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ASTM F2097-08

(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
This design and evaluation guide describes seven categories for evaluating flexible medical packages and packaging materials. These include safety, barrier properties, durability, package and seal integrity, visibility and appearance, processing, and printing ink properties.
The intent of this design and evaluation guide is to evaluate all seven 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.
Product characterization shall include mass or weight, geometry (length and width, height, and shape) and product composition.
All seven categories must be considered for applicability.
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.
Test Description and Applicability (see Table 1):
Table 1 lists the test methods commonly used to evaluate flexible medical packaging. The test methods are used in two phases.
Package Design: Characterization of the Materials and Evaluation of the Resultant Package—This is referred to as “R&D Evaluation” in Table 1. Testing during this phase is characterized by the generation of quantitative data on the performance of the component materials and the package assembly. These test methods are lengthy, making them inappropriate for the manufacturing environment where rapid response is required for process control. Often, they are expensive and require specialized equipment not readily available at a medical packaging or device manufacturing facility.
Package Compliance: Routine Monitoring of Adherence to Specifications—This is referred to as “Compliance Testing” in Table 1. Testi...
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.
1.5 The values stated in SI units are to be regarded as standard. The values given in parentheses are mathematical conversions to inch-pound units that are provided for information only and are not considered standard.

General Information

Status
Historical
Publication Date
30-Apr-2008
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 F2097-07 - Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
Effective Date
01-May-2008
Replaced By
ASTM F2097-10 - Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
Effective Date
01-Apr-2010
Referred By
ASTM F99-21 - Standard Guide for Writing a Specification for Flexible Barrier Rollstock Materials
Effective Date
01-May-2008
Referred By
ASTM F392/F392M-21 - Standard Practice for Conditioning Flexible Barrier Materials for Flex Durability
Effective Date
01-May-2008
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-2008
Referred By
ASTM F2902-16e1 - Standard Guide for Assessment of Absorbable Polymeric Implants
Effective Date
01-May-2008
Referred By
ASTM F2559/F2559M-21 - Standard Guide for Writing a Specification for Sterilizable Peel Pouches
Effective Date
01-May-2008
Referred By
ASTM F3263-17 - Standard Guide for Packaging Test Method Validation
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-2008

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ASTM F2097-08 - 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:F2097–08
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 D882 Test Method for Tensile Properties of Thin Plastic
Sheeting
1.1 This guide provides directions for the design and evalu-
D1003 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-
D1434 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.
D1709 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
D1777 Test Method for Thickness of Textile Materials
and the purpose for testing, research and development, or
D1894 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
D1922 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.
D1938 Test Method for Tear-Propagation Resistance (Trou-
1.4 This guide does not assess the product to be packaged;
ser Tear) of Plastic Film and Thin Sheeting by a Single-
the sterilization method to be used; or package performance
Tear Method
through sterilization, distribution, and handling.
D2019 Test Method for Dirt in Paper and Paperboard
1.5 The values stated in SI units are to be regarded as
D2457 Test Method for Specular Gloss of Plastic Films and
standard. The values given in parentheses are mathematical
Solid Plastics
conversions to inch-pound units that are provided for informa-
D3078 Test Method for Determination of Leaks in Flexible
tion only and are not considered standard.
Packaging by Bubble Emission
2. Referenced Documents
D3079 Test Method for Water Vapor Transmission of Flex-
2
ible Heat-Sealed Packages for Dry Products
2.1 ASTM Standards:
D3335 Test Method for Low Concentrations of Lead, Cad-
D374 Test Methods for Thickness of Solid Electrical Insu-
mium, and Cobalt in Paint by Atomic Absorption Spec-
lation
troscopy
D589 Test Method for Opacity of Paper (15° Diffuse
D3420 Test Method for Pendulum Impact Resistance of
IlluminantA, 89 % Reflectance Backing and Paper Back-
Plastic Film
ing)
D3718 Test Method for Low Concentrations of Chromium
D638 Test Method for Tensile Properties of Plastics
in Paint by Atomic Absorption Spectroscopy
D645/D645M Test Method for Thickness of Paper and
D3776 Test Methods for Mass Per Unit Area (Weight) of
Paperboard
Fabric
D726 Test Method for Resistance of Nonporous Paper to
D3985 Test Method for Oxygen Gas Transmission Rate
Passage of Air
Through Plastic Film and Sheeting Using a Coulometric
Sensor
1
This guide is under the jurisdiction of ASTM Committee F02 on Flexible
D4279 Test Methods for Water Vapor Transmission of
Barrier Packaging and is the direct responsibility of Subcommittee F02.50 on
Shipping Containers—Constant and Cycle Methods
Package Design and Development.
D4321 Test Method for Package Yield of Plastic Film
Current edition approved May 1, 2008. Published June 2008. Originally
D4754 Test Method for Two-Sided Liquid Extraction of
approved in 2001. Last previous edition approved in 2007as F2097 – 07. DOI:
10.1520/F2097-08.
Plastic Materials Using FDA Migration Cell
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
D5264 Practice for Abrasion Resistance of Printed Materi-
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
als by the Sutherland Rub Tester
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 ----------------------
F2097–08
E398 Test Method for Water Vapor Transmission Rate of F2029 Practices for Making Heatseals for Determination of
Sheet Materials Using Dynamic Relative Humidity Mea- Heatsealability of Flexible Webs as Measured by Seal
surement Strength
F17 Terminology Relating to Flexible Barrier Packaging F
...

