ASTM F1862 F1862M-2017 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)《医用口罩抗.pdf

1、Designation: F1862/F1862M 13F1862/F1862M 17Standard 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 desig

2、nation indicates 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

3、 health care healthcare profession, 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 especiall

4、y true of blood-borne viruses which cause Hepatitis (Hepatitishepatitis(hepatitis B Virusvirus (HBV) and Hepatitishepatitis C Virusvirus (HCV) and Acquired ImmuneDeficiency Syndrome (AIDS) Human Immunodeficiency Virus (HIV).acquired immune deficiencysyndrome (AIDS) (human immunodeficiency virus (HIV

5、). Because engineering controls can noteliminate all possible exposures, attention is placed on reducing the potential of direct skin andmucous membrane contact through the use of protective clothing that resists penetration (29 CFR Part1910.1030). This test method was developed for ranking the synt

6、hetic blood penetration resistanceperformance of medical ace masks in a manner representing actual use as might occur when the facemask is contacted by a high velocity high-velocity stream of blood from a punctured wound.1. Scope1.1 This test method is used to evaluate the resistance of medical face

7、 masks to penetration by the impact of a small volume(2 mL) of a high velocity high-velocity stream of synthetic blood. Medical face mask pass/fail determinations are based on visualdetection of synthetic blood penetration.1.2 This test method does not apply to all forms or conditions of blood-borne

8、 pathogen exposure. Users of the test method mustreview modes for face exposure and assess the appropriateness of this test method for their specific application.1.3 This test method primarily addresses the performance of materials or certain material constructions used in medical facemasks. This te

9、st method does not address the performance of the medical face masks design, construction, or interfaces or otherfactors with the potential to affect the overall protection offered by the medical face mask and its operation (such as filtrationefficiency and pressure drop). Procedures for measuring t

10、hese properties are contained in Test MethodsMethod F2101 andMIL-M-36954C.1.4 This test method does not address breathability of the medical face mask materials or any other properties affecting the easeof breathing through the medical face mask. This test method evaluates medical face masks as an i

11、tem of protective clothing. Thistest method does not evaluate the performance of medical face masks for airborne exposure pathways or in the prevention of thepenetration of aerosolized body fluids deposited on the medical face mask.1.5 The values stated in SI units or inch-pound units are to be rega

12、rded separately as standard. The pressure values stated ineach system are not exact equivalents. However, as the corresponding velocities are within 1 % of each other, (see X1.4.2),reporting of the results in either units is permitted.1.6 This standard does not purport to address all of the safety c

13、oncerns, if any, associated with its use. It is the responsibilityof the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatorylimitations prior to use.1 This test method is under the jurisdiction of ASTM Committee F23 on Personal Pro

14、tective Clothing and Equipment and is the direct responsibility of SubcommitteeF23.40 on Biological.Current edition approved Dec. 1, 2013June 1, 2017. Published December 2013June 2017. Originally approved in 1998. Last previous edition approved in 20072013 asF1862 - 07.F1862/F1862M 13. DOI: 10.1520/

15、F1862_F1862M-13.10.1520/F1862_F1862M-17.This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Becauseit may not be technically possible to adequately depict all changes accurately, ASTM

16、 recommends that users consult prior editions as appropriate. In all cases only the current versionof the standard as published by ASTM is to be considered the official document.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States11.7 This

17、 international standard was developed in accordance with internationally recognized principles on standardizationestablished in the Decision on Principles for the Development of International Standards, Guides and Recommendations issuedby the World Trade Organization Technical Barriers to Trade (TBT

18、) Committee.2. Referenced Documents2.1 ASTM Standards:2D891 Test Methods for Specific Gravity, Apparent, of Liquid Industrial ChemicalsD1331 Test Methods for Surface and Interfacial Tension of Solutions of Paints, Solvents, Solutions of Surface-Active Agents,and Related MaterialsE105 Practice for Pr

19、obability Sampling of MaterialsE171E171/E171M Practice for Conditioning and Testing Flexible Barrier PackagingF1494 Terminology Relating to Protective ClothingF1670F1670/F1670M Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic BloodF1671F1671/F1671M Test

20、 Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-BornePathogens Using Phi-X174 Bacteriophage Penetration as a Test SystemF2101 Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a BiologicalAerosol of Stap

