ASTM_F_2027_-_08.pdf

Designation:F202708Standard Guide forCharacterization and Testing of Raw or StartingBiomaterials for Tissue-Engineered Medical Products1This standard is issued under the fixed designation F2027;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 document provides guidance on writing a materialsspecification for raw or starting biomaterials intended for use intissue engineering scaffolds for growth,support,or delivery ofcells and/or biomolecules.This guide does not apply tobiomaterials that are already in a scaffold form or are finishedtissue-engineered medical products.1.2 The purpose of this guide is to provide a compendium ofrelevant existing standards and test methods for biomaterialsalready commonly used within medical products and to pro-vide characterization guidance for interim use of raw bioma-terials for which a standard does not exist.1.3 This guide covers specifications and characterizations ofall the major classes of materials including polymers,ceramics,metals,composites,and natural tissues of human,animal,orplant origin.This guide does not apply to pharmaceuticals.1.4 This guide is focused on specification of chemical,physical,and mechanical properties of the raw or startingmaterial.It does not include safety and biocompatibilityrequirements since safety and biocompatibility testing is typi-cally done on materials fabricated into a final form to includeall possible effects of fabrication and sterilization techniques.1.5 Compliance with materials specifications developed inaccordance with this standard may not necessarily result in amaterial suitable for its intended purpose.Additional testingspecific to the intend use may be required.2.Referenced Documents2.1 ASTM Standards:2D1763 Specification for Epoxy ResinsD1898 Practice for Sampling of Plastics(Withdrawn 1998)3E1298 Guide for Determination of Purity,Impurities,andContaminants in Biological Drug Products(Withdrawn2014)3F67 Specification for Unalloyed Titanium,for Surgical Im-plant Applications(UNS R50250,UNS R50400,UNSR50550,UNS R50700)F75 Specification for Cobalt-28 Chromium-6 MolybdenumAlloy Castings and Casting Alloy for Surgical Implants(UNS R30075)F90 SpecificationforWroughtCobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applica-tions(UNS R30605)F136 Specification for Wrought Titanium-6Aluminum-4Vanadium ELI(Extra Low Interstitial)Alloy for SurgicalImplant Applications(UNS R56401)F138 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for SurgicalImplants(UNS S31673)F139 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Sheet and Strip for Sur-gical Implants(UNS S31673)F451 Specification for Acrylic Bone CementF560 Specification for Unalloyed Tantalum for SurgicalImplant Applications(UNS R05200,UNS R05400)F562 SpecificationforWrought35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical ImplantApplications(UNS R30035)F563 SpecificationforWroughtCobalt-20Nickel-20Chromium-3.5Molybdenum-3.5Tungsten-5Iron Alloyfor Surgical Implant Applications(UNS R30563)(With-drawn 2005)3F602 Criteria for Implantable Thermoset Epoxy PlasticsF603 Specification for High-Purity Dense Aluminum Oxidefor Medical ApplicationF604 Specification for Silicone Elastomers Used in MedicalApplications(Withdrawn 2001)3F619 Practice for Extraction of Medical PlasticsF624 Guide for Evaluation of Thermoplastic Polyurethane1This guide is under the jurisdiction of ASTM Committee F04 on Medical andSurgical Materials and Devices and is the direct responsibility of SubcommitteeF04.42 on Biomaterials and Biomolecules for TEMPs.Current edition approved May 1,2008.Published June 2008.Originallyapproved in 2000.Last previous edition approved in 2000 as F2027 001.DOI:10.1520/F2027-08.2For 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 Solids and Solutions for Biomedical ApplicationsF639 Specification for Polyethylene Plastics for MedicalApplicationsF641 Specification for Implantable Epoxy Electronic Encap-sulantsF648 Specification for Ultra-High-Molecular-Weight Poly-ethylene Powder and Fabricated Form for Surgical Im-plantsF665 Classification for Vinyl Chloride Plastics Used inBiomedical ApplicationF702 Specification for Polysulfone Resin for MedicalAppli-cationsF755 Specification for Selection of Porous Polyethylene forUse in Surgical ImplantsF755 Specification for Selectio