ASTM_F_2903_-_11.pdf

Designation:F290311Standard Guide forTissue Engineered Medical Products(TEMPs)forReinforcement of Tendon and Ligament Surgical Repair1This standard is issued under the fixed designation F2903;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 is intended as a resource for individuals andorganizations involved in the development,production,anddelivery of tissue engineered medical products(TEMPs)in-tended to provide a mechanical(functional)reinforcement ofthe surgical repair of tendons and ligaments.1.2 Surgical repair can include procedures that repair tendonto tendon,tendon to bone,tendon to muscle,ligament toligament,and ligament to bone.In the context of this guide,atendon is a fibrous cord or band that connects a muscle to abone or other structure and consists of both dense collagenousfibers and rows of elongated tendon cells.In contrast,aligament is a band or sheet of fibrous tissue connecting two ormore bones,or cartilagenous structures.1.3 Examples of TEMPs for use in reinforcement of tendonor ligament repairs include extracellular matrices(includingallograft tissue,xenograft tissue,and tissue engineered extra-cellular matrix),polymeric matrices,membranes,or combina-tions of two or more of these,with or without cells and/ormolecular mediators,where the function is to reinforce thesurgical repair of tendon to tendon,tendon to bone,tendon tomuscle,ligament to ligament,or ligament to bone.1.4 The products may be rapidly degrading,slowlydegrading,or non-degrading.1.5 The guide is not intended to apply to TEMPs that havea primary function to induce a biological repair through cell ormolecular action,although biologic activity may be a feature ofthe TEMPs.Examples of products or product concepts that arenot included are(a)growth factors or cytokines applied to abiologic or synthetic scaffold,and(b)platelet-enriched plasmaapplied to or within a biologic or polymeric scaffold,where theprimary function of the product is biologic.1.6 The guide is not intended to apply to TEMPs that havea primary function to induce a chemical repair.An example ofa product or product concept that would not be included wouldbe a polymeric matrix containing reagents that glue collag-enous tissues together.1.7 The guide is not intended to apply to TEMPs that aredesigned to be used to achieve primary surgical repair ofinjured tendons and ligaments.1.8 The guide is not intended to apply to TEMPs that aredesigned to replace tendons or ligaments.1.9 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.1.10 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:2D1004 Test Method for Tear Resistance(Graves Tear)ofPlastic Film and SheetingD2990 Test Methods for Tensile,Compressive,and FlexuralCreep and Creep-Rupture of PlasticsD3786 Test Method for Bursting Strength of TextileFabricsDiaphragm Bursting Strength Tester MethodD3787 Test Method for Bursting Strength of TextilesConstant-Rate-of-Traverse(CRT)Ball Burst TestD5035 Test Method for Breaking Force and Elongation ofTextile Fabrics(Strip Method)E139 Test Methods for Conducting Creep,Creep-Rupture,and Stress-Rupture Tests of Metallic MaterialsF1635 Test Method forin vitro Degradation Testing of Hy-drolytically Degradable Polymer Resins and FabricatedForms for Surgical ImplantsF1978 Test Method for Measuring Abrasion Resistance ofMetallic Thermal Spray Coatings by Using the TaberAbraser1This 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 March 1,2011.Published April 2011.DOI:10.1520/F290311.2For 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.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 F2150 Guide for Characterization and Testing of Biomate-rial Scaffolds Used in Tissue-Engineered Medical Prod-uctsF2210 Guide for Processing Cells,Tissues,and Organs forUse in Tissue Engineered Medical ProductsF2211 Classification for Tissue Engineered Medical Prod-ucts(TEMPs)F2212 Guide for Characterization of Type I Collagen asStarting Material for Surgical Implants and Substrates forTissue Engineered Medical Products(TEMPs)F