1、Designation: F2097 16Standard 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 l
2、ast 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. Thepac
3、kage 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 pro
4、duct 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
5、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 Referenced Documents2.1 ASTM Standards:2D374 Test Methods for Thickness of Solid Electrical Insu-lation (Withdrawn 2013)3D589 Test Method for Opacity of Paper (
6、15 Diffuse Illu-minant A, 89 % Reflectance Backing and Paper Backing)(Withdrawn 2010)3D638 Test Method for Tensile Properties of PlasticsD645/D645M Test Method for Thickness of Paper andPaperboard (Withdrawn 2010)3D726 Test Method for Resistance of Nonporous Paper toPassage of Air (Withdrawn 2009)3D
7、882 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 Fre
8、e-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-Propag
9、ation 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 B
10、ubble 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 Metho
11、d 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
12、-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.Curre
13、nt edition approved April 1, 2016. Published June 2016. Originallyapproved in 2001. Last previous edition approved in 2014 as F2097 14. DOI:10.1520/F2097-16.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of AS
14、TMStandards 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 States1D4321
15、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 for Abrasion Resistance of Printed Materialsby the Sutherl
16、and 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 o
17、f 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 Barrier Materials Using an Infrared DetectionTech
18、nique (Withdrawn 2009)3F392 Test Method for Flex Durability of Flexible BarrierMaterialsF748 Practice for Selecting Generic Biological Test Methodsfor Materials and DevicesF813 Practice for Direct Contact Cell Culture Evaluation ofMaterials for Medical DevicesF895 Test Method forAgar Diffusion Cell
19、Culture Screeningfor CytotoxicityF904 Test Method for Comparison of Bond Strength or PlyAdhesion of Similar Laminates Made from Flexible Ma-terialsF1140 Test Methods for Internal Pressurization Failure Re-sistance of Unrestrained PackagesF1249 Test Method for Water Vapor Transmission RateThrough Pla
20、stic Film and Sheeting Using a ModulatedInfrared SensorF1306 Test Method for Slow Rate Penetration Resistance ofFlexible Barrier Films and LaminatesF1307 Test Method for Oxygen Transmission Rate ThroughDry Packages Using a Coulometric SensorF1443 Practice for Using 0.008-in. (0.203-mm) ApertureRefle
21、ctometers as Test Instruments for Measuring VisualImage Quality of Business Copy ImagesF1608 Test Method for Microbial Ranking of Porous Pack-aging Materials (Exposure Chamber Method)F1884 Test Methods for Determining Residual Solvents inPackaging MaterialsF1886 Test Method for Determining Integrity
22、 of Seals forMedical Packaging by Visual InspectionF1921 Test Methods for Hot Seal Strength (Hot Tack) ofThermoplastic Polymers and Blends Comprising the Seal-ing Surfaces of Flexible WebsF1927 Test Method for Determination of Oxygen Gas Trans-mission Rate, Permeability and Permeance at ControlledRe
23、lative Humidity Through Barrier Materials Using aCoulometric DetectorF1929 Test Method for Detecting Seal Leaks in PorousMedical Packaging by Dye PenetrationF1980 Guide for Accelerated Aging of Sterile Barrier Sys-tems for Medical DevicesF2029 Practices for Making Heatseals for Determination ofHeats
24、ealability of Flexible Webs as Measured by SealStrengthF2054 Test Method for Burst Testing of Flexible PackageSeals Using InternalAir Pressurization Within RestrainingPlatesF2095 Test Methods for Pressure Decay Leak Test forFlexible Packages With and Without Restraining PlatesF2096 Test Method for D
25、etecting Gross Leaks in Packagingby Internal Pressurization (Bubble Test)F2203 Test Method for Linear Measurement Using PrecisionSteel RuleF2217 Practice for Coating/Adhesive Weight DeterminationF2250 Practice for Evaluation of Chemical Resistance ofPrinted Inks and Coatings on Flexible Packaging Ma
26、teri-alsF2251 Test Method for Thickness Measurement of FlexiblePackaging MaterialF2252 Practice for Evaluating Ink or Coating Adhesion toFlexible Packaging Materials Using TapeF2227 Test Method for Non-Destructive Detection of Leaksin Non-sealed and Empty Packaging Trays by CO2TracerGas MethodF2228
27、Test Method for Non-Destructive Detection of Leaksin Packaging Which Incorporates Porous Barrier Materialby CO2Tracer Gas MethodF2338 Test Method for Nondestructive Detection of Leaksin Packages by Vacuum Decay MethodF2391 Test Method for Measuring Package and Seal Integ-rity Using Helium as the Tra
28、cer GasF2475 Guide for Biocompatibility Evaluation of MedicalDevice Packaging MaterialsF2476 Test Method for the Determination of Carbon Diox-ide Gas Transmission Rate (CO2TR) Through BarrierMaterials Using An Infrared DetectorF2559 Guide for Writing a Specification for Sterilizable PeelPouchesF2622
29、 Test Method for Oxygen Gas Transmission RateThrough Plastic Film and Sheeting Using Various SensorsF2638 Test Method for Using Aerosol Filtration for Measur-ing the Performance of Porous Packaging Materials as aSurrogate Microbial BarrierF2714 Test Method for Oxygen Headspace Analysis ofPackages Us
30、ing Fluorescent DecayF2824 Test Method for Mechanical Seal Strength Testing forRound Cups and Bowl Containers with Flexible PeelableLidsF2825 Practice for Climatic Stressing of Packaging Systemsfor Single Parcel DeliveryF2981 Test Method for Verifying Nonporous Flexible Bar-rier Material Resistance
