Standard Test Method

ASTM	F	2097	2005
Standard Guide for Design and Evaluation of Primary Packaging for Medical Products
1. Scope 1.1 This guide provides directions for the design and evaluation of primary 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 D374 Test Methods for Thickness of Solid Electrical Insulation D589 Test Method for Opacity of Paper (15% Diffuse Illuminant A, 89% Reflectance Backing and Paper Backing) D645/D645M Test Method for Thickness of Paper and Paperboard D726 Test Methods for Resistance of Nonporous Paper to Passage of Air D882 Test Methods for Tensile Properties of Thin Plastic Sheeting D1003 Test Method for Haze and Luminous Transmittance of Transparent Plastics (Gardner) D1709 Test Methods for Impact Resistance of Plastic Film by Free-Falling Dart Method D1777 Test Method for Thickness of Textile Materials D1894 Test Method for Static and Kinetic Coefficients of Friction of Plastic Film and Sheeting D1922 Test Method for Propagation Tear Resistance of Plastic Film and Thin Sheeting by Pendulum Method D1938 Test Method for Tear Propagation Resistance of Plastic Film and Thin Sheeting by a Single Tear Method D2019 Test Method for Dirt in Paper and Paperboard D2457 Test Method for Specular Gloss of Plastic Film and Solid Plastics D3078 Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission D3335 Test Method for Low Concentrations of Lead, Cadmium, and Cobalt in Paint by Atomic Absorption Spectroscopy D3420 Test Method for Dynamic Ball Burst Pendulum Impact Resistance of Plastic Film D3718 Test Method for Low Concentrations of Chromium in Paint by Atomic Absorption Spectroscopy D3776 Test Methods for Mass per Unit Area (Weight) of Woven Fabric D3985 Test Method for Oxygen Gas Transmission Rate Through Plastic Film and Sheeting Using a Columetric Sensor D4279 Test Methods for Water Vapor Transmission of Shipping Containers-Constant and Cycle Methods D4321 Test Method for Package Yield of Plastic Film D4754 Test Method for Two-Sided Liquid Extraction of Plastic Materials Using FDA Migration Cell D5264 Practice for Abrasion Resistance of Printed Materials by the Sutherland Rub Tester F88 Test Method for Seal Strength of Flexible Barrier Materials F372 Test Method for Water Vapor Transmission Rate of Flexible Barrier Materials Using an Infrared Detection Technique F392 Test Method for Flex Durability of Flexible Barrier Materials F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices F813 Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices F895 Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity F904 Test Method for Comparison of Bond Strength or Ply Adhesion of Similar Laminates Made from Flexible Barrier Materials F1140 Test Methods for Failure Resistance of Unrestrained and Nonrigid Packages for Medical Applications F1249 Test Method for Water Vapor Transmission Rate Through Plastic Film and Sheeting Using a Modulated Infrared Sensor F1306 Test Method for Slow Rate Penetration Resistance of Flexible Barrier Films and Laminates F1327 Terminology Relating to Barrier Materials for Medical Packaging F1443 Practice for Using 0.008-in. (0.203-mm) Aperature Reflectometers as Test Instruments for Measuring Visual Image Quality of Business Copy Images F1608 Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method) F1884 Test Method for Determining Residual Solvents in Packaging Materials F1886 Test Method for Determining Integrity of Seals for Medical Packaging by Visual Inspection F1929 Test Method for Detecting Seal Leaks in Porous Packaging by Dye Penetration F1980 Guide for Accelerated Aging of Sterile Medical Device Packages F2054 Test Method for Burst Testing of Flexible Package Seals using Internal Air Pressurization with Restraining Plates F2096 Test Method for Detecting Gross Leaks in Porous Medical Packaging by Internal Pressurization (Bubble Test) F151 Test Method for Residual Solvents in Flexible Barrier Materials EN 868/1 Annex C Gurley, Schopper, Dye Penetration ISO 5636/5 ISO 11607 Annex A Gurley Mil Spec 36954C Bacterial Filtration Efficiency FPA/SPMC 009 Standard Test Method for Coating/Adhesive Weight Determination TAPPI T 404 Tensile Breaking Strength and Elongation of Paper and Paperboard TAPPI T 437 Dirt in Paper and Paperboard TAPPI T 460 Air Resistance of Paper TAPPI T 494 Tensile Breaking Properties of Paper and Paperboard (Using Constant Rate of Elongation Apparatus) TAPPI T 536 Resistance of Paper to Passage of Air
Index Terms primary packaging for medical products; design and evaluation; manufacturing process; end use; 11.020; 55.020

Applicable Apparatus: The Frazier Differential Pressure Air Permeability Tester; The Frazier Compressometer; The Frazier Schiefer Thickness Tester

ASTM F2097

F2097-05 Standard Guide for Design and Evaluation of Primary Packaging for Medical Products