ASTM F1862 F1862M-2013 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)《医用面罩耐.pdf

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1、Designation: F1862/F1862M 13Standard Test Method forResistance of Medical Face Masks to Penetration bySynthetic Blood (Horizontal Projection of Fixed Volume at aKnown Velocity)1This standard is issued under the fixed designation F1862/F1862M; the number immediately following the designation indicate

2、s the yearof original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval.A superscript epsilon () indicates an editorial change since the last revision or reapproval.INTRODUCTIONWorkers, primarily those in the health care pr

3、ofession, involved in treating and caring forindividuals injured or sick, can be exposed to biological liquids capable of transmitting disease. Thesediseases, which may be caused by a variety of microorganisms, can pose significant risks to life andhealth. This is especially true of blood-borne viru

4、ses which cause Hepatitis (Hepatitis B Virus (HBV)and Hepatitis C Virus (HCV) and Acquired Immune Deficiency Syndrome (AIDS) HumanImmunodeficiency Virus (HIV). Because engineering controls can not eliminate all possibleexposures, attention is placed on reducing the potential of direct skin and mucou

5、s membrane contactthrough the use of protective clothing that resists penetration (29 CFR Part 1910.1030). This testmethod was developed for ranking the synthetic blood penetration resistance performance of medicalace masks in a manner representing actual use as might occur when the face mask is con

6、tacted by ahigh velocity stream of blood from a punctured wound.1. Scope1.1 This test method is used to evaluate the resistance ofmedical face masks to penetration by the impact of a smallvolume (2 mL) of a high velocity stream of synthetic blood.Medical face mask pass/fail determinations are based

7、on visualdetection of synthetic blood penetration.1.2 This test method does not apply to all forms or condi-tions of blood-borne pathogen exposure. Users of the testmethod must review modes for face exposure and assess theappropriateness of this test method for their specific applica-tion.1.3 This t

8、est method primarily addresses the performance ofmaterials or certain material constructions used in medical facemasks. This test method does not address the performance ofthe medical face masks design, construction, or interfaces orother factors with the potential to affect the overall protectionof

9、fered by the medical face mask and its operation (such asfiltration efficiency and pressure drop). Procedures for measur-ing these properties are contained in Test Methods F2101 andMIL-M-36954C.1.4 This test method does not address breathability of themedical face mask materials or any other propert

10、ies affectingthe ease of breathing through the medical face mask. This testmethod evaluates medical face masks as an item of protectiveclothing. This test method does not evaluate the performanceof medical face masks for airborne exposure pathways or in theprevention of the penetration of aerosolize

11、d body fluids depos-ited on the medical face mask.1.5 The values stated in SI units or inch-pound units are tobe regarded separately as standard. The pressure values statedin each system are not exact equivalents. However, as thecorresponding velocities are within 1 % of each other, (seeX1.4.2), rep

12、orting of the results in either units is permitted.1.6 This standard does not purport to address all of thesafety concerns, if any, associated with its use. It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of

13、regulatory limitations prior to use.2. Referenced Documents2.1 ASTM Standards:21This test method is under the jurisdiction ofASTM Committee F23 on PersonalProtective Clothing and Equipment and is the direct responsibility of SubcommitteeF23.40 on Biological.Current edition approved Dec. 1, 2013. Pub

14、lished December 2013. Originallyapproved in 1998. Last previous edition approved in 2007 as F1862 - 07. DOI:10.1520/F1862_F1862M-13.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume inform

15、ation, refer to the standards Document Summary page onthe ASTM website.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States1D891 Test Methods for Specific Gravity,Apparent, of LiquidIndustrial ChemicalsD1331 Test Methods for Surface and In

16、terfacial Tension ofSolutions of Surface-Active AgentsE105 Practice for Probability Sampling of MaterialsE171 Practice for Conditioning and Testing Flexible BarrierPackagingF1494 Terminology Relating to Protective ClothingF1670 Test Method for Resistance of Materials Used inProtective Clothing to Pe

