ASTM F2100-02

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-Aug-2002
• ICS: 11.140 - Hospital equipment
• Technical Committee: F23 - Personal Protective Clothing and Equipment
• Drafting Committee: F23.40 - Biological

Relations

• Replaced By: ASTM F2100-03 - Standard Specification for Performance of Materials Used in Medical Face Masks
• Effective Date: 10-Mar-2003

Standards Content (Sample)

Designation: F 2100 – 02
Standard Specification for
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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 F 2101 Test Method for Evaluating the Bacterial Filtration
Efficiency (BFE) of Medical Face Mask Materials, Using a
1.1 This specification covers testing and requirements for
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Biological Aerosol of Staphylococcus aureus
materials used in the construction of medical face masks that
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2.2 ANSI/ASQC Standard:
are used in providing health care services such as surgery and
ANSI/ASQC Z1.4 Sampling Procedures and Tables for
patient care.
Inspection by Attributes
1.2 This specification provides for the classification of
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2.3 ISO Standard:
medical face mask material performance. Medical face mask
ISO 2859-1 Sampling Plans for Inspection by Attributes
material performance is based on testing for bacterial filtration
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2.4 Military Standard:
efficiency, differential pressure, sub-micron particulate filtra-
MIL-M-36954C Military Specification, Mask, Surgical,
tion efficiency, resistance to penetration by synthetic blood, and
Disposable
flammability.
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2.5 Federal Standards:
1.3 This specification does not address all aspects of medi-
16 CFR Part 1610 Standard for the Flammability of Cloth-
cal face mask design and performance. This specification does
ing Textiles
not specifically evaluate the effectiveness of medical face mask
29 CFR Part 1910.1030 Occupational Exposure to Blood-
designs as related to the barrier and breathability properties.
borne Pathogens: Final Rule
This specification does not also apply to respiratory protection,
42 CFR Part 84 Approval of Respiratory Protective Devices
which may be necessary for some health care services.
1.4 The values stated in SI units or in other units shall be
3. Terminology
regarded separately as standard. The values stated in each
3.1 Definitions:
system must be used independently of the other, without
3.1.1 bacterial filtration effıciency (BFE), n—the effective-
combining values in any way.
ness of medical face mask material in preventing the passage of
1.5 The following precautionary caveat pertains only to the
aerosolized bacteria; expressed in the percentage of a known
test methods portion, Section 9, of this specification: This
quantity that does not pass the medical face mask material at a
standard does not purport to address all of the safety concerns,
given aerosol flow rate.
if any, associated with its use. It is the responsibility of the user
3.1.2 body fluid, n—any liquid produced, secreted, or ex-
of this standard to establish appropriate safety and health
creted by the human body.
practices and determine the applicability of regulatory limita-
3.1.2.1 Discussion—In this specification, body fluids in-
tions prior to use.
clude liquids potentially infected with blood-borne pathogens,
2. Referenced Documents including, but not limited to, blood, semen, vaginal secretions,
cerebrospinal fluid, synovial fluid and peritoneal fluid, amni-
2.1 ASTM Standards:
otic fluid, saliva in dental procedures, and any body fluid that
F 1215 Test Method for Determining the Initial Efficiency
is visibly contaminated with blood, and all body fluids in
of a Flatsheet Filter Medium in an Airflow Using Latex
2
situations where it is difficult or impossible to differentiate
Spheres
3 between body fluids (see 29 CFR Part 1910.1030).
F 1494 Terminology Relating to Protective Clothing
3.1.3 body fluid simulant, n—a liquid which is used to act as
F 1862 Test Method for Resistance of Medical Face Masks
a model for human body fluids.
to Penetration by Synthetic Blood (Horizontal Projection of
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Fixed Volume at a Known Velocity)
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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 August 10, 2002. Published October 2002. Orifinally Available from Standardization Documents Order Desk, DODSSP, Bldg. 4,
published F 2100 – 01. Last previous edition F 2100 – 01. 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.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
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