ASTM F2097-2010 Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products《医用产品用一级软包装的设计和评估标准指南》.pdf

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1、Designation: F2097 10Standard 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-lationD589 Test Method for Opacity of Paper (15 DiffuseIllumina

6、nt A, 89 % Reflectance Backing and Paper Back-ing)3D638 Test Method for Tensile Properties of PlasticsD645/D645M Test Method for Thickness of Paper andPaperboard3D726 Test Method for Resistance of Nonporous Paper toPassage of Air3D882 Test Method for Tensile Properties of Thin PlasticSheetingD1003 T

7、est Method for Haze and Luminous Transmittanceof Transparent PlasticsD1434 Test Method for Determining Gas PermeabilityCharacteristics of Plastic Film and SheetingD1709 Test Methods for Impact Resistance of Plastic Filmby the Free-Falling Dart MethodD1777 Test Method for Thickness of Textile Materia

8、lsD1894 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

9、 Single-Tear MethodD2019 Test Method for Dirt in Paper and PaperboardD2457 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 Pack

10、ages for Dry ProductsD3335 Test Method for Low Concentrations of Lead, Cad-mium, and Cobalt in Paint by Atomic Absorption Spec-troscopyD3420 Test Method for Pendulum Impact Resistance ofPlastic FilmD3718 Test Method for Low Concentrations of Chromiumin Paint by Atomic Absorption SpectroscopyD3776 Te

11、st 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 ofShipping Contain

12、ersConstant 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, 2010. Published May 2010. Originallyapproved in 2001. Last

13、previous edition approved in 2008 as F2097 08. DOI:10.1520/F2097-10.2For 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 w

14、ebsite.3Withdrawn. The last approved version of this historical standard is referencedon www.astm.org.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.D4321 Test Method for Package Yield of Plastic FilmD4754 Test Method for Two-Sided

15、Liquid Extraction ofPlastic Materials Using FDA Migration CellD5264 Practice for Abrasion Resistance of Printed Materi-als by the Sutherland Rub TesterD7386 Practice for Performance Testing of Packages forSingle Parcel Delivery SystemsE398 Test Method for Water Vapor Transmission Rate ofSheet Materi

16、als 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 BarrierM

17、aterials3F372 Test Method for Water Vapor Transmission Rate ofFlexible Barrier Materials Using an Infrared DetectionTechnique3F392 Test Method for Flex Durability of Flexible BarrierMaterialsF748 Practice for Selecting Generic Biological Test Meth-ods for Materials and DevicesF813 Practice for Direc

18、t Contact Cell Culture Evaluation ofMaterials for Medical DevicesF895 Test Method for Agar Diffusion Cell Culture Screen-ing for CytotoxicityF904 Test Method for Comparison of Bond Strength or PlyAdhesion of Similar Laminates Made from Flexible Mate-rialsF1140 Test Methods for Internal Pressurizatio

19、n FailureResistance of Unrestrained PackagesF1249 Test Method for Water Vapor Transmission RateThrough Plastic 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

20、 ThroughDry Packages Using a Coulometric SensorF1443 Practice for Using 0.008-in. (0.203-mm) ApertureReflectometers 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

21、Methods for Determining Residual Solvents inPackaging MaterialsF1886 Test Method for Determining Integrity 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

22、Test Method for Determination of Oxygen GasTransmission Rate, Permeability and Permeance at Con-trolled Relative Humidity Through Barrier Materials Usinga Coulometric DetectorF1929 Test Method for Detecting Seal Leaks in PorousMedical Packaging by Dye PenetrationF1980 Guide for Accelerated Aging of

23、Sterile Barrier Sys-tems for Medical DevicesF2029 Practices for Making Heatseals for Determination ofHeatsealability of Flexible Webs as Measured by SealStrengthF2054 Test Method for Burst Testing of Flexible PackageSeals Using Internal Air Pressurization Within RestrainingPlatesF2095 Test Methods f

24、or Pressure Decay Leak Test forFlexible Packages With and Without Restraining PlatesF2096 Test Method for Detecting Gross Leaks in MedicalPackaging by Internal Pressurization (Bubble Test)F2203 Test Method for Linear Measurement Using Preci-sion Steel RuleF2217 Practice for Coating/Adhesive Weight D

