ASTM F2097-2014 Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products《医疗产品初级软包装的设计和评估标准指南》.pdf

1、Designation: F2097 10F2097 14Standard 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 y

2、ear 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 evaluation of primary flexible packages for medical products.

3、 The packagematerials must be selected appropriately for manufacturing process, end use, and the product being packaged.1.2 This guide provides a compendium of test methods, practices, and procedures. Specific individual test methods must beselected based on the pertinent characteristics of the spec

4、ific product to be packaged and the purpose for testing, research anddevelopment, 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 themedical products manufacturer.1.4 This g

5、uide does not assess the product to be packaged or the sterilization method to be used.1.5 The units cited in the referenced standard should be used.2. Referenced Documents2.1 ASTM Standards:2D374 Test Methods for Thickness of Solid Electrical Insulation (Withdrawn 2013)3D589 Test Method for Opacity

6、 of Paper (15 Diffuse Illuminant A, 89 % Reflectance Backing and Paper Backing) (Withdrawn2010)3D638 Test Method for Tensile Properties of PlasticsD645/D645M Test Method for Thickness of Paper and Paperboard (Withdrawn 2010)3D726 Test Method for Resistance of Nonporous Paper to Passage of Air (Withd

7、rawn 2009)3D882 Test Method for Tensile Properties of Thin Plastic SheetingD1003 Test Method for Haze and Luminous Transmittance of Transparent PlasticsD1434 Test Method for Determining Gas Permeability Characteristics of Plastic Film and SheetingD1709 Test Methods for Impact Resistance of Plastic F

8、ilm by the Free-Falling Dart MethodD1777 Test Method for Thickness of Textile MaterialsD1894 Test Method for Static and Kinetic Coefficients of Friction of Plastic Film and SheetingD1922 Test Method for Propagation Tear Resistance of Plastic Film and Thin Sheeting by Pendulum MethodD1938 Test Method

9、 for Tear-Propagation Resistance (Trouser Tear) of Plastic Film and Thin Sheeting by a Single-Tear MethodD2019 Test Method for Dirt in Paper and Paperboard (Withdrawn 2010)3D2457 Test Method for Specular Gloss of Plastic Films and Solid PlasticsD3078 Test Method for Determination of Leaks in Flexibl

10、e Packaging by Bubble EmissionD3079 Test Method for Water Vapor Transmission of Flexible Heat-Sealed Packages for Dry ProductsD3335 Test Method for Low Concentrations of Lead, Cadmium, and Cobalt in Paint by Atomic Absorption SpectroscopyD3420 Test Method for Pendulum Impact Resistance of Plastic Fi

11、lmD3718 Test Method for Low Concentrations of Chromium in Paint by Atomic Absorption SpectroscopyD3776 Test Methods for Mass Per Unit Area (Weight) of Fabric1 This guide is under the jurisdiction of ASTM Committee F02 on Flexible Barrier Packaging and is the direct responsibility of Subcommittee F02

12、.50 on Package Designand Development.Current edition approved April 1, 2010April 1, 2014. Published May 2010May 2014. Originally approved in 2001. Last previous edition approved in 20082010 asF2097 08.F2097 10. DOI: 10.1520/F2097-10.10.1520/F2097-14.2 For referencedASTM standards, visit theASTM webs

13、ite, www.astm.org, or contactASTM Customer Service at serviceastm.org. For Annual Book of ASTM Standardsvolume information, refer to the standards Document Summary page on the ASTM website.3 The last approved version of this historical standard is referenced on www.astm.org.This document is not an A

14、STM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Becauseit may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In

15、all cases only the current versionof the standard as published by ASTM is to be considered the official document.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States1D3985 Test Method for Oxygen Gas Transmission Rate Through Plastic Film a

16、nd Sheeting Using a Coulometric SensorD4169 Practice for Performance Testing of Shipping Containers and SystemsD4279 Test Methods for Water Vapor Transmission of Shipping ContainersConstant and Cycle MethodsD4321 Test Method for Package Yield of Plastic FilmD4332 Practice for Conditioning Containers

17、, Packages, or Packaging Components for TestingD4754 Test Method for Two-Sided Liquid Extraction of Plastic Materials Using FDA Migration CellD5264 Practice for Abrasion Resistance of Printed Materials by the Sutherland Rub TesterD7386 Practice for Performance Testing of Packages for Single Parcel D

18、elivery SystemsE398 Test Method for Water Vapor Transmission Rate of Sheet Materials Using Dynamic Relative Humidity MeasurementF17 Terminology Relating to Flexible Barrier PackagingF88 Test Method for Seal Strength of Flexible Barrier MaterialsF99 Guide for Writing a Specification for Flexible Barr