17、netration by Synthetic BloodF1671 Test Method for Resistance of Materials Used inProtective Clothing to Penetration by Blood-Borne Patho-gens Using Phi-X174 Bacteriophage Penetration as a TestSystemF2101 Test Method for Evaluating the Bacterial FiltrationEfficiency (BFE) of Medical Face Mask Materia

18、ls, Usinga Biological Aerosol of Staphylococcus aureus2.2 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 Standards:5MIL-M-36954C Military Specification, Mask, Surgical

19、, Dis-posable2.5 OSHA Standard629 CFR Part 1910.1030 Occupational Exposure to Blood-borne Pathogens: Final Rule, Federal Register, Vol 56, No235, Dec. 6, 1991, pp. 64175641823. Terminology3.1 Definitions:3.1.1 aerosolized body fluids, nbody fluids that have beendispersed into air as very small liqui

20、d droplets.3.1.2 airborne exposure pathways, ninhalation routes ofexposure to the medical face mask wearer.3.1.3 blood-borne pathogen, nan infectious bacterium orvirus, or other disease inducing microbe carried in blood orother potentially infectious body fluids.3.1.4 body fluid, nany liquid produce

21、d, secreted, or ex-creted by the human body.3.1.4.1 DiscussionIn this test method, body fluids includeliquids 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, sal

22、iva in dental procedures, and any body fluid thatis visibly contaminated with blood, and all body fluids insituations where it is difficult or impossible to differentiatebetween body fluids (see 29 CFR Part 1910.1030).3.1.5 body fluid simulant, na liquid that is used to act as amodel for human body

23、fluids.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.3.1.7 penetration, n for biological protective cloth

24、ing, theflow of a body fluid on a non-molecular level through closures,porous materials, seams, and pinholes, or other imperfectionsin protective clothing.3.1.7.1 DiscussionIn this test method, the penetrationliquid is synthetic blood, a body fluid simulant.3.1.8 protective clothing, nan item of clo

25、thing 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 DiscussionIn this test method, medical face masksare evaluated. The p

26、otential hazard of contact with blood orother body fluids is being simulated.3.1.9 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.3.1.9.1 Discuss

27、ionThe synthetic blood in this test methoddoes not simulate all of the characteristics of blood or bodyfluids, for example, polarity (wetting characteristics),coagulation, content of cell matter.3.1.10 spurt, na short duration gush or volume of fluid.3.1.10.1 DiscussionIn this test method, a spurt r

28、efers tothe volume of fluid disbursed from the apparatus at the samplemask. It can also refer to the volume of fluid ejected from apunctured blood vessel.3.1.11 For definitions of other protective clothing-relatedterms used in this test method, refer to Terminology F1494.4. Summary of Test Method4.1

29、 A volume of synthetic blood is disbursed at a specimenmask by a pneumatically controlled valve from a set distanceto simulate the impact (splatter) of blood or other body fluidonto the specimen. The velocity and volume of fluid are set tosimulate a given health care scenario.4.2 Any evidence of syn

30、thetic blood penetration on theinner facing of the medical face mask (side contacting thewearers face) constitutes a failure. Results are reported aspass/fail.4.3 Specimen medical face masks are evaluated at velocitiesof 450, 500 and 635 cm/s. These correspond to the velocityexiting a small arterial

31、 puncture at human blood pressures of10.7, 16.0, and 21.3 kPa (80, 120, and 160 mmHg). Test resultsare reported at each velocity, or corresponding pressure, andthe medical face mask is rated at the highest correspondingblood pressure for which medical face mask specimens dem-onstrate an acceptable q

32、uality limit of 4.0.3Available 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 Standardization Documents Order Desk, Bldg. 4 Section D, 700Ro

33、bbins Ave., Philadelphia, PA 191115094, Attn: NPODS.6Available from Superintendent of Documents, U.S. Government PrintingOffice, Washington, DC 20402.F1862/F1862M 1325. Significance and Use5.1 This test method offers a procedure for evaluatingmedical face mask resistance to synthetic blood penetrati

34、onthat is useful in establishing claims for penetration resistanceperformance of medical face masks and ranking their perfor-mance. However, this test method does not define acceptablelevels of penetration resistance because this determinationmust be made by each responsible user organization based

