1、Designation: F2759 11Standard Guide forAssessment of the Ultra High Molecular WeightPolyethylene (UHMWPE) Used in Orthopedic and SpinalDevices1This standard is issued under the fixed designation F2759; the number immediately following the designation indicates the year oforiginal adoption or, in the
2、 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, mecha
3、nical, 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 i
4、mplant 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 arebri
5、efly 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 The values stated in SI units are to be regarded asstanda
6、rd. No other units of measurement are included in thisstandard.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 the applic
7、a-bility of regulatory limitations prior to use.2. Referenced Documents2.1 ASTM Standards:2D256 Test Methods for Determining the Izod PendulumImpact Resistance of PlasticsD638 Test Method for Tensile Properties of PlasticsD695 Test Method for Compressive Properties of RigidPlasticsD883 Terminology R
8、elating to PlasticsD2765 Test Methods for Determination of Gel Content andSwell Ratio of Crosslinked Ethylene PlasticsD4020 Specification for Ultra-High-Molecular-WeightPolyethylene Molding and Extrusion MaterialsE647 Test Method for Measurement of Fatigue CrackGrowth RatesF619 Practice for Extracti
9、on of Medical PlasticsF648 Specification for Ultra-High-Molecular-Weight Poly-ethylene Powder and Fabricated Form for Surgical Im-plantsF732 Test Method for Wear Testing of Polymeric MaterialsUsed in Total Joint ProsthesesF748 Practice for Selecting Generic Biological Test Meth-ods for Materials and
10、 DevicesF749 Practice for Evaluating Material Extracts by Intracu-taneous Injection in the RabbitF756 Practice for Assessment of Hemolytic Properties ofMaterialsF763 Practice for Short-Term Screening of Implant Materi-alsF813 Practice for Direct Contact Cell Culture Evaluation ofMaterials for Medica
11、l DevicesF895 Test Method for Agar Diffusion Cell Culture Screen-ing for CytotoxicityF981 Practice for Assessment of Compatibility of Biomate-rials for Surgical Implants with Respect to Effect ofMaterials on Muscle and BoneF1714 Guide for Gravimetric Wear Assessment of Pros-thetic Hip Designs in Sim
12、ulator DevicesF1715 Guide for Wear Assessment of Prosthetic KneeDesigns in Simulator Devices3F2003 Practice for Accelerated Aging of Ultra-High Mo-lecular Weight Polyethylene after Gamma Irradiation inAirF2025 Practice for Gravimetric Measurement of PolymericComponents for Wear Assessment1This guide
13、 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 April 15, 2011. Published May 2011. Originallyapproved in 2009. Last previous edition approved in 2009
14、as F2759 09. DOI:10.1520/F2759-11.2For 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 approv
15、ed 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.F2102 Guide for Evaluating the Extent of Oxidation inUltra-High-Molecular-Weight Polyethylene FabricatedForms Intende
16、d for Surgical ImplantsF2183 Test Method for Small Punch Testing of Ultra-HighMolecular Weight Polyethylene Used in Surgical ImplantsF2214 Test Method for In Situ Determination of NetworkParameters of Crosslinked Ultra High Molecular WeightPolyethylene (UHMWPE)F2381 Test Method for Evaluating Trans-
17、Vinylene Yield inIrradiated Ultra-High Molecular Weight Polyethylene Fab-ricated Forms Intended for Surgical Implants by InfraredSpectroscopyF2423 Guide for Functional, Kinematic, and Wear Assess-ment of Total Disc ProsthesesF2625 Test Method for Measurement of Enthalpy of Fu-sion, Percent Crystalli
18、nity, and Melting Point of Ultra-High-Molecular Weight Polyethylene by Means of Differ-ential Scanning CalorimetryF2695 Specification for Ultra-High Molecular Weight Poly-ethylene Powder Blended WithAlpha-Tocopherol (VitaminE) and Fabricated Forms for Surgical Implant Applications2.2 ISO Standards:4
19、ISO 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 FormsISO
20、 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: Loadin
21、g 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 142423 Implants for SurgeryWear of Total Hip-Joint Prostheses. Part 3: Loading and Displacem
22、ent Pa-rameters for Orbital Bearing Type Wear Testing Machinesand Corresponding Environmental Conditions for TestISO 142431 Implants for SurgeryWear of Total Knee-Joint Prostheses. Part 1: Load and Displacement Param-eters for Wear-Testing Machines with Load Control andCorresponding Environmental Co
23、nditions 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 Displacement Pa-rameters for Wear-Testing Machines with DisplacementControl and Corresponding Env
24、ironmental Conditions forTestISO 181921 Implants for SurgeryWear of Total Interver-tebral Disc Prostheses. Part 1: Loading and DisplacementParameters for Wear Testing and Corresponding Environ-mental Conditions for Test2.3 Federal Standard:21 CFR 58 Good Laboratory Practices Regulations53. Terminolo
25、gy3.1 DefinitionsAdditional terminology related to ultrahigh molecular weight polyethylene (UHMWPE) and plasticscan be found in Terminology D883 and Specifications D4020and F648 and referenced publications (1-8).63.2 Definition of Term Specific to This Standard:3.2.1 fabricated form, nany bulk shape
