ASTM_F_981_-_04_2010.pdf

Designation:F98104(Reapproved 2010)Standard Practice forAssessment of Compatibility of Biomaterials for SurgicalImplants with Respect to Effect of Materials on Muscle andBone1This standard is issued under the fixed designation F981;the number immediately following the designation indicates the year of originaladoption or,in the case of revision,the year of last revision.Anumber in parentheses indicates the year of last reapproval.Asuperscriptepsilon()indicates an editorial change since the last revision or reapproval.1.Scope1.1 This practice provides a series of experimental protocolsfor biological assays of tissue reaction to nonabsorbablebiomaterials for surgical implants.It assesses the effects of thematerial on animal tissue in which it is implanted.Theexperimental protocol is not designed to provide a comprehen-sive assessment of the systemic toxicity,immune response,carcinogenicity,teratogenicity,or mutagenicity of the materialsince other standards deal with these issues.It applies only tomaterials with projected applications in humans where thematerials will reside in bone or soft tissue in excess of 30 daysand will remain unabsorbed.It is recommended that short-termassays,according to Practice F763,first be performed.Appli-cations in other organ systems or tissues may be inappropriateand are therefore excluded.Control materials will consist ofany one of the metal alloys in Specifications F67,F75,F90,F136,F138,or F562,high purity dense aluminum oxide asdescribed in Specification F603,ultra high molecular weightpolyethylene as stated in Specification F648 or USP polyeth-ylene negative control.1.2 This practice is a combination of Practice F361 andPractice F469.The purpose,basic procedure,and method ofevaluation of each type of material are similar;therefore,theyhave been combined.1.3 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.1.4 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:2F67 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)F86 Practice for Surface Preparation and Marking of Metal-lic Surgical ImplantsF90 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)F361 Practice for Assessment of Compatibility of MetallicMaterials for Surgical Implants with Respect to Effect ofMaterials on Tissue(Withdrawn 1987)3F469 Practice for Assessment of Compatibility of Nonpo-rous Polymeric Materials for Surgical Implants withRegard to Effect of Materials on Tissue(Withdrawn1986)3F562 SpecificationforWrought35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical ImplantApplications(UNS R30035)F603 Specification for High-Purity Dense Aluminum Oxidefor Medical ApplicationF648 Specification for Ultra-High-Molecular-Weight Poly-ethylene Powder and Fabricated Form for Surgical Im-plants1This practice is under the jurisdiction ofASTM Committee F04 on Medical andSurgical Materials and Devices and is the direct responsibility of SubcommitteeF04.16 on Biocompatibility Test Methods.Current edition approved June 1,2010.Published September 2010.Originallyapproved in 1986.Last previous edition approved in 2004 as F981 04.DOI:10.1520/F0981-04R10.2For 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 F763 Practice for Short-Term Screening of Implant Materi-als3.Summary of Practice3.1 This practice describes the preparation of implants,thenumber of implants and test hosts,test sites,exposureschedule,implant sterilization techniques,and methods ofimplant retrieval and tissue examination of each test site.Histological criteria for evaluating tissue reaction are provided.4.Significance and Use4.1 This practice covers a test protocol for comparing thelocal tissue response evoked by biomaterials,from whichmedical implantable devices might ultimately be fabricated,with the local tissue response elicited by control materialscu