ASTM F 2097 : 2020
Superseded
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
Available format(s)
Hardcopy , PDF
Superseded date
11-09-2023
Language(s)
English
Published date
09-17-2020
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.
| Committee |
F 02
|
| DocumentType |
Guide
|
| Pages |
27
|
| PublisherName |
American Society for Testing and Materials
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| 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) |
| 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 CO<inf>2</inf> 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 CO<sub>2</sub> 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 P<inf>2</inf>O<inf >5</inf> 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 P<inf>2</inf>O<inf >5</inf> Sensor) |
| ASTM F 2228 : 2013 : R2021 | Standard Test Method for Non-Destructive Detection of Leaks in Packaging Which Incorporates Porous Barrier Material by CO<inf>2</inf> 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 CO<sub>2</sub> 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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Hardcopy - English
PDF - English
Hardcopy - English
PDF - English
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