The values stated in SI units or in other units shall bethe face covering.Bacterial filtration efficiency testing is also optional andregarded separately as standard.The values stated in eachnot required.It is significantly different than sub-micron filtrationsystem must be used independently of the other,withoutefficiency,and the results of BFE testing cannot be interchanged orcombining values in any waydirectly compared.The scope of this standard does not include accessoriesto barrier face coverings1.11 This standard does not purport to address all of the1.2.3 Labelling requirements specify the minimum contentsafety concerns,if any,associated with its use.It is theresponsibility of the user of this standard to establish appro-for labels that appear on the barrier face covering,its imme-diate packaging,and if different,point-of-sale packaging.priate safety,health,and environmental practices and deter-mine the applicability of regulatory limitations prior to use.1.2.4 User instructions are required to guide selection and1.12 This international standard was developed in accor-sizing,proper use(positioning and adjustment),and caredance with internationally recognized principles on standard-including cleaning or laundering if product reuse is intended;ization established in the Decision on Principles for theinform on product cautions and limitations:and describeDevelopment of International Standards,Guides and Recomproduct replacement and disposal procedures.mendations issued by the World Trade Organization Technical1.2.5 Conformity assessment is demonstrated followingBarriers to Trade(TBT)Committee.Guide F3050,Annex A3,Model A to issue a declaration ofconformity indicating that each barrier face covering labelled2.Referenced Documentsas compliant has met all of the requirements of this standardspecification including design criteria,performance criteria,2.1 ASTM Standards:2test methods,labelling,and user information.Additionally,conformance to this standard requires that sub-micron particu-late filtration efficiency and airflow resistance tests have been2 For referenced ASTM standards,visit the ASTM website,www.astm.org.orcontact ASTM Customer Service at serviceastm.org.For Annual Book of ASTMperformed by a laboratory accredited for conducting theseStandards volume information,refer to the standards Document Summary page ontests.the ASTM website.Copyright by ASTM Intl(all rights reserved):Tue Feb 23 06:36:35 EST 20212Downloadedprinted bvF3502-21D3938 Guide for Determining or Confirming Care Instruc-2.6 NPPTL Standard Test Procedure:tions for Apparel and Other Textile ProductsTEB-APR-STP-0059 Determination of Particulate Filter Ef-D5489 Guide for Care Symbols for Care Instructions onficiency Level for N95 Series Filters Against Solid Par-Textile Productsticulates for Non-Powered,Air-Purifying RespiratorsF1494 Terminology Relating to Protective Clothing2.7 NFPA Standard:8F1506 Performance Specification for Flame Resistant andNFPA 2112 Standard on Flame-Resistant Clothing for Pro-Electric Arc Rated Protective Clothing Worn by Workerstection of Industrial Personnel Against Short-DurationExposed to Flames and Electric ArcsThermal Exposures from FireF2100 Specification for Performance of Materials Used inMedical Face Masks3.TerminologyF2101 Test Method for Evaluating the Bacterial Filtration3.1 Definitions:Efficiency(BFE)of Medical Face Mask Materials,Using3.1.1 airflow resistance,n-in the testing of a barrier facea Biological Aerosol of Staphylococcus aureuscovering,the degree to which a product worn over the wearersF2302 Performance Specification for Labeling Protectivenose and mouth restricts the ability of the wearer to inhale andClothing Which Provides Resistance to Incidental Expo-exhale(also referred to as breathing resistance).sures to Heat or Open Flame3.1.1.1 Discussion-This specification requires the mea-F3050 Guide for Conformity Assessment of Personal Pro-surement of airflow resistance of the barrier face coveringtective Clothing and Equipmentduring inhalation.The performance requirement is set toF3407 Test Method for Respirator Fit Capability forreduce the restriction of inhaling and exhaling as much asNegative-Pressure Half-Facepiece Particulate Respiratorspossible.2.2 AATCC Monograph:33.1.2 bacterial filtration efficiency(BFE),n-the effective-M14 Guidance and Considerations for General Purposeness of a material in preventing the passage of aerosolizedTextile Face Coverings:Adultbacteria,expressed as the percentage of a known quantity that2.3 ANSI/ASOC Standard:does not pass through the barrier face covering at a givenaerosol flow rate.ANSI/ASQC Z1.4 Sampling Procedures and Tables for In-3.1.2.1 Discussion-In this specification,BFE is only anspection by Attributesoptional