This document is not anASTM standard and is intended only to provide the user of anASTM 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:F2097–07 Designation:F2097–08
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 (´) indicates an editorial change since the last revision or reapproval.
1. Scope
1.1 Thisguideprovidesdirectionsforthedesignandevaluationofprimaryflexiblepackagesformedicalproducts.Thepackage
materials must be selected appropriately for manufacturing process, end use, and the product being packaged.
1.2 Thisguideprovidesacompendiumoftestmethods.Specificindividualtestmethodsmustbeselectedbasedonthepertinent
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.
1.5 The values stated in SI units are to be regarded as standard. The values given in parentheses are mathematical conversions
to inch-pound units that are provided for information only and are not considered standard.
2. Referenced Documents
2
2.1 ASTM Standards:
D 374 Test Methods for Thickness of Solid Electrical Insulation
D 589 Test Method for Opacity of Paper (15 Diffuse IlluminantA, 89 % Reflectance Backing and Paper Backing)
D 638 Test Method for Tensile Properties of Plastics
D 645/D 645M Test Method for Thickness of Paper and Paperboard
D 726 Test Method for Resistance of Nonporous Paper to Passage of Air
D 882 Test Method for Tensile Properties of Thin Plastic Sheeting
D 1003 Test Method for Haze and Luminous Transmittance of Transparent Plastics
D 1434 Test Method for Determining Gas Permeability Characteristics of Plastic Film and Sheeting
D 1709 Test Methods for Impact Resistance of Plastic Film by the Free-Falling Dart Method
D 1777 Test Method for Thickness of Textile Materials
D 1894 Test Method for Static and Kinetic Coefficients of Friction of Plastic Film and Sheeting
D 1922 Test Method for Propagation Tear Resistance of Plastic Film and Thin Sheeting by Pendulum Method
D 1938 TestMethodforTear-PropagationResistance(TrouserTear)ofPlasticFilmandThinSheetingbyaSingle-TearMethod
D 2019 Test Method for Dirt in Paper and Paperboard
D 2457 Test Method for Specular Gloss of Plastic Films and Solid Plastics
D 3078 Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission
D 3079 Test Method for Water Vapor Transmission of Flexible Heat-Sealed Packages for Dry Products
D 3335 Test Method for Low Concentrations of Lead, Cadmium, and Cobalt in Paint by Atomic Absorption Spectroscopy
D 3420 Test Method for Pendulum Impact Resistance of Plastic Film
D 3718 Test Method for Low Concentrations of Chromium in Paint by Atomic Absorption Spectroscopy
D 3776 Test Methods for Mass Per Unit Area (Weight) of Fabric
D 3985 Test Method for Oxygen Gas Transmission Rate Through Plastic Film and Sheeting Using a Coulometric Sensor
D 4279 Test Methods for Water Vapor Transmission of Shipping ContainersConstant and Cycle Methods
1
This guide is under the jurisdiction ofASTM Committee F02 on Flexible Barrier Packaging and is the direct responsibility of Subcommittee F02.50 on Package Design
and Development.
Current edition approved May 1, 2007.2008. Published June 2007.2008. Originally approved in 2001. Last previous edition approved in 2005 as F2097–05.2007as
F 2097 – 07.
2
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM 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 ----------------------
F2097–08
D 4321 Test Method for Package Yield of Plastic Film
D 4754 Test Method for Two-Sided Liquid Extraction of Plastic Materials Using FDA Migration Cell
D 5264 Practice for Abrasion Resistance of Printed Materials by the Sutherland Rub Tester
E 398 Test Method for Water Vapor Transm
...

