1、Designation: F 2100 07Standard Specification forPerformance of Materials Used in Medical Face Masks1This standard is issued under the fixed designation F 2100; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revisi
2、on. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon (e) 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 p
3、roviding health care 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 f
4、iltra-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 barr
5、ier and breathability properties.This specification does not also apply to respiratory protection,which may be necessary for some health care services.1.4 The values stated in SI units or in other units shall beregarded separately as standard. The values stated in eachsystem must be used independent
6、ly of the other, withoutcombining values in any way.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
7、userof this standard to establish appropriate safety and healthpractices and determine the applicability of regulatory limita-tions prior to use.2. Referenced Documents2.1 ASTM Standards:2F 1494 Terminology Relating to Protective ClothingF 1862 Test Method for Resistance of Medical Face Masksto Pene
8、tration by Synthetic Blood (Horizontal Projection ofFixed Volume at a Known Velocity)F 2101 Test Method for Evaluating the Bacterial FiltrationEfficiency (BFE) of Medical Face Mask Materials, Using aBiological Aerosol of Staphylococcus aureusF 2299 Test Method for Determining the Initial Efficiencyo
9、f Materials Used in Medical Face Masks to Penetration byParticulates Using Latex Spheres2.2 ANSI/ASQC Standard:3ANSI/ASQC Z1.4 Sampling Procedures and Tables forInspection by Attributes2.3 ISO Standard:4ISO 2859-1 Sampling Plans for Inspection by Attributes2.4 Military Standard:5MIL-M-36954C Militar
10、y Specification, Mask, Surgical,Disposable2.5 Federal Standards:616 CFR Part 1610 Standard for the Flammability of Cloth-ing Textiles29 CFR Part 1910.1030 Occupational Exposure to Blood-borne Pathogens: Final Rule42 CFR Part 84 Approval of Respiratory Protective Devices3. Terminology3.1 Definitions:
11、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 at agiven aerosol flow rate.3.1.2 body fluid, nany liquid p
12、roduced, secreted, or ex-creted by the human body.3.1.2.1 DiscussionIn this specification, body fluids in-clude liquids potentially infected with blood-borne pathogens,including, but not limited to, blood, semen, vaginal secretions,cerebrospinal fluid, synovial fluid and peritoneal fluid, amni-otic
13、fluid, saliva in dental procedures, and any body fluid thatis visibly contaminated with blood, and all body fluids in1This specification is under the jurisdiction of ASTM Committee F23 onPersonal Protective Clothing and Equipment and is the direct responsibility ofSubcommittee F23.40 on Biological.C
14、urrent edition approved Feb. 1, 2007. Published February 2007. Originallyapproved in 2001. Last previous edition approved in 2004 as F 2100 04.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards vo
15、lume information, refer to the standards Document Summary page onthe ASTM website.3Available from American Society for Quality (ASQ), 600 N. Plankinton Ave.,Milwaukee, WI 53203.4Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036.5Available from
16、Standardization Documents Order Desk, DODSSP, Bldg. 4,Section D, 700 Robbins Ave., Philadelphia, PA 19111-50986Available from U.S. Government Printing Office Superintendent of Documents,732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401.1Copyright ASTM International, 100 Barr Harbor Drive,
17、 PO Box C700, West Conshohocken, PA 19428-2959, United States.situations where it is difficult or impossible to differentiatebetween body fluids (see 29 CFR Part 1910.1030).3.1.3 body fluid simulant, na liquid which is used to act asa model for human body fluids.3.1.4 differential pressure, nthe mea
18、sured pressure dropacross a medical face mask material.3.1.4.1 DiscussionIn this specification, differential pres-sure is expressed as a pressure per unit area.3.1.5 flammability, nthose characteristics of a materialthat pertain to its relative ease of ignition and relative ability tosustain combust
19、ion.3.1.6 medical face mask, nan item of protective clothingdesigned to protect portions of the wearers face, including themucous membrane areas of the wearers nose and mouth, fromcontact with blood and other body fluids during medicalprocedures.3.1.6.1 DiscussionExamples of medical face masks in-cl
