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ASTM F2097-07

(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

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. 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; the sterilization method to be used; or package performance through sterilization, distribution, and handling.

General Information

Status
Historical
Publication Date
30-Apr-2007
ICS
11.020 - Medical sciences and health care facilities in general
55.020 - Packaging and distribution of goods in general
Technical Committee
F02 - Primary Barrier Packaging
Drafting Committee
F02.50 - Package Design and Development
Current Stage
Ref Project

Relations

Replaces
ASTM F2097-05 - Standard Guide for Design and Evaluation of Primary Packaging for Medical Products
Effective Date
01-May-2007
Replaced By
ASTM F2097-08 - Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
Effective Date
01-May-2008
Referred By
ASTM F1980-21 - Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices
Effective Date
01-May-2007
Referred By
ASTM D8233-19 - Standard Guide for Packaging and Labeling of Consumer Resin Cannabis Products for Sale to Adult Consumers, Legally Authorized Medical Users, and Caregivers in a Business-to-Consumer Retail Environment (Retailers)
Effective Date
01-May-2007
Referred By
ASTM F3263-17 - Standard Guide for Packaging Test Method Validation
Effective Date
01-May-2007
Referred By
ASTM F2559/F2559M-21 - Standard Guide for Writing a Specification for Sterilizable Peel Pouches
Effective Date
01-May-2007
Referred By
ASTM F392/F392M-21 - Standard Practice for Conditioning Flexible Barrier Materials for Flex Durability
Effective Date
01-May-2007
Referred By
ASTM F2902-16e1 - Standard Guide for Assessment of Absorbable Polymeric Implants
Effective Date
01-May-2007
Referred By
ASTM F99-21 - Standard Guide for Writing a Specification for Flexible Barrier Rollstock Materials
Effective Date
01-May-2007

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ASTM F2097-07 - Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical ProductsASTM F2097-07 - Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
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ASTM F2097-07 - Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
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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:F2097–07
Standard Guide for
Design and Evaluation of Primary Flexible Packaging for
1
Medical Products
This standard is issued under the fixed designation F 2097; 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 D 882 Test Method for Tensile Properties of Thin Plastic
Sheeting
1.1 This guide provides directions for the design and evalu-
D 1003 Test Method for Haze and Luminous Transmittance
ation of primary flexible packages for medical products. The
of Transparent Plastics
package materials must be selected appropriately for manufac-
D 1434 Test Method for Determining Gas Permeability
turing process, end use, and the product being packaged.
Characteristics of Plastic Film and Sheeting
1.2 This guide provides a compendium of test methods.
D 1709 Test Methods for Impact Resistance of Plastic Film
Specific individual test methods must be selected based on the
by the Free-Falling Dart Method
pertinent characteristics of the specific product to be packaged
D 1777 Test Method for Thickness of Textile Materials
and the purpose for testing, research and development, or
D 1894 Test Method for Static and Kinetic Coefficients of
compliance. Not all test methods will be applicable.
Friction of Plastic Film and Sheeting
1.3 This guide does not address acceptability criteria, which
D 1922 Test Method for Propagation Tear Resistance of
need to be determined jointly by the package producer and the
Plastic Film and Thin Sheeting by Pendulum Method
medical products manufacturer.
D 1938 Test Method for Tear-Propagation Resistance
1.4 This guide does not assess the product to be packaged;
(Trouser Tear) of Plastic Film and Thin Sheeting by a
the sterilization method to be used; or package performance
Single-Tear Method
through sterilization, distribution, and handling.
D 2019 Test Method for Dirt in Paper and Paperboard
2. Referenced Documents D 2457 TestMethodforSpecularGlossofPlasticFilmsand
2
Solid Plastics
2.1 ASTM Standards:
D 3078 Test Method for Determination of Leaks in Flexible
D 374 Test Methods for Thickness of Solid Electrical Insu-
Packaging by Bubble Emission
lation
D 3079 Test Method for Water Vapor Transmission of
D 589 Test Method for Opacity of Paper (15° Diffuse
Flexible Heat-Sealed Packages for Dry Products
Illuminant A, 89 % Reflectance Backing and Paper Back-
D 3335 Test Method for Low Concentrations of Lead,
ing)
Cadmium, and Cobalt in Paint by Atomic Absorption
D 638 Test Method for Tensile Properties of Plastics
Spectroscopy
D 645/D 645M Test Method for Thickness of Paper and
D 3420 Test Method for Pendulum Impact Resistance of
Paperboard
Plastic Film
D 726 Test Method for Resistance of Nonporous Paper to
D 3718 Test Method for Low Concentrations of Chromium
Passage of Air
in Paint by Atomic Absorption Spectroscopy
D 3776 Test Method for Mass Per Unit Area (Weight) of
1
This guide is under the jurisdiction of ASTM Committee F02 on Flexible
Fabric
Barrier Packaging and is the direct responsibility of Subcommittee F02.50 on
D 3985 Test Method for Oxygen Gas Transmission Rate
Package Design and Development.
Through Plastic Film and Sheeting Using a Coulometric
Current edition approved May 1, 2007. Published June 2007. Originally
approved in 2001. Last previous edition approved in 2005 as F 2097 – 05.
Sensor
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.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

---------------------- Page: 1 ----------------------
F2097–07
D 4279 Test Methods for Water Vapor Transmission of F 1929 Test Method for Detecting Seal Leaks in Porous
Shipping Containers—Constant and Cycle Methods Medical Packaging by Dye Penetration
D 4321 Test Method for Package Yield of Plastic Film F 1980 Guide for Accelerated Aging of Sterile Barrier
D 4754 Test Method for Two-Sided Liquid Extraction of Systems for Medical Devices
Plastic Materials Using FDA Migration Cell F 2029 PracticesforMakingHeatsealsforDeterminationof
D 5264 Practice forAbrasion Resistance of Printed Materi- Heatsealability of Flexible Webs as Measured by Seal
als by the Sutherland Rub Tester Strength
E 398 Test Method for Water Vapor Transmission Rate of F 2054 Test Method for Burst Testing of Flexible Package
Sheet Materials Using Dynamic Relative Humidity Mea- Seals Using InternalAir Pressurization Within Restraining
surement Plate
...

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Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products

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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.  
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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.  
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SIGNIFICANCE AND USE
3.1 The compression resistance perpendicular to the faces, the resistance to the extrusion during compression, and the ability to recover after release of the load are indicative of a joint filler's ability to continuously fill a concrete expansion joint and thereby prevent damage that might otherwise occur during thermal expansion. The asphalt content is a measure of the fiber-type joint filler's durability and life expectancy. In the case of cork-type fillers, the resistance to water absorption and resistance to boiling hydrochloric acid are relative measures of durability and life expectancy.
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SCOPE
1.1 These test methods cover the physical properties associated with preformed expansion joint fillers. The test methods include:    
Property  
Section  
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7.1  
Recovery and Compression  
7.2  
Extrusion  
7.3  
Boiling in Hydrochloric Acid  
7.4  
Asphalt Content  
7.5  
Water Absorption  
7.6  
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