Designation:F1719−96(Reapproved2008)StandardSpecificationforImage-InteractiveStereotacticandLocalizationSystems1ThisstandardisissuedunderthefixeddesignationF1719;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thisspecificationcoversthecombineduseofstereot-acticinstrumentsorsystemswithimagingtechniques,todirectadiagnosticortherapeuticmodalityintoaspecifictargetwithinthebrain,basedonlocalizationinformationderivedfromsuchimagingtechniques.1.2Forthepurposeofthisspecification,astereotacticinstrumentorsystemisaguiding,aiming,orviewingdeviceusedinhumanneurosurgeryforthepurposeofmanuallydirectingasystemortreatingmodalitytoaspecificpointwithinthebrainbyradiographic,imaging,orothervisualiza-tionoridentificationoflandmarksortargetsorlesions.1.3DefinitionofStereotacticImagingSystems—Typesofimaging-guidedsystemsallrequirethreecomponents:animagingsystem,astereotacticframe,orotherphysicaldevicetoidentifythepositionofapointinspace,andamethodtorelateimage-generatedcoordinatestoframeordevicecoordi-nates.SeePerformanceSpecificationF1266.Theimagingtechniquemustreliablyandreproduciblygeneratedatacon-cerningnormalorabnormalanatomicstructures,orboth,thatcaninterfacewiththecoordinatesystemofthestereotacticframeorotherstereotacticsystem.Theimaging-guidedsys-temsmustallowaccuratedirectionoftherapeutic,viewingordiagnosticmodalitiestoaspecificpointorvolumeoralongaspecifictrajectorywithinthebrainoroftenaccurateestimationofstructuresizeandlocationallowingbiopsy,resection,vaporization,implantation,aspiration,orothermanipulation,orcombinationthereof.Thestandardsofaccuracy,reproducibility,andsafetymustbemetfortheimagingmodality,thestereotacticsystem,andthemethodofinterfacebetweenthetwo,andforthesystemasawhole.Themechani-calpartsoftheimagingmodalityandthestereotacticsystemshould...
