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ASTM F2097-14

(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 properties, durability, package and seal integrity, visibility and appearance, processing, printing ink properties, and package performance.  
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 Medical Device Standards Program at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/default.htm.  
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.  
4.6 Test Description and Applicability (see Table 1):  
4.6.1 Table 1 lists the test methods commonly used to evaluate flexible medical packaging. The test methods are used in two phases.
4.6.1.1 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...
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.

General Information

Status
Historical
Publication Date
31-Mar-2014
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 F2097-10 - Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
Effective Date
01-Apr-2014
Referred By
ASTM F1980-21 - Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices
Effective Date
01-Apr-2014
Referred By
ASTM F99-21 - Standard Guide for Writing a Specification for Flexible Barrier Rollstock Materials
Effective Date
01-Apr-2014
Referred By
ASTM F2902-16e1 - Standard Guide for Assessment of Absorbable Polymeric Implants
Effective Date
01-Apr-2014
Referred By
ASTM F3263-17 - Standard Guide for Packaging Test Method Validation
Effective Date
01-Apr-2014
Referred By
ASTM F2559/F2559M-21 - Standard Guide for Writing a Specification for Sterilizable Peel Pouches
Effective Date
01-Apr-2014
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-Apr-2014
Referred By
ASTM F392/F392M-21 - Standard Practice for Conditioning Flexible Barrier Materials for Flex Durability
Effective Date
01-Apr-2014

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ASTM F2097-14 - 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 − 14
StandardGuide 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 D726 Test Method for Resistance of Nonporous Paper to
3
Passage of Air (Withdrawn 2009)
1.1 This guide provides directions for the design and evalu-
D882 Test Method for Tensile Properties of Thin Plastic
ation of primary flexible packages for medical products. The
Sheeting
package materials must be selected appropriately for manufac-
D1003 Test Method for Haze and Luminous Transmittance
turing process, end use, and the product being packaged.
of Transparent Plastics
1.2 This guide provides a compendium of test methods,
D1434 TestMethodforDeterminingGasPermeabilityChar-
practices, and procedures. Specific individual test methods
acteristics of Plastic Film and Sheeting
must be selected based on the pertinent characteristics of the
D1709 Test Methods for Impact Resistance of Plastic Film
specific product to be packaged and the purpose for testing,
by the Free-Falling Dart Method
research and development, or compliance. Not all test methods
D1777 Test Method for Thickness of Textile Materials
will be applicable.
D1894 Test Method for Static and Kinetic Coefficients of
1.3 This guide does not address acceptability criteria, which
Friction of Plastic Film and Sheeting
need to be determined jointly by the package producer and the
D1922 Test Method for Propagation Tear Resistance of
medical products manufacturer.
Plastic Film and Thin Sheeting by Pendulum Method
1.4 Thisguidedoesnotassesstheproducttobepackagedor D1938 Test Method for Tear-Propagation Resistance (Trou-
the sterilization method to be used. ser Tear) of Plastic Film and Thin Sheeting by a Single-
Tear Method
1.5 The units cited in the referenced standard should be
D2019 Test Method for Dirt in Paper and Paperboard (With-
used.
3
drawn 2010)
D2457 Test Method for Specular Gloss of Plastic Films and
2. Referenced Documents
Solid Plastics
2
2.1 ASTM Standards:
D3078 Test Method for Determination of Leaks in Flexible
D374 Test Methods for Thickness of Solid Electrical Insu-
Packaging by Bubble Emission
3
lation (Withdrawn 2013)
D3079 Test Method for Water Vapor Transmission of Flex-
D589 Test Method for Opacity of Paper (15° Diffuse Illu-
ible Heat-Sealed Packages for Dry Products
minantA, 89 % Reflectance Backing and Paper Backing)
3 D3335 Test Method for Low Concentrations of Lead,
(Withdrawn 2010)
Cadmium, and Cobalt in Paint by Atomic Absorption
D638 Test Method for Tensile Properties of Plastics
Spectroscopy
D645/D645M Test Method for Thickness of Paper and
3 D3420 Test Method for Pendulum Impact Resistance of
Paperboard (Withdrawn 2010)
Plastic Film
D3718 Test Method for Low Concentrations of Chromium
in Paint by Atomic Absorption Spectroscopy
1
This guide is under the jurisdiction of ASTM Committee F02 on Flexible
D3776 Test Methods for Mass Per Unit Area (Weight) of
Barrier Packaging and is the direct responsibility of Subcommittee F02.50 on
Fabric
Package Design and Development.
Current edition approved April 1, 2014. Published May 2014. Originally
D3985 Test Method for Oxygen Gas Transmission Rate
approved in 2001. Last previous edition approved in 2010 as F2097 – 10. DOI:
Through Plastic Film and Sheeting Using a Coulometric
10.1520/F2097-14.
2 Sensor
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
D4169 Practice for Performance Testing of Shipping Con-
Standards volume information, refer to the standard’s Document Summary page on
tainers and Systems
the ASTM website.
3
D4279 Test Methods for Water Vapor Transmission of Ship-
The last approved version of this historical standard is referenced on
www.astm.org. ping Containers—Constant and Cycle Methods
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F2097 − 14
D4321 Test Method for Package Yield of Plastic Film F1929 Test Method for Detecting Seal Leaks in Porous
D4332 Practice for Conditioning Containers, Packages, or Medical Packaging by Dye Penetration
Packaging Components for Testing F1980 Guide for Accelerated Aging of Sterile Barrier Sys-
D4754 Test Method for Two-Sided Liquid Extraction of
tems for Medical Devices
Plastic Materials Using FDA Migration Cell
F2029 Practices for Making Heatseals for Determination of
D5264 Practice fo
...

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 − 10 F2097 − 14
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.
2. Referenced Documents
2
2.1 ASTM Standards:
3
D374 Test Methods for Thickness of Solid Electrical Insulation (Withdrawn 2013)
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)
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
D1003 Test Method for Haze and Luminous Transmittance of Transparent Plastics
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
D1894 Test Method for Static and Kinetic Coefficients of Friction of Plastic Film and Sheeting
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
D3079 Test Method for Water Vapor Transmission of Flexible Heat-Sealed Packages for Dry Products
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 in Paint by Atomic Absorption Spectroscopy
D3776 Test Methods for Mass Per Unit Area (Weight) of Fabric
1
This guide is under the jurisdiction of ASTM Committee F02 on Flexible Barrier Packaging and is the direct responsibility of Subcommittee F02.50 on Package Design
and Development.
Current edition approved April 1, 2010April 1, 2014. Published May 2010May 2014. Originally approved in 2001. Last previous edition approved in 20082010 as
F2097 – 08.F2097 – 10. DOI: 10.1520/F2097-10.10.1520/F2097-14.
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 − 14
D3985 Test Method for Oxygen Gas Transmission Rate Through Plastic Film and Sheeting Using a Coulometric Sensor
D4169 Practice for Performance Testing of Shipping Containers and Systems
D4279 Test Methods for Water Vapor Transmission of Shipping Containers—Constant and Cycle Methods
D4321 Test Method for Package Yield of Plastic Film
D4332 Practice for Conditioning Containers, Packages, or Packaging Components for Testing
D475
...

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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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