美标ASTM-F2100-19-USA STANDARD Specification-level1-level2-level3

Standard Specification for
Performance of Materials Used in Medical Face Masks

Keywords
bacterial filtration efficiency-（BFE）; differential pressure; fluid
resistance; general use; medical face masks; particle filtration
efficiency-(PFE); sub-micron filtration

This standard is issued under the fixed designation F2100; the number immediately following the designation indicates 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 last revision or reapproval.

1. Scope
   1.1 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
   patient 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 pressure, sub-micron particulate filtration
   efficiency, resistance to penetration by synthetic blood, and
   flammability.
   1.3 This specification does not address all aspects of medical
   face mask design and performance. This 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
   protection, 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 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 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 accordance
   with internationally recognized principles 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) Committee.

2.  Referenced Documents
   2.1 ASTM Standards:2
   F1494 Terminology Relating to Protective Clothing
   F1862 Test Method for Resistance of Medical Face Masks to
   Penetration by Synthetic Blood (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 aureus
   F2299 Test Method for Determining the Initial Efficiency of
   Materials Used in Medical Face Masks to Penetration by
   Particulates Using Latex Spheres
   2.2 ANSI/ASQC Standard:3
   ANSI/ASQC Z1.4 Sampling Procedures and Tables for Inspection
   by Attributes
   2.3 ISO Standard:4
   ISO 2859-1 Sampling Plans for Inspection by Attributes
   2.4 European Standard:5
   EN 14683 Medical Fask Masks—Requirements and Test
   Methods
   2.5 Federal Standards:6
   16 CFR Part 1610 Standard for the Flammability of Clothing
   Textiles
   29 CFR Part 1910.1030 Occupational Exposure to Bloodborne
   Pathogens: Final Rule
   42 CFR Part 84 Approval of Respiratory Protective Devices

3. Terminology
   3.1 Definitions:
   3.1.1 bacterial filtration effıciency (BFE), n—the effectiveness
   of medical face mask material in preventing the passage of
   aerosolized bacteria, expressed in the percentage of a knownquantity that does not pass the medical face mask material at a
   given aerosol flow rate.
   3.1.2 body fluid, n—any liquid produced, secreted, or excreted
   by the human body.
   3.1.2.1 Discussion—In this specification, 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 dental procedures, any body fluid that is
   visibly contaminated with blood, and all body fluids in situations
   where it is difficult or impossible to differentiate between
   body fluids (see 29 CFR Part 1910.1030).
   3.1.3 body fluid simulant, n—a liquid which is used to act as
   a model for human body fluids.
   3.1.4 differential pressure, n—the measured pressure drop
   across a medical face mask material.
   3.1.4.1 Discussion—In this specification, differential pressure
   is expressed as a pressure per unit area.
   3.1.5 flammability, n—those characteristics of a material
   that pertain to its relative ease of ignition and relative ability to
   sustain combustion.
   3.1.6 medical face mask, n—an item of protective clothing
   designed to protect portions of the wearer’s face, including the
   mucous membrane areas of the wearer’s nose and mouth, from
   contact with blood and other body fluids during medical
   procedures.
   3.1.6.1 Discussion—Examples of medical face masks include
   surgical masks, procedure masks, isolation masks, laser
   masks, dental masks, and patient care masks.
   3.1.7 penetration, n—in a protective clothing material or
   item, the flow of a chemical on a non-molecular level through
   closures, porous materials, seams and pinholes, or other
   imperfections in protective clothing.
   3.1.7.1 Discussion—In this specification, blood or body
   fluids replace the term chemical and the specific penetration
   liquid is synthetic blood, a body fluid simulant.
   3.1.8 protective clothing, n—an item of clothing that is
   specifically designed and constructed for the intended purpose
   of isolating all or part of the body from a potential hazard; or,
   isolating the external environment from contamination by the
   wearer of the clothing.
   3.1.8.1 Discussion—The primary purpose of protective
   clothing is to act as a barrier for the wearer to a hazard.
   However, the product may also offer protection as a barrier
   which prevents the body from being a source of contamination.
   3.1.9 sub-micron particulate filtration effıciency, n—the efficiency
   of the filter material in capturing aerosolized particles
   smaller than one micron, expressed as the percentage of a
   known number of particles that does not pass the medical face
   mask material at a given flow rate.
   3.1.10 synthetic blood, n—a mixture of a red dye/surfactant,
   thickening agent, and distilled water having a surface tension
   and viscosity representative of blood and some other body
   fluids, and the color of blood.
   3.1.10.1 Discussion—The synthetic blood in this test
   method does not simulate all of the characteristics of blood or body fluids, for example, polarity (wetting characteristics),
   coagulation, or content of cell matter.
   3.2 For definitions of other protective clothing-related terms
   used in this test method, refer to Terminology F1494.

