ASTM F2100-2011(2018) Standard Specification for Performance of Materials Used in Medical Face Masks《医用面罩用材料性能的标准规格》.pdf

1、Designation: F2100 11 (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 yea

2、r 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 th

3、atare 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

4、 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 relat

5、ed 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 foll

6、owing 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, an

7、denvironmental 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 Sta

8、ndards, 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 (H

9、orizontal 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 Fac

10、e 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, Surgic

11、al, 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

12、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:

13、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 Qual

14、ity (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,Section D, 700 Robbins Ave., P

15、hiladelphia, 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.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken

16、, 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 Organizati

17、on Technical Barriers to Trade (TBT) Committee.13.1.1 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 a

18、erosol flow rate.3.1.2 body fluid, nany liquid produced, 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,

19、 synovial fluid and peritoneal fluid, amni-otic fluid, saliva in dental procedures, any body fluid that isvisibly contaminated with blood, and all body fluids in situa-tions where it is difficult or impossible to differentiate betweenbody fluids (see 29 CFR Part 1910.1030).3.1.3 body fluid simulant,

20、 na liquid which is used to act asa model for human body fluids.3.1.4 differential 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 characterist

21、ics of a materialthat pertain to its relative ease of ignition and relative 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

22、and other body fluids during medicalprocedures.3.1.6.1 DiscussionExamples 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-mo

23、lecular level throughclosures, porous materials, seams and pinholes, or otherimperfections 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 cloth

24、ing, nan item of clothing that isspecifically designed and constructed for 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 protectiveclothi

25、ng is to act as a barrier for the wearer to a hazard.However, the product may also offer protection as a barrierwhich prevents the body from being a source of contamination.3.1.9 sub-micron particulate filtration effciency, nthe ef-ficiency of the filter material in capturing aerosolized particlessm

26、aller than one micron; expressed as the percentage of aknown number of particles that does not pass the medical facemask 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

27、 of blood and some other bodyfluids, and the color of blood.3.1.10.1 DiscussionThe synthetic blood in this testmethod does not simulate all of the characteristics of blood orbody fluids, for example, polarity (wetting characteristics),coagulation, or content of cell matter.3.2 For definitions of oth

28、er protective clothing-related termsused in this test method, refer to Terminology 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 performancef

29、or a range of medical face mask materials. Medical face maskperformance classes 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 ind

30、ustrypractices for characterizing material performance, but does notinclude all aspects of performance that may be necessary toprotect healthcare workers. Therefore, this specification doesnot cover medical face masks for all possible use situations.For example, the Center for Disease Control and Pr

31、evention(CDC) specifically requires NIOSH respirators that are at least95 % 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 mask

32、sdepends on several factors not considered in this specification. Examplesinclude facial fit and material degradation from wearer challenges(perspiration, talking, sneezing, and the length of time the medical facemask is worn).4.3 Users of this specification are cautioned that improvedresistance of

33、medical face masks to penetration by syntheticblood can cause a reduction in 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 orreduct

34、ion of breathability for medical face masks of the samedesign.4.4 This specification (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 th

35、e medicalface mask against the wearers face or other design featuresthat determine 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.

36、5 The selection of the appropriate medical face mask mustbe governed by the potential 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 settin

37、gsand for certain types of patient care. Where procedures involvethe generation of sub-micron particles, such as in laser orF2100 11 (2018)2electrocautery surgery, sub-micron filtering masks are appro-priate. Where procedures involve the probability or likelyexposure to blood or body fluids, select

38、fluid-resistant medicalfaces masks.5. Classification5.1 Medical face mask materials covered under 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, Leve

39、l 2 barrier, and Level 3 barrier.5.1.1 Level 1 barrier medical face mask materials areevaluated 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 press

40、ure.5.1.2 Level 2 barrier medical face mask materials areevaluated for their ability to capture sub-micron particles andare evaluated for resistance to penetration by synthetic blood atthe middle velocity specified in Test Method F1862, bacterialfiltration efficiency, and differential pressure.5.1.3

41、 Level 3 barrier medical face mask materials areevaluated for resistance to penetration 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 medi

42、cal face mask material shallconform to the specifications requirements in Table 1, as 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

43、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 taken frommanufactured medical face masks.7.2 An acceptable quality limit of 4 % shall be used for allrequired testing to establish confo

44、rmance 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 sufficient number of medical face masks shall beevaluated for each test to achieve the established acceptablequality limit or confid

45、ence level.9. Test Methods9.1 Bacterial Filtration EffciencyDetermine the bacterialfiltration 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

46、 measurement of pressure per unitarea of material specimen tested.9.3 Sub-Micron Particulate 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 Me

47、thod F1862.9.5 FlammabilityDetermine flammability as specified in16 CFR Part 1610.10. Report10.1 The primary package containing the medical facemasks that meet this specification shall be prominently labeledwith the following information:10.1.1 Manufacturer name,10.1.2 Product or style name,10.1.3 P

48、roduct lot, and10.1.4 A graphic representation indicating the performancelevel met in Table 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 effici

49、ency; differential pressure; fluidresistance; general use; medical face masks; particle filtrationefficiency; sub-micron filtrationTABLE 1 Medical Face Mask Material Requirements byPerformance LevelCharacteristicLevel 1BarrierLevel 2BarrierLevel 3BarrierBacterial filtration efficiency, % $95 $98 $98Differential pressure, mm H2O/cm24.0 5.0 5.0Sub-micron particulate filtration efficiencyat 0.1 micron, %$95 $98 $98Resistance to penetration by syntheticblood,minimum pressure in mm Hg for passresult80 120 160Flame spread Class 1 Class 1 Class 1F2100 1