ASTM_F_2695_-_12.pdf

Designation:F269512Standard Specification forUltra-High Molecular Weight Polyethylene Powder BlendedWith Alpha-Tocopherol(Vitamin E)and Fabricated Forms forSurgical Implant Applications1This standard is issued under the fixed designation F2695;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 specification covers ultra-high molecular weightpolyethylene(UHMWPE)powder blended with alpha-tocopherol(vitamin E)intended for use in surgical implants.1.2 The requirements of this specification apply to alpha-tocopherol-containing UHMWPE in two forms.One is virginpolymer powder blended with alpha-tocopherol prior to con-solidation(Section 4).The second is any form fabricated fromthis blended,alpha-tocopherol-containing powder from whicha finished product is subsequently produced(Section 5).Thisspecification does not apply to finished or semi-finishedproducts that are doped with vitamin E after consolidation.1.3 Aside from blending with alpha-tocopherol,the provi-sions of Specifications F648 and D4020 apply.Special require-ments detailed in this specification are added to describepowders containing alpha-tocopherol that will be used insurgical implants.This specification addresses material char-acteristics and does not apply to the packaged and sterilizedfinished implant.This specification also does not apply toUHMWPE materials extensively crosslinked by gamma andelectron beam sources of ionizing radiation.1.4 The following precautionary caveat pertains only to thefabricated forms portion,Section 5,of this specification.Thisstandard does not purport to address all of the safety concerns,if any,associated with its use.It is the responsibility of the userof this standard to establish appropriate safety and healthpractices and determine the applicability of regulatory limita-tions prior to use.2.Referenced Documents2.1 ASTM Standards:2D648 Test Method for Deflection Temperature of PlasticsUnder Flexural Load in the Edgewise PositionD790 Test Methods for Flexural Properties of Unreinforcedand Reinforced Plastics and Electrical Insulating Materi-alsD1898 Practice for Sampling of Plastics(Withdrawn 1998)3D4020 Specification for Ultra-High-Molecular-Weight Poly-ethylene Molding and Extrusion MaterialsF619 Practice for Extraction of Medical PlasticsF648 Specification for Ultra-High-Molecular-Weight Poly-ethylene Powder and Fabricated Form for Surgical Im-plantsF748 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 Bone2.2 ISO Standards:ISO 34511 PlasticsDetermination ofAsh,Part 1:GeneralMethods41This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibility ofSubcommittee F04.11 on Polymeric Materials.Current edition approved May 15,2012.Published June 2012.Originallyapproved in 2007.Last previous edition approved in 2007 as F2695 07.DOI:10.1520/F2695-12.2For 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.4Available from American National Standards Institute(ANSI),25 W.43rd St.,4th Floor,New York,NY 10036,http:/www.ansi.org.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 ISO 10993 Biological Evaluation of Medical Devices,Parts11243.Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 crosslinkingthe process by which ionizing irradia-tion produces chemical bonds between two UHMWPE mol-ecules.3.1.2 extensively crosslinked UHMWPEUHMWPE mate-rial that has been subjected to total doses of gamma and/orelectron beam ionizing irradiation greater than 40 kGy.3.1.3 fabricated formany bulk shape of UHMWPE,fab-ricated from the virgin polymer powder,used during theprocess of fabricating surgical implants prior to crosslinking,packaging,and sterilization.A fabricated form includes asemi-finished rod or sheet as well as a direct compressionmolded component.3.1.4 generic propertythat property which is determinedsolely by the chemical compositio