19、ier Rollstock MaterialsF151 Test Method for Residual Solvents in Flexible Barrier Materials (Withdrawn 2004)3F372 Test Method for Water Vapor Transmission Rate of Flexible Barrier Materials Using an Infrared Detection Technique(Withdrawn 2009)3F392 Test Method for Flex Durability of Flexible Barrier

20、 MaterialsF748 Practice for Selecting Generic Biological Test Methods for Materials and DevicesF813 Practice for Direct Contact Cell Culture Evaluation of Materials for Medical DevicesF895 Test Method for Agar Diffusion Cell Culture Screening for CytotoxicityF904 Test Method for Comparison of Bond S

21、trength or Ply Adhesion of Similar Laminates Made from Flexible MaterialsF1140 Test Methods for Internal Pressurization Failure Resistance of Unrestrained PackagesF1249 Test Method for Water Vapor Transmission Rate Through Plastic Film and Sheeting Using a Modulated Infrared SensorF1306 Test Method

22、for Slow Rate Penetration Resistance of Flexible Barrier Films and LaminatesF1307 Test Method for Oxygen Transmission Rate Through Dry Packages Using a Coulometric SensorF1443 Practice for Using 0.008-in. (0.203-mm)Aperture Reflectometers asTest Instruments for MeasuringVisual Image Qualityof Busine

23、ss Copy ImagesF1608 Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method)F1884 Test Methods for Determining Residual Solvents in Packaging MaterialsF1886 Test Method for Determining Integrity of Seals for Medical Packaging by Visual InspectionF1921 Test Methods fo

24、r Hot Seal Strength (Hot Tack) of Thermoplastic Polymers and Blends Comprising the Sealing Surfacesof Flexible WebsF1927 Test Method for Determination of Oxygen Gas Transmission Rate, Permeability and Permeance at Controlled RelativeHumidity Through Barrier Materials Using a Coulometric DetectorF192

25、9 Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye PenetrationF1980 Guide for Accelerated Aging of Sterile Barrier Systems for Medical DevicesF2029 Practices for Making Heatseals for Determination of Heatsealability of Flexible Webs as Measured by Seal StrengthF2054 Test Metho

26、d for Burst Testing of Flexible Package Seals Using Internal Air Pressurization Within Restraining PlatesF2095 Test Methods for Pressure Decay Leak Test for Flexible Packages With and Without Restraining PlatesF2096 Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubbl

27、e Test)F2203 Test Method for Linear Measurement Using Precision Steel RuleF2217 Practice for Coating/Adhesive Weight DeterminationF2250 Practice for Evaluation of Chemical Resistance of Printed Inks and Coatings on Flexible Packaging MaterialsF2251 Test Method for Thickness Measurement of Flexible P

28、ackaging MaterialF2252 Practice for Evaluating Ink or Coating Adhesion to Flexible Packaging Materials Using TapeF2227 Test Method for Non-Destructive Detection of Leaks in Non-sealed and Empty Packaging Trays by CO2 Tracer GasMethodF2228 Test Method for Non-Destructive Detection of Leaks in Packagi

29、ng Which Incorporates Porous Barrier Material by CO2Tracer Gas MethodF2338 Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay MethodF2391 Test Method for Measuring Package and Seal Integrity Using Helium as the Tracer GasF2475 Guide for Biocompatibility Evaluation of Medic

30、al Device Packaging MaterialsF2476 Test Method for the Determination of Carbon Dioxide Gas Transmission Rate (CO2TR) Through Barrier Materials UsingAn Infrared DetectorF2559 Guide for Writing a Specification for Sterilizable Peel PouchesF2622 Test Method for Oxygen Gas Transmission Rate Through Plas

31、tic Film and Sheeting Using Various SensorsF2638 Test Method for Using Aerosol Filtration for Measuring the Performance of Porous Packaging Materials as a SurrogateMicrobial BarrierF2714 Test Method for Oxygen Headspace Analysis of Packages Using Fluorescent DecayF2097 142F2824 Test Method for Mecha

32、nical Seal Strength Testing for Round Cups and Bowl Containers with Flexible Peelable LidsF2825 Practice for Climatic Stressing of Packaging Systems for Single Parcel DeliveryF3004 Test Method for Evaluation of Seal Quality and Integrity Using Airborne UltrasoundF3039 Test Method for Detecting Leaks