reported test and not part of the requirements.BFE2.4 ISO Standards:5testing primarily involves the evaluation of larger sized par-ISO 2859-1 Sampling Procedures for Inspection byticles and lower exposure conditions as compared to sub-Attributes-Part 1:Sampling Schemes Indexed by Accep-micron particulate filtration efficiency.tance Quality Limit(AQL)for Lot-by-Lot Inspection3.1.3 barrier face covering,n-a product worn on the face,ISO/ANSI/AAMI 10993-5 Biological Evaluation of Medicalspecifically covering at least the wearers nose and mouth,withDevices-Part 5:Tests for In Vitro Cytotoxicitythe primary purpose of providing source control and to provideISO/ANSI/AAMI 10993-10 Biological Evaluation of Medi-a degree of particulate filtration to reduce the amount ofcal Devices-Part 10:Tests for Irritation and Skin Sensi-inhaled particulate matter.tization3.1.3.1 Discussion-In this specification,barrier face cov-ISO/IEC 17025 General Requirements for the Competenceerings are assessed for airflow resistance;filtration perfor-of Testing and Calibration Laboratoriesmance using sub-micron particulate filtration efficiency testing:2.5 Federal Regulations:and the degree of face coverage per a leakage assessment using16 CFR Part 1610 Standard for the Flammability of Clothinga product design analysis that can be supplemented by quan-Textilestitative testing using test subjects.16 CFR Part 303 Rules and Regulations Under the Textile3.1.4 design analysis,n-a process applied to represent theFiber Products Identification Actcoverage and potential leakage pathways in the design of a16 CFR Part 423 Care Labeling of Textile Wearing Apparelbarrier face covering as worn by an individual.and Certain Piece Goods as Amended3.1.4.1 Discussion-In this specification,a design analysis29 CFR 1910.134 Respiratory Protectionis used for assessing the leakage associated with a barrier face42 CFR Part 84 Approval of Respiratory Protective Devicescovering when worn by the general user population.3.1.5 flammability,n-a quality of a product related to itsrate of flame spread when contacted by a flame source.3 Available from American Association of Textile Chemists and Colorists3.1.5.1 Discussion-In this specification,flammability ap-(AATCC).P.O.Box 12215.Research Triangle Park,NC 27709-2215,http:/plies to barrier face coverings as determined by 16 CFR Partwww.aatcc.org.1610 as part of the Consumer Product Safety Commission4 Available from American Society for Quality(ASQ),600 N.Plankinton Ave.Milwaukee,WI 53203,http:/www.asq.org.3 Available from American National Standards Institute(ANSD.25 W.43rd St.4th Floor,New York.NY 10036,http:/www.ansi.org.7 Available from National Personal Protective Technology Laboratory(NPPTL).6 Available from U.S.Government Printing Office.Superintendent ofhttps:/www.cdc.gov/niosh/npptl/stps/pdfs/TEB-APR-STP-0059-508.pdf.Documents,732 N.Capitol St.,NW,Washington,DC 20401-0001,http:/Available from National Fire Protection Association(NFPA),I Batterymarchwww.access.gpo.gov.Park.Quincy.MA 02169-7471.http:/www.nfpa.org.Copyright by ASTM Intl(all rights reserved);Tue Feb 23 06:36:35 EST 2021Downloadedprinted bvF3502-21regulations for wearing apparel.However,products that com-3.1.9.1 Discussion-The use of the term reusablein thisply with these regulations by having Class I or 2 flammabilityspecification is intended to distinguish types of barrier faceare considered not flame resistant when exposed to flame,highcoverings that are durable and that can be further subjected toheat,electrical arc,or other thermal hazardslaundering or cleaning which permits their use multiple times3.1.6 leakage assessment,n-the evaluation of a barrier faceuntil they are damaged,cannot be effectively cleaned,or havecovering for its potential to fit snugly to the wearers face atsurpassed the expiration date or are beyond the manufacturersleast over their nose and mouth and to reduce the likelihood ofdesignated service life.leakage of unfiltered air from the wearer to the outside3.1.10 service life,n-in the specification of barrier faceenvironment.coverings,the maximum number of use and laundering or3.1.6.1 Discussion-In this specification,the leakage as-cleaning cycles that barrier face coverings can undergo and stillsessment addresses particulates passing through the barriermaintain their performance properties.face covering and around the perimeter of the barrier face3.1.10.1 Discussion-For the purpose of this specification,covering.When quantitative testing is performed,the leakagethe service life is the maximum number of cleaning orassessment is permitted to be presented as the ratio of thelaundering cycles that can be applied to a reusable barrier faceparticulate level upstream(outside)of a barrier face coveringcovering as