4.  Significance and Use
   4.1 This specification covers the minimum performance
   requirements for materials used in the construction of medical
   face masks.
   4.2 This specification provides classification of performance
   for a range of medical face mask materials. Medical face mask
   performance classes are based on the barrier performance
   properties of the medical face mask materials (fluid resistance,
   bacterial filtration efficiency, and sub-micron filtration efficiency).
   The list of specified properties represents industry
   practices for characterizing material performance, but does not
   include all aspects of performance that may be necessary to
   protect healthcare workers. Therefore, this specification does
   not cover medical face masks for all possible use situations.
   For example, the Centers for Disease Control and Prevention
   (CDC) specifically requires NIOSH respirators that are at least
   95 % efficient for tuberculosis exposure control.
   NOTE 1—This specification does not provide specific criteria for
   demonstrating medical face mask protection of the patient.
   NOTE 2—The level of protection provided by medical face masks
   depends on several factors not considered in this specification. Examples
   include facial fit and material degradation from wearer challenges
   (perspiration, talking, sneezing, and the length of time the medical face
   mask is worn).
   4.3 Users of this specification are cautioned that improved
   resistance of medical face masks to penetration by synthetic
   blood can cause a reduction in medical face mask breathability.
   In general, increasing synthetic blood penetration resistance
   (and bacterial filtration efficiency and sub-micron particulate
   filtration efficiency) results in increasing pressure drop or
   reduction of breathability for medical face masks of the same
   design.
   4.4 This specification (or its requirements) does not evaluate
   medical face masks for regulatory approval as respirators. It
   specifically only evaluates the materials used in the construction
   of the medical face mask and not the seal of the medical
   face mask against the wearer’s face or other design features
   that determine its effectiveness of preventing particle or liquid
   exposure to the wearer. If respiratory protection for the wearer
   is needed, a NIOSH-certified respirator meeting the requirements
   of 42 CFR Part 84 should be used.
   4.5 The selection of the appropriate medical face mask must
   be governed by the potential exposure hazards based on the
   specific areas of performance associated with class of medical
   face masks. General-use masks provide minimal fluid resistance
   and are suitable for situations such as in isolation settings
   and for certain types of patient care. Where procedures involve
   the generation of sub-micron particles, such as in laser or
   electrocautery surgery, sub-micron filtering masks are appropriate.
   Where procedures involve the probability or likely
   exposure to blood or body fluids, select fluid-resistant medical
   faces masks.

   
   

5.  Classification FTI 
   5.1 Medical face mask materials covered under this specification
   shall be designated as one or more of the following
   performance classes as based on the barrier performance
   properties of the 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 to 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 their 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 pressure.
   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, submicron
   particulate filtration, bacterial filtration efficiency, and
   differential pressure.

6.  Requirements
   6.1 The properties of the medical face mask material shall
   conform to the specifications requirements in Table 1, as tested
   in accordance with Section 9.
   NOTE 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 requirements for Class 1, normal flammability
   specified in 16 CFR Part 1610.

7.  Sampling
   7.1 Testing shall be performed on materials taken from
   manufactured medical face masks.

   7.2 An acceptable quality limit of 4 % shall be used for 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 Tests
   8.1 A sufficient number of medical face masks shall be
   evaluated for each test to achieve the established acceptable
   quality limit or confidence level.

9. Test Methods
   9.1 Bacterial Filtration Effıciency—Determine the bacterial
   filtration 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 pressure per unit
   area of material specimen tested.
   9.3 Sub-Micron Particulate Filtration—Determine particulate
   filtration efficiency as directed in Test Method F2299.
   9.4 Resistance to Penetration by Synthetic Blood—
   Determine synthetic blood penetration resistance as specified
   in Test Method F1862.
   9.5 Flammability—Determine flammability as specified in
   16 CFR Part 1610.

10.  Report
    10.1 The primary package containing the medical face
    masks 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, and
    10.1.4 A graphic representation indicating the performance
    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. Keywords
    11.1 bacterial filtration efficiency; differential pressure; fluid
    resistance; general use; medical face masks; particle filtration
    efficiency; sub-micron filtration