ASTM F1862-2007 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)《用合成血液进行医用面具抗.pdf

1、Designation: F 1862 07Standard 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 F 1862; the number immediately following the designation indicates the year o

2、foriginal adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon (e) indicates an editorial change since the last revision or reapproval.INTRODUCTIONWorkers, primarily those in the health care profession, i

3、nvolved 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 viruses which c

4、ause 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 mucous membrane

5、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 contacted by a

6、high 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 on visualde

7、tection 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 test method

8、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 protectionoffered by th

9、e medical face mask and its operation (such asfiltration efficiency and pressure drop). Procedures for measur-ing these properties are contained in Test Methods F 2101 andMIL-M-36954C.1.4 This test method does not address breathability of themedical face mask materials or any other properties affect

10、ingthe 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 aerosolized body flu

11、ids 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), reporting of

12、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 regulatory

13、 limitations prior to use.2. Referenced Documents2.1 ASTM Standards:2D 891 Test Methods for Specific Gravity, Apparent, ofLiquid Industrial ChemicalsD 1331 Test Methods for Surface and Interfacial Tension ofSolutions of Surface-Active Agents1This test method is under the jurisdiction ofASTM Committe

14、e F23 on PersonalProtective Clothing and Equipment and is the direct responsibility of SubcommitteeF23.40 on Biological.Current edition approved Feb. 1, 2007. Published February 2007. Originallyapproved in 1998. Last previous edition approved in 2005 as F 1862 - 05.2For referenced ASTM standards, vi

15、sit 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.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-

16、2959, United States.E 105 Practice for Probability Sampling Of MaterialsE 171 Specification for Atmospheres for Conditioning andTesting Flexible Barrier MaterialsF 1494 Terminology Relating to Protective ClothingF 1670 Test Method for Resistance of Materials Used inProtective Clothing to Penetration

17、 by Synthetic BloodF 1671 Test Method for Resistance of Materials Used inProtective Clothing to Penetration by Blood-Borne Patho-gens Using Phi-X174 Bacteriophage Penetration as a TestSystemF 2101 Test Method for Evaluating the Bacterial FiltrationEfficiency (BFE) of Medical Face Mask Materials, Usi

18、ng aBiological 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,Dispos

19、able2.5 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 liquid droplet

20、s.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 produced, secret

21、ed, or ex-creted by the human body.3.1.4.1 DiscussionIn this test method, body fluids includeliquids potentially infected with blood-borne pathogens, in-cluding, but not limited to, blood, semen, vaginal secretions,cerebrospinal fluid, synovial fluid and peritoneal fluid, amni-otic fluid, saliva in

22、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 asa model for human body fluids.

23、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, nfor biological protective clothing, the

24、flow 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 clothing th

25、at 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 potential

26、 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 DiscussionThe s

27、ynthetic blood in this test methoddoes not simulate all of the characteristics of blood or bodyfluids, for example, polarity (wetting characteristics), coagula-tion, 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 refers

28、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 F 1494.4. Summary of Test Method4.1 A vo

29、lume 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 syntheti

30、c 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 punc

31、ture 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 qualit

32、y limit of 4.0.5. Significance and Use5.1 This test method offers a procedure for evaluatingmedical face mask resistance to synthetic blood penetrationthat is useful in establishing claims for penetration resistanceperformance of medical face masks and ranking their perfor-mance. However, this test

33、method does not define acceptablelevels of penetration resistance because this determination3Available 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 10036.5Avail

34、able from Standardization Documents Order Desk, Bldg. 4 Section D, 700Robbins Ave., Philadelphia, PA 191115094, Attn: NPODS.6Available from Superintendent of Documents, U.S. Government PrintingOffice, Washington, DC 20402.F 1862 072must be made by each responsible user organization based onits own s

35、pecific 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 or splashin

36、g 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 materials and t

37、he 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 of this surf

38、ace 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 duplicate the polar

39、ity, 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 mask. The i

40、mpact 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 the pres-sure, and thus velocity drops quickly with large punctures,large punctures were not used to model the r

41、ange 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 blood pres

42、sure, 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 masks are tes

43、ted 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 penetrationresistance con

44、sistent with specific applications.5.6 This test method differs from Test Method F 1670 bydispensing a stream of 2 mL of synthetic blood against thetarget area of a complete medical mask specimen whereas TestMethod F 1670 involves the continuous contact of a specimenof protective clothing with synth

45、etic blood over the period ofan hour. One minute of the exposure in Test Method F 1670 isat hydrostatic pressure of 13.8 kPa 2.0 psig. Test MethodF 1670 is used for preliminary evaluation of protective clothingpenetration resistance to synthetic blood in conjunction withTest Method F 1671 that uses

46、a microbiological challenge.Both procedures are intended for assessment of protectiveclothing which has the potential to contact blood or other bodyfluids for extended periods of time, and under pressure.5.7 Users of this test method must realize that certaintradeoffs exist between improved resistan

47、ce 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 for m

48、edical 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 MSHA/NIOSH-certified respirator must be

49、 used.This test method is useful to evaluate the resistance of arespirator to penetration 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