26、 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 DiscussionThis form results from the applicationof heat and pressure to the virgin polymer powder,
27、 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 shapes that are subsequently trimmed.4. Significance and Use4.1 This guide aims to provide guidanc
28、e 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 ofmusculoskeletal disorders.4.2 This guide includes brief descriptions of various assess-ments, representative d
29、ata, 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 appropriate ASTMInternational and other standards to conduct the physical,chemical, mechanical, biocompatibi
30、lity, 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 CFR 58 where feasible.4.5 Studies to support investigational device exemption(IDE), premarket approv
31、al (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-compatibility, and preclinical tests on UHMWPE componentsare not necessarily predictive of human res
32、ults 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 thisguide for further review.4Available from American National Standards Institute (ANSI), 25 W. 43r
33、d 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:/www.access.gpo.gov.6The boldface numbers in parentheses refer to the list of references at the end o
34、fthis standard.F2759 1125. UHMWPE Fabricated Forms and Conditions5.1 Conventional UHMWPE is manufactured by compres-sion molding or ram extrusion and has not been intentionallycross-linked before terminal sterilization.5.2 Extensively radiation-cross-linked UHMWPE is manu-factured by compression mol
35、ding 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 UHMWPE form (Vitamin E-stabilizedor alpha-tocopherol) are blending or diffusing. The blendingmethod
36、 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 after radiation cross-linking.Also, antioxidant UHMWPE could potentially be used withoutany radiation
37、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 cross-linking. The thermal history shouldbe documented and its effects assessed with mechanical,phy
38、sical, 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 F648.6. UHMWPE Decision Chart (Table 1)6.1 The assessment chart shown in Table 1 should beperformed as indicate
39、d 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. Assessmentparameters should include and be compared to clinicallysuccessful UHMWPE materials.7. Test Methods7.
40、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 documented analy-sis and rationale.7.2 UHMWPE Mechanical and Physical AssessmentsPart1The tests shown
41、 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 shown in Table 4 should be conducted on the UHMWPEtypes designated in Table 1. Alternative tests ma
42、y be consid-ered, such as electron spin resonance (see X1.1), with docu-mented analysis and rationale.7.4 Preclinical SimulationFunctional testing on the fin-ished UHMWPE component that simulates clinical functionsand known failure modes should be considered. Testing thatshould be considered include
43、 creep, accelerated aging, and/orshelf- life testing, and functional fatigue loading. PracticeF2003 should be considered for determining relative oxidativestability.7.4.1 WearSee Table 5.TABLE 1 UHMWPE Fabricated Forms and ConditionsTest Method Group ConventionalExtensivelyCross-Linked(Irradiation)A
44、ntioxidantVirgin 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 terminally sterilized by gamma or e-be
45、am irradiation.TABLE 2 Requirements for UHMWPE PowdersProperty Test Method RequirementsResin Type Type 1 Type 2 Type 3Viscosity number, mL/g D4020 (0.02%) 2000-3200 3200 3200Elongation stress (minimum) D4020 0.20 0.42 0.42Ash, mg/kg (maximum) ISO 34511 125 125 300Extraneous matter, number ofparticle
46、s (maximum)F648 3325Titanium, mg/kg (maximum) F648 40 40 150Aluminum, mg/kg (maximum) F648 20 20 100Calcium, mg/kg (maximum) F648 5550Chlorine, mg/kg (maximum) F648 30 30 90TABLE 3 UHMWPE Mechanical and Physical Assessments,Part 1Test Description MethodTensile strength D638 or ISO 527UltimateYieldEl
47、ongation, % D638Izod or Charpy impact strength,kJ/m2F648, Annex A1 orISO 115422 Annex B/D256Elastic modulus D638Compression modulus, MPa D695Thermal properties F2625Percent crystallinityMelting temperatureTABLE 4 Mechanical and Physical Assessment, Part 2Test Description MethodSmall punch ultimate l
48、oad, N F2183Fatigue crack propagation E647Swell ratio D2765 or F2214Oxidation index (OI), surface oxidation index (SOI),and OI maximumF2102t-Vinylene content, trans-vinylene index (TVI) F2381F2759 1137.4.2 Functional Device or Material TestingUHMWPEimplant components have experienced known device fa
49、iluremodes. Examination of known clinical failure modes throughfunctional device or material testing, such as fatigue testing ofthe post in a posterior-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.Implant materials produced by blendin
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