ASTM_F_2759_-_11.pdf

Designation:F275911Standard 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 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,mechanical,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 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 arebriefly 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 asstandard.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 applica-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 Relating to PlasticsD2765 Test Methods for Determination of Gel Content andSwell Ratio of Crosslinked Ethylene PlasticsD4020 Specification for Ultra-High-Molecular-Weight Poly-ethylene Molding and Extrusion MaterialsE647 Test Method for Measurement of Fatigue CrackGrowth RatesF619 Practice for Extraction 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 Methodsfor Materials and DevicesF749 Practice for Evaluating Material Extracts by Intracuta-neous 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 Medical DevicesF895 Test Method forAgar Diffusion Cell Culture Screeningfor CytotoxicityF981 Practice for Assessment of Compatibility of Biomate-rials for Surgical Implants with Respect to Effect ofMaterials on Muscle and BoneF1714 Guide for Gravimetric WearAssessment of ProstheticHip Designs in Simulator DevicesF1715 Guide for Wear Assessment of Prosthetic Knee De-signs in Simulator Devices(Withdrawn 2006)31This 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 April 15,2011.Published May 2011.Originallyapproved in 2009.Last previous edition approved in 2009 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.3The last approved version of this historical standard is referenced onwww.astm.org.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 F2003 Practice for Accelerated Aging of Ultra-High Mo-lecular Weight Polyethylene after Gamma Irradiation inAirF2025 Practice for Gravimetric Measurement of PolymericComponents for Wear AssessmentF2102 Guide for Evaluating the Extent of Oxidation inPolyethylene Fabricated Forms Intended for SurgicalImplantsF2183 Test Method for Small Punch Testing of Ultra-HighMolecular Weight Polyethylene Used in Surgical ImplantsF2214 Test Method forIn Situ Determination of NetworkParameters of Crosslinked Ultra High Molecular WeightPolyethylene(UHMWPE)F2381 Test Method for Evaluating Trans-Vinylene Yield inIrradiated Ultra-High Molecular Weight PolyethyleneFabricated Forms Intended for Surgical Implants by In-frared SpectroscopyF2423 Guide for Functional,Kinematic,and Wear Assess-ment of Total Disc ProsthesesF2625 Test Method for Measurement of Enthalpy of Fusion,Pe