astm f2100-2019醫(yī)用口罩用材料性能規(guī)格

1、Designation: F2100 ? 19Standard Specification for Performance of Materials Used in Medical Face Masks1This standard is issued under the fixed designation F2100; the number immediately following the designation indicates

2、the year of 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

3、last revision or reapproval.1. Scope1.1 This specification covers testing and requirements for materials used in the construction of medical face masks that are used in providing healthcare services such as surgery and p

4、atient care.1.2 This specification provides for the classification of medical face mask material performance. Medical face mask material performance is based on testing for bacterial filtration efficiency, differential p

5、ressure, sub-micron particulate filtra- tion efficiency, resistance to penetration by synthetic blood, and flammability.1.3 This specification does not address all aspects of medi- cal face mask design and performance. T

6、his specification does not specifically evaluate the effectiveness of medical face mask designs as related to the barrier and breathability properties. This specification does not apply to regulated respiratory protectio

7、n, which may be necessary for some healthcare services.1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.1.5 The following precautionary caveat

8、pertains only to the test methods portion, Section 9, of this specification: This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of

9、this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.1.6 This international standard was developed in accor- dance with

10、 internationally recognized principles on standard- ization established in the Decision on Principles for the Development of International Standards, Guides and Recom- mendations issued by the World Trade Organization Te

11、chnical Barriers to Trade (TBT) Committee.2. Referenced Documents2.1 ASTM Standards:2F1494 Terminology Relating to Protective Clothing F1862 Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Bl

12、ood (Horizontal Projection of Fixed Volume at a Known Velocity)F2101 Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureu

13、sF2299 Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres2.2 ANSI/ASQC Standard:3ANSI/ASQC Z1.4 Sampling Procedures and Tables fo

14、r In- spection by Attributes2.3 ISO Standard:4ISO 2859-1 Sampling Plans for Inspection by Attributes 2.4 European Standard:5EN 14683 Medical Fask Masks—Requirements and Test Methods2.5 Federal Standards:616 CFR Part 1610

15、 Standard for the Flammability of Clothing Textiles29 CFR Part 1910.1030 Occupational Exposure to Blood- borne Pathogens: Final Rule42 CFR Part 84 Approval of Respiratory Protective Devices3. Terminology3.1 Definitions:

16、3.1.1 bacterial filtration eff?ciency (BFE), n—the effective- ness of medical face mask material in preventing the passage of aerosolized bacteria, expressed in the percentage of a known1 This specification is under the

17、jurisdiction of ASTM Committee F23 on Personal Protective Clothing and Equipment and is the direct responsibility of Subcommittee F23.40 on Biological. Current edition approved Aug. 1, 2019. Published August 2019. Origin

18、ally approved in 2001. Last previous edition approved in 2018 as F2100 – 11 (2018). DOI: 10.1520/F2100-19.2 For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at service

19、@astm.org. For Annual Book of ASTM Standards volume information, refer to the standard’s Document Summary page on the ASTM website. 3 Available from American Society for Quality (ASQ), 600 N. Plankinton Ave., Milwaukee,

20、WI 53203, http://www.asq.org. 4 Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org. 5 Available from British Standards Institution (BSI), 389 C

21、hiswick High Rd., London W4 4AL, U.K., http://www.bsigroup.com. 6 Available from U.S. Government Printing Office Superintendent of Documents, 732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401, http:// www.acce

22、ss.gpo.gov.Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United StatesThis international standard was developed in accordance with internationally recognized p

23、rinciples on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) C

24、ommittee.15. Classification5.1 Medical face mask materials covered under this speci- fication shall be designated as one or more of the following performance classes as based on the barrier performance properties of the

25、materials used in medical face masks: Level 1 barrier, Level 2 barrier, and Level 3 barrier. 5.1.1 Level 1 barrier medical face mask materials are evaluated for their ability to capture sub-micron particles, resistance t

26、o penetration by synthetic blood at the minimum velocity specified in Test Method F1862, bacterial filtration efficiency, and differential pressure. 5.1.2 Level 2 barrier medical face mask materials are evaluated for the

27、ir ability to capture sub-micron particles and are evaluated for resistance to penetration by synthetic blood at the middle velocity specified in Test Method F1862, bacterial filtration efficiency, and differential press

28、ure. 5.1.3 Level 3 barrier medical face mask materials are evaluated for resistance to penetration by synthetic blood at the maximum velocity specified in Test Method F1862, sub- micron particulate filtration, bacterial

29、filtration efficiency, and differential pressure.6. Requirements6.1 The properties of the medical face mask material shall conform to the specifications requirements in Table 1, as tested in accordance with Section 9.NOT

30、E 3—Medical face mask materials comprise specimens taken from manufactured medical face masks, with all layers arranged in proper order.6.2 Materials used in the construction of medical face masks shall meet the requirem

31、ents for Class 1, normal flammability specified in 16 CFR Part 1610.7. Sampling7.1 Testing shall be performed on materials taken from manufactured medical face masks.7.2 An acceptable quality limit of 4 % shall be used f

32、or all required testing to establish conformance of medical face masks to a specific performance class.7.3 Examples of acceptable sampling plans are found in ANSI/ASQC Z1.4 and ISO 2859-1.8. Number of Tests8.1 A sufficie

33、nt number of medical face masks shall be evaluated for each test to achieve the established acceptable quality limit or confidence level.9. Test Methods9.1 Bacterial Filtration Eff?ciency—Determine the bacterial filtrati

34、on efficiency as directed in Test Method F2101.9.2 Differential Pressure—Determine breathing resistance or differential pressure as directed in EN 14683:2019, Annex C.NOTE 4—This test method provides a measurement of pre

35、ssure per unit area of material specimen tested.9.3 Sub-Micron Particulate Filtration—Determine particu- late filtration efficiency as directed in Test Method F2299.9.4 Resistance to Penetration by Synthetic Blood— Deter

36、mine synthetic blood penetration resistance as specified in Test Method F1862.9.5 Flammability—Determine flammability as specified in 16 CFR Part 1610.10. Report10.1 The primary package containing the medical face masks

37、that meet this specification shall be prominently labeled with the following information:10.1.1 Manufacturer name,10.1.2 Product or style name,10.1.3 Product lot, and10.1.4 A graphic representation indicating the perform

38、ance level met in Table 1 with the technical requirements of the indicated performance level. The graphic representation shall include a prominent visual indication of the performance level.11. Keywords11.1 bacterial fil

39、tration efficiency; differential pressure; fluid resistance; general use; medical face masks; particle filtration efficiency; sub-micron filtrationTABLE 1 Medical Face Mask Material Requirements by Performance LevelChara

40、cteristic Level 1 Barrier Level 2 Barrier Level 3 BarrierBacterial filtration efficiency, % $95 $98 $98 Differential pressure, mm H2O/cm2 <5.0 <6.0 <6.0 Sub-micron particulate filtration efficiency at 0.1 micron