ASTM F2097-16
Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products

Standard No.

ASTM F2097-16

Release Date

2016

Published By

American Society for Testing and Materials (ASTM)

Status

Be replaced

Replace By

ASTM F2097-20

Latest

ASTM F2097-23

Scope

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.

or alteration.

This practice is designed as conditioning prior to testing for overnight or two-day delivery systems of a single parcel packaging system or as a standalone test for climatic stressing of packaging systems. This practice does not cover refrigerated, frozen food storage, or cryogenic storage conditions. Only the climatic environments encountered in various regions of the world are covered by this practice.

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 a......

ASTM F2097-16 Referenced Document

• ASTM D1003 Standard Test Method for Haze and Luminous Transmittance of Transparent Plastics
• ASTM D1434 Standard Test Method for Determining Gas Permeability Characteristics of Plastic Film and Sheeting
• ASTM D1709 Standard Test Methods for Impact Resistance of Plastic Film by the Free-Falling Dart Method
• ASTM D1777 Standard Test Method for Thickness of Textile Materials
• ASTM D1894 Standard Test Method for Static and Kinetic Coefficients of Friction of Plastic Film and Sheeting
• ASTM D1922 Standard Test Method for Propagation Tear Resistance of Plastic Film and Thin Sheeting by Pendulum Method
• ASTM D1938 Standard Test Method for Tear-Propagation Resistance (Trouser Tear) of Plastic Film and Thin Sheeting by a Single-Tear Method
• ASTM D2019 Standard Test Method for Dirt in Paper and Paperboard
• ASTM D2457 Standard Test Method for Specular Gloss of Plastic Films and Solid Plastics
• ASTM D3078 Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission
• ASTM D3079 Standard Test Method for Water Vapor Transmission of Flexible Heat-Sealed Packages for Dry Products
• ASTM D3335 Standard Test Method for Low Concentrations of Lead, Cadmium, and Cobalt in Paint by Atomic Absorption Spectroscopy
• ASTM D3420 Standard Test Method for Pendulum Impact Resistance of Plastic Film
• ASTM D3718 Standard Test Method for Low Concentrations of Chromium in Paint by Atomic Absorption Spectroscopy
• ASTM D374 Standard Test Methods for Thickness of Solid Electrical Insulation
• ASTM D3776 Standard Test Methods for Mass Per Unit Area (Weight) of Fabric
• ASTM D3985 Standard Test Method for Oxygen Gas Transmission Rate Through Plastic Film and Sheeting Using a Coulometric Sensor
• ASTM D4169 Standard Practice for Performance Testing of Shipping Containers and Systems
• ASTM D4279 Standard Test Methods for Water Vapor Transmission of Shipping Containers—Constant and Cycle Methods
• ASTM D4321 Standard Test Method for Package Yield of Plastic Film
• ASTM D4332 Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing
• ASTM D4754 Standard Test Method for Two-Sided Liquid Extraction of Plastic Materials Using FDA Migration Cell
• ASTM D5264 Standard Practice for Abrasion Resistance of Printed Materials by the Sutherland Rub Tester
• ASTM D589 Standard Test Method for Opacity of Paper (15&176; Diffuse Illuminant A, 89 % Reflectance Backing and Paper Backing)
• ASTM D638 Standard Test Method for Tensile Properties of Plastics
• ASTM D645/D645M Standard Test Method for Thickness of Paper and Paperboard
• ASTM D726 Standard Test Method for Resistance of Nonporous Paper to Passage of Air
• ASTM D7386 Standard Practice for Performance Testing of Packages for Single Parcel Delivery Systems
• ASTM D882 Standard Test Method for Tensile Properties of Thin Plastic Sheeting
• ASTM E398 Standard Test Method for Water Vapor Transmission Rate of Sheet Materials Using Dynamic Relative Humidity Measurement
• ASTM F1140 Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages
• ASTM F1249 Standard Test Method for Water Vapor Transmission Rate Through Plastic Film and Sheeting Using a Modulated Infrared Sensor
• ASTM F1306 Standard Test Method for Slow Rate Penetration Resistance of Flexible Barrier Films and Laminates
• ASTM F1307 Test Method for Oxygen Transmission Rate Through Dry Packages Using a Coulometric Sensor
• ASTM F1443 Standard Practice for Using 0.008-in. (0.203-mm) Aperture Reflectometers as Test Instruments for Measuring Visual Image Quality of Business Copy Images
• ASTM F151 Standard Test Method for Residual Solvents in Flexible Barrier Materials (Withdrawn 2004)
• ASTM F1608 Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method)
• ASTM F17 Standard Terminology Relating to Flexible Barrier Materials
• ASTM F1884 Standard Test Method for Determining Residual Solvents in Packaging Materials
• ASTM F1886 Standard Test Method for Determining Integrity of Seals for Medical Packaging by Visual Inspection
• ASTM F1921 Standard Test Method for Hot Seal Strength (Hot Tack) of Thermoplastic Polymers and Blends Comprising the Sealing Surfaces of Flexible Webs
