1、Designation: F 2759 09Standard Guide forAssessment of the Ultra High Molecular WeightPolyethylene (UHMWPE) Used in Orthopedic and SpinalDevices1This standard is issued under the fixed designation F 2759; the number immediately following the designation indicates the year oforiginal adoption or, in t
2、he 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 covers general guidelines for the physical,chemical, biocompatibility, mec
3、hanical, and preclinical assess-ments of ultra-high molecular weight polyethylene (UHM-WPE) in implantable orthopedic and spinal devices intended toreplace a musculoskeletal joint. The UHMWPE componentsmay include knee, hip, shoulder, elbow, ankle, total discreplacement, toe, finger, and wrist joint
4、 implant devices. Thisguide does not cover UHMWPE in fiber or tape forms.1.2 This guide includes a description and rationale ofassessments for the various UHMWPE types and processingconditions. Assessment testing based on physical, chemical,biocompatibility, mechanical, and preclinical analyses areb
5、riefly described and referenced. The user should refer tospecific test methods for additional details.1.3 This guide does not attempt to define all of the assess-ment methods associated with UHMWPE components inorthopedic and spinal devices.1.4 UnitsThe values given in SI units are to be regardedas
6、the standard. No other units of measurement are included inthis standard.1.5 This standard does not purport to address all of thesafety concerns, if any, associated with its use. It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine
7、the applica-bility of regulatory limitations prior to use.2. Referenced Documents2.1 ASTM Standards:2D 256 Test Methods for Determining the Izod PendulumImpact Resistance of PlasticsD 638 Test Method for Tensile Properties of PlasticsD 883 Terminology Relating to PlasticsD 1621 Test Method for Compr
8、essive Properties Of RigidCellular PlasticsD 2765 Test Methods for Determination of Gel Content andSwell Ratio of Crosslinked Ethylene PlasticsD 4020 Specification for Ultra-High-Molecular-WeightPolyethylene Molding and Extrusion MaterialsE 132 Test Method for Poissons Ratio at Room Tempera-tureE 64
9、7 Test Method for Measurement of Fatigue CrackGrowth RatesF 619 Practice for Extraction of Medical PlasticsF 648 Specification for Ultra-High-Molecular-Weight Poly-ethylene Powder and Fabricated Form for Surgical Im-plantsF 732 Test Method for Wear Testing of Polymeric MaterialsUsed in Total Joint P
10、rosthesesF 748 Practice for Selecting Generic Biological Test Meth-ods for Materials and DevicesF 749 Practice for Evaluating Material Extracts by Intracu-taneous Injection in the RabbitF 756 Practice for Assessment of Hemolytic Properties ofMaterialsF 763 Practice for Short-Term Screening of Implan
11、t Mate-rialsF 813 Practice for Direct Contact Cell Culture Evaluation ofMaterials for Medical DevicesF 895 Test Method for Agar Diffusion Cell Culture Screen-ing for CytotoxicityF 981 Practice for Assessment of Compatibility of Bioma-terials for Surgical Implants with Respect to Effect ofMaterials o
12、n Muscle and BoneF 1714 Guide for Gravimetric Wear Assessment of Pros-thetic Hip Designs in Simulator DevicesF 1715 Guide for Wear Assessment of Prosthetic KneeDesigns in Simulator Devices3F 2003 Practice for Accelerated Aging of Ultra-High Mo-lecular Weight Polyethylene after Gamma Irradiation inAi
13、rF 2025 Practice for Gravimetric Measurement of Polymeric1This guide is under the jurisdiction of ASTM Committee F04 on Medical andSurgical Materials and Devices and is the direct responsibility of SubcommitteeF04.11 on Polymeric Materials.Current edition approved Feb. 1, 2009. Published February 20
14、09.2For 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.3Withdrawn. The last approved version of this historical s
15、tandard is referencedon www.astm.org.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.Components for Wear AssessmentF 2102 Guide for Evaluating the Extent of Oxidation inUltra-High-Molecular-Weight Polyethylene FabricatedForms Intende
16、d for Surgical ImplantsF 2183 Test Method for Small Punch Testing of Ultra-HighMolecular Weight Polyethylene Used in Surgical ImplantsF 2214 Test Method for In Situ Determination of NetworkParameters of Crosslinked Ultra High Molecular WeightPolyethylene (UHMWPE)F 2381 Test Method for Evaluating Tra
17、ns-Vinylene Yield inIrradiated Ultra-High-Molecular-Weight Polyethylene Fab-ricated Forms Intended for Surgical Implants by InfraredSpectroscopyF 2423 Guide for Functional, Kinematic, and Wear Assess-ment of Total Disc ProsthesesF 2625 Test Method for Measurement of Enthalpy of Fu-sion, Percent Crys
18、tallinity, and Melting Point of Ultra-High-Molecular Weight Polyethylene by Means of Differ-ential Scanning CalorimetryF 2695 Specification for Ultra-High Molecular WeightPolyethylene Powder Blended WithAlpha-Tocopherol (Vi-tamin E) and Fabricated Forms for Surgical ImplantApplications2.2 ISO Standa