25、eterminationF2250 Practice for Evaluation of Chemical Resistance ofPrinted Inks and Coatings on Flexible Packaging MaterialsF2251 Test Method for Thickness Measurement of FlexiblePackaging MaterialF2252 Practice for Evaluating Ink or Coating Adhesion toFlexible Packaging Materials Using TapeF2227 Te

26、st Method for Non-Destructive Detection of Leaksin Non-sealed and Empty Medical Packaging Trays by CO2Tracer Gas MethodF2228 Test Method for Non-Destructive Detection of Leaksin Medical Packaging Which Incorporates Porous BarrierMaterial by CO2Tracer Gas MethodF2338 Test Method for Nondestructive De

27、tection of Leaksin Packages by Vacuum Decay MethodF2391 Test Method for Measuring Package and Seal Integ-rity Using Helium as the Tracer GasF2475 Guide for Biocompatibility Evaluation of MedicalDevice Packaging MaterialsF2476 Test Method for the Determination of Carbon Diox-ide Gas Transmission Rate

28、 (Co2TR) Through BarrierMaterials Using An Infrared DetectorF2559 Guide for Writing a Specification for SterilizablePeel PouchesF2638 Test Method for Using Aerosol Filtration for Mea-suring the Performance of Porous Packaging Materials as aSurrogate Microbial Barrier2.2 EN/ISO Standards:4EN 868/1 An

29、nex 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 (Medium Range)Part 5: Gurley MethodISO 116071 Packaging for Terminally Sterilized

30、MedicalDevices, Annex CISO 151051 PlasticsFilm and SheetingDeterminationof Gas Transmission RatePart 1: Differential-PressureMethodISO 151052 PlasticsFilm and SheetingDetermination4Available from International Organization for Standardization (ISO), 1 rue deVaremb, Case postale 56, CH-1211, Geneva 2

31、0, Switzerland, http:/www.iso.ch.F2097 102of 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 Paper

32、boardTAPPI T 460 Air Resistance of 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(Sheffie

33、ld Method)2.5 ISTA Procedures:7ISTA 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 Testin

34、g PackagedProducts Weighing Up to 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, nmater

35、ial properties rel-evant to the ability 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

36、 ability of the packagingsystem, including 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 req

37、uirements, nthe material characteris-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 de-sired package aesthetics needed to p

38、ermit or inhibit viewing ofthe product 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 incl

39、ude safety, barrier properties, dura-bility, 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 toevaluate all cited categories and select those that are appli-cable. Once the produc

40、t has been characterized and thesterilization 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 monitori

41、ng package compliance.NOTE 1Many of the 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

42、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 productc

43、omposition.4.4 All categories must be considered 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 Tabl

44、e 1 lists the test methods commonly used toevaluate flexible medical packaging. The test methods are usedin two phases.4.6.1.1 Package Design: Characterization of the Materialsand Evaluation of the Resultant PackageThis is referred toas “R only that the L929 is an established cell line, well charact

45、erized andreadily available, that has demonstrated reproducibleresults 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 certaincondi

46、tions. Test Method F1884, for example, specifies apre-heat condition of 90C for 20 min. Test Method F151defines a procedure for determining optimum heatingtime and temperature conditions for the preheat.Because solvents will escape from surface wraps on aroll of film, this test should be performed i

47、mmediatelyafter manufacturing to provide an indication of solventlevels in the inner wraps of the roll of film.Retained solventsUsageRfurther steps would be needed to correlate these relativenumbers to end-use applications.F2097 1010TABLE 1 ContinuedTest Test Method Description ApplicabilityPuncture

48、 resistanceUsageR further steps would be needed tocorrelate these relative numbers to end-use applications.This test method could be used to address concerns oversharp edged products packaged in thin flexible materialpenetrating the integrity. This test method will create arelative number for penetr

49、ation resistance but does notaddress abrasion.Puncture resistanceUsageR any hazard (test) element maybe assigned one of three intensities. The user must beable to designate each of the aforementioned criteria.Program inputs and test plans may be in English ormetric units. Test plans may require relativelysophisticated laboratory testing equipment. As amaximum, the required equipment may include severaltypes of appropriate drop test apparatus, a randomvibration test system, an inclined impact tester,compression test apparatus,ASTM International takes