ASTM_F_2451_-_05_2010.pdf

Designation:F245105(Reapproved 2010)Standard Guide forin vivo Assessment of Implantable Devices Intended toRepair or Regenerate Articular Cartilage1This standard is issued under the fixed designation F2451;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 implantable devices intended to repair or regen-erate articular cartilage.Devices included in this guide may becomposed of natural or synthetic biomaterials(biocompatibleand biodegradable)or composites thereof and may containcells or biologically active agents such as growth factors,synthetic peptides,plasmids,or cDNA.1.2 Guidelines include a description and rationale of variousanimal models utilizing a range of species such as rabbit(lupine),dog(canine),pig(porcine),goat(caprine),sheep(ovine),and horse(equine).Outcome measures based onhistologic,biochemical,and mechanical analyses are brieflydescribed and referenced.The user should refer to specific testmethods for additional detail.1.3 This guide is not intended to include the testing of rawmaterials,preparation of biomaterials,sterilization,or packag-ing of product.ASTM standards for these steps are available inReference Documents.1.4 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.1.5 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 requirements 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 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 Documents:ISO-10993 Biological Evaluation of Medical DevicesPart5:Tests for in vitro Cytotoxicity321 CFR Part 58 Good Laboratory Practice for NonclinicalLaboratory Studies43.Terminology3.1 Definitions:3.1.1 cartilage regenerationthe formation of articular-likecartilage that has histologic,biochemical,and mechanicalproperties similar to that of native articular cartilage(1,2).53.1.2 cartilage repairthe process of healing injured carti-lage or its replacement through cell proliferation and synthesisof new extracellular matrix(1,2).3.1.3 compact boneclassification of ossified boney con-nective tissue characterized by the presence of osteons con-taining lamellar bone.3.1.4 femoral condylesthe anatomic site corresponding tothe distal end of the femur characterized by medial and lateralconvex surfaces that are lined by cartilage and articulate withthe proximal tibia and medial and lateral menisci.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 Sept.1,2010.Published November 2010.Originallyapproved in 2005.Last previous edition approved in 2005 as F2451 05.DOI:10.1520/F2451-05R10.2For 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 10036.4Available from U.S.Government Printing Office Superintendent of Documents,732 N.Capitol St.,NW,Mail Stop:SDE,Washington,DC 20401.5The boldface numbers in parentheses refer to the list of references at the end ofthis standard.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 3.1.5 fibrocartilagedisorganized cartilagenous tissue hav-ing an abnormally high content of type I collagen.3.1.6 growth platethe anatomic location within theepiphyseal region of long bones corresponding to the site ofgrowth of bone through endochondral bone formation.Thegrowth plate in skeletally mature animals is fused.3.1.7 hyaline articular cartilagecartilagenous connectivetissue located in diarthrodial joints and characterized by itslocalization to articulating surfaces.3.1.8 marrowalso called myeloid tissue;soft,gelatinoustissue that fills