33、 in Nonporous Packaging or Flexible Barrier Materials by Dye Penetration2.2 EN/ISO Standards:4EN 868/1 Annex C Gurley, Schopper, Dye PenetrationISO 2556 PlasticsDetermination of Gas Transmission Rate of Films and Thin Sheets Under Atmospheric PressureManometric MethodISO 56365 Paper and BoardDetermi

34、nation of Air Permeance (Medium Range)Part 5: Gurley MethodISO 10993 Biological Evaluation of Medical DevicesISO 116071 Packaging for Terminally Sterilized Medical Devices, Annex CISO 151051 PlasticsFilm and SheetingDetermination of Gas Transmission RatePart 1: Differential-Pressure MethodISO 151052

35、 PlasticsFilm and SheetingDetermination of Gas Transmission RatePart 2: Equal-Pressure Method2.3 Military Specification:5Mil Spec 36954C Bacterial Filtration Efficiency2.4 TAPPI Standards:6TAPPI T 404 Tensile Breaking Strength and Elongation of Paper and PaperboardTAPPI T 437 Dirt in Paper and Paper

36、boardTAPPI T 460 Air Resistance of Paper (Gurley Method)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 (High Pressure Gurley Method)TAPPI T 547 Air Permeance of Paper and Paperboard (Sheff

37、ield Method)2.5 ISTA Procedures:7ISTA 3A Packaged Products for Parcel Delivery System Shipments 70 kg (150 lb) or Less (standard, small, flat, or elongated)ISTA 3E Unitized Loads of Same ProductISTA 4AB Packaged-Products for Shipment in Known Distribution ChannelsISTA 6FEDEX-A FedEx Procedures for T

38、esting Packaged Products Weighing Up to 150 lbs3. Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 barrier requirements, nthe need to promote or inhibit moisture, gas, or light, or a combination thereof, while maintainingnecessary levels of sterility.3.1.2 durability requirements,

39、 nmaterial properties relevant to the ability of the package to protect the product.3.1.3 integrity and seal requirements, nthe ability of the package to prevent inadvertent escape of contents or entrance ofoutside substances while preserving intended opening for use features.3.1.4 package performan

40、ce, nthe ability of the packaging system, including the sterile barrier system and protectivepackaging, to withstand the hazards of handling, distribution, and storage.3.1.5 printing requirements, nthe printed ink properties needed to ensure physical and chemical resistance to degradation.3.1.6 proc

41、essing requirements, nthe material characteristics needed to ensure the consistent and reliable production of thepackage.3.1.7 safety requirements, nsafeguard product against contamination and deleterious health effects.3.1.8 visibility and appearance requirements, nthe desired package aesthetics ne

42、eded to permit or inhibit viewing of theproduct 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 multiple categories for evaluating flexible medical packages and packagingmaterials. Th

43、ese include safety, barrier properties, durability, package and seal integrity, visibility and appearance, processing,printing ink properties, and package performance.4 Available from International Organization for Standardization (ISO), 1 rue de Varemb, Case postale 56, CH-1211, Geneva 20, Switzerl

44、and, http:/www.iso.ch.5 Available from Standardization Documents Order Desk, Bldg. 4 Section D, 700 Robbins Ave., Philadelphia, PA 19111-5094, Attn: NPOPS.6 Available from Technical Association of the Pulp and Paper Industry (TAPPI), 15 Technology Parkway South, Norcross, GA 30092, http:/www.tappi.o

45、rg.7 Available from International Safe Transit Association (ISTA), 1400 Abbot Rd., Suite 160, East Lansing, MI 48823-1900, http:/www.ista.org.F2097 1434.2 The intent of this design and evaluation guide is to evaluate all cited categories and select those that are applicable. Oncethe product has been

46、 characterized and the sterilization methodology has been defined, there are numerous sets of requirementsfor any specific package. This design and evaluation guide provides an avenue for assessing these requirements and choosing testmethods for both evaluating the package design and monitoring pack

47、age compliance.NOTE 1Many of the standards included in this guide are consensus standards that are recognized by the United States Food and DrugAdministration(FDA). Selection and use of a U.S. FDArecognized consensus standard is voluntary and the sole responsibility of the user in determining its ap

48、plicability.For further information, consult the U.S. FDAMedical 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 productcomposi

49、tion.FIG. 1 Summary of Test Methods for Medical Packaging Design and EvaluationF2097 1444.4 All categories must be considered for applicability.4.5 The Summary of Test Methods for Medical Packaging Design 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 used to evaluate flexible medical packaging. The test methods are used in twophases.4.6.1.1 Package Design: Characterization of the Mate