ASTM F2097-2007 Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products《医疗产品用基本柔软包装的设计和评估用标准指南》.pdf

1、Designation: F 2097 07Standard Guide forDesign and Evaluation of Primary Flexible Packaging forMedical Products1This standard is issued under the fixed designation F 2097; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of

2、 last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon (e) 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. The

3、package 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.Specific individual test methods must be selected based on thepertinent characteristics of the specific product to be packagedand

4、the purpose for testing, research and development, orcompliance. Not all test methods will 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

5、to be packaged;the sterilization method to be used; or package performancethrough sterilization, distribution, and handling.2. Referenced Documents2.1 ASTM Standards:2D 374 Test Methods for Thickness of Solid Electrical Insu-lationD 589 Test Method for Opacity of Paper (15 DiffuseIlluminant A, 89 %

6、Reflectance Backing and Paper Back-ing)D 638 Test Method for Tensile Properties of PlasticsD 645/D 645M Test Method for Thickness of Paper andPaperboardD 726 Test Method for Resistance of Nonporous Paper toPassage of AirD 882 Test Method for Tensile Properties of Thin PlasticSheetingD 1003 Test Meth

7、od for Haze and Luminous Transmittanceof Transparent PlasticsD 1434 Test Method for Determining Gas PermeabilityCharacteristics of Plastic Film and SheetingD 1709 Test Methods for Impact Resistance of Plastic Filmby the Free-Falling Dart MethodD 1777 Test Method for Thickness of Textile MaterialsD 1

8、894 Test Method for Static and Kinetic Coefficients ofFriction of Plastic Film and SheetingD 1922 Test Method for Propagation Tear Resistance ofPlastic Film and Thin Sheeting by Pendulum MethodD 1938 Test Method for Tear-Propagation Resistance(Trouser Tear) of Plastic Film and Thin Sheeting by aSing

9、le-Tear MethodD 2019 Test Method for Dirt in Paper and PaperboardD 2457 Test Method for Specular Gloss of Plastic Films andSolid PlasticsD 3078 Test Method for Determination of Leaks in FlexiblePackaging by Bubble EmissionD 3079 Test Method for Water Vapor Transmission ofFlexible Heat-Sealed Package

10、s for Dry ProductsD 3335 Test Method for Low Concentrations of Lead,Cadmium, and Cobalt in Paint by Atomic AbsorptionSpectroscopyD 3420 Test Method for Pendulum Impact Resistance ofPlastic FilmD 3718 Test Method for Low Concentrations of Chromiumin Paint by Atomic Absorption SpectroscopyD 3776 Test

11、Method for Mass Per Unit Area (Weight) ofFabricD 3985 Test Method for Oxygen Gas Transmission RateThrough Plastic Film and Sheeting Using a CoulometricSensor1This guide is under the jurisdiction of ASTM Committee F02 on FlexibleBarrier Packaging and is the direct responsibility of Subcommittee F02.5

12、0 onPackage Design and Development.Current edition approved May 1, 2007. Published June 2007. Originallyapproved in 2001. Last previous edition approved in 2005 as F 2097 05.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For

13、Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.D 4279 Test Methods for Water Vapor Transmission ofShipping ContainersCo

14、nstant and Cycle MethodsD 4321 Test Method for Package Yield of Plastic FilmD 4754 Test Method for Two-Sided Liquid Extraction ofPlastic Materials Using FDA Migration CellD 5264 Practice for Abrasion Resistance of Printed Materi-als by the Sutherland Rub TesterE 398 Test Method for Water Vapor Trans

15、mission Rate ofSheet Materials Using Dynamic Relative Humidity Mea-surementF88 Test Method for Seal Strength of Flexible BarrierMaterialsF 151 Test Method for Residual Solvents in Flexible BarrierMaterials3F 372 Test Method for Water Vapor Transmission Rate ofFlexible Barrier Materials Using an Infr

16、ared DetectionTechniqueF 392 Test Method for Flex Durability of Flexible BarrierMaterialsF 748 Practice for Selecting Generic Biological Test Meth-ods for Materials and DevicesF 813 Practice for Direct Contact Cell Culture Evaluation ofMaterials for Medical DevicesF 895 Test Method for Agar Diffusio

17、n Cell Culture Screen-ing for CytotoxicityF 904 Test Method for Comparison of Bond Strength or PlyAdhesion of Similar Laminates Made from Flexible Mate-rialsF 1140 Test Methods for Internal Pressurization FailureResistance of Unrestrained Packages for Medical Applica-tionsF 1249 Test Method for Wate

18、r Vapor Transmission RateThrough Plastic Film and Sheeting Using a ModulatedInfrared SensorF 1306 Test Method for Slow Rate Penetration Resistanceof Flexible Barrier Films and LaminatesF 1307 Test Method for Oxygen Transmission RateThrough Dry Packages Using a Coulometric SensorF 1327 Terminology Re

19、lating to Barrier Materials for Medi-cal Packaging3F 1443 Practice for Using 0.008-in. (0.203-mm) ApertureReflectometers as Test Instruments for Measuring VisualImage Quality of Business Copy ImagesF 1608 Test Method for Microbial Ranking of Porous Pack-aging Materials (Exposure Chamber Method)F 188

20、4 Test Methods for Determining Residual Solvents inPackaging MaterialsF 1886 Test Method for Determining Integrity of Seals forMedical Packaging by Visual InspectionF 1921 Test Methods for Hot Seal Strength (Hot Tack) ofThermoplastic Polymers and Blends Comprising the Seal-ing Surfaces of Flexible W

