ASTM F2981-15(2020)
(Test Method)Standard Test Method for Verifying Nonporous Flexible Barrier Material Resistance to the Passage of Air
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
- Technical Committee
- F02 - Primary Barrier Packaging
- Drafting Committee
- F02.20 - Physical Properties
Relations
- Effective Date
- 01-May-2020
- Effective Date
- 01-Apr-2007
- Effective Date
- 15-Nov-1994
- Effective Date
- 01-May-2020
Overview
ASTM F2981-15(2020): Standard Test Method for Verifying Nonporous Flexible Barrier Material Resistance to the Passage of Air is an internationally recognized standard developed by ASTM International. This test method provides a consistent procedure for evaluating flexible barrier materials designed to resist air permeability, confirming their status as nonporous materials. By challenging materials under specified conditions, the standard establishes whether these materials meet essential requirements for air impermeability and contribute to effective microbial barrier properties, as referenced in ISO 11607-1 for medical device packaging.
Key Topics
- Air Resistance Verification: Focuses on confirming the nonporous nature of flexible barrier materials by exposing them to a controlled volume of air under pressure and observing measurable movement over a fixed period.
- Material Characterization: Designed specifically to verify the design property of nonporous barrier materials. It does not measure air diffusion rates or detect pinholes or leaks from material damage.
- Pass/Fail Criteria: Materials are classified as nonporous if air movement through the sample does not exceed a predefined threshold, validating their integrity in demanding packaging applications.
- Apparatus and Procedure: Utilizes a cylinder-type densometer, commonly known as a Gurley apparatus, and follows a repeatable method for preparing and testing samples.
- Safety and Units Compliance: Tests are performed using SI units, aligned with international safety, health, and environmental best practices.
Applications
The ASTM F2981-15(2020) test method has critical applications in the evaluation and quality assurance of materials used for:
- Medical Packaging: Vital for terminally sterilized medical device packaging systems, ensuring the maintenance of sterile barriers by preventing air and microbial ingress.
- Pharmaceutical Packaging: Supports compliance with packaging requirements where controlled atmosphere and barrier integrity are essential.
- Food Packaging: Assists in verifying flexible films and barrier pouches to preserve freshness and prevent contamination through unwanted air exchange.
- Industrial and Technical Packaging: Suitable for protective packaging where air impermeability is necessary to safeguard product quality and performance during storage or transport.
By certifying nonporous material performance, the standard helps manufacturers select suitable materials for critical product protection and regulatory compliance.
Related Standards
Several international and industry standards complement ASTM F2981-15(2020), supporting a harmonized approach to barrier material testing:
- ISO 11607-1: Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems - references this test for microbial barrier validation.
- ISO 5636-5: Paper and board – Determination of air permeance and air resistance (Medium range) – Part 5: Gurley Method - provides a basis for comparable air resistance testing equipment and procedures.
- TAPPI Test Method T 460: Air Resistance of Paper (Gurley Method) - standardized method for testing air resistance in paper materials, widely used in packaging.
- ASTM E171: Practice for Conditioning and Testing Flexible Barrier Packaging - outlines material pre-conditioning best practices to ensure repeatability and reliability in package testing.
By adhering to these standards, organizations ensure robust verification of flexible barrier materials, contributing to the safety, sterility, and shelf-life of packaged products in various industries.
Keywords: flexible barrier material, nonporous, air resistance, Gurley method, packaging standards, ASTM, microbial barrier, air impermeability, quality assurance
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Frequently Asked Questions
ASTM F2981-15(2020) is a standard published by ASTM International. Its full title is "Standard Test Method for Verifying Nonporous Flexible Barrier Material Resistance to the Passage of Air". This standard covers: 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.
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.
ASTM F2981-15(2020) is classified under the following ICS (International Classification for Standards) categories: 11.080.30 - Sterilized packaging. The ICS classification helps identify the subject area and facilitates finding related standards.
ASTM F2981-15(2020) has the following relationships with other standards: It is inter standard links to ASTM F2981-15, ASTM E171-94(2007), ASTM E171-94(2002), ASTM F2097-20. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
ASTM F2981-15(2020) is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
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 service@astm.org. 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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