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  • ASTM F 2097 : 2020

    View superseded by
    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
    View superseded by

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

    Available format(s):  Hardcopy, PDF

    Superseded date:  09-11-2023

    Language(s):  English

    Published date:  17-09-2020

    Publisher:  American Society for Testing and Materials

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    Scope - (Show below) - (Hide below)

    1.1This 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.

    1.2This 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.

    1.3This guide does not address acceptability criteria, which need to be determined jointly by the package producer and the medical products manufacturer.

    1.4This guide does not assess the product to be packaged or the sterilization method to be used.

    1.5The units cited in the referenced standard should be used.

    1.6This 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 Product Information - (Show below) - (Hide below)

    Committee F 02
    Document Type Guide
    Publisher American Society for Testing and Materials
    Status Superseded
    Superseded By
    Supersedes

    Standards Referenced By This Book - (Show below) - (Hide below)

    ASTM F 2902 : 2016 : EDT 1 Standard Guide for Assessment of Absorbable Polymeric Implants
    ASTM F 3263 : 2017 Standard Guide for Packaging Test Method Validation
    ASTM F 2559/F2559M : 2021 Standard Guide for Writing a Specification for Sterilizable Peel Pouches
    ASTM F 392/F392M : 2021 Standard Practice for Conditioning Flexible Barrier Materials for Flex Durability
    ASTM D 8233 : 2019 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)

    Standards Referencing This Book - (Show below) - (Hide below)

