ASTM_F_763_-_04_2016.pdf

Designation:F76304(Reapproved 2016)Standard Practice forShort-Term Screening of Implant Materials1This standard is issued under the fixed designation F763;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 guidelines for short-term testingor screening of candidate materials,both porous and dense,asto the effects of the material on animal tissue in which it isimplanted.This is a rapid screening procedure for determiningacceptability of candidate materials.1.2 This practice,along with other appropriate biologicaltests(including other appropriate ASTM tests)may be used inthe biocompatibility assessment of the candidate materials foruse in the fabrication of devices for clinical application.1.3 This experimental protocol is not designed to provide acomprehensiveassessmentofthesystemictoxicity,carcinogenicity,teratogenicity,or mutagenicity of the materialsince other standards deal with these issues.1.4 This practice is one of several developed for theassessment of the biocompatibility of materials.Practice F748provides guidance for the selection of appropriate methods fortesting materials for a specific application.1.5 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.1.6 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:2F75 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)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)3F603 Specification for High-Purity Dense Aluminum Oxidefor Medical ApplicationF648 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 DevicesF981 Practice for Assessment of Compatibility of Biomate-rials for Surgical Implants with Respect to Effect ofMaterials on Muscle and Bone3.Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 biocompatibility assaya comparison of the tissueresponse produced through the close association of the im-planted candidate material to its implant site within the hostanimal to that tissue response recognized and established assuitable with control materials.4.Summary of Practice4.1 Under aseptic conditions,test specimens of the candi-date material and of controls are inserted into a muscle orgroup of muscles of the animal host.After a period of time the1This practice is under the jurisdiction ofASTM Committee F04 on Medical andSurgical Materials and Devicesand is the direct responsibility of SubcommitteeF04.16 on Biocompatibility Test Methods.Current edition approved April 1,2016.Published June 2016.Originallyapproved in 1982.Last previous edition approved in 2010 as F763 04(2010).DOI:10.1520/F0763-04R16.2For 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 animals are euthanized.The tissue reactions to implants of thecandidate material during the acute to subchronic time periodof healing are compared with tissue reactions to controlmaterials which have a well characterized response.Theimplants are not subject to major stress while in situ.5.Significance and Use5.1 The use of in vivo implantation techniques for charac-terizing the biocompatibility of materials to be utilized invarious medical applications provides a unique assessment ofsuch materials not achieved by other procedures.Physicalcharacteristics(that is,