ASTM F2097-23
(Guide)Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
SIGNIFICANCE AND USE
4.1 This design and evaluation guide describes multiple categories for evaluating flexible medical packages and packaging materials. These include safety, barrier, material and package performance attributes and characteristics, package integrity, visibility and appearance, processing, printed ink, distribution simulation, and conditioning.
4.2 The intent of this design and evaluation guide is to evaluate all cited categories and select those that are applicable. Once the product has been characterized and the sterilization methodology has been defined, there are numerous sets of requirements for any specific package. This design and evaluation guide provides an avenue for assessing these requirements and choosing test methods for both evaluating the package design and monitoring package compliance.
Note 1: Many of the standards included in this guide are consensus standards that are recognized by the United States Food and Drug Administration (FDA). Selection and use of a U.S. FDA recognized consensus standard is voluntary and the sole responsibility of the user in determining its applicability. For further information, consult the U.S. FDA Standards and Conformity Assessment Program at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatoryassistance/standards-and-conformity-assessment-program
4.3 Product characterization shall include mass or weight, geometry (length and width, height, and shape) and product composition.
4.4 All categories must be considered for applicability.
4.5 The Summary of Test Methods for Medical Packaging Design and Evaluation (Fig. 1) provides a compact graphical presentation of the test methods referenced in this guide.
SCOPE
1.1 This guide provides directions for the design and evaluation of primary flexible packages for medical products. The package materials must be selected appropriately for manufacturing process, end use, and the product being packaged.
1.2 This guide provides a compendium of test methods, practices, and procedures. Specific individual test methods must be selected based on the pertinent characteristics of the specific product to be packaged and the purpose for testing, research and development, or compliance. Not all test methods will be applicable.
1.3 This guide does not address acceptability criteria, which need to be determined jointly by the package producer and the medical products manufacturer.
1.4 This guide does not assess the product to be packaged or the sterilization method to be used.
1.5 The units cited in the referenced standard should be used.
1.6 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.
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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: F2097 − 23
Standard Guide for
Design and Evaluation of Primary Flexible Packaging for
1
Medical Products
This standard is issued under the fixed designation F2097; 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 (´) indicates an editorial change since the last revision or reapproval.
1. Scope minant A, 89 % Reflectance Backing and Paper Backing)
3
(Withdrawn 2010)
1.1 This guide provides directions for the design and evalu-
D638 Test Method for Tensile Properties of Plastics
ation of primary flexible packages for medical products. The
D645/D645M Test Method for Thickness of Paper and
package materials must be selected appropriately for manufac-
3
Paperboard (Withdrawn 2010)
turing process, end use, and the product being packaged.
D685 Practice for Conditioning Paper and Paper Products
1.2 This guide provides a compendium of test methods,
for Testing
practices, and procedures. Specific individual test methods
D726 Test Method for Resistance of Nonporous Paper to
3
must be selected based on the pertinent characteristics of the
Passage of Air (Withdrawn 2009)
specific product to be packaged and the purpose for testing,
D882 Test Method for Tensile Properties of Thin Plastic
research and development, or compliance. Not all test methods
Sheeting
will be applicable.
D1003 Test Method for Haze and Luminous Transmittance
of Transparent Plastics
1.3 This guide does not address acceptability criteria, which
D1251 Test Method for Water Vapor Permeability of Pack-
need to be determined jointly by the package producer and the
3
ages by Cycle Method (Withdrawn 1999)
medical products manufacturer.
D1434 Test Method for Determining Gas Permeability Char-
1.4 This guide does not assess the product to be packaged or
acteristics of Plastic Film and Sheeting
the sterilization method to be used.
D1709 Test Methods for Impact Resistance of Plastic Film
1.5 The units cited in the referenced standard should be
by the Free-Falling Dart Method
used.
D1777 Test Method for Thickness of Textile Materials
D1894 Test Method for Static and Kinetic Coefficients of
1.6 This international standard was developed in accor-
3
Friction of Plastic Film and Sheeting (Withdrawn 2023)
dance with internationally recognized principles on standard-
D1922 Test Method for Propagation Tear Resistance of
ization established in the Decision on Principles for the
Plastic Film and Thin Sheeting by Pendulum Method
Development of International Standards, Guides and Recom-
D1938 Test Method for Tear-Propagation Resistance (Trou-
mendations issued by the World Trade Organization Technical
ser Tear) of Plastic Film and Thin Sheeting by a Single-
Barriers to Trade (TBT) Committee.