• ASTM F1927 Standard Test Method for Determination of Oxygen Gas Transmission Rate, Permeability and Permeance at Controlled Relative Humidity Through Barrier Materials Using a Coulometric Detector
• ASTM F1929 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
• ASTM F1980 Standard Guide for Accelerated Aging of Sterile Medical Device Packages
• ASTM F2029 Standard Practices for Making Laboratory Heat Seals for Determination of Heat Sealability of Flexible Barrier Materials as Measured by Seal Strength
• ASTM F2054 Standard Test Method for Burst Testing of Flexible Package Seals Using Internal Air Pressurization Within Restraining Plates
• ASTM F2095 Standard Test Methods for Pressure Decay Leak Test for Flexible Packages With and Without Restraining Plates
• ASTM F2096 Standard Test Method for Detecting Gross Leaks in Medical Packaging by Internal Pressurization (Bubble Test)*， 2024-04-20 Update
• ASTM F2203 Standard Test Method for Linear Measurement Using Precision Steel Rule
• ASTM F2217 Standard Practice for Coating/Adhesive Weight Determination
• ASTM F2227 Standard Test Method for Non-Destructive Detection of Leaks in Non-sealed and Empty Packaging Trays by CO2 Tracer Gas Method
• ASTM F2228 Standard Test Method for Non-Destructive Detection of Leaks in Packaging Which Incorporates Porous Barrier Material by CO2 Tracer Gas Method
• ASTM F2250 Standard Practice for Evaluation of Chemical Resistance of Printed Inks and Coatings on Flexible Packaging Materials*， 2024-04-20 Update
• ASTM F2251 Standard Test Method for Thickness Measurement of Flexible Packaging Material
• ASTM F2252 Standard Practice for Evaluating Ink or Coating Adhesion to Flexible Packaging Materials Using Tape
• ASTM F2338 Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method
• ASTM F2391 Standard Test Method for Measuring Package and Seal Integrity Using Helium as the Tracer Gas
• ASTM F2475 Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials*， 2024-04-20 Update
• ASTM F2476 Standard Test Method for the Determination of Carbon Dioxide Gas Transmission Rate (CO2TR) Through Barrier Materials Using an Infrared Detector
• ASTM F2559 Standard Guide for Writing a Specification for Sterilizable Peel Pouches
• ASTM F2622 Standard Test Method for Oxygen Gas Transmission Rate Through Plastic Film and Sheeting Using Various Sensors
• ASTM F2638 Standard Test Method for Using Aerosol Filtration for Measuring the Performance of Porous Packaging Materials as a Surrogate Microbial Barrier
• ASTM F2714 Standard Test Method for Oxygen Headspace Analysis of Packages Using Fluorescent Decay
• ASTM F2824 Standard Test Method for Mechanical Seal Strength Testing for Round Cups and Bowl Containers with Flexible Peelable Lids
• ASTM F2825 Standard Practice for Climatic Stressing of Packaging Systems for Single Parcel Delivery
• ASTM F2981 Standard Test Method for Verifying Nonporous Flexible Barrier Material Resistance to the Passage of Air
• ASTM F3004 Standard Test Method for Evaluation of Seal Quality and Integrity Using Airborne Ultrasound
• ASTM F3039 Standard Test Method for Detecting Leaks in Nonporous Packaging or Flexible Barrier Materials by Dye Penetration
• ASTM F3136 Standard Test Method for Oxygen Gas Transmission Rate through Plastic Film and Sheeting using a Dynamic Accumulation Method
• ASTM F372 Standard Test Method for Water Vapor Transmission Rate of Flexible Barrier Materials Using an Infrared Detection Technique
• ASTM F392 Standard Test Method for Flex Durability of Flexible Barrier Materials
• ASTM F748 Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
• ASTM F813 Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices
• ASTM F88 Standard Test Method for Seal Strength of Flexible Barrier Materials
• ASTM F895 Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity
• ASTM F904 Standard Test Method for Comparison of Bond Strength or Ply Adhesion of Similar Laminates Made from Flexible Materials
• ASTM F99 Standard Practice for Preparation of Flexible Barrier Material Specifications
• ISO 10993 Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products
• ISO 2556 Plastics; Determination of the gas transmission rate of films and thin sheets under atmospheric pressure; Manometric method

ASTM F2097-16 history

• 2023 ASTM F2097-23 Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
• 2020 ASTM F2097-20 Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
• 2016 ASTM F2097-16 Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
• 2014 ASTM F2097-14 Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
• 2010 ASTM F2097-10 Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
• 2008 ASTM F2097-08 Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
• 2007 ASTM F2097-07 Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
• 2005 ASTM F2097-05 Standard Guide for Design and Evaluation of Primary Packaging for Medical Products
• 2001 ASTM F2097-01 Standard Guide for Design and Evaluation of Primary Packaging for Medical Products