ASTM_F_2884_-_12.pdf

Designation:F288412Standard Guide forPre-clinical in vivo Evaluation of Spinal Fusion1This standard is issued under the fixed designation F2884;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 pre-clinicalin vivo assessment of tissue-engineered medical products(TEMPs)intended to repair or regenerate bone in an interbodyand/or posterolateral spinal environment.TEMPs included inthis guide may be composed of,but are not limited to,naturalor synthetic biomaterials or composites thereof,and maycontain cells or biologically active agents such as growthfactors,synthetic peptides,plasmids,or cDNA.The modelsdescribed in this document represent a stringent test of amaterials ability to induce and/or augment bone growth in thespinal environment.1.2 While clinically TEMPs may be combined with hard-ware for initial stabilization or other purposes,the focus of thisguide is on the appropriateness of the animal model chosen andevaluation of the TEMP induced repair and as such does notfocus on issues of hardware.1.3 Guidelines include a description and rationale of variousanimal models for the in vivo assessment of the TEMP.Theanimal models utilize a range of species including rat(murine),rabbit(lapine),dog(canine),goat(caprine),pig(porcine),sheep(ovine),and non-human primate(primates).Outcomemeasures include in vivo assessments based on radiographic,histologic,CT imaging as well as subsequent in vitro assess-ments of the repair,including histologic analyses and mechani-cal testing.All methods are described briefly and referenced.The user should refer to specific test methods for additionaldetail.1.4 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 Referenced Documents(Section 2).1.5 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.1.6 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.1.7 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.1.8 The values stated in inch-pound units are to be regardedas standard.The values given in parentheses are mathematicalconversions to SI units that are provided for information onlyand are not considered standard.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 Practicefor AssessmentofCompatibilityofAbsorbable/Resorbable Biomaterials for Implant Applica-tionsF2150 Guide for Characterization and Testing of Biomate-rial Scaffolds Used in Tissue-Engineered Medical Prod-ucts2.2 Other StandardsISO 10993 Biological Evaluation of Medical TEMPsPart5:Tests for in vitro Cytotoxicity321 CFR Part 58 Good Laboratory Practice for NonclinicalLaboratory Studies421 CFR 610.12 General Biological Product Standards Sterility41This 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 April 1,2012.Published April 2012.DOI:10.1520/F288412.2For 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 American National Standards Institute(ANSI),25 W.43rd St.,4th Floor,New York,NY 10036,http:/www.ansi.org.4Available 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.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 remodelinga lifelong process where old boneis removed from the skeleton(a sub-process called boneresorption)and new bone is added(a sub-process called boneformation).3.1.2.1 DiscussionThese processes also control the re-