specified by the manufacturer.to the level downstream(inside)of the barrier face covering on3.1.11 shelf life,n-in the specification of barrier facetest subjects.coverings,the length of time after the date of manufacture thatNorE 5-The leakage assessment represents the total inward leakagea barrier face covering can be stored as specified by thelikely to occur during wear.Whether measured quantitatively or assessedmanufacturer.qualitatively,the leakage assessment does not represent the likely outward3.1.12 source control,n-the use of a barrier face coveringleakage of particles generated by the wearer.This is because there arecurrently no specific accepted techniques that are available to measureover the wearers nose and mouth that is intended to containoutward leakage from a barrier face covering or other products.Thus,nothe wearers respiratory secretions,including droplets andclaims may be made with respect to the degree of source control offeredaerosols,to help prevent the transmission from infected indi-by the barrier face covering based on the leakage assessment.viduals who may or may not have symptoms of a specificNorE 6-Leakage assessment,if measured quantitatively on a barrierrespiratory disease.face covering that rests closely on the face and thus has minimal inwardvolume,may not be representative of true inward leakage or particles that3.1.12.1 Discussion-When worn properly,barrier face cov-come through or around the barrier face covering.erings meeting the requirements of this specification provide a3.1.7 medical face mask,n-an item of protective clothinglevel of source controldesigned to protect portions of the wearers face,including the3.1.13 sub-micron particulate filtration efficiency,n-a mea-mucous membrane areas of the wearers nose and mouth,fromsure of the ability of a barrier face covering to capturecontact with blood and other body fluids during medicalaerosolized particles smaller than one micron,expressed as aprocedurespercentage of a known number of particles that do not pass the3.1.7.1 Discussion-Medical face masks include surgicalbarrier face covering at a given face velocity for flat samples ormasks,procedure masks,isolation masks,laser masks,dentalflow rate for whole article testing.masks,and patient care masks.Isolation masks,laser masks,3.1.13.1 Discussion-In this specification,a specific form ofdental masks,and patient care masks are considered isolationsub-micron particulate efficiency testing is performed as de-masks.For many user groups,the term maskhas becomescribed in 8.1.synonymous with any product worn on the wearers face that3.1.14 surgical N95 respirator,n-a respirator that has bothoffers a level of filtration efficiency;however,in the context ofNIOSH approval as an N95 filtering facepiece respirator per 42this specification,maskrefers only to medical face masksCFR Part 84 and FDA clearance as a Class II medical devicethat are different from barrier face coverings.Requirements forunder 21 CFR Section 878.4040.medical face masks are provided in Specification F2100.This3.1.14.1 Discussion-Surgical N95 respirators are N95 fil-standard is not intended to address regulatory requirements.tering facepiece respirators that are approved under 42 CFR3.1.8 respirator;n-personal protective equipment(PPE)Part 84 criteria and meet additional performance criteria fordesigned to protect the wearer from inhalation of hazardousmaterial biocompatibility,fluid resistance,and flammabilitycontaminants.required by the FDA.3.1.8.1 Discussion-Barrier face coverings are not designed3.2 For definitions of other protective clothing-related termsto meet the performance requirements of NIOSH-approvedused in this standard,refer to Terminology F1494.respirators.For the purpose of this specification,healthcareworkers are typically instructed to wear filtering facepiece4.Significance and Userespirators with N95 or higher levels of filtration efficiency as4.1 Barrier face coverings are worn over at least the nosedefined in 42 CFR Part 84 that are intended to protect theand mouth with the primary purpose of providing sourcewearer from exposure to pathogenic biological airborne par-control and to potentially reduce inhaled particulates.It isticulates.See also the definition for surgical N95 respirators.expected that a range of barrier face covering products with3.1.9 reusable,adj-referring to the ability of a product todifferent configurations,designs,and materials of constructionbe used and laundered or cleaned multiple times and maintaincan be developed and qualified in accordance with thisits specified performance characteristics.specification.For this reason,a limited number of principalCopyright by ASTM Intl(all rights reserved);Tue Feb 23 06:36:35 EST 2021Downloadedprinted bv