    ASTM D 3078 : 2002 : R2021 : EDT 1 Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission
    ASTM D 3718 : 1985 : REV A : R2015 Standard Test Method for Low Concentrations of Chromium in Paint by Atomic Absorption Spectroscopy
    ASTM F 2638 : 2022 Standard Test Method for Using Aerosol Filtration for Measuring the Performance of Porous Packaging Materials as a Surrogate Microbial Barrier
    ASTM D 4169 : 2016 Standard Practice for Performance Testing of Shipping Containers and Systems
    ASTM F 1884 : 2004 : R2023 Standard Test Methods for Determining Residual Solvents in Packaging Materials
    ASTM D 2019 : 1997 Standard Test Method for Dirt in Paper and Paperboard
    ASTM D 4279 : 1995 : R2017 Standard Test Methods for Water Vapor Transmission of Shipping Containers—Constant and Cycle Methods
    ASTM D 645/D645M : 1997 Standard Test Method for Thickness of Paper and Paperboard
    ASTM D 685 : 2017 Standard Practice for Conditioning Paper and Paper Products for Testing
    ASTM F 2227 : 2013 : R2021 Standard Test Method for Non-Destructive Detection of Leaks in Non-sealed and Empty Packaging Trays by CO2 Tracer Gas Method
    ASTM D 1709 : 2022 Standard Test Methods for Impact Resistance of Plastic Film by the Free-Falling Dart Method
    ASTM F 1980 : 2021 Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices
    ASTM D 3420 : 2014 Standard Test Method for Pendulum Impact Resistance of Plastic Film
    ASTM F 3136 : 2015 Standard Test Method for Oxygen Gas Transmission Rate through Plastic Film and Sheeting using a Dynamic Accumulation Method
    ASTM F 2029 : 2016 Standard Practices for Making Laboratory Heat Seals for Determination of Heat Sealability of Flexible Barrier Materials as Measured by Seal Strength
    ASTM D 3718 : 1985 : REV A : R2022 : EDT 1 Standard Test Method for Low Concentrations of Chromium in Paint by Atomic Absorption Spectroscopy
    ASTM D 3078 : 1994 Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission
    ASTM D 1003 : 2013 Standard Test Method for Haze and Luminous Transmittance of Transparent Plastics
    ASTM F 2228 : 2013 Standard Test Method for Non-Destructive Detection of Leaks in Packaging Which Incorporates Porous Barrier Material by CO2 Tracer Gas Method
    ASTM F 2714 : 2008 : R2013 Standard Test Method for Oxygen Headspace Analysis of Packages Using Fluorescent Decay
    ASTM D 1922 : 2023 Standard Test Method for Propagation Tear Resistance of Plastic Film and Thin Sheeting by Pendulum Method
    ASTM F 904 : 1998 Standard Test Method for Comparison of Bond Strength or Ply Adhesion of Similar Laminates Made from Flexible Materials
    ASTM F 904 : 2022 Standard Practice for Separation of Plies for Bond Strength of Laminated Flexible Materials
    ASTM F 2638 : 2018 Standard Test Method for Using Aerosol Filtration for Measuring the Performance of Porous Packaging Materials as a Surrogate Microbial Barrier
    ASTM D 3420 : 2021 Standard Test Method for Pendulum Impact Resistance of Plastic Film
    ASTM F 3299 : 2018 Standard Test Method for Water Vapor Transmission Rate Through Plastic Film and Sheeting Using an Electrolytic Detection Sensor (Coulometric P2O5 Sensor)
    ASTM F 2391 : 2022 Standard Test Method for Measuring Package and Seal Integrity Using Helium as the Tracer Gas
    ASTM D 4332 : 2022 Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing
    ASTM D 3078 : 2002 : R2013 Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission
    ASTM D 4279 : 1995 : R2022 Standard Test Methods for Water Vapor Transmission of Shipping Containers—Constant and Cycle Methods
    ASTM F 2095 : 2007 : R2013 Standard Test Methods for Pressure Decay Leak Test for Flexible Packages With and Without Restraining Plates
    ASTM F 3039 : 2023 Standard Test Method for Detecting Leaks in Nonporous Packaging or Flexible Barrier Materials by Dye Penetration
    ASTM F 3039 : 2015 Standard Test Method for Detecting Leaks in Nonporous Packaging or Flexible Barrier Materials by Dye Penetration
    ASTM D 4279 : 1995 Standard Test Methods for Water Vapor Transmission of Shipping Containers-Constant and Cycle Methods
    ASTM F 1980 : 2016 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
    ASTM F 2714 : 2008 : R2021 Standard Test Method for Oxygen Headspace Analysis of Packages Using Fluorescent Decay
    ASTM F 3299 : 2018 : R2023 Standard Test Method for Water Vapor Transmission Rate Through Plastic Film and Sheeting Using an Electrolytic Detection Sensor (Coulometric P2O5 Sensor)
    ASTM F 2228 : 2013 : R2021 Standard Test Method for Non-Destructive Detection of Leaks in Packaging Which Incorporates Porous Barrier Material by CO2 Tracer Gas Method
    ASTM D 1894 : 2014 Standard Test Method for Static and Kinetic Coefficients of Friction of Plastic Film and Sheeting (Withdrawn 2023)
    ASTM F 904 : 2016 Standard Test Method for Comparison of Bond Strength or Ply Adhesion of Similar Laminates Made from Flexible Materials
    ASTM F 3300 : 2023 Standard Test Method for Abrasion Resistance of Flexible Packaging Films Using a Reciprocating Weighted Stylus
    ASTM D 2457 : 2013 Standard Test Method for Specular Gloss of Plastic Films and Solid Plastics
    ASTM D 685 : 2022 Standard Practice for Conditioning Paper and Paper Products for Testing
    ASTM F 2203 : 2013 : R2022 Standard Test Method for Linear Measurement Using Precision Steel Rule
    ASTM F 2029 : 2016 : R2021 Standard Practices for Making Laboratory Heat Seals for Determination of Heat Sealability of Flexible Barrier Materials as Measured by Seal Strength
    ASTM F 2227 : 2013 Standard Test Method for Non-Destructive Detection of Leaks in Non-sealed and Empty Packaging Trays by CO2 Tracer Gas Method
    ASTM D 4169 : 2022 Standard Practice for Performance Testing of Shipping Containers and Systems
    ASTM F 1608 : 2016 Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method)
    ASTM D 638 : 2014 Standard Test Method for Tensile Properties of Plastics
    ASTM F 99 : 2007 : R2015 Standard Guide for Writing a Specification for Flexible Barrier Rollstock Materials
    ASTM E 171/E171M : 2011 : R2020 Standard Practice for Conditioning and Testing Flexible Barrier Packaging
    ASTM F 2251 : 2013 : R2023 Standard Test Method for Thickness Measurement of Flexible Packaging Material
    ASTM D 1922 : 2015 : R2020 Standard Test Method for Propagation Tear Resistance of Plastic Film and Thin Sheeting by Pendulum Method
    ASTM D 1003 : 2021 Standard Test Method for Haze and Luminous Transmittance of Transparent Plastics
    ASTM D 1434 : 1982 : R2015 : EDT 1 Standard Test Method for Determining Gas Permeability Characteristics of Plastic Film and Sheeting
    ASTM D 4332 : 2014 Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing
    ASTM F 2203 : 2013 : R2018 Standard Test Method for Linear Measurement Using Precision Steel Rule
    ASTM F 3300 : 2018 Standard Test Method for Abrasion Resistance of Flexible Packaging Films Using a Reciprocating Weighted Stylus
    ASTM D 3985 : 1995 Standard Test Method for Oxygen Gas Transmission Rate Through Plastic Film and Sheeting Using a Coulometric Sensor
    ASTM F 99 : 2021 Standard Guide for Writing a Specification for Flexible Barrier Rollstock Materials
    ASTM F 99 : 1976 : R1993 Standard Practice for Preparation of Flexible Barrier Material Specifications
    ASTM F 2095 : 2007 : R2021 Standard Test Methods for Pressure Decay Leak Test for Flexible Packages With and Without Restraining Plates
    ASTM D 1251 : 1994 Standard Test Method for Water Vapor Permeability of Packages by Cycle Method (Withdrawn 1999)
    ASTM D 3420 : 1995 Standard Test Method for Pendulum Impact Resistance of Plastic Film
    ASTM F 1306 : 2016 Standard Test Method for Slow Rate Penetration Resistance of Flexible Barrier Films and Laminates
    ASTM D 1709 : 2016 : REV A : EDT 1 Standard Test Methods for Impact Resistance of Plastic Film by the Free-Falling Dart Method
    ASTM F 3136 : 2022 Standard Test Method for Oxygen Gas Transmission Rate through Plastic Film and Sheeting using a Dynamic Accumulation Method
    ASTM F 1306 : 2021 Standard Test Method for Slow Rate Penetration Resistance of Flexible Barrier Films and Laminates
    ASTM D 1434 : 2023 Standard Test Method for Determining Gas Permeability Characteristics of Plastic Film and Sheeting
    ASTM F 1884 : 2004 : R2018 Standard Test Methods for Determining Residual Solvents in Packaging Materials
    ASTM F 1608 : 2021 Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method)
    ASTM D 2457 : 2021 Standard Test Method for Specular Gloss of Plastic Films and Solid Plastics
    ASTM F 2391 : 2005 : R2016 Standard Test Method for Measuring Package and Seal Integrity Using Helium as the Tracer Gas
    ASTM F 2251 : 2013 : R2018 Standard Test Method for Thickness Measurement of Flexible Packaging Material
    ASTM D 685 : 1993 : R1998 Standard Practice for Conditioning Paper and Paper Products for Testing
    ASTM D 638 : 2022 Standard Test Method for Tensile Properties of Plastics
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