35、onits own specific application and conditions. Therefore, whenusing this test method to make claims for the performance ofmedical face masks, the specific conditions under which testingis conducted must be described.5.2 Medical face masks are intended to resist liquid pen-etration from the splatter

36、or splashing of blood, body fluids,and other potentially infectious materials. Many factors affectthe wetting and penetration characteristics of body fluids, suchas surface tension, viscosity, and polarity of the fluid, as well asthe structure and relative hydrophilicity or hydrophobicity ofthe mate

37、rials and the design of the mask itself. The surfacetension range for blood and body fluids (excluding saliva) isapproximately 0.042 to 0.060 N/m.7To help simulate thewetting characteristics of blood and body fluids, the surfacetension of the synthetic blood is adjusted to approximate thelower end o

38、f this surface tension range. The resulting surfacetension of the synthetic blood is 0.042 6 0.002 N/m.5.3 The synthetic blood mixture is prepared with a red dyeto aid in visual detection and a thickening agent to simulate theflow characteristics of blood. The synthetic blood will notalways duplicat

39、e the polarity, and thus the wetting behaviorand subsequent penetration, of real blood and other body fluidsthrough protective clothing materials.5.4 During a medical procedure, a blood vessel is occasion-ally punctured resulting in a high velocity stream of bloodimpacting a protective medical face

40、mask. The impact velocitydepends on several factors, the most important being the bloodpressure of the patient. Other factors include the size of thepuncture, and distance from the puncture. Because thepressure, and thus velocity drops quickly with large punctures,large punctures were not used to mo

41、del the range of bloodsplatter velocities considered in this test. Furthermore, this testmethod is based on the assumption that the medical face maskwill be in close proximity (within 300 mm or 12 in.) to thepuncture area. The use of this test method is, therefore, basedon selecting an appropriate b

42、lood pressure, finding the corre-sponding stream or impact velocity, and determining the valvetime to create that stream velocity as shown in Appendix X1.5.4.1 The mean human blood pressure generally varies overa range of about 10.7 to 16.0 kPa (80 to 120 mmHg).8In thistest method, medical face mask

43、s are tested at stream velocitiescorresponding to 10.7 kPa, 16.0 kPa, and 21.3 kPa (80 mmHg,120 mm Hg, and 160 mm Hg).5.5 This test method permits the use of other non-standardtest pressures, stream velocities, fluid volumes, and specimenorientations for evaluating medical face mask penetrationresis

44、tance consistent with specific applications.5.6 This test method differs from Test Method F1670 bydispensing a stream of 2 mL of synthetic blood against thetarget area of a complete medical mask specimen whereas TestMethod F1670 involves the continuous contact of a specimenof protective clothing wit

45、h synthetic blood over the period ofan hour. One minute of the exposure in Test Method F1670 isat hydrostatic pressure of 13.8 kPa 2.0 psig. Test MethodF1670 is used for preliminary evaluation of protective clothingpenetration resistance to synthetic blood in conjunction withTest Method F1671 that u

46、ses a microbiological challenge. Bothprocedures are intended for assessment of protective clothingwhich has the potential to contact blood or other body fluids forextended periods of time, and under pressure.5.7 Users of this test method must realize that certaintradeoffs exist between improved resi

47、stance of medical facemasks to penetration by synthetic blood and in pressure dropacross mask materials as an indicator of medical face maskbreathability. In general, increasing synthetic blood penetrationresistance for medical face masks results in increasing pressuredrop or reduced breathability f

48、or medical face masks of thesame design and fit of the individual wearer.5.8 This test method evaluates medical face masks as anitem of protective clothing and does not evaluate medical facemasks as respirators. If respiratory protection for the wearer isneeded, a NIOSH-certified respirator must be

49、used. This testmethod is useful to evaluate the resistance of a respirator topenetration by synthetic blood, if warranted.5.9 This test method involves the preconditioning of speci-men medical face masks in a relatively high humidity environ-ment (85 6 5 % relative humidity at 21 6 5C 70 6 10F)to simulate the conditions of use when the wearer creates highhumidity conditions by breathing through the mask. Thispreconditioning does not account for saturation of the interiormedical face mask layer. However, additional pretreatmenttechniques in conjunction wi