ASTM F1266-1989(2008) 脑部立体手术器械的标准性能规范

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【英文标准名称】:StandardPerformanceSpecificationforCerebralStereotacticInstruments
【原文标准名称】:脑部立体手术器械的标准性能规范
【标准号】:ASTMF1266-1989(2008)
【标准状态】:现行
【国别】:美国
【发布日期】:1989
【实施或试行日期】:
【发布单位】:美国材料与试验协会(US-ASTM)
【起草单位】:F04.31
【标准类型】:(Specification)
【标准水平】:()
【中文主题词】:
【英文主题词】:Anesthesiaequipment--specifications;Application;Cerebralstereotacticinstruments;Mechanicalperformanceconsiderations;Neurosurgicalmedicaldevices/applications--specifications;Performance--surgicalmaterials/applications(specifications);Probe;
【摘要】:Thepurposeofastereotacticapparatusistoguidetheadvanceofanelectrodeorotherprobeaccuratelyandinacontrolledfashiontoagivenpointinspace,relativetotheapparatus,tothestereotactictarget.Thus,whentheapparatusisattachedtotheskull,theelectrodeorprobecanbeadvancedtoagivengeographicalpointwithinthecranialcavity,nearthebaseoftheskullorinthespinalcanal.Asgenerallyemployed,theventriclesorcavitieswithinthebrainorotherneurosurgicallandmarksareidentifiedroentgenographicallybyothermeansand,byconsultinganatlasorothertable,themeandistanceanddirectionbetweenthevisualizedlandmarkandagivenanatomicaltargetaremeasured.Theelectrodeorprobeistheninsertedtothestereotactictarget,thatis,thepointinspacewhichiscalculatedfromthedistanceanddirectionbetweenthevisualizedlandmarkandthedesiredtargetinrelationtothecoordinatesystemofthestereotacticapparatus.Itisrecognizedthatthereisconsiderableanatomicalvariabilityinthesizeandshapeofthecentralnervoussystemsothatthetargetpointthatisidentifiedfromtheatlasortableisonlyapproximate.Usually,wherepossible,physiologicalverificationmayalsobeobtained.Onemustdistinguishbetweentheanatomicalaccuracy,whichisinexactbecauseofthevariabilityofbrains,andthemechanicalaccuracy,whichisafunctionoftheprecisionofthestereotacticinstrument.Therequirementssetforthhereinareconcernedonlywiththemechanicalaccuracyofstereotacticinstruments.Itisalsorecognizedthatonceminimumstandardsformechanicalaccuracyhavebeenobtained,increasedmechanicalprecisionwillnotnecessarilyleadtoincreasedanatomicalprecision.1.1Thisspecificationcoversstereotacticinstrumentsusedbyneurosurgeonstoassistintheplacementofprobes,suchascannulae,needles,forceps,orelectrodesortodirectradiationintobrainregionsoranatomicaltargetsthatarenotvisibleonthesurface.ThegenerallocationoftheseregionsisdeterminedbymeasurementsfromlandmarksvisualizedbyXrayorothermeans,suchmeasurementsbeingbasedonatlasesderivedfromanatomicalstudiesandautopsy.Becauseoftheanatomicalvariability,morepreciselocationinanysinglepatientmaybedeterminedbyphysiologicalresponsesinthatpatient.Thedegreeofsuccessinstereotacticsurgerydependsupontheexperienceofthesurgeonaswellastheprecisionofthestereotacticinstrument.Nevertheless,minimumstandardsofaccuracyforstereotacticinstrumentsthatarewithintherangeofvariabilityofhumananatomymustbemaintained.1.2Forthepurposeofthisspecification,astereotacticinstrumentisaguidingdeviceusedinhumanneurosurgeryforthepurposeofdirectinganinstrumentortreatingmodalitytoaspecificpointwithinthebrainbyradiographicorothervisualizationoflandmarks.1.3Stereotacticinstrumentsmustbeconstructedtoaffordthesurgeonreliablyreproducibleaccuracyinplacinginstrumentsintotargetareas.ProperpositioningoftheprobeisoftenverifiedbyXraystocontrolerrorsincalculationandtocorrectdeflectionoftheprobeduringinsertion.Physiologicalparametersmaybeusedtofurtherdefinetheoptimaltarget.1.4Atthepresenttime,stereotacticinstrumentsareusedmostfrequently,butnotexclusivelyinthefollowingoperations.Thelistispresentedonlytopresentexamplesandshouldnotbeconstruedtorestrictadvancesordevelopmentsofnewprocedures.Forsomeapplicationsitisnotrequiredtohitapointinspace,buttohitavolumeormakealesionwithinamass.Forthatpurpose,devicesotherthanthosecoveredbythisspecificationmaybeemployed,butshouldberestrictedtosuchuses:1.4.1Thalam......
【中国标准分类号】:C36
【国际标准分类号】:11_040_30
【页数】:6P.;A4
【正文语种】:英语