ASTM F2097-07 - 1.5.2007
 
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. 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; the sterilization method to be used; or package performance through sterilization, distribution, and handling.

 
2. Referenced Documents

D3078-02(2021)e1

Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission (Includes all amendments and changes 2/15/2021).

D3079-94(1999)

Standard Test Method for Water Vapor Transmission of Flexible Heat-Sealed Packages for Dry Products

D3335-85a(2020)

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).

D3420-21

Standard Test Method for Pendulum Impact Resistance of Plastic Film

D3776-09

Standard Test Methods for Mass Per Unit Area (Weight) of Fabric

D3985-17

Standard Test Method for Oxygen Gas Transmission Rate Through Plastic Film and Sheeting Using a Coulometric Sensor

D4169-23

Standard Practice for Performance Testing of Shipping Containers and Systems

D4279-95(2022)

Standard Test Methods for Water Vapor Transmission of Shipping Containers—Constant and Cycle Methods

D4321-15

Standard Test Method for Package Yield of Plastic Film (Withdrawn 2024)

D4332-22

Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing

D4754-18

Standard Test Method for Two-Sided Liquid Extraction of Plastic Materials Using FDA Migration Cell

D5264-98(2019)

Standard Practice for Abrasion Resistance of Printed Materials by the Sutherland Rub Tester

D7386-16

Standard Practice for Performance Testing of Packages for Single Parcel Delivery Systems

E398-20

Standard Test Method for Water Vapor Transmission Rate of Sheet Materials Using Dynamic Relative Humidity Measurement

F17-20

Standard Terminology Relating to Primary Barrier Packaging

F88-07

Standard Test Method for Seal Strength of Flexible Barrier Materials

F99-21

Standard Guide for Writing a Specification for Flexible Barrier Rollstock Materials

F151-86(1997)

Standard Test Method for Residual Solvents in Flexible Barrier Materials (Withdrawn 2004)

F372-99

Standard Test Method for Water Vapor Transmission Rate of Flexible Barrier Materials Using an Infrared Detection Technique

F392-93(1999)

Standard Test Method for Flex Durability of Flexible Barrier Materials

F748-16

Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices

D3718-85A(2022)e1

Standard Test Method for Low Concentrations of Chromium in Paint by Atomic Absorption Spectroscopy (Includes all amendments and changes 7/7/2022).

F2391-22

Standard Test Method for Measuring Package and Seal Integrity Using Helium as the Tracer Gas

F2475-20

Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials

F2476-20

Standard Test Method for the Determination of Carbon Dioxide Gas Transmission Rate (CO2TR) Through Barrier Materials Using an Infrared Detector

F2559-06

Standard Guide for Writing a Specification for Sterilizable Peel Pouches

F2622-20

Standard Test Method for Oxygen Gas Transmission Rate Through Plastic Film and Sheeting Using Various Sensors

F2638-22

Standard Test Method for Using Aerosol Filtration for Measuring the Performance of Porous Packaging Materials as a Surrogate Microbial Barrier

F2714-08(2021)

Standard Test Method for Oxygen Headspace Analysis of Packages Using Fluorescent Decay

F2824-10(2020)

Standard Test Method for Mechanical Seal Strength Testing for Round Cups and Bowl Containers with Flexible Peelable Lids

F2825-18

Standard Practice for Climatic Stressing of Packaging Systems for Single Parcel Delivery

F2981-15(2020)

Standard Test Method for Verifying Nonporous Flexible Barrier Material Resistance to the Passage of Air

F3004-13(2020)

Standard Test Method for Evaluation of Seal Quality and Integrity Using Airborne Ultrasound

F3039-23

Standard Test Method for Detecting Leaks in Nonporous Packaging or Flexible Barrier Materials by Dye Penetration

D589-97

Standard Test Method for Opacity of Paper (15°Diffuse Illuminant A, 89% Reflectance Backing and Paper Backing)

