ASTM F2100-03a

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-Jun-2003
• ICS: 11.140 - Hospital equipment
• Technical Committee: F23 - Personal Protective Clothing and Equipment
• Drafting Committee: F23.40 - Biological

Relations

• Replaces: ASTM F2100-03 - Standard Specification for Performance of Materials Used in Medical Face Masks
• Effective Date: 10-Jun-2003
• Replaced By: ASTM F2100-04 - Standard Specification for Performance of Materials Used in Medical Face Masks
• Effective Date: 01-Mar-2004
• Referred By: ASTM F3502-23a - Standard Specification for Barrier Face Coverings
• Effective Date: 10-Jun-2003

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: F 2100 – 03a
Standard Specification for
1
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.
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1. Scope Fixed Volume at a Known Velocity)
F 2101 Test Method for Evaluating the Bacterial Filtration
1.1 This specification covers testing and requirements for
Efficiency (BFE) of Medical Face Mask Materials, Using a
materials used in the construction of medical face masks that
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Biological Aerosol of Staphylococcus aureus
are used in providing health care services such as surgery and
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2.2 ANSI/ASQC Standard:
patient care.
ANSI/ASQC Z1.4 Sampling Procedures and Tables for
1.2 This specification provides for the classification of
Inspection by Attributes
medical face mask material performance. Medical face mask
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2.3 ISO Standard:
material performance is based on testing for bacterial filtration
ISO 2859-1 Sampling Plans for Inspection by Attributes
efficiency, differential pressure, sub-micron particulate filtra-
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2.4 Military Standard:
tion efficiency, resistance to penetration by synthetic blood, and
MIL-M-36954C Military Specification, Mask, Surgical,
flammability.
Disposable
1.3 This specification does not address all aspects of medi-
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2.5 Federal Standards:
cal face mask design and performance. This specification does
16 CFR Part 1610 Standard for the Flammability of Cloth-
not specifically evaluate the effectiveness of medical face mask
ing Textiles
designs as related to the barrier and breathability properties.
29 CFR Part 1910.1030 Occupational Exposure to Blood-
This specification does not also apply to respiratory protection,
borne Pathogens: Final Rule
which may be necessary for some health care services.
42 CFR Part 84 Approval of Respiratory Protective Devices
1.4 The values stated in SI units or in other units shall be
regarded separately as standard. The values stated in each
3. Terminology
system must be used independently of the other, without
3.1 Definitions:
combining values in any way.
3.1.1 bacterial filtration effıciency (BFE), n—the effective-
1.5 The following precautionary caveat pertains only to the
ness of medical face mask material in preventing the passage of
test methods portion, Section 9, of this specification: This
aerosolized bacteria; expressed in the percentage of a known
standard does not purport to address all of the safety concerns,
quantity that does not pass the medical face mask material at a
if any, associated with its use. It is the responsibility of the user
given aerosol flow rate.
of this standard to establish appropriate safety and health
3.1.2 body fluid, n—any liquid produced, secreted, or ex-
practices and determine the applicability of regulatory limita-
creted by the human body.
tions prior to use.
3.1.2.1 Discussion—In this specification, body fluids in-
2. Referenced Documents clude liquids potentially infected with blood-borne pathogens,
including, but not limited to, blood, semen, vaginal secretions,
2.1 ASTM Standards:
cerebrospinal fluid, synovial fluid and peritoneal fluid, amni-
F 1215 Test Method for Determining the Initial Efficiency
otic fluid, saliva in dental procedures, and any body fluid that
of a Flatsheet Filter Medium in an Airflow Using Latex
2 is visibly contaminated with blood, and all body fluids in
Spheres
3
situations where it is difficult or impossible to differentiate
F 1494 Terminology Relating to Protective Clothing
between body fluids (see 29 CFR Part 1910.1030).
F 1862 Test Method for Resistance of Medical Face Masks
to Penetration by Synthetic Blood (Horizontal Projection of
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Available from American Society for Quality Control, 611 East Wisconsin Ave.,
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This specification is under the jurisdiction of ASTM Committee F23 on Milwaukee, WI 53202.
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Protective Clothing and is the direct responsibility of Subcommittee F23.40 on Available from American National Standards Institute (ANSI), 25 W. 43rd St.,
Biological. 4th Floor, New York, NY 10036.
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Current edition approved June 10, 2003. Published August 2003. Originally Available from Standardization Documents Order Desk, DODSSP, Bldg. 4,
published F 2100 – 01. Last previous edition F 2100 – 03. Section D, 700 Robbins Ave., Philadelphia, PA 19111-5098
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Discontinued; see 1999 Annual Book of ASTM Standards, Vol 14.04. Available from U.S. Government Printing Office Superintendent of Documents,
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Annual Book of ASTM Standards, Vol 11.03. 732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401.
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