ASTM F2100-2011 Standard Specification for Performance of Materials Used in Medical Face Masks《医疗口罩材料性能的标准规范》.pdf

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1、Designation: F2100 11Standard 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

2、. 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 prov

3、iding 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 filt

4、ra-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

5、 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 are to be regarded asstandard. No other units of measurement are included in thisstandard.1.5 The following precaution

6、ary 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 and healthpractices and det

7、ermine the applicability of regulatory limita-tions prior to use.2. Referenced Documents2.1 ASTM Standards:2F1494 Terminology Relating to Protective ClothingF1862 Test Method for Resistance of Medical Face Masksto Penetration by Synthetic Blood (Horizontal Projection ofFixed Volume at a Known Veloci

8、ty)F2101 Test Method for Evaluating the Bacterial FiltrationEfficiency (BFE) of Medical Face Mask Materials, Using aBiological Aerosol of Staphylococcus aureusF2299 Test Method for Determining the Initial Efficiency ofMaterials Used in Medical Face Masks to Penetration byParticulates Using Latex Sph

9、eres2.2 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 Military Specification, Mask, Surgical,Disposable2.5 Federal Standards:616 CFR Part 1610 St

10、andard 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:3.1.1 bacterial filtration effciency (BFE), nthe effective-ness of medical face mask

11、 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 produced, secreted, or ex-creted by the human body.3.1.2.1 DiscussionIn this specific

12、ation, 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 fluid, saliva in dental procedures, and any body fluid thatis visibly contaminated w

13、ith 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.Current edition approved April 1, 2011. Published April 2011. Originallyapproved in 2

14、001. Last previous edition approved in 2007 as F2100 07. DOI:10.1520/F2100-11.2For 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 on

15、the 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

16、Order Desk, DODSSP, Bldg. 4,Section D, 700 Robbins Ave., Philadelphia, PA 19111-5098, 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.1Copyright ASTM Internati

17、onal, 100 Barr Harbor Drive, 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 dif

18、ferential pressure, nthe measured 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 relati

19、ve ability tosustain combustion.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

20、 of medical face masks in-clude 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 ot

21、her imper-fections in protective 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 f

22、or the intended purposeof isolating 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 produc

23、t may also offer protection 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 p

24、articles that does not pass 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 Dis

25、cussionThe synthetic blood in 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 Term

26、inology F1494.4. Significance 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 cla

27、sses are based on the barrier 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

28、 all aspects of performance 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

29、% efficient for tuberculosis 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. Examples

30、include facial fit, material 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

31、 medical face mask breathability.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 speci

32、fication or its requirements 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 deter

33、mine its effectiveness of preventing 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 po

34、tential exposure hazards based 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 generatio

35、n of sub-micron particles, 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 un

36、der this speci-fication shall be designated as one or more of the followingperformance classes as based on the barrier performanceproperties of the materials used in medical face masks: Level1 Barrier, Level 2 Barrier, and Level 3 Barrier.5.1.1 Level 1 barrier medical face mask materials areevaluate

37、d for their ability to capture sub-micron particles,resistance to penetration by synthetic blood at the minimumvelocity specified in Test Method F1862, bacterial filtrationefficiency and differential pressure.5.1.2 Level 2 barrier medical face mask materials areevaluated for their ability to capture

38、 sub-micron particles andare evaluated for resistance to penetration by synthetic blood atF2100 112the middle velocity specified in Test Method F1862, bacterialfiltration efficiency, and differential pressure.5.1.3 Level 3 barrier medical face mask materials areevaluated for resistance to penetratio

39、n by synthetic blood at themaximum velocity specified in Test Method F1862, sub-micron 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

40、testedin accordance with Section 9.NOTE 3Medical face mask materials comprise specimens 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 flammabilityspecifie

41、d in 16 CFR Part 1610.7. Sampling7.1 Testing shall be performed on materials taken 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

42、 sampling plans are found inANSI/ASQC Z1.4 and ISO 2859-1.8. Number of Tests8.1 A 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 bacterialfil

43、tration efficiency as directed in Test Method F2101.9.2 Differential PressureDetermine 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 Parti

44、culate FiltrationDetermine particu-late filtration efficiency as directed in Test Method F2299.9.4 Resistance to Penetration by Synthetic BloodDetermine synthetic blood penetration resistance as specifiedin Test Method F1862.9.5 FlammabilityDetermine flammability as specified in16 CFR Part 1610.10.

45、Report10.1 The primary package containing the medical facemasks, which meet this specification shall be prominentlylabeled with the following information:10.1.1 Manufacturer name,10.1.2 Product or style name,10.1.3 Product lot,10.1.4 A graphic representation indicating the performancelevel met in Ta

46、ble 1 with the technical requirements of theindicated performance level. The graphic representation shallinclude a prominent visual indication of the performance level.11. Keywords11.1 bacterial filtration efficiency; differential pressure; fluidresistance; general use; medical face masks; particle

47、filtrationefficiency; 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

48、the riskof 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

49、 of this standard or for additional standardsand should be addressed to ASTM International Headquarters. Your comments will receive careful consideration at a meeting of theresponsible technical committee, which you may attend. If you feel that your comments have not received a fair hearing you shouldmake your views known to the ASTM Committee on Standards, at the address shown below.This standard is copyrighted by ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959,United States. Individual reprints (single or