21、hylococcus aureus2.2 ANSI/ASQC Standard:3ANSI/ASQC Z1.4 Sampling Procedures and Tables for Inspection by Attributes2.3 ISO Standard:4ISO 2859-1 Sampling Plans for Inspection by Attributes2.4 Military Standards:5MIL-M-36954C Military Specification, Mask, Surgical, Disposable2.5 OSHA StandardStandard:

22、629 CFR Part 1910.1030 Occupational Exposure to Blood-borne Pathogens: Final Rule, Federal Register, Vol 56, No 235, Dec.6, 1991, pp. 64175641823. Terminology3.1 Definitions:3.1.1 aerosolized body fluids, nbody fluids that have been dispersed into air as very small liquid droplets.3.1.2 airborne exp

23、osure pathways, ninhalation routes of exposure to the medical face mask wearer.3.1.3 blood-borne pathogen, nan infectious bacterium or virus, or other disease inducing disease-inducing microbe carried inblood or other potentially infectious body fluids.3.1.4 body fluid, nany liquid produced, secrete

24、d, or excreted by the human body.3.1.4.1 DiscussionIn this test method, body fluids include liquids potentially infected with blood-borne pathogens, including, but not limited to, blood,semen, vaginal secretions, cerebrospinal fluid, synovial fluid and peritoneal fluid, amniotic fluid, saliva in den

25、tal procedures, andany body fluid that is visibly contaminated with blood, and all body fluids in situations where it is difficult or impossible todifferentiate between body fluids (see 29 CFR Part 1910.1030).3.1.5 body fluid simulant, na liquid that is used to act as a model for human body fluids.3

26、.1.6 medical face mask, nan item of protective clothing designed to protect portions of the wearers face, including themucous membrane areas of the wearers nose and mouth, from contact with blood and other body fluids during medical procedures.3.1.7 penetration, n for biological protective clothing,

27、 the flow of a body fluid on a non-molecular level through closures,porous materials, seams, and pinholes, or other imperfections in protective clothing.3.1.7.1 DiscussionIn this test method, the penetration liquid is synthetic blood, a body fluid simulant.2 For referencedASTM standards, visit theAS

28、TM website, www.astm.org, or contactASTM Customer Service at serviceastm.org. For Annual Book of ASTM Standardsvolume information, refer to the standards Document Summary page on the ASTM website.3 Available from American Society for Quality (ASQ), 600 N. Plankinton Ave., Milwaukee, WI 53203.4 Avail

29、able from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036.5 Available from Standardization Documents Order Desk, Bldg. 4 Section D, 700 Robbins Ave., Philadelphia, PA 191115094, Attn: NPODS.6 Available from Superintendent of Documents, U.S. Government Prin

30、ting Office, Washington, DC 20402.F1862/F1862M 1723.1.8 protective clothing, nan item of clothing that is specifically designed and constructed for the intended purpose ofisolating all or part of the body from a potential hazard; or, isolating the external environment from contamination by the weare

31、rof the clothing.3.1.8.1 DiscussionIn this test method, medical face masks are evaluated. The potential hazard of contact with blood or other body fluids is beingsimulated.3.1.9 spurt, na short duration gush or volume of fluid.3.1.9.1 DiscussionIn this test method, a spurt refers to the volume of fl

32、uid disbursed from the apparatus at the sample mask. It can also refer to thevolume of fluid ejected from a punctured blood vessel.3.1.10 synthetic blood, na mixture of a red dye/surfactant, thickening agent, and distilled water having a surface tension andviscosity representative of blood and some

33、other body fluids, and the color of blood.3.1.10.1 DiscussionThe synthetic blood in this test method does not simulate all of the characteristics of blood or body fluids, for example, polarity(wetting characteristics), coagulation, and content of cell matter.3.1.10 spurt, na short duration gush or v

34、olume of fluid.3.1.10.1 DiscussionIn this test method, a spurt refers to the volume of fluid disbursed from the apparatus at the sample mask. It can also refer to thevolume of fluid ejected from a punctured blood vessel.3.1.11 For definitions of other protective clothing-related terms used in this t

