| ASTM F2097-16 - 1.4.2016 | |
| 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. 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 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.
Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission (Includes all amendments and changes 2/15/2021). | |
Standard Test Method for Water Vapor Transmission of Flexible Heat-Sealed Packages for Dry Products | |
Standard Test Method for Low Concentrations of Lead, Cadmium, and Cobalt in Paint by Atomic Absorption Spectroscopy (Includes all amendments and changes 2/6/2020). | |
Standard Test Method for Pendulum Impact Resistance of Plastic Film | |
Standard Test Methods for Mass Per Unit Area (Weight) of Fabric | |
Standard Test Method for Oxygen Gas Transmission Rate Through Plastic Film and Sheeting Using a Coulometric Sensor | |
Standard Practice for Performance Testing of Shipping Containers and Systems | |
Standard Test Methods for Water Vapor Transmission of Shipping Containers—Constant and Cycle Methods | |
Standard Test Method for Package Yield of Plastic Film (Withdrawn 2024) | |
Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing | |
Standard Test Method for Two-Sided Liquid Extraction of Plastic Materials Using FDA Migration Cell | |
Standard Practice for Abrasion Resistance of Printed Materials by the Sutherland Rub Tester | |
Standard Practice for Performance Testing of Packages for Single Parcel Delivery Systems | |
Standard Test Method for Water Vapor Transmission Rate of Sheet Materials Using Dynamic Relative Humidity Measurement | |
Standard Terminology Relating to Primary Barrier Packaging | |
Standard Test Method for Seal Strength of Flexible Barrier Materials | |
Standard Guide for Writing a Specification for Flexible Barrier Rollstock Materials | |
Standard Test Method for Residual Solvents in Flexible Barrier Materials (Withdrawn 2004) | |
Standard Test Method for Water Vapor Transmission Rate of Flexible Barrier Materials Using an Infrared Detection Technique | |
Standard Test Method for Flex Durability of Flexible Barrier Materials | |
Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices | |
Standard Test Method for Low Concentrations of Chromium in Paint by Atomic Absorption Spectroscopy (Includes all amendments and changes 7/7/2022). | |
Standard Test Method for Measuring Package and Seal Integrity Using Helium as the Tracer Gas | |
Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials | |
Standard Test Method for the Determination of Carbon Dioxide Gas Transmission Rate (CO2TR) Through Barrier Materials Using an Infrared Detector | |
Standard Guide for Writing a Specification for Sterilizable Peel Pouches | |
Standard Test Method for Oxygen Gas Transmission Rate Through Plastic Film and Sheeting Using Various Sensors | |
Standard Test Method for Using Aerosol Filtration for Measuring the Performance of Porous Packaging Materials as a Surrogate Microbial Barrier | |
Standard Test Method for Oxygen Headspace Analysis of Packages Using Fluorescent Decay | |
Standard Test Method for Mechanical Seal Strength Testing for Round Cups and Bowl Containers with Flexible Peelable Lids | |
Standard Practice for Climatic Stressing of Packaging Systems for Single Parcel Delivery | |
Standard Test Method for Verifying Nonporous Flexible Barrier Material Resistance to the Passage of Air | |
Standard Test Method for Evaluation of Seal Quality and Integrity Using Airborne Ultrasound | |
Standard Test Method for Detecting Leaks in Nonporous Packaging or Flexible Barrier Materials by Dye Penetration | |
Standard Test Method for Opacity of Paper (15°Diffuse Illuminant A, 89% Reflectance Backing and Paper Backing) | |
Standard Test Method for Tensile Properties of Plastics | |
| Bacterial Filtration Efficiency |
Standard Test Method for Determination of Oxygen Gas Transmission Rate, Permeability and Permeance at Controlled Relative Humidity Through Barrier Materials Using a Coulometric Detector | |
Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration | |
Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices | |
Standard Practices for Making Laboratory Heat Seals for Determination of Heat Sealability of Flexible Barrier Materials as Measured by Seal Strength | |
Standard Test Method for Burst Testing of Flexible Package Seals Using Internal Air Pressurization Within Restraining Plates | |
Standard Test Methods for Pressure Decay Leak Test for Flexible Packages With and Without Restraining Plates | |
Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test) | |
Standard Test Method for Linear Measurement Using Precision Steel Rule | |
Standard Practice for Coating/Adhesive Weight Determination | |
Standard Practice for Evaluation of Chemical Resistance of Printed Inks and Coatings on Flexible Packaging Materials | |
Standard Test Method for Thickness Measurement of Flexible Packaging Material | |
Standard Practice for Evaluating Ink or Coating Adhesion to Flexible Packaging Materials Using Tape | |
Standard Test Method for Non-Destructive Detection of Leaks in Non-sealed and Empty Packaging Trays by CO2 Tracer Gas Method | |
Standard Test Method for Non-Destructive Detection of Leaks in Packaging Which Incorporates Porous Barrier Material by CO2 Tracer Gas Method | |
Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices | |
Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity | |
Standard Practice for Separation of Plies for Bond Strength of Laminated Flexible Materials | |
Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method | |
Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages | |
Standard Test Method for Water Vapor Transmission Rate Through Plastic Film and Sheeting Using a Modulated Infrared Sensor | |
Standard Test Method for Slow Rate Penetration Resistance of Flexible Barrier Films and Laminates | |
Standard Test Method for Oxygen Transmission Rate Through Dry Packages Using a Coulometric Sensor | |
Standard Practice for Using 0.008-in. (0.203-mm) Aperture Reflectometers as Test Instruments for Measuring Visual Image Quality of Business Copy Images | |
Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method) | |
Standard Test Methods for Determining Residual Solvents in Packaging Materials | |
Standard Test Method for Determining Integrity of Seals for Medical Packaging by Visual Inspection | |
Standard Test Methods for Hot Seal Strength (Hot Tack) of Thermoplastic Polymers and Blends Comprising the Sealing Surfaces of Flexible Webs | |
Standard Test Method for Oxygen Gas Transmission Rate through Plastic Film and Sheeting using a Dynamic Accumulation Method | |
EN 868/1 | Annex C Gurley, Schopper, Dye Penetration |
| Plastics--Determination of Gas Transmission Rate of Films and Thin Sheets Under Atmospheric Pressure--Manometric Method |
| Paper and Board--Determination of Air Permeance (Medium Range)--Part 5: Gurley Method |
ISO 10993 | Biological Evaluation of Medical Devices |
| Packaging for Terminally Sterilized Medical Devices, Annex C |
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Standard Test Method for Thickness of Paper and Paperboard | |
Standard Test Method for Resistance of Nonporous Paper to Passage of Air | |
Standard Test Methods for Thickness of Solid Electrical Insulation | |
Standard Test Method for Tensile Properties of Thin Plastic Sheeting | |
Standard Test Method for Haze and Luminous Transmittance of Transparent Plastics | |
Standard Test Method for Determining Gas Permeability Characteristics of Plastic Film and Sheeting | |
Standard Test Methods for Impact Resistance of Plastic Film by the Free-Falling Dart Method | |
Standard Test Method for Thickness of Textile Materials | |
Standard Test Method for Static and Kinetic Coefficients of Friction of Plastic Film and Sheeting (Withdrawn 2023) | |
Standard Test Method for Propagation Tear Resistance of Plastic Film and Thin Sheeting by Pendulum Method | |
Standard Test Method for Tear-Propagation Resistance (Trouser Tear) of Plastic Film and Thin Sheeting by a Single-Tear Method | |
Standard Test Method for Dirt in Paper and Paperboard | |
Standard Test Method for Specular Gloss of Plastic Films and Solid Plastics |