1、Designation:F215013Standard Guide forCharacterization and Testing of Biomaterial Scaffolds Usedin Tissue-Engineered Medical Products1This standard is issued under the fixed designation F2150;the number immediately following the designation indicates the year oforiginal adoption or,in the case of rev
2、ision,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 a resource of currently available testmethods for the characterization of the compositional
3、 andstructural aspects of biomaterial scaffolds used to develop andmanufacture tissue-engineered medical products(TEMPs).1.2 The test methods contained herein guide characteriza-tion of the bulk physical,chemical,mechanical,and surfaceproperties of a scaffold construct.Such properties may beimportan
4、t for the success of a TEMP,especially if they affectcell retention,activity and organization,the delivery of bioac-tive agents,or the biocompatibility and bioactivity within thefinal product.1.3 This guide may be used in the selection of appropriatetest methods for the generation of an original equ
5、ipmentmanufacture(OEM)specification.This guide also may be usedto characterize the scaffold component of a finished medicalproduct.1.4 This guide is intended to be utilized in conjunction withappropriate characterization(s)and evaluation(s)of any raw orstarting material(s)utilized in the fabrication
6、 of the scaffold,such as described in Guide F2027.1.5 This guide addresses natural,synthetic,or combinationscaffold materials with or without bioactive agents or biologi-cal activity.This guide does not address the characterization orrelease profiles of any biomolecules,cells,drugs,or bioactiveagent
7、s that are used in combination with the scaffold.Adetermination of the suitability of a particular starting materialand/or finished scaffold structure to a specific cell type and/ortissue engineering application is essential,but will requireadditional in vitro and/or in vivo evaluations considered t
8、o beoutside the scope of this guide.1.6 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 require
9、ments prior to use.2.Referenced Documents2.1 ASTM Standards:2D412 Test Methods for Vulcanized Rubber and Thermoplas-tic ElastomersTensionD570 Test Method for Water Absorption of PlasticsD638 Test Method for Tensile Properties of PlasticsD648 Test Method for Deflection Temperature of PlasticsUnder Fl
10、exural Load in the Edgewise PositionD695 Test Method for Compressive Properties of RigidPlasticsD747 Test Method for Apparent Bending Modulus of Plas-tics by Means of a Cantilever BeamD790 Test Methods for Flexural Properties of Unreinforcedand Reinforced Plastics and Electrical Insulating Materi-al
11、sD792 Test Methods for Density and Specific Gravity(Rela-tive Density)of Plastics by DisplacementD882 Test Method for Tensile Properties of Thin PlasticSheetingD1042 Test Method for Linear Dimensional Changes ofPlastics Caused by Exposure to Heat and MoistureD1238 Test Method for Melt Flow Rates of
12、Thermoplasticsby Extrusion PlastometerD1388 Test Method for Stiffness of FabricsD1621 Test Method for Compressive Properties of RigidCellular PlasticsD1623 Test Method for Tensile and Tensile Adhesion Prop-erties of Rigid Cellular PlasticsD1708 Test Method for Tensile Properties of Plastics by Useof
13、 Microtensile SpecimensD2857 Practice for Dilute Solution Viscosity of PolymersD2990 Test Methods for Tensile,Compressive,and FlexuralCreep and Creep-Rupture of PlasticsD3016 Practice for Use of Liquid Exclusion Chromatogra-phy Terms and Relationships1This guide is under the jurisdiction of ASTM Com
14、mittee F04 on Medical andSurgical Materials and Devices and is the direct responsibility of SubcommitteeF04.42 on Biomaterials and Biomolecules for TEMPs.Current edition approved Oct.1,2013.Published December 2013.Originallyapproved in 2002.Last previous edition approved in 2007 as F2150 07.DOI:10.1
15、520/F2150-13.2For 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
16、 Box C700,West Conshohocken,PA 19428-2959.United States1 D3039/D3039M Test Method for Tensile Properties of Poly-mer Matrix Composite MaterialsD3418 Test Method for Transition Temperatures and En-thalpies of Fusion and Crystallization of Polymers byDifferential Scanning CalorimetryD4001 Test Method for Determination of Weight-AverageMolecular Weight of Polymers By Light ScatteringD4404 Test Method for Determination of Pore Volume andPore Volume Distribution of Soil and Rock by MercuryIntrusion P