35、est method, refer to Terminology F1494.4. Summary of Test Method4.1 A volume of synthetic blood is disbursed at a specimen mask by a pneumatically controlled valve from a set distance tosimulate the impact (splatter) of blood or other body fluid onto the specimen. The velocity and volume of fluid ar

36、e set to simulatea given health care healthcare scenario.4.2 Any evidence of synthetic blood penetration on the inner facing of the medical face mask (side contacting the wearers face)constitutes a failure. Results are reported as pass/fail.4.3 Specimen medical face masks are evaluated at velocities

37、 of 450, 500, and 635 cm/s. These correspond to the velocity exitinga small arterial puncture at human blood pressures of 10.7, 16.0, and 21.3 kPa (80, 120, and 160 mmHg). Test results are reportedat each velocity,velocity or corresponding pressure, and the medical face mask is rated at the highest

38、corresponding blood pressurefor which medical face mask specimens demonstrate an acceptable quality limit of 4.0.5. Significance and Use5.1 This test method offers a procedure for evaluating medical face mask resistance to synthetic blood penetration that is usefulin establishing claims for penetrat

39、ion resistance performance of medical face masks and ranking their performance. However, thistest method does not define acceptable levels of penetration resistance because this determination must be made by eachresponsible user organization based on its own specific application and conditions. Ther

40、efore, when using this test method to makeclaims for the performance of medical face masks, the specific conditions under which testing is conducted must be described.5.2 Medical face masks are intended to resist liquid penetration from the splatter or splashing of blood, body fluids, and otherpoten

41、tially infectious materials. Many factors affect the wetting and penetration characteristics of body fluids, such as surfacetension, viscosity, and polarity of the fluid, as well as the structure and relative hydrophilicity or hydrophobicity of the materialsand the design of the mask itself. The sur

42、face tension range for blood and body fluids (excluding saliva) is approximately 0.042to 0.060 N/m.7 To help simulate the wetting characteristics of blood and body fluids, the surface tension of the synthetic blood isadjusted to approximate the lower end of this surface tension range. The resulting

43、surface tension of the synthetic blood is 0.0426 0.002 N/m.7 Lentner, C., ed., Geigy Scientific Tables, Vol 1 - Units of Measurement, Body Fluids, Composition of Blood, Hematology, Somatometric Data, Medical Education Div.,Ciba-Geigy Corp., West Caldwell, NJ, 1984.F1862/F1862M 1735.3 The synthetic b

44、lood mixture is prepared with a red dye to aid in visual detection and a thickening agent to simulate the flowcharacteristics of blood. The synthetic blood will not always duplicate the polarity, and thus the wetting behavior and subsequentpenetration, of real blood and other body fluids through pro

45、tective clothing materials.5.4 During a medical procedure, a blood vessel is occasionally punctured resulting in a high velocity stream of blood impactinga protective medical face mask. The impact velocity depends on several factors, the most important being the blood pressure ofthe patient. Other f

46、actors include the size of the puncture,puncture and distance from the puncture. Because the pressure, and thusvelocity drops quickly with large punctures, large punctures were not used to model the range of blood splatter velocitiesconsidered in this test. Furthermore, this test method is based on

47、the assumption that the medical face mask will be in closeproximity (within 300 mm or 12 in.) to the puncture area.The use of this test method is, therefore, based on selecting an appropriateblood pressure, finding the corresponding stream or impact velocity, and determining the valve time to create

48、 that stream velocityas shown in Appendix X1.5.4.1 The mean human blood pressure generally varies over a range of about 10.7 to 16.0 kPa (80 to 120 mmHg).8 In this testmethod, medical face masks are tested at stream velocities corresponding to 10.7 kPa, 16.0 kPa, and 21.3 kPa (80 mmHg, 120 mmHg, mmH

49、g, and 160 mm Hg).mmHg).5.5 This test method permits the use of other non-standard test pressures, stream velocities, fluid volumes, and specimenorientations for evaluating medical face mask penetration resistance consistent with specific applications.5.6 This test method differs from Test Method F1670F1670/F1670M by dispensing a stream of 2 mL of synthetic blood againstthe target area of a complete medical mask specimen, whereas Test Method F1670F1670/F1670M involves the continuous contactof a specimen of protective clothing with synthetic blood ove