ASTM_F_2529_-_13.pdf

Designation:F252913Standard Guide forin vivo Evaluation of Osteoinductive Potential for MaterialsContaining Demineralized Bone(DBM)1This standard is issued under the fixed designation F2529;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 to evaluate theeffectiveness of DBM-containing products intended to causeand/or promote bone formation when implanted or injected invivo.This guide is applicable to products that may be com-posed of one or more of the following components:naturalbiomaterials(such as demineralized bone),and synthetic bio-materials(such as calcium sulfate,glycerol,and reverse phasepolymeric compounds)that act as additives,fillers,and/orexcipients(radioprotective agents,preservatives,and/or han-dling agents)to make the demineralized bone easier to ma-nipulate.It should not be assumed that products evaluatedfavorably using this guidance will form bone when used in aclinical setting.The primary purpose of this guide is tofacilitate the equitable comparison of unique bone-formingproducts in in vivo heterotopic models of osteoinductivity.Thepurpose of this guide is not to exclude other establishedmethods.1.2 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.1.3 This standard does not purport to address all of thesafety concerns,if any,associated with the use of DBM-containing bone-forming/promoting products.It is the respon-sibility of the user of this standard to establish appropriatesafety and health practices involved in the development of saidproducts in accordance with applicable regulatory guidancedocuments and in implementing this guide to evaluate thebone-forming/promoting capabilities of the product.2.Referenced Documents2.1 ASTM Standards:2D1193 Specification for Reagent WaterD5056 Test Method for Trace Metals in Petroleum Coke byAtomic AbsorptionE508 Test Method for Determination of Calcium and Mag-nesium in Iron Ores by Flame Atomic Absorption Spec-trometryF565 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 BoneF1854 Test Method for Stereological Evaluation of PorousCoatings on Medical ImplantsF2131 Test Method forIn Vitro Biological Activity of Re-combinant Human Bone Morphogenetic Protein-2(rhBMP-2)Using the W-20 Mouse Stromal Cell LineF2721 Guide for Pre-clinical in vivo Evaluation in CriticalSize Segmental Bone Defects2.2 Federal Documents:321 CFR 58 Good Laboratory Practice for Nonclinical Labo-ratory Studies21 CFR 820 Quality System Regulation21 CFR 1270 Human Tissue Intended for Transplantation21 CFR 1271 Human Cells,Tissues,and Cellular andTissue-Based Products21 CFR 610.12 General Biological Products StandardsGeneral ProvisionsSterilityQ1E Evaluation of Stability Data,FDA Guidance for Indus-tryContainer and Closure Integrity Testing in Lieu of SterilityTesting as a Component of the Stability Protocol forSterile Products,FDA Guidance DocumentEligibility Determination for Donors of Human Cells,Tissues,and Cellular and Tissue-Based Products,Guid-ance for IndustryGuidance for the Preparation of a Premarket NotificationApplication for a Surgical Mesh,Guidance for Industryand/or for FDA Reviewers/Staff and/or Compliance1This test method is under the jurisdiction ofASTM Committee F04 on Medicaland Surgical Materials and Devices and is the direct responsibility of SubcommitteeF04.44 on Assessment for TEMPs.Current edition approved Feb.1,2013.Published August 2013.DOI:10.1520/F252913.2For 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 Food and Drug Administration(FDA),10903 New HampshireAve.,Silver Spring,MD 20993-0002,http:/www.fda.gov.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 2.3 AAMI/ISO Documents:4AAMI TIR 17 Compatibility of Materials Subject to Steril-izationAAMI/ISO 22442-01 Medical Devices Utilizing AnimalTissues and their DerivativesPart 1:Application of RiskManagementAAMI/ISO 22442-03 Medical Devices Utilizing AnimalTissues and their DerivativesPart 3:Validation of theElimination and/or Inactivation of Viruses and Transmis-sible Spongiform Encephalopathy(TSE)Agents2.4 ANSI/AAMI/ISO Documents:5ANSI/AAMI/ISO 11137 Parts 13 Sterilization of HealthCare ProductsRadiationANSI/AAMI/ISO 10993 Biological Evaluation of MedicalProducts2.5 ICH Docu