ASTM_F_640_-_12.pdf

Designation:F64012Standard Test Methods forDetermining Radiopacity for Medical Use1This standard is issued under the fixed designation F640;the number immediately following the designation indicates the year of originaladoption or,in the case of revision,the year of last revision.Anumber in parentheses indicates the year of last reapproval.Asuperscriptepsilon()indicates an editorial change since the last revision or reapproval.1.Scope*1.1 These test methods cover the determination of theradiopacity of materials and products utilizing X-ray basedtechniques,including fluoroscopy,angiography,CT(computedtomography)and DEXA(dual energy X-ray absorptiometry),also known as DXA,The results of these measurements are anindication of the likelihood of locating the product within thehuman body.1.2 Radiopacity is determined by(a)qualitatively compar-ing image(s)of a test specimen and a user-defined standard,with or without the use of a body mimic,or(b)quantitativelydetermining the specific difference in optical density or pixelintensity between the image of a test specimen and the imageof a user-defined standard,with or without the use of a bodymimic.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,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:2B209 Specification for Aluminum and Aluminum-AlloySheet and PlateD3182 Practice for RubberMaterials,Equipment,and Pro-cedures for Mixing Standard Compounds and PreparingStandard Vulcanized SheetsE94 Guide for Radiographic ExaminationE1316 Terminology for Nondestructive ExaminationsF647 Practice for Evaluating and Specifying ImplantableShunt Assemblies for Neurosurgical Application3.Terminology3.1 DefinitionsFor definitions of terms relating to X-rayprocedures,refer to Terminology E1316.3.2 Descriptions of Terms:3.2.1 body mimic,na piece of material,a phantom,acadaver,or an animal utilized to mimic the appropriate X-rayattenuation through a particular part of the human body.3.2.2 digital resolution,nthe number of pixels per inch ina digital image.3.2.2.1 DiscussionThis may be different in the x and ydirections3.2.3 grayscale range,nthe number of levels in pixelintensity resolved in the digital image.3.2.3.1 DiscussionThis is normally 256 levels in an 8-bitgrayscale image3.2.4 optical density,nthe range of values of opticaldensity as measured by a densitometer;in this test method theexpected range is 0.50 to 1.50.3.2.5 optical density difference,nthe difference in opticaldensity units between two regions or objects in an image,reported to at least two digits to the right of the decimal point.3.2.6 pixel intensity,nthe grayscale level of a pixelbetween 0 and 255,as determined by the digital analysisprogram.3.2.7 pixel intensity difference,nthe difference in gray-scale level between two regions or objects in an image,reported to within the significance capability of the digitalanalysis program.3.2.8 user-defined standard,na comparison standard se-lected by the user.3.2.8.1 DiscussionThis standard may be an existing medi-cal product or a material in a particular form,it may be acommercially available standard,or it may be one developedby the user.4.Summary of Test Methods4.1 The test specimen is placed so it sits at or near themiddle of the X-ray image area in the X-ray imaging system.X-ray images are made at specified voltages,times,and1These test methods are under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and are the direct responsibility ofSubcommittee F04.15 on Material Test Methods.Current edition approved Dec.15,2012.Published January 2013.Originallyapproved in 1979.Last previous edition approved in 2007 as F640 07.DOI:10.1520/F0640-12.2For 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.*A Summary of Changes section appears at the end of this standardCopyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 currents that are typical of those used in the X-ray diagnosis ofhumans.Preferred settings are those appropriate for the prod-uct and for the particular area of body interest(for example,leg,heart,and so forth).The radiopacity of the test specimenand user-defined standard is evaluated in terms of the imagebackground with or without the use of a body mimic.Theradiopacity may be reported qualitatively or quantitatively.5.Significance and Use5.1 These methods are intended to determine whether amaterial,product,or part of a product has the degree ofradiopacity desi