21、ebsF 1927 Test Method for Determination of Oxygen GasTransmission Rate, Permeability and Permeance at Con-trolled Relative Humidity Through Barrier Materials Usinga Coulometric DetectorF 1929 Test Method for Detecting Seal Leaks in PorousMedical Packaging by Dye PenetrationF 1980 Guide for Accelerat

22、ed Aging of Sterile BarrierSystems for Medical DevicesF 2029 Practices for Making Heatseals for Determination ofHeatsealability of Flexible Webs as Measured by SealStrengthF 2054 Test Method for Burst Testing of Flexible PackageSeals Using Internal Air Pressurization Within RestrainingPlatesF 2095 T

23、est Methods for Pressure Decay Leak Test forNonporous Flexible Packages With and Without Restrain-ing PlatesF 2096 Test Method for Detecting Gross Leaks in MedicalPackaging by Internal Pressurization (Bubble Test)F 2203 Test Method for Linear Measurement Using Preci-sion Steel RuleF 2217 Practice fo

24、r Coating/Adhesive Weight Determina-tionF 2250 Practice for Evaluation of Chemical Resistance ofPrinted Inks and Coatings on Flexible Packaging MaterialsF 2251 Test Method for Thickness Measurement of FlexiblePackaging MaterialF 2252 Practice for Evaluating Ink or Coating Adhesion toFlexible Packagi

25、ng Materials Using TapeF 2227 Test Method for Non-Destructive Detection ofLeaks in Non-sealed and Empty Medical Packaging Traysby CO2Tracer Gas MethodF 2228 Test Method for Non-Destructive Detection ofLeaks in Medical Packaging Which Incorporates PorousBarrier Material by CO2Tracer Gas MethodF 2338

26、Test Method for Nondestructive Detection of Leaksin Packages by Vacuum Decay MethodF 2391 Test Method for Measuring Package and Seal Integ-rity Using Helium as the Tracer GasF 2475 Guide for Biocompatibility Evaluation of MedicalDevice Packaging MaterialsF 2476 Test Method for the Determination of C

27、arbon Diox-ide Gas Transmission Rate (Co2TR) Through BarrierMaterials Using An Infrared DetectorF 2559 Guide for Writing a Specification for SterilizablePeel Pouches2.2 EN/ISO Standards:4EN 868/1 Annex C Gurley, Schopper, Dye PenetrationISO 5636/5ISO 116071 Annex C2.3 Military Specification:5Mil Spe

28、c 36954C Bacterial Filtration Efficiency2.4 TAPPI Standards:6TAPPI T 404 Tensile Breaking Strength and Elongation ofPaper and PaperboardTAPPI T 437 Dirt in Paper and Paperboard3Withdrawn.4Available from International Organization for Standardization (ISO), 1 rue deVaremb, Case postale 56, CH-1211, G

29、eneva 20, Switzerland, http:/www.iso.ch.5Available from Standardization Documents Order Desk, Bldg. 4 Section 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, htt

30、p:/www.tappi.org.F2097072TAPPI 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)3. Terminology3.1 Definitions of Term

31、s 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 ability of the package to protect the product.

32、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 printing requirements, nthe printed ink propertiesneeded to ensure physical and chemical resistance to

33、degrada-tion.3.1.5 processing requirements, nthe material characteris-tics needed to ensure the consistent and reliable production ofthe package.3.1.6 safety requirements, nsafeguard product againstcontamination and deleterious health effects.3.1.7 visibility and appearance requirements, nthe de-sir

34、ed package aesthetics needed to permit or inhibit viewing ofthe product or to enhance product presentation.3.2 For other terms used in this guide, see TerminologyF 1327.4. Significance and Use4.1 This design and evaluation guide describes seven cat-egories for evaluating flexible medical packages an

35、d packagingmaterials. These include safety, barrier properties, durability,package and seal integrity, visibility and appearance, process-ing, and printing ink properties.4.2 The intent of this design and evaluation guide is toevaluate all seven categories and select those that are appli-cable. Once

36、 the product 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 a

37、nd monitoring package compliance.4.3 Product characterization shall include mass or weight,geometry (length and width, height, and shape) and productcomposition.4.4 All seven categories must be considered for applicabil-ity.4.5 The Summary of Test Methods for Medical PackagingDesign and Evaluation (

38、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 used toevaluate flexible medical packaging. The test methods are usedin two phases.4.6.1.1 Package Design:

39、Characterization of the Materialsand Evaluation of the Resultant PackageThis is referred toas “R only that the L929 is an established cell line, well characterized andreadily available, that has demonstrated reproducibleresults in several laboratories.F2097075TABLE 1 ContinuedTest Test Method Descri

40、ption ApplicabilityToxicityUsageR25 %) between laboratories.It is a simplified version of Test Method F 151 providingabout the same level of accuracy. This method differsfrom Test Method F 151 in that it specifies certainconditions. Test Method F 1884, for example, specifies apre-heat condition of 9

41、0C for 20 min. Test Method F 151defines 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 immediatelyafter manufacturing to provide an indication of solventlevels

42、in the inner wraps of the roll of film.Retained solventsUsageRfurther steps would be needed to correlate these relativenumbers to end-use applications.F2097079TABLE 1 ContinuedTest Test Method Description ApplicabilityPuncture resistanceUsageR further steps would be needed tocorrelate these relative

43、 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 penetration resistance but does notaddress abrasion.Puncture resistanceUsageR or through the ASTM website(www.astm.org).F20970714