19、rds:4ISO 527 Plastics: Determination of Tensile PropertiesISO 34511 Plastics: Determination of Ash Part 1: GeneralMethodsISO 58341 Implants for SurgeryUltra High MolecularWeight Polyethylene. Part 1: Powder FormISO 58342 Implants for SurgeryUltra High MolecularWeight Polyethylene. Part 2: Molded For
20、msISO 115422 PlasticsUltra-High-Molecular-Weight-Polyethylene (PE-UHMWPE) Molding and ExtrusionMaterials. Part 2: Preparation of Test Specimens andDetermination of PropertiesISO 10993 Biological Evaluation of Medical DevicesISO 142421 Implants for SurgeryWear of Total Hip-Joint Prostheses. Part 1: L
21、oading and Displacement Pa-rameters for Wear-Testing Machines and CorrespondingEnvironmental Conditions for TestISO 142422 Implants for SurgeryWear of Total Hip-Joint Prostheses. Part 2: Methods of MeasurementISO 142431 Implants for SurgeryWear of Total Knee-Joint Prostheses. Part 1: Load and Displa
22、cement Param-eters for Wear-Testing Machines with Load Control andCorresponding Environmental Conditions for TestISO 142432 Implants for SurgeryWear of Total Knee-Joint Prostheses. Part 2: Methods of MeasurementISO 142433 Implants for SurgeryWear of Total Knee-Joint Prostheses. Part 3: Loading and D
23、isplacement Pa-rameters for Wear-Testing Machines with DisplacementControl and Corresponding Environmental Conditions forTestISO 181921 Implants for SurgeryWear of Total Interver-tebral Disc Prostheses. Part 1: Loading and DisplacementParameters for Wear Testing and Corresponding Environ-mental Cond
24、itions for Test2.3 Federal Standard:21 CFR 58 Good Laboratory Practices Regulations53. Terminology3.1 DefinitionsAdditional terminology related to ultrahigh molecular weight polyethylene (UHMWPE) and plasticscan be found in Terminology D 883 and Specifications D 4020and F 648 and referenced publicat
25、ions (1-7).63.2 Definition of Term Specific to This Standard:3.2.1 fabricated form, nany bulk shape of UHMWPEfabricated from the virgin polymer powder with or withoutadditives or prior irradiation and used during the process offabricating surgical implants before packaging and steriliza-tion.3.2.1.1
26、 DiscussionThis form results from the applicationof heat and pressure to the virgin polymer powder, and thematerial characteristics of this form are subject to the appli-cable requirements of this guide. In present practice, thisincludes ram-extruded bars, compression-molded sheets, anddirect-molded
27、 shapes that are subsequently trimmed.4. Significance and Use4.1 This guide aims to provide guidance for a range ofvarious assessments and evaluations to aid in preclinicalresearch and device development of various UHMWPE com-ponents in orthopedic and spinal devices used for the repair ofmusculoskel
28、etal disorders.4.2 This guide includes brief descriptions of various assess-ments, representative data, processing conditions, and intendeduse or uses, as well as the qualitative and quantitative analysesof the UHMWPE powder to a finished product component.4.3 The user is encouraged to use appropria
29、te ASTMInternational and other standards to conduct the physical,chemical, mechanical, biocompatibility, and preclinical testson UHMWPE materials, device components, or devices beforeassessment of an in vivo model.4.4 Assessments of UHMWPE should be performed inaccordance with the provisions of 21 C
30、FR 58 where feasible.4.5 Studies to support investigational device exemption(IDE), premarket approval (PMA), or 510K submissionsshould conform to appropriate Food and Drug Administration(FDA) guidelines for the development of medical devices.4.6 Assessments with physical, chemical, mechanical, bio-c
31、ompatibility, and preclinical tests on UHMWPE componentsare not necessarily predictive of human results and should be,therefore, interpreted cautiously with respect to potential ap-plicability to human conditions. Referenced UHMWPE publi-cations can be found in the References section at the end of t
32、hisguide for further review.4Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036, http:/www.ansi.org.5Available from U.S. Government Printing Office Superintendent of Documents,732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401, http:/w
33、ww.access.gpo.gov.6The boldface numbers in parentheses refer to the list of references at the end ofthis standard.F27590925. UHMWPE Fabricated Forms and Conditions5.1 Conventional UHMWPE is manufactured by compres-sion molding or ram extrusion and has not been intentionallycross-linked before termin
34、al sterilization.5.2 Extensively radiation-cross-linked UHMWPE is manu-factured by compression molding or extrusion and irradiatedwith a dosage higher than 40 kGy of gamma or e-beamradiation for improved wear resistance.5.3 Antioxidant (Alpha-Tocopherol)Two stabilizing meth-ods for the antioxidant U
