ASTM F2603-2006 Standard Guide for Interpreting Images of Polymeric Tissue Scaffolds《聚合物组织假体释图的标准指南》.pdf
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1、Designation: F 2603 06Standard Guide forInterpreting Images of Polymeric Tissue Scaffolds1This standard is issued under the fixed designation F 2603; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revision. A numb
2、er in parentheses indicates the year of last reapproval. Asuperscript epsilon (e) 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 sele
3、ction, instrument resolution and image qual-ity, 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)
4、may require unique orvaried sample preparation methods that are not specificallycovered in this guide.1.3 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 he
5、alth practices and to determine theapplicability of regulatory limitations prior to use.2. Referenced Documents2.1 ASTM Standards:2E 1919 Guide for Worldwide Published Standards Relatingto Particle and Spray CharacterizationE 2245 Test Method for Residual Strain Measurements ofThin, Reflecting Films
6、 Using an Optical InterferometerF 1854 Test Method for Stereological Evaluation of PorousCoatings on Medical ImplantsF 1877 Practice for Characterization of ParticlesF 2150 Guide for Characterization and Testing of Biomate-rial Scaffolds Used in Tissue-Engineered Medical ProductsF 2450 Guide for Ass
7、essing Microstructure of PolymericScaffolds for Use in Tissue Engineered Medical Products3. Terminology3.1 Definitions:3.1.1 aliasing, nartifactual data that originates from aninsufficient sampling rate.3.1.2 biomaterial, na natural or synthetic material that issuitable for introduction into living
8、tissue especially as part ofa medical device (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 through a single orifice smallerthan the pores depth.3.1.4 closed cell, nvoid within a solid, lacking anyconnectivity with a
9、n 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 F 1877).3.1.6 hydrogel, na water-based open network of polymerchains that are cross-linked either chemically or throughcry
10、stalline 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 nomenclature are given in Appendix X2. (Adaptedfrom Practice F 1877).3.1.8 Nyquist criterionstates that a signal must
11、besampled at a rate greater than or equal to twice its highestfrequency component to avoid aliasing.3.1.9 permeability, na measure of fluid, particle, or gasflow through an open pore structure.3.1.10 pixel, ntwo-dimensional picture element.3.1.11 polymer, na long chain molecule composed ofmonomers.3
12、.1.11.1 DiscussionA polymer may be a natural or syn-thetic material.3.1.11.2 DiscussionExamples of polymers include col-lagen and polycaprolactone.3.1.12 pore, na liquid (fluid or gas) filled externallyconnecting channel, void, or open space within an otherwisesolid or gelatinous material (for examp
13、le, textile meshescomposed of many or single fibers (textile based scaffolds),open cell foams, (hydrogels). Synonyms: open pore, throughpore.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 rati
14、o of pore1This 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 Dec. 1, 2006. Published February 2007.2For referenced ASTM stan
15、dards, 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.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken,
16、PA 19428-2959, United States.(void) volume to the apparent (total) volume of a porousmaterial and is commonly expressed as a percentage (GuideF 2150).3.1.14 rectangular, adjA pore that approximates a squareor rectangle in shape (derived from Practice F 1877).3.1.15 roundness (R), na measure of how c
17、losely anobject represents a circle (Practice F 1877).3.1.16 scaffold, na support, delivery vehicle, or matrix forfacilitating the migration, binding, or transport of cells orbioactive molecules used to replace, repair, or regeneratetissues. (Guide F 2150).3.1.17 segmentation, na methodology for dis
18、tinguishingdifferent regions (for example, pores and walls) within a tissuescaffold image.3.1.18 spherical pore, adja pore with a generally spheri-cal shape.3.1.18.1 DiscussionA spherical pore appears round in aphotograph (Practice F 1877).3.1.19 threshold, nisolation of a range of grayscale valuese
19、xhibited by one constituent within an image.3.1.20 through pores, nan inherent or induced network ofvoids or channels that permit flow of fluid from one side of thestructure to the other.3.1.21 tortuosity, na measure of the mean free path lengthof through pores relative to the sample thickness. Alte
20、rnativedefinition: The squared ratio of the mean free path to theminimum possible path length.3.1.22 voxel, nthree-dimensional picture element.4. Significance and Use4.1 This document provides guidance for users who wish toobtain quantifiable data from images of tissue scaffolds manu-factured from p
21、olymers that include both high water contentgels and woven textiles.4.2 Information derived from tissue scaffold images can beused to optimize the structural characteristics of the matrix fora particular application, to develop better manufacturing pro-cedures or to provide a measure of quality assu
22、rance andproduct traceability. Fig. 1 provides a summary of the keystages of image capture and analysis.4.3 There is a synergy between the analysis of pores intissue scaffolds and that of particles that is reflected instandards cited and in the analysis described in Section 9.Guide E 1919 provides a
23、 compendium of standards for particleanalysis that includes measurement techniques, data analyticaland sampling methodologies.5. Measurement Objectives5.1 Much of the research activity in tissue engineering isfocused on the development of suitable materials and structuresfor optimal growth of a rang
24、e of tissue types includingcartilage, bone, and nerve. This requires a quantitative assess-ment of the scaffold structure.The key parameters that need to be determined are (1) theoverall level of porosity, (2) the pore size distribution, whichcan range from tens of nanometers to several hundred mi-c
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