ASTM_F_2097_-_14.pdf

Designation:F209714Standard Guide forDesign and Evaluation of Primary Flexible Packaging forMedical Products1This standard is issued under the fixed designation F2097;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last revision.A number in parentheses indicates the year of last reapproval.Asuperscript epsilon()indicates an editorial change since the last revision or reapproval.1.Scope1.1 This guide provides directions for the design and evalu-ation of primary flexible packages for medical products.Thepackage materials must be selected appropriately for manufac-turing process,end use,and the product being packaged.1.2 This guide provides a compendium of test methods,practices,and procedures.Specific individual test methodsmust be selected based on the pertinent characteristics of thespecific product to be packaged and the purpose for testing,research and development,or compliance.Not all test methodswill be applicable.1.3 This guide does not address acceptability criteria,whichneed to be determined jointly by the package producer and themedical products manufacturer.1.4 This guide does not assess the product to be packaged orthe sterilization method to be used.1.5 The units cited in the referenced standard should beused.2.Referenced Documents2.1 ASTM Standards:2D374 Test Methods for Thickness of Solid Electrical Insu-lation(Withdrawn 2013)3D589 Test Method for Opacity of Paper(15 Diffuse Illu-minant A,89%Reflectance Backing and Paper Backing)(Withdrawn 2010)3D638 Test Method for Tensile Properties of PlasticsD645/D645M Test Method for Thickness of Paper andPaperboard(Withdrawn 2010)3D726 Test Method for Resistance of Nonporous Paper toPassage of Air(Withdrawn 2009)3D882 Test Method for Tensile Properties of Thin PlasticSheetingD1003 Test Method for Haze and Luminous Transmittanceof Transparent PlasticsD1434 Test Method for Determining Gas Permeability Char-acteristics of Plastic Film and SheetingD1709 Test Methods for Impact Resistance of Plastic Filmby the Free-Falling Dart MethodD1777 Test Method for Thickness of Textile MaterialsD1894 Test Method for Static and Kinetic Coefficients ofFriction of Plastic Film and SheetingD1922 Test Method for Propagation Tear Resistance ofPlastic Film and Thin Sheeting by Pendulum MethodD1938 Test Method for Tear-Propagation Resistance(Trou-ser Tear)of Plastic Film and Thin Sheeting by a Single-Tear MethodD2019 Test Method for Dirt in Paper and Paperboard(With-drawn 2010)3D2457 Test Method for Specular Gloss of Plastic Films andSolid PlasticsD3078 Test Method for Determination of Leaks in FlexiblePackaging by Bubble EmissionD3079 Test Method for Water Vapor Transmission of Flex-ible Heat-Sealed Packages for Dry ProductsD3335 Test Method for Low Concentrations of Lead,Cadmium,and Cobalt in Paint by Atomic AbsorptionSpectroscopyD3420 Test Method for Pendulum Impact Resistance ofPlastic FilmD3718 Test Method for Low Concentrations of Chromiumin Paint by Atomic Absorption SpectroscopyD3776 Test Methods for Mass Per Unit Area(Weight)ofFabricD3985 Test Method for Oxygen Gas Transmission RateThrough Plastic Film and Sheeting Using a CoulometricSensorD4169 Practice for Performance Testing of Shipping Con-tainers and SystemsD4279 Test Methods for Water Vapor Transmission of Ship-ping ContainersConstant and Cycle Methods1This guide is under the jurisdiction of ASTM Committee F02 on FlexibleBarrier Packaging and is the direct responsibility of Subcommittee F02.50 onPackage Design and Development.Current edition approved April 1,2014.Published May 2014.Originallyapproved in 2001.Last previous edition approved in 2010 as F2097 10.DOI:10.1520/F2097-14.2For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Service at serviceastm.org.For Annual Book of ASTMStandards volume information,refer to the standards Document Summary page onthe ASTM website.3The last approved version of this historical standard is referenced onwww.astm.org.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 D4321 Test Method for Package Yield of Plastic FilmD4332 Practice for Conditioning Containers,Packages,orPackaging Components for TestingD4754 Test Method for Two-Sided Liquid Extraction ofPlastic Materials Using FDA Migration CellD5264 Practice forAbrasion Resistance of Printed Materialsby the Sutherland Rub TesterD7386 Practice for Performance Testing of Packages forSingle Parcel Delivery SystemsE398 Test Method for Water Vapor Transmission Rate ofSheet Materials Using Dynamic Relative Humidity Mea-surementF17 Terminology Relating to Flexible Barrier PackagingF88 Test Method for Seal Strength of Flexible BarrierMaterialsF99 Guide for Writing a Specification for Flexible BarrierRollstock MaterialsF151 Test Method for Residual Solvents in Flexible BarrierMaterials(Withdrawn 2004)3F372 Test Method for Water Vapor Transmission Rate ofFlexible