1、Designation:F288311Standard Guide forCharacterization of Ceramic and Mineral Based Scaffoldsused for Tissue-Engineered Medical Products(TEMPs)andas Device for Surgical Implant Applications1This standard is issued under the fixed designation F2883;the number immediately following the designation indi
2、cates 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 guidance document covers the chemical,physic
3、al,biological,and mechanical characterization requirements forbiocompatible mineral-and ceramic-based scaffolds usedsolely as device or to manufacture tissue-engineered medicalproducts(TEMPs).In this guide,the pure device or the TEMPsproduct will be referred to as scaffold.1.2 The test methods conta
4、ined herein provide guidance onthecharacterizationofthebulkphysical,chemical,mechanical,and surface properties of a scaffold construct.These properties may be important for the performance of thescaffold,especially if they affect cell behavior,adhesion,proliferation and differentiation.In addition,t
5、hese propertiesmay affect the delivery of bioactive agents,the biocompatibil-ity and the bioactivity of the final product.1.3 This document may be used as guidance in the selectionof test methods for the comprehensive characterization of a rawmaterials,granules,pre-shaped blocks,or an original equip
6、-ment manufacture(OEM)specification.This guide may alsobe used to characterize the scaffold component of a finishedmedical product.1.4 While a variety of materials can be used to manufacturesuch scaffolds,the composition of the final scaffold shallcontain mineral or ceramic components as its main in
7、gredients.1.5 This guide assumes that the scaffold is homogeneous innature.Chemical or physical inhomogeneity or mechanicalanisotropy of the scaffold shall be declared in the manufactur-ers material and scaffold specification.1.6 This guide addresses neither the biocompatibility of thescaffold,nor t
8、he characterization or release profiles of anybiomolecules,cells,drugs,or bioactive agents that are used incombination with the scaffold.1.7 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.1.8 This standard does not purport to ad
9、dress 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:2C373 Test Method
10、 for Water Absorption,Bulk Density,Apparent Porosity,andApparent Specific Gravity of FiredWhiteware ProductsC693 Test Method for Density of Glass by BuoyancyC729 Test Method for Density of Glass by the Sink-FloatComparatorC830 TestMethodsforApparentPorosity,LiquidAbsorption,Apparent Specific Gravity
11、,and Bulk Densityof Refractory Shapes by Vacuum PressureC1198 Test Method for Dynamic Youngs Modulus,ShearModulus,and Poissons Ratio for Advanced Ceramics bySonic ResonanceC1274 Test Method for Advanced Ceramic Specific SurfaceArea by Physical AdsorptionC1424 Test Method for Monotonic Compressive St
12、rength ofAdvanced Ceramics at Ambient TemperatureD695 Test Method for Compressive Properties of RigidPlasticsD1621 Test Method for Compressive Properties of RigidCellular PlasticsD4404 Test Method for Determination of Pore Volume andPore Volume Distribution of Soil and Rock by MercuryIntrusion Poros
13、imetryD6226 Test Method for Open Cell Content of Rigid CellularPlastics1This guide is under the jurisdiction of ASTM Committee F04 on Medical andSurgical Materials and Devices and is the direct responsibility of SubcommitteeF04.42 on Biomaterials and Biomolecules for TEMPs.Current edition approved D
14、ec.1,2011.Published January 2012.DOI:10.1520/F288311.2For 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 AST
15、M International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 D6420 Test Method for Determination of Gaseous OrganicCompounds by Direct Interface Gas Chromatography-Mass SpectrometryE128 Test Method for Maximum Pore Diameter and Perme-ability of Rigid Porous Filter
16、s for Laboratory UseE177 Practice for Use of the Terms Precision and Bias inASTM Test MethodsE456 Terminology Relating to Quality and StatisticsE691 Practice for Conducting an Interlaboratory Study toDetermine the Precision of a Test MethodE996 Practice for Reporting Data in Auger Electron Spec-troscopy and X-ray Photoelectron SpectroscopyE1078 Guide for Specimen Preparation and Mounting inSurface AnalysisE1131 Test Method for Compositional Analysis by Thermo-gravimetryE1252 Practice for General