ASTM_F_2721_-_09_2014.pdf

Designation:F272109(Reapproved 2014)Standard Guide forPre-clinical in vivo Evaluation in Critical Size SegmentalBone Defects1This standard is issued under the fixed designation F2721;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 in vivoassessment of tissue-engineered medical products(TEMPs)intended to repair or regenerate bone.TEMPs included in thisguide may be composed of natural or synthetic biomaterials(biocompatible and biodegradable)or composites thereof,andmay contain cells or biologically active agents such as growthfactors,synthetic peptides,plasmids,or cDNA.The modelsdescribed in this guide are segmental critical size defectswhich,by definition,will not fill with viable tissue withouttreatment.Thus,these models represent a stringent test of amaterials ability to induce or augment bone growth.1.2 Guidelines include a description and rationale of variousanimal models including rat(murine),rabbit(leporine),dog(canine),goat(caprine),and sheep(ovine).Outcome measuresbased on radiographic,histologic,and mechanical analyses aredescribed briefly and referenced.The user should refer tospecific test methods for additional detail.1.3 This guide is not intended to include the testing of rawmaterials,preparation of biomaterials,sterilization,or packag-ing of the product.ASTM standards for these steps areavailable in the Referenced Documents(Section 2).1.4 The use of any of the methods included in this guidemay not produce a result that is consistent with clinicalperformance in one or more specific applications.1.5 Other pre-clinical methods may also be appropriate andthis guide is not meant to exclude such methods.The materialmust be suitable for its intended purpose.Additional biologicaltesting in this regard would be required.1.6 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.1.7 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:2F561 Practice for Retrieval and Analysis of MedicalDevices,and Associated Tissues and FluidsF565 Practice for Care and Handling of Orthopedic Implantsand InstrumentsF895 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 BoneF1983 Practice for Assessment of Selected Tissue Effects ofAbsorbable Biomaterials for Implant ApplicationsF2150 Guide for Characterization and Testing of Biomate-rial Scaffolds Used in Tissue-Engineered Medical Prod-ucts2.2 Other Documents:21 CFR Part 58 Good Laboratory Practice for NonclinicalLaboratory Studies321 CFR 610.12 General Biological Products StandardsSterility33.Terminology3.1 Definitions:3.1.1 bone regenerationthe formation of bone that hashistologic,biochemical,and mechanical properties similar tothat of native bone.3.1.2 bone repairthe process of healing injured bonethrough cell proliferation and synthesis of new extracellularmatrix.1This guide is under the jurisdiction of ASTM Committee F04 on Medical andSurgical Materials and Devices and is the direct responsibility of SubcommitteeF04.44 on Assessment for TEMPs.Current edition approved Nov.1,2014.Published March 2015.Originallyapproved in 2008.Last previous version approved in 2009 as F2721 09.DOI:10.1520/F2721-09R14.2For 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.3Available from U.S.Government Printing Office Superintendent of Documents,732 N.Capitol St.,NW,Mail Stop:SDE,Washington,DC 20401,http:/www.access.gpo.gov.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 3.1.3 compact boneclassification of ossified bony connec-tive tissue characterized by the presence of osteon-containinglamellar bone.Lamellar bone is highly organized in concentricsheets.3.1.4 cortical boneone of the two main types of osseoustissue.Cortical bone is dense and forms the surface of bones.3.1.5 critical size defecta bone defect,either naturallyoccurring or artificially created,which will not heal withoutintervention.In the clinical setting,this term applies toexceeding a healing period of approximately 6 months(inotherwise healthy adults).3.1.6 diaphysealpertaining to the mid-section of longbones.3.1.