ASTM F2100-01

Standard Specification for Performance of Materials Used in Medical Face Masks

SCOPE
1.1 This specification covers testing and requirements for materials used in the construction of medical face masks that are used in providing health care 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 also apply to respiratory protection, which may be necessary for some health care services.
1.4 The values stated in SI units or in other units shall be regarded separately as standard. The values stated in each system must be used independently of the other, without combining values in any way.
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 and health practices and determine the applicability of regulatory limitations prior to use.

General Information

• Status: Historical
• Publication Date: 09-May-2001
• ICS: 11.140 - Hospital equipment
• Technical Committee: F23 - Personal Protective Clothing and Equipment
• Drafting Committee: F23.40 - Biological

Relations

• Referred By: ASTM F3502-23a - Standard Specification for Barrier Face Coverings
• Effective Date: 10-May-2001

Standards Content (Sample)

NOTICE: This standard has either been superceded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
Designation: F 2100 – 01
Standard Specification for
Performance of Materials Used in Medical Face Masks
This standard is issued under the fixed designation F 2100; 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 (e) indicates an editorial change since the last revision or reapproval.
1. Scope Efficiency (BFE) of Medical Face Mask Materials, Using a
Biological Aerosol of Staphylococcus aureus
1.1 This specification covers testing and requirements for
2.2 ANSI/ASQC Standard:
materials used in the construction of medical face masks that
ANSI/ASQC Z1.4 Sampling Procedures and Tables for
are used in providing health care services such as surgery and
Inspection by Attributes
patient care.
2.3 ISO Standard:
1.2 This specification provides for the classification of
ISO 2859-1 Sampling Plans for Inspection by Attributes
medical face mask material performance. Medical face mask
2.4 Military Standard:
material performance is based on testing for bacterial filtration
MIL-M-36954C Military Specification, Mask, Surgical,
efficiency, differential pressure, sub-micron particulate filtra-
Disposable
tion efficiency, resistance to penetration by synthetic blood, and
2.5 Federal Standards:
flammability.
16 CFR Part 1610 Standard for the Flammability of Cloth-
1.3 This specification does not address all aspects of medi-
ing Textiles
cal face mask design and performance. This specification does
29 CFR Part 1910.1030 Occupational Exposure to Blood-
not specifically evaluate the effectiveness of medical face mask
borne Pathogens: Final Rule
designs as related to the barrier and breathability properties.
42 CFR Part 84 Approval of Respiratory Protective Devices
This specification does not also apply to respiratory protection,
which may be necessary for some health care services.
3. Terminology
1.4 The values stated in SI units or in other units shall be
3.1 Definitions:
regarded separately as standard. The values stated in each
3.1.1 bacterial filtration effıciency (BFE), n—the effective-
system must be used independently of the other, without
ness of medical face mask material in preventing the passage of
combining values in any way.
aerosolized bacteria; expressed in the percentage of a known
1.5 The following precautionary caveat pertains only to the
quantity that does not pass the medical face mask material at a
test methods portion, Section 9, of this specification: This
given aerosol flow rate.
standard does not purport to address all of the safety concerns,
3.1.2 body fluid, n—any liquid produced, secreted, or ex-
if any, associated with its use. It is the responsibility of the user
creted by the human body.
of this standard to establish appropriate safety and health
3.1.2.1 Discussion—In this specification, body fluids in-
practices and determine the applicability of regulatory limita-
clude liquids potentially infected with blood-borne pathogens,
tions prior to use.
including, but not limited to, blood, semen, vaginal secretions,
2. Referenced Documents cerebrospinal fluid, synovial fluid and peritoneal fluid, amni-
otic fluid, saliva in dental procedures, and any body fluid that
2.1 ASTM Standards:
is visibly contaminated with blood, and all body fluids in
F 1215 Test Method for Determining the Initial Efficiency
situations where it is difficult or impossible to differentiate
of a Flatsheet Filter Medium in an Airflow Using Latex
between body fluids (see 29 CFR Part 1910.1030).
Spheres
3 3.1.3 body fluid simulant, n—a liquid which is used to act as
F 1494 Terminology Relating to Protective Clothing
a model for human body fluids.
F 1862 Test Method for Resistance of Medical Face Masks
3.1.4 differential pressure, n—the measured pressure drop
to Penetration by Synthetic Blood (Horizontal Projection of
across a medical face mask material.
Fixed Volume at a Known Velocity)
F 2101 Test Method for Evaluating the Bacterial Filtration
Available from American Society for Quality Control, 611 East Wisconsin Ave.,
Milwaukee, WI 53202.
1 5
This specification is under the jurisdiction of ASTM Committee F23 on Available from American National Standards Institute, 11 W. 42nd St., 13th
Protective Clothing and is the direct responsibility of Subcommittee F23.40 on Floor, New York, NY 10036.
Biological. Available from Standardization Documents Order Desk, Bldg. 4 Section D, 700
Current edition approved May 10, 2001. Published July 2001. Robbins Ave., Philadelphia, PA 19111-5094, Attn: NPODS.
2 7
Discontinued; see 1999 Annual Book of ASTM Standards, Vol 14.04. Available from Superintendent of Documents, U.S. Government Printing
Annual Book of ASTM Standards, Vol 11.03. Office, Washington, DC 20402.
Copyright © ASTM, 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959, United States.
NOTICE: This standard has either been superceded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
F 2100
tion, talking, sneezing and the length of time the medical face mask is
3.1.4.1 Discussion—In this specification, differential pres-
worn).
sure is expressed as a pressure per unit area.
3.1.5 flammability, n—those characteristics of a material
4.3 Users of this specification are cautioned that improved
that pertain to its relative ease of ignition and relative ability to
resistance of medical face masks to penetration by synthetic
sustain combustion.
blood can cause a reduction in medical face mask breathability.
3.1.6 penetration, n—in a protective clothing material or
In general, increasing synthetic blood penetration resistance
item, the flow of a chemical on a non-molecular level through
(and bacterial filtration efficiency and sub-micron particulate
closures, porous materials, seams and pinholes or other imper-
filtration efficiency) results in increasing pressure drop or
fections in protective clothing.
reduction of breathability for medical face masks of the same
3.1.6.1 Discussion—In this specification, blood or body
design.
fluids replace the term chemical and the specific penetration
4.4 This specification or its requirements does not evaluate
liquid is synthetic blood, a body fluid simulant.
medical face masks for regulatory approval as respirators. It
3.1.7 protective clothing, n—a product which is specifically
specifically only evaluates the materials used in the construc-
designed and constructed for the intended purpose of isolating
tion of the medical face mask and not the seal of the medical
parts of the body from a potential hazard.
face mask against the wearer’s face or other design features
3.1.7.1 Discussion—The primary purpose of protective
that determine its effectiveness of preventing particle or liquid
clothing is to act as a barrier for the wearer to a hazard.
exposure to the wearer. If respiratory protection for the wearer
However, the product may also offer protection as a barrier
is needed, a NIOSH-certified respirator, meeting the require-
which prevents the body from being a source of contamination.
ments of 42 CFR Part 84, should be used.
3.1.8 medical face mask, n—an ite
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