35、HMWPE form (Vitamin E-stabilizedor alpha-tocopherol) are blending or diffusing. The blendingmethod has the Vitamin E mixed (blended) into the UHMWPEpowder before consolidation and radiation cross-linking. Thediffusing method has the Vitamin E diffusing into a consoli-dated UHMWPE form before or afte
36、r radiation cross-linking.Also, antioxidant UHMWPE could potentially be used withoutany radiation cross-linking.5.4 Thermal ProcessingUHMWPE-fabricated forms un-dergo at least one or more thermal treatments during theconsolidation processes of extrusion or molding, annealing,cross-linking or after c
37、ross-linking. The thermal history shouldbe documented and its effects assessed with mechanical,physical, chemical, and preclinical testing.5.5 UMHWPE powder is classified as Types 1, 2, or 3.These types have different molecular weights and materialproperties as defined in Specification F 648.6. UHMW
38、PE Decision Chart (Table 1)6.1 The assessment chart shown in Table 1 should beperformed as indicated on the listed UHMWPE types.6.2 UMHWPE fabricated form testing should be pursuedwith samples that are in the final conditions with respect toannealing, sterilization, aging, and packaging. Assessmentp
39、arameters should include and be compared to clinicallysuccessful UHMWPE materials.7. Test Methods7.1 Virgin UHMWPE PowderThe tests shown in Table 2should be conducted on the UHMWPE types designated inTable 1. Alternative tests, such as ones found in ISO 58341and ISO 58342), may be considered with do
40、cumented analy-sis and rationale.7.2 UHMWPE Mechanical and Physical AssessmentsPart1The tests shown in Table 3 should be conducted on theUHMWPE types designated in Table 1. Alternative tests maybe considered with documented analysis and rationale.7.3 Mechanical and Physical AssessmentPart 2Thetests
41、shown in Table 4 should be conducted on the UHMWPEtypes designated in Table 1. Alternative tests may be consid-ered with documented analysis and rationale.7.4 Preclinical SimulationFunctional testing on the fin-ished UHMWPE component that simulates clinical functionsand known failure modes should be
42、 considered. Testing thatshould be considered include creep, accelerated aging, and/orshelf- life testing, and functional fatigue loading. PracticeF 2003 should be considered for determining relative oxidativestability.TABLE 1 UHMWPE Fabricated Forms and ConditionsTest Method Group ConventionalExten
43、sivelyCross-Linked(Irradiation)AntioxidantVirgin powder (7.1)XXXMechanical and physicalPart 1 (7.2)XMechanical and physicalPart 2 (7.3AXXPreclinical wear simulation (7.4AAntioxidant assessment (7.5) XPackaging and sterilization rationale (Section 8)X XBiocompatibility (Section 9AFor materials termin
44、ally sterilized by gamma or e-beam irradiation.TABLE 2 Requirements for UHMWPE PowdersProperty Test Method RequirementsResin Type Type 1 Type 2 Type 3Viscosity number, mL/g D 4020 (0.02%) 2000-3200 3200 3200Elongation stress (minimum) D 4020 0.20 0.42 0.42Ash, mg/kg (maximum) ISO 34511 125 125 300Ex
45、traneous matter, number ofparticles (maximum)F 648 3325Titanium, mg/kg (maximum) F 648 40 40 150Aluminum, mg/kg (maximum) F 648 20 20 100Calcium, mg/kg (maximum) F 648 5550Chlorine, mg/kg (maximum) F 648 30 30 90TABLE 3 UHMWPE Mechanical and Physical Assessments,Part 1Test Description MethodTensile
46、strength D 638 or ISO 527UltimateYieldElongation, % D 638Izod impact strength, kJ/m2F 648, Annex A1Charpy impact strength, kJ/m2ISO 115422 Annex B/D 256Elastic modulus D 638Poissons ratio E 132Compression modulus, MPa D 1621Thermal properties F 2625Percent crystallinityMelting temperatureTABLE 4 Mec
47、hanical and Physical Assessment, Part 2Test Description MethodSmall punch ultimate load, N F 2183Fatigue crack propagation E 647Residual free radicals, spins/g Ref 7Swell ratio D 2765 or F 2214Oxidation index (OI), surface oxidation index (SOI),and OI maximumF 2102t-Vinylene content, trans-vinylene
48、index (TVI) F 2381F27590937.4.1 WearSee Table 5.7.4.2 Functional Device or Material TestingUHMWPEimplant components have experienced known device failuremodes. Examination of known clinical failure modes throughfunctional device or material testing, such as fatigue testing ofthe post in a posterior-
49、stabilized tibial insert or fatigue-impingement testing of the stem neck and polyethylene liner ina hip implant, should be considered with new UHMWPEprocesses, material additives, or implant designs.7.5 UHMWPE with Antioxidant (Alpha-Tocopherol)Commercially available UHMWPEs for implants containingantioxidants are blended or doped with alpha-tocopherol.Implants materials produced by blending alpha-tocopherolwith polyethylene before consolidation are specified in TestMethod F 2695. Standardized methods for evaluating thecontent of alpha-tocop