D638-22

Standard Test Method for Tensile Properties of Plastics

Bacterial Filtration Efficiency

F1927-20

Standard Test Method for Determination of Oxygen Gas Transmission Rate, Permeability and Permeance at Controlled Relative Humidity Through Barrier Materials Using a Coulometric Detector

F1929-23

Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration

F1980-21

Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices

F2029-16(2021)

Standard Practices for Making Laboratory Heat Seals for Determination of Heat Sealability of Flexible Barrier Materials as Measured by Seal Strength

F2054-07

Standard Test Method for Burst Testing of Flexible Package Seals Using Internal Air Pressurization Within Restraining Plates

F2095-07(2021)

Standard Test Methods for Pressure Decay Leak Test for Flexible Packages With and Without Restraining Plates

F2096-11(2019)

Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)

F2203-13(2022)

Standard Test Method for Linear Measurement Using Precision Steel Rule

F2217-02

Standard Practice for Coating/Adhesive Weight Determination

F2250-13(2018)

Standard Practice for Evaluation of Chemical Resistance of Printed Inks and Coatings on Flexible Packaging Materials

F2251-13(2023)

Standard Test Method for Thickness Measurement of Flexible Packaging Material

F2252-13

Standard Practice for Evaluating Ink or Coating Adhesion to Flexible Packaging Materials Using Tape

F2227-13(2021)

Standard Test Method for Non-Destructive Detection of Leaks in Non-sealed and Empty Packaging Trays by CO2 Tracer Gas Method

F2228-13(2021)

Standard Test Method for Non-Destructive Detection of Leaks in Packaging Which Incorporates Porous Barrier Material by CO2 Tracer Gas Method

F813-20

Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices

F895-11(2016)

Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity

F904-22

Standard Practice for Separation of Plies for Bond Strength of Laminated Flexible Materials

F2338-09(2020)

Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method

F1140-07

Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages

F1249-20

Standard Test Method for Water Vapor Transmission Rate Through Plastic Film and Sheeting Using a Modulated Infrared Sensor

F1306-21

Standard Test Method for Slow Rate Penetration Resistance of Flexible Barrier Films and Laminates

F1307-20

Standard Test Method for Oxygen Transmission Rate Through Dry Packages Using a Coulometric Sensor

F1443-93(1998)

Standard Practice for Using 0.008-in. (0.203-mm) Aperture Reflectometers as Test Instruments for Measuring Visual Image Quality of Business Copy Images

F1608-21

Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method)

F1884-04(2023)

Standard Test Methods for Determining Residual Solvents in Packaging Materials

F1886-98

Standard Test Method for Determining Integrity of Seals for Medical Packaging by Visual Inspection

F1921-12

Standard Test Methods for Hot Seal Strength (Hot Tack) of Thermoplastic Polymers and Blends Comprising the Sealing Surfaces of Flexible Webs

F3136-22

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

D645-D645M-97

Standard Test Method for Thickness of Paper and Paperboard

D726-94(1999)

Standard Test Method for Resistance of Nonporous Paper to Passage of Air

D374-99

Standard Test Methods for Thickness of Solid Electrical Insulation

D882-18

Standard Test Method for Tensile Properties of Thin Plastic Sheeting

D1003-21

Standard Test Method for Haze and Luminous Transmittance of Transparent Plastics

D1434-23

Standard Test Method for Determining Gas Permeability Characteristics of Plastic Film and Sheeting

D1709-22

Standard Test Methods for Impact Resistance of Plastic Film by the Free-Falling Dart Method

D1777-96(2019)

Standard Test Method for Thickness of Textile Materials

D1894-14

Standard Test Method for Static and Kinetic Coefficients of Friction of Plastic Film and Sheeting (Withdrawn 2023)

D1922-23

Standard Test Method for Propagation Tear Resistance of Plastic Film and Thin Sheeting by Pendulum Method

D1938-19

Standard Test Method for Tear-Propagation Resistance (Trouser Tear) of Plastic Film and Thin Sheeting by a Single-Tear Method

D2019-97

Standard Test Method for Dirt in Paper and Paperboard

D2457-21

Standard Test Method for Specular Gloss of Plastic Films and Solid Plastics