1、Designation:F260306(Reapproved 2012)Standard Guide forInterpreting Images of Polymeric Tissue Scaffolds1This standard is issued under the fixed designation F2603;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last revisi
2、on.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 the factors that need to be consideredin obtaining and interpreting images of tissue scaffolds includ-ing technique
3、selection,instrument resolution and imagequality,quantification and sample preparation.1.2 The information in this guide is intended to be appli-cable to porous polymer-based tissue scaffolds,includingnaturally derived materials such as collagen.However,somematerials(both synthetic and natural)may r
4、equire unique orvaried sample preparation methods that are not specificallycovered in this guide.1.3 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.1.4 This standard does not purport to address all of thesafety concerns,if any,a
5、ssociated with its use.It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and to determine theapplicability of regulatory limitations prior to use.2.Referenced Documents2.1 ASTM Standards:2E1919 Guide for Worldwide Published Standards Relating
6、toParticle and Spray Characterization(Withdrawn 2014)3E2245 Test Method for Residual Strain Measurements ofThin,Reflecting Films Using an Optical InterferometerF1854 Test Method for Stereological Evaluation of PorousCoatings on Medical ImplantsF1877 Practice for Characterization of ParticlesF2150 Gu
7、ide for Characterization and Testing of Biomate-rial Scaffolds Used in Tissue-Engineered Medical Prod-uctsF2450 Guide for Assessing Microstructure of PolymericScaffolds for Use in Tissue-Engineered Medical Products3.Terminology3.1 Definitions:3.1.1 aliasing,nartifactual data that originates from ani
8、nsufficient sampling rate.3.1.2 biomaterial,na natural or synthetic material that issuitable for introduction into living tissue especially as part ofa medical device,such as an artificial heart valve or joint.3.1.3 blind(end)pore,na pore that is in contact with anexposed internal wall or surface th
9、rough a single orifice smallerthan the pores depth.3.1.4 closed cell,nvoid within a solid,lacking any con-nectivity with an external surface.Synonym:closed pore.3.1.5 feret diameter,nthe mean value of the distancebetween pairs of parallel tangents to the periphery of a pore(adapted from Practice F18
10、77).3.1.6 hydrogel,na water-based open network of polymerchains that are cross-linked either chemically or throughcrystalline junctions or by specific ionic interactions.3.1.7 irregular,adjan irregular pore that cannot be de-scribed as round or spherical.A set of reference figures thatdefine the nom
11、enclature are given in Appendix X2.(Adaptedfrom Practice F1877).3.1.8 Nyquist criteriona criterion that states that a signalmust be sampled at a rate greater than or equal to twice itshighest frequency component to avoid aliasing.3.1.9 permeability,na measure of fluid,particle,or gasflow through an
12、open pore structure.3.1.10 pixel,ntwo-dimensional picture element.3.1.11 polymer,na long chain molecule composed ofmonomers.3.1.11.1 DiscussionA polymer may be a natural or syn-thetic material.3.1.11.2 DiscussionExamples of polymers include colla-gen and polycaprolactone.3.1.12 pore,na liquid,fluid,
13、or gas-filled externally con-necting channel,void,or open space within an otherwise solidor gelatinous material(for example,textile meshes composed1This guide is under the jurisdiction of ASTM Committee F04 on Medical andSurgical Materials and Devicesand is the direct responsibility of SubcommitteeF
14、04.42 on Biomaterials and Biomolecules for TEMPs.Current edition approved Oct.1,2012.Published February 2007.DOI:10.1520/F2603-06.2For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Service at serviceastm.org.For Annual Book of ASTMStandards volume information,
15、refer to the standards Document Summary page onthe ASTM website.3The last approved version of this historical standard is referenced onwww.astm.org.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 of many or single fibers(textile-based sca
16、ffolds),open cellfoams,(hydrogels).Synonyms:open pore,through pore.3.1.13 porosity,nproperty of a solid which contains aninherent or induced network of channels and open spaces.Porosity can be determined by measuring the ratio of pore(void)volume to the apparent(total)volume of a porousmaterial and is commonly expressed as a percentage(GuideF2150).3.1.14 rectangular,adjA pore that approximates a squareor rectangle in shape(derived from Practice F1877).3.1.15 roundness(R),na measure of how closel