Tear Method
D2019 Test Method for Dirt in Paper and Paperboard (With-
2. Referenced Documents
3
drawn 2010)
2
2.1 ASTM Standards:
D2457 Test Method for Specular Gloss of Plastic Films and
D374 Test Methods for Thickness of Solid Electrical Insu-
Solid Plastics
lation (Metric) D0374_D0374M
D3078 Test Method for Determination of Leaks in Flexible
D589 Test Method for Opacity of Paper (15° Diffuse Illu-
Packaging by Bubble Emission
D3079 Test Method for Water Vapor Transmission of Flex-
ible Heat-Sealed Packages for Dry Products (Withdrawn
3
1
This guide is under the jurisdiction of ASTM Committee F02 on Primary
2018)
Barrier Packaging and is the direct responsibility of Subcommittee F02.50 on
D3335 Test Method for Low Concentrations of Lead,
Package Design and Development.
Cadmium, and Cobalt in Paint by Atomic Absorption
Current edition approved Oct. 1, 2023. Published November 2023. Originally
approved in 2001. Last previous edition approved in 2020 as F2097 – 20. DOI: Spectroscopy
10.1520/F2097-23.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
3
Standards volume information, refer to the standard’s Document Summary page on The last approved version of this historical standard is referenced on
the ASTM website. www.astm.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F2097 − 23
D3420 Test Method for Pendulum Impact Resistance of F1608 Test Method for Microbial Ranking of Porous Pack-
Plastic Film aging Materials (Exposure Chamber Method)
D3718 Test Method for Low Concentrations of Chromium F1884 Test Methods for Determining Residual Solvents in
in Paint by
...
This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: F2097 − 20 F2097 − 23
Standard Guide for
Design and Evaluation of Primary Flexible Packaging for
1
Medical Products
This standard is issued under the fixed designation F2097; 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 (´) indicates an editorial change since the last revision or reapproval.
1. Scope
1.1 This guide provides directions for the design and evaluation of primary flexible packages for medical products. The package
materials must be selected appropriately for manufacturing process, end use, and the product being packaged.
1.2 This guide provides a compendium of test methods, practices, and procedures. Specific individual test methods must be
selected based on the pertinent characteristics of the specific product to be packaged and the purpose for testing, research and
development, or compliance. Not all test methods will be applicable.
1.3 This guide does not address acceptability criteria, which need to be determined jointly by the package producer and the
medical products manufacturer.
1.4 This guide does not assess the product to be packaged or the sterilization method to be used.
1.5 The units cited in the referenced standard should be used.
1.6 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.
2. Referenced Documents
2
2.1 ASTM Standards:
D374 Test Methods for Thickness of Solid Electrical Insulation (Metric) D0374_D0374M
D589 Test Method for Opacity of Paper (15° Diffuse Illuminant A, 89 % Reflectance Backing and Paper Backing) (Withdrawn
3
2010)
D638 Test Method for Tensile Properties of Plastics
3
D645/D645M Test Method for Thickness of Paper and Paperboard (Withdrawn 2010)
D685 Practice for Conditioning Paper and Paper Products for Testing
3
D726 Test Method for Resistance of Nonporous Paper to Passage of Air (Withdrawn 2009)
D882 Test Method for Tensile Properties of Thin Plastic Sheeting
1
This guide is under the jurisdiction of ASTM Committee F02 on Primary Barrier Packaging and is the direct responsibility of Subcommittee F02.50 on Package Design
and Development.
Current edition approved May 1, 2020Oct. 1, 2023. Published September 2020November 2023. Originally approved in 2001. Last previous edition approved in 20162020
as F2097 – 16.F2097 – 20. DOI: 10.1520/F2097-20.10.1520/F2097-23.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
3
The last approved version of this historical standard is referenced on www.astm.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F2097 − 23
D1003 Test Method for Haze and Luminous Transmittance of Transparent Plastics
3
D1251 Test Method for Water Vapor Permeability of Packages by Cycle Method (Withdrawn 1999)
D1434 Test Method for Determining Gas Permeability Characteristics of Plastic Film and Sheeting
D1709 Test Methods for Impact Resistance of Plastic Film by the Free-Falling Dart Method
D1777 Test Method for Thickness of Textile Materials
3
D1894 Test Method for Static and Kinetic Coefficients of Friction of Plastic Film and Sheeting (Withdrawn 2023)
D1922 Test Method for Propagation Tear Resistance of Plastic Film and Thin Sheeting by Pendulum Method
D1938 Test Method for Tear-Propagation Resistance (Trouser Tear) of Plastic Film and Thin Sheeting by a Single-Tear Method
3
D2019 Test Method for Dirt in Paper and Paperboard (Withdrawn 2010)
D2457 Test Method for Specular Gloss of Plastic Films and Solid Plastics
D3078 Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission
3
D3079 Test Method for Water Vapor Transmission of Flexible Heat-Sealed Packages for Dry Products (Withdrawn 2018)
D3335 Test Method for Low Concentrations of Lead, Cadmium, and Cobalt in Paint by Atomic Absorption Spectroscopy
D3420 Test Method for Pendulum Impact Resistance of Plastic Film
D3718 Test Method for Low Concentrations of Chromium i
...
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