ASTM_F_2100_-_11_2018.pdf

Designation:F210011(Reapproved 2018)Standard Specification forPerformance of Materials Used in Medical Face Masks1This standard is issued under the fixed designation F2100;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.1.Scope1.1 This specification covers testing and requirements formaterials used in the construction of medical face masks thatare used in providing healthcare services such as surgery andpatient care.1.2 This specification provides for the classification ofmedical face mask material performance.Medical face maskmaterial performance is based on testing for bacterial filtrationefficiency,differential pressure,sub-micron particulate filtra-tion efficiency,resistance to penetration by synthetic blood,andflammability.1.3 This specification does not address all aspects of medi-cal face mask design and performance.This specification doesnot specifically evaluate the effectiveness of medical face maskdesigns as related to the barrier and breathability properties.This specification does not also apply to respiratory protection,which may be necessary for some healthcare services.1.4 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.1.5 The following precautionary caveat pertains only to thetest methods portion,Section 9,of this specification:Thisstandard does not purport to address all of the safety concerns,if any,associated with its use.It is the responsibility of the userof this standard to establish appropriate safety,health,andenvironmental practices and determine the applicability ofregulatory limitations prior to use.1.6 This international standard was developed in accor-dance with internationally recognized principles on standard-ization established in the Decision on Principles for theDevelopment of International Standards,Guides and Recom-mendations issued by the World Trade Organization TechnicalBarriers to Trade(TBT)Committee.2.Referenced Documents2.1 ASTM Standards:2F1494 Terminology Relating to Protective ClothingF1862 Test Method for Resistance of Medical Face Masks toPenetration by Synthetic Blood(Horizontal Projection ofFixed Volume at a Known Velocity)F2101 Test Method for Evaluating the Bacterial FiltrationEfficiency(BFE)of Medical Face Mask Materials,Usinga Biological Aerosol of Staphylococcus aureusF2299 Test Method for Determining the Initial Efficiency ofMaterials Used in Medical Face Masks to Penetration byParticulates Using Latex Spheres2.2 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-M-36954C Military Specification,Mask,Surgical,Dis-posable2.5 Federal Standards:616 CFR Part 1610 Standard for the Flammability of ClothingTextiles29 CFR Part 1910.1030 Occupational Exposure to Blood-borne Pathogens:Final Rule42 CFR Part 84 Approval of Respiratory Protective Devices3.Terminology3.1 Definitions:1This specification is under the jurisdiction of ASTM Committee F23 onPersonal Protective Clothing and Equipment and is the direct responsibility ofSubcommittee F23.40 on Biological.Current edition approved Jan.1,2018.Published January 2018.Originallyapproved in 2001.Last previous edition approved in 2011 as F2100 11.DOI:10.1520/F2100-11R18.2For 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.3Available from American Society for Quality(ASQ),600 N.Plankinton Ave.,Milwaukee,WI 53203,http:/www.asq.org.4Available from American National Standards Institute(ANSI),25 W.43rd St.,4th Floor,New York,NY 10036,http:/www.ansi.org.5Available from Standardization Documents Order Desk,DODSSP,Bldg.4,SectionD,700RobbinsAve.,Philadelphia,PA19111-5098,http:/dodssp.daps.dla.mil.6Available from U.S.Government Printing Office Superintendent of Documents,732 N.Capitol St.,NW,Mail Stop:SDE,Washington,DC 20401,http:/www.access.gpo.gov.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United StatesThis 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.1 3.1.1 bacterial filtration effciency(BFE),nthe effective-ness of medical face mask material in preventing the passage ofaerosolized bacteria,expressed in the percentage of a knownquantity that does not pass the medical face mask material