ASTM F2981-15(2020)

Standard Test Method for Verifying Nonporous Flexible Barrier Material Resistance to the Passage of Air

SIGNIFICANCE AND USE
3.1 This material challenge is presented in ISO-11607-1 Annex C as a normative test method to demonstrate that a material is nonporous and satisfies the microbial barrier requirements.
SCOPE
1.1 This test method is to be used to verify a specific material design property. Some flexible barrier materials are designed to have a resistance to the passage of air through the membrane structure. These materials are characterized as nonporous. This test method provides a means to verify this property by challenging a material with a given volume of air under pressure over a specific time period.  
1.2 This test method is not intended to measure the diffusion properties of a material nor to identify or quantify the presence of pinhole damage to the design that may result in leaks.  
1.3 Units—The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.4 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.  
1.5 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.

General Information

• Status: Published
• Publication Date: 30-Apr-2020
• ICS: 11.080.30 - Sterilized packaging
• Technical Committee: F02 - Primary Barrier Packaging
• Drafting Committee: F02.20 - Physical Properties

Relations

• Replaces: ASTM F2981-15 - Standard Test Method for Verifying Nonporous Flexible Barrier Material Resistance to the Passage of Air
• Effective Date: 01-May-2020
• Refers: ASTM E171-94(2007) - Standard Specification for Standard Atmospheres for Conditioning and Testing Flexible Barrier Materials
• Effective Date: 01-Apr-2007
• Refers: ASTM E171-94(2002) - Standard Specification for Standard Atmospheres for Conditioning and Testing Flexible Barrier Materials
• Effective Date: 15-Nov-1994
• Referred By: ASTM F2097-20 - Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
• Effective Date: 01-May-2020

Standards Content (Sample)

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.
Designation: F2981 − 15 (Reapproved 2020)
Standard Test Method for
Verifying Nonporous Flexible Barrier Material Resistance to
the Passage of Air
This standard is issued under the fixed designation F2981; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope 2.2 ISO Standards:
ISO 11607-1Packaging for Terminally Sterilized Medical
1.1 This test method is to be used to verify a specific
Devices—Part 1: Requirements for Materials, Sterile Bar-
material design property. Some flexible barrier materials are
rier Systems and Packaging Systems
designed to have a resistance to the passage of air through the
ISO 5636-5Paper and Board—Determination of Air Per-
membrane structure. These materials are characterized as
meance and Air Resistance (Medium Range)—Part 5:
nonporous. This test method provides a means to verify this
Gurley Method
property by challenging a material with a given volume of air
2.3 TAPPI Standard:
under pressure over a specific time period.
TAPPI Test Method T 460 om-06Air Resistance of Paper
1.2 Thistestmethodisnotintendedtomeasurethediffusion
(Gurley Method)
propertiesofamaterialnortoidentifyorquantifythepresence
of pinhole damage to the design that may result in leaks.
3. Significance and Use
3.1 This material challenge is presented in ISO-11607-1
1.3 Units—The values stated in SI units are to be regarded
Annex C as a normative test method to demonstrate that a
asstandard.Nootherunitsofmeasurementareincludedinthis
material is nonporous and satisfies the microbial barrier re-
standard.
quirements.
1.4 This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the
4. Apparatus
responsibility of the user of this standard to establish appro-
4.1 Gurley Cylinder-type Densometer, or equivalent appa-
priate safety, health, and environmental practices and deter-
ratus compliant with ISO 5636-5.
mine the applicability of regulatory limitations prior to use.
4.1.1 Air Volume and Pressure, as standardized in TAPPI
1.5 This international standard was developed in accor-
T-460 and ISO 5636-5.
dance with internationally recognized principles on standard-
4.2 Clock or Timer.
ization established in the Decision on Principles for the
Development of International Standards, Guides and Recom-
4.3 Dimensional Scale, in 0.1mm increments.
mendations issued by the World Trade Organization Technical
Barriers to Trade (TBT) Committee.
5. Conditioning
5.1 Conditioning of samples will depend on the material
2. Referenced Documents
under evaluation. If conditioning before testing is appropriate,
2.1 ASTM Standards:
normal and desirable, then condition the test specimens fol-
E171Practice for Conditioning and Testing Flexible Barrier lowing Practice E171.
Packaging
6. Preparation and Procedure
6.1 Measureandcutsampleofmaterialtobetestedapproxi-
1 mately50mm×50mmsquare.Othercutsizesofsamplescan
ThistestmethodisunderthejurisdictionofASTMCommitteeF02onPrimary
Barrier Packaging and is the direct responsibility of Subcommittee F02.20 on
be used if easier to manipulate and position in holder without
Physical Properties.
damage, wrinkling or introducing leaks.
CurrenteditionapprovedMay1,2020.PublishedJuly2020.Originallyapproved
in 2015. Last previous edition approved in 2015 as F2981–15. DOI: 10.1520/
F2981-15R20.
2 3
For referenced ASTM standards, visit the ASTM website, www.astm.org, or Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM 4th Floor, New York, NY 10036, http://www.ansi.org.
Standards volume information, refer to the standard’s Document Summary page on Available from TechnicalAssociation of the Pulp and Paper Industry (TAPPI),
the ASTM website. 15 Technology Parkway South, Norcross, GA 30092, http://www.tappi.org.
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