20、ude surgical masks, procedure masks, isolation masks, lasermasks, dental masks, and patient care masks.3.1.7 penetration, nin a protective clothing material oritem, the flow of a chemical on a non-molecular level throughclosures, porous materials, seams and pinholes or other imper-fections in protec
21、tive clothing.3.1.7.1 DiscussionIn this specification, blood or bodyfluids replace the term chemical and the specific penetrationliquid is synthetic blood, a body fluid simulant.3.1.8 protective clothing, nan item of clothing that isspecifically designed and constructed for the intended purposeof is
22、olating all or part of the body from a potential hazard; or,isolating the external environment from contamination by thewearer of the clothing.3.1.8.1 DiscussionThe primary purpose of protectiveclothing is to act as a barrier for the wearer to a hazard.However, the product may also offer protection
23、as a barrierwhich prevents the body from being a source of contamination.3.1.9 sub-micron particulate filtration effciency, ntheefficiency of the filter material in capturing aerosolized par-ticles smaller than one micron; expressed as the percentage ofa known number of particles that does not pass
24、the medicalface mask material at a given flow rate.3.1.10 synthetic blood, na mixture of a red dye/surfactant,thickening agent, and distilled water having a surface tensionand viscosity representative of blood and some other bodyfluids, and the color of blood.3.1.10.1 DiscussionThe synthetic blood i
25、n this testmethod does not simulate all of the characteristics of blood orbody fluids, for example, polarity (wetting characteristics),coagulation, content of cell matter.3.2 For definitions of other protective clothing-related termsused in this test method, refer to Terminology F 1494.4. Significan
26、ce and Use4.1 This specification covers the minimum performancerequirements for materials used in the construction of medicalface masks.4.2 This specification provides classification of performancefor a range of medical face mask materials. Medical face maskperformance classes are based on the barri
27、er performanceproperties of the medical face mask materials (fluid resistance,bacterial filtration efficiency, and sub-micron filtration effi-ciency). The list of specified properties represents industrypractices for characterizing material performance, but does notinclude all aspects of performance
28、 that may be necessary toprotect health care workers. Therefore, this specification doesnot cover medical face masks for all possible use situations.For example, the Center for Disease Control and Prevention(CDC) specifically requires NIOSH respirators that are at least95 % efficient for tuberculosi
29、s exposure control.NOTE 1This specification does not provide specific criteria fordemonstrating medical face mask protection of the patient.NOTE 2The level of protection provided by medical face masksdepends on several factors not considered in this specification. Examplesinclude facial fit, materia
30、l degradation from wearer challenges (perspira-tion, talking, sneezing and the length of time the medical face mask isworn).4.3 Users of this specification are cautioned that improvedresistance of medical face masks to penetration by syntheticblood can cause a reduction in medical face mask breathab
31、ility.In general, increasing synthetic blood penetration resistance(and bacterial filtration efficiency and sub-micron particulatefiltration efficiency) results in increasing pressure drop orreduction of breathability for medical face masks of the samedesign.4.4 This specification or its requirement
32、s does not evaluatemedical face masks for regulatory approval as respirators. Itspecifically only evaluates the materials used in the construc-tion of the medical face mask and not the seal of the medicalface mask against the wearers face or other design featuresthat determine its effectiveness of p
33、reventing particle or liquidexposure to the wearer. If respiratory protection for the weareris needed, a NIOSH-certified respirator, meeting the require-ments of 42 CFR Part 84, should be used.4.5 The selection of the appropriate medical face mask mustbe governed by the potential exposure hazards ba
