Designation:F1266−89(Reapproved2008)StandardPerformanceSpecificationforCerebralStereotacticInstruments1ThisstandardisissuedunderthefixeddesignationF1266;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thisspecificationcoversstereotacticinstrumentsusedbyneurosurgeonstoassistintheplacementofprobes,suchascannulae,needles,forceps,orelectrodesortodirectradiationintobrainregionsoranatomicaltargetsthatarenotvisibleonthesurface.ThegenerallocationoftheseregionsisdeterminedbymeasurementsfromlandmarksvisualizedbyXrayorothermeans,suchmeasurementsbeingbasedonatlasesderivedfromanatomicalstudiesandautopsy.Becauseoftheanatomi-calvariability,morepreciselocationinanysinglepatientmaybedeterminedbyphysiologicalresponsesinthatpatient.Thedegreeofsuccessinstereotacticsurgerydependsupontheexperienceofthesurgeonaswellastheprecisionofthestereotacticinstrument.Nevertheless,minimumstandardsofaccuracyforstereotacticinstrumentsthatarewithintherangeofvariabilityofhumananatomymustbemaintained.1.2Forthepurposeofthisspecification,astereotacticinstrumentisaguidingdeviceusedinhumanneurosurgeryforthepurposeofdirectinganinstrumentortreatingmodalitytoaspecificpointwithinthebrainbyradiographicorothervisualizationoflandmarks.1.3Stereotacticinstrumentsmustbeconstructedtoaffordthesurgeonreliablyreproducibleaccuracyinplacinginstru-mentsintotargetareas.ProperpositioningoftheprobeisoftenverifiedbyXraystocontrolerrorsincalculationandtocorrectdeflectionoftheprobeduringinsertion.Physiologicalparam-etersmaybeusedtofurtherdefinetheoptimaltarget.1.4Atthepresenttime,stereotacticinstrumentsareusedmostfrequently,butnotexclusivelyinthefollowingopera-tions.Thelistispresentedonlytopresentexamplesandshouldnotbeconstruedtorestrictadvancesordevelopmentsofnewprocedures.Forsomeapplicationsitisnotrequiredtohit...