31、to the Passage of AirF3004 Test Method for Evaluation of Seal Quality andIntegrity Using Airborne UltrasoundF2097 162F3039 Test Method for Detecting Leaks in Nonporous Pack-aging or Flexible Barrier Materials by Dye PenetrationF3136 Test Method for Oxygen Gas Transmission Ratethrough Plastic Film an
32、d Sheeting using a DynamicAccumulation Method2.2 EN/ISO Standards:4EN 868/1 Annex C Gurley, Schopper, Dye PenetrationISO 2556 PlasticsDetermination of Gas TransmissionRate of Films and Thin Sheets Under AtmosphericPressureManometric MethodISO 56365 Paper and BoardDetermination of Air Per-meance (Med
33、ium Range)Part 5: Gurley MethodISO 10993 Biological Evaluation of Medical DevicesISO 116071 Packaging for Terminally Sterilized MedicalDevices, Annex CISO 151051 PlasticsFilm and SheetingDeterminationof Gas Transmission RatePart 1: Differential-PressureMethodISO 151052 PlasticsFilm and SheetingDeter
34、minationof Gas Transmission RatePart 2: Equal-PressureMethod2.3 Military Specification:5Mil Spec 36954C Bacterial Filtration Efficiency2.4 TAPPI Standards:6TAPPI T 404 Tensile Breaking Strength and Elongation ofPaper and PaperboardTAPPI T 437 Dirt in Paper and PaperboardTAPPI T 460 Air Resistance of
35、 Paper (Gurley Method)TAPPI T 494 Tensile Breaking Properties of Paper andPaperboard (Using Constant Rate of Elongation Appara-tus)TAPPI T 536 Resistance of Paper to Passage of Air (HighPressure Gurley Method)TAPPI T 547 Air Permeance of Paper and Paperboard(Sheffield Method)2.5 ISTA Procedures:7IST
36、A 3A Packaged Products for Parcel Delivery SystemShipments 70 kg (150 lb) or Less (standard, small, flat, orelongated)ISTA 3E Unitized Loads of Same ProductISTA 4AB Packaged-Products for Shipment in KnownDistribution ChannelsISTA 6FEDEX-A FedEx Procedures for Testing PackagedProducts Weighing Up to
37、150 lbs3. Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 barrier requirements, nthe need to promote orinhibit moisture, gas, or light, or a combination thereof, whilemaintaining necessary levels of sterility.3.1.2 durability requirements, nmaterial properties rel-evant to the ab
38、ility of the package to protect the product.3.1.3 integrity and seal requirements, nthe ability of thepackage to prevent inadvertent escape of contents or entranceof outside substances while preserving intended opening foruse features.3.1.4 package performance, nthe ability of the packagingsystem, i
39、ncluding the sterile barrier system and protectivepackaging, to withstand the hazards of handling, distribution,and storage.3.1.5 printing requirements, nthe printed ink propertiesneeded to ensure physical and chemical resistance to degrada-tion.3.1.6 processing requirements, nthe material character
40、is-tics needed to ensure the consistent and reliable production ofthe package.3.1.7 safety requirements, nsafeguard product againstcontamination and deleterious health effects.3.1.8 visibility and appearance requirements, nthe desiredpackage aesthetics needed to permit or inhibit viewing of theprodu
41、ct or to enhance product presentation.3.2 For other terms used in this guide, see Terminology F17.4. Significance and Use4.1 This design and evaluation guide describes multiplecategories for evaluating flexible medical packages and pack-aging materials. These include safety, barrier properties,durab
42、ility, package and seal integrity, visibility andappearance, processing, printing ink properties, and packageperformance.4.2 The intent of this design and evaluation guide is toevaluate all cited categories and select those that are appli-cable. Once the product has been characterized and thesterili
43、zation methodology has been defined, there are numeroussets of requirements for any specific package. This design andevaluation guide provides an avenue for assessing theserequirements and choosing test methods for both evaluating thepackage design and monitoring package compliance.NOTE 1Many of the
44、 standards included in this guide are consensusstandards that are recognized by the United States Food and DrugAdministration (FDA). Selection and use of a U.S. FDA recognizedconsensus standard is voluntary and the sole responsibility of the user indetermining its applicability. For further informat
45、ion, 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 productcomposition.4.4 All categories must be c
46、onsidered for applicability.4.5 The Summary of Test Methods for Medical PackagingDesign and Evaluation (Fig. 1) provides a compact graphicalpresentation of the test methods referenced in this guide.4.6 Test Description and Applicability (see Table 1):4.6.1 Table 1 lists the test methods commonly use
47、d toevaluate flexible medical packaging. The test methods are usedin two phases.4Available from International Organization for Standardization (ISO), 1 rue deVaremb, Case postale 56, CH-1211, Geneva 20, Switzerland, http:/www.iso.ch.5Available from Standardization Documents Order Desk, Bldg. 4 Secti
48、on D, 700Robbins Ave., Philadelphia, PA 19111-5094, Attn: NPOPS.6Available from Technical Association of the Pulp and Paper Industry (TAPPI),15 Technology Parkway South, Norcross, GA 30092, http:/www.tappi.org.7Available from International Safe Transit Association (ISTA), 1400 Abbot Rd.,Suite 160, E
49、ast Lansing, MI 48823-1900, http:/www.ista.org.F2097 1634.6.1.1 Package Design: Characterization of the Materialsand Evaluation of the Resultant PackageThis is referred to as“R only that the L929 is an established cell line, well characterized andreadily available, that has demonstrated reproducible re-sults in several laboratories.ToxicityUsageR25 %) between laboratories.It is a simplified version of Test Method F151 providingabout the same level of accuracy. This method differsfrom Test Method F151 in that it specifies certain condi-tions. Test Me