34、sed on thespecific areas of performance associated with class of medicalface masks. General use masks provide minimal fluid resis-tance and are suitable for situations such as in isolation settingsand for certain types of patient care. Where procedures involvethe generation of sub-micron particles,
35、such as in laser orelectrocautery surgery, sub-micron filtering masks are appro-priate. Where procedures involve the probability or likelyexposure to blood or body fluids, select fluid-resistant medicalfaces masks.5. Classification5.1 Medical face mask materials covered under this speci-fication sha
36、ll be designated as one or more of the followingperformance classes as based on the barrier performanceproperties of the materials used in medical face masks: LowBarrier, Moderate Barrier, and High Barrier.5.1.1 Low barrier medical face mask materials are evaluatedfor resistance to penetration by sy
37、nthetic blood at the minimumvelocity specified in Test Method F 1862, bacterial filtrationefficiency and differential pressure.5.1.2 Moderate barrier medical face mask materials areevaluated for their ability to capture sub-micron particles andare evaluated for resistance to penetration by synthetic
38、 blood atF2100072the middle velocity specified in Test Method F 1862, bacterialfiltration efficiency, and differential pressure.5.1.3 High barrier medical face mask materials are evalu-ated for resistance to penetration by synthetic blood at themaximum velocity specified in Test Method F 1862, sub-m
39、icron particulate filtration, bacterial filtration efficiency, anddifferential pressure.6. Requirements6.1 The properties of the medical face mask material shallconform to the specifications requirements in Table 1, as testedin accordance with Section 9.NOTE 3Medical face mask materials comprise spe
40、cimens taken frommanufactured medical face masks, with all layers arranged in proper order.6.2 Materials used in the construction of medical face masksshall meet the requirements for Class 1, normal flammabilityspecified in 16 CFR Part 1610.7. Sampling7.1 Testing shall be performed on materials take
41、n frommanufactured medical face masks.7.2 An acceptable quality limit of 4 % shall be used for allrequired testing to establish conformance of medical facemasks to a specific performance class.7.3 Examples of acceptable sampling plans are found inANSI/ASQC Z1.4 and ISO 2859-1.8. Number of Tests8.1 A
42、 sufficient number of medical face masks shall beevaluated for each test to achieve the established acceptablequality limit or confidence level.9. Test Methods9.1 Bacterial Filtration EffciencyDetermine the bacterialfiltration efficiency as directed in Test Method F 2101.9.2 Differential PressureDet
43、ermine breathing resistanceor differential pressure as specified in paragraph 4.4.1.2 ofMIL-M-36954C.NOTE 4This test method provides a measurement of pressure per unitarea of material specimen tested.9.3 Sub-Micron Particulate FiltrationDetermine particu-late filtration efficiency as directed in Tes
44、t Method F 2299.9.4 Resistance to Penetration by Synthetic BloodDetermine synthetic blood penetration resistance as specifiedin Test Method F 1862.9.5 FlammabilityDetermine flammability as specified in16 CFR Part 1610.10. Report10.1 When requested by the purchaser, a report shall beprovided with the
45、 following information:10.1.1 Manufacturer name.10.1.2 Manufacturer address and phone number.10.1.3 Product or style name.10.1.4 The performance class as classified by this specifi-cation.10.1.5 The results of each test used for classifying themedical face mask material to this specification.10.1.6
46、An optional statement indicating compliance of themedical face mask materials with this specification, includingthe number, year or issue, and revision letter.11. Keywords11.1 bacterial filtration efficiency; differential pressure; fluidresistance; general use; medical face masks; particle filtratio
47、nefficiency; sub-micron filtrationASTM International takes no position respecting the validity of any patent rights asserted in connection with any item mentionedin this standard. Users of this standard are expressly advised that determination of the validity of any such patent rights, and the risko
48、f infringement of such rights, are entirely their own responsibility.This standard is subject to revision at any time by the responsible technical committee and must be reviewed every five years andif not revised, either reapproved or withdrawn. Your comments are invited either for revision of this
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