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Standard Test Method for Determination of Draindown Characteristics in Uncompacted Asphalt Mixtures

SIGNIFICANCE AND USE
5.1 This test method can be used to determine whether the amount of draindown measured for a given asphalt mixture is within specified acceptable levels. The test provides an evaluation of the draindown potential of an asphalt mixture during mixture design and/or during field production. This test is primarily used for mixtures with high coarse aggregate content such as porous asphalt (open-graded friction course) and stone matrix asphalt (SMA).
Note 1: The quality of the results produced by this standard are dependent on the competence of the personnel performing the procedure and the capability, calibration, and maintenance of the equipment used. Agencies that meet the criteria of Specification D3666 are generally considered capable of competent and objective testing, sampling, inspection, etc. Users of this standard are cautioned that compliance with Specification D3666 alone does not completely ensure reliable results. Reliable results depend on many factors; following the suggestions of Specification D3666 or some similar acceptable guideline provides a means of evaluating and controlling some of those factors.
SCOPE
1.1 This test method covers the determination of the amount of draindown in an uncompacted asphalt mixture sample when the sample is held at elevated temperatures comparable to those encountered during the production, storage, transport, and placement of the mixture. The test is particularly applicable to mixtures such as porous asphalt (open-graded friction course) and stone matrix asphalt (SMA).  
1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.3 The text of this standard references notes and footnotes which provide explanatory material. These notes and footnotes (excluding those in tables and figures) shall not be considered as requirements of the 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.

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ASTM
ASTM B472-23(Specification)
Standard Specification for Nickel Alloy Billets and Bars for Reforging

ABSTRACT
This specification covers UNS N06002, UNS N06030, UNS N06035, UNS N06022, UNS N06200, UNS N06230, UNS N06600, UNS N06617, UNS N06625, UNS N08020, UNS N08026, UNS N08024, UNS N08120, UNS N08926, UNS N08367, UNS N10242, UNS N10276, UNS N10665, UNS N10675, UNS N12160, UNS R20033, UNS N06059, UNS N06686, UNS N10629, UNS N08031, UNS N06045, UNS N06025, and UNS R30556 nickel alloy billets and bars for reforging. The products shall be hot worked from ingots by rolling, forging, extruding, hammering, or pressing. The material shall conform to the chemical composition requirements prescribed by the reference material. The chemical composition of the material shall be determined by chemical analysis in accordance with test method E1473.
SCOPE
1.1 This specification covers UNS N06002, UNS N06030, UNS N06035, UNS N06022, UNS N06200, UNS N10362, UNS N06230, UNS N06600, UNS N06617, UNS N06625, UNS N08020, UNS N08026, UNS N08024, UNS N08120, UNS N08926, UNS N08367, UNS N10242, UNS N10276, UNS N10665, UNS N10675, UNS N12160, UNS R20033, UNS N06059, UNS N06686, UNS N10629, UNS N08031, UNS N06045, UNS N06025, UNS N06699, and UNS R305562 billets and bars for reforging.  
1.2 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard.  
1.3 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 become familiar with all hazards including those identified in the appropriate Safety Data Sheet (SDS) for this product/material as provided by the manufacturer, to establish appropriate safety, health, and environmental practices, and determine the applicability of regulatory limitations prior to use.  
1.4 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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  • Technical specification
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