ASTM_F_1719_-_96_2008.pdf

Designation:F171996(Reapproved 2008)Standard Specification forImage-Interactive Stereotactic and Localization Systems1This standard is issued under the fixed designation F1719;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last revision.A number in parentheses indicates the year of last reapproval.Asuperscript epsilon()indicates an editorial change since the last revision or reapproval.1.Scope1.1 This specification covers the combined use of stereot-actic instruments or systems with imaging techniques,to directa diagnostic or therapeutic modality into a specific targetwithin the brain,based on localization information derivedfrom such imaging techniques.1.2 For the purpose of this specification,a stereotacticinstrument or system is a guiding,aiming,or viewing deviceused in human neurosurgery for the purpose of manuallydirecting a system or treating modality to a specific pointwithin the brain by radiographic,imaging,or other visualiza-tion or identification of landmarks or targets or lesions.1.3 Definition of Stereotactic Imaging SystemsTypes ofimaging-guided systems all require three components:animaging system,a stereotactic frame,or other physical deviceto identify the position of a point in space,and a method torelate image-generated coordinates to frame or device coordi-nates.See Performance Specification F1266.The imagingtechnique must reliably and reproducibly generate data con-cerning normal or abnormal anatomic structures,or both,thatcan interface with the coordinate system of the stereotacticframe or other stereotactic system.The imaging-guided sys-tems must allow accurate direction of therapeutic,viewing ordiagnostic modalities to a specific point or volume or along aspecific trajectory within the brain or often accurate estimationof structure size and location allowing biopsy,resection,vaporization,implantation,aspiration,or other manipulation,orcombinationthereof.Thestandardsofaccuracy,reproducibility,and safety must be met for the imagingmodality,the stereotactic system,and the method of interfacebetween the two,and for the system as a whole.The mechani-cal parts of the imaging modality and the stereotactic systemshould be constructed to allow maximal interaction withminimal interference with each other,to minimize imagingartifact and distortion,and minimize potential contamination ofthe surgical field.1.4 General Types of Imaging that May Be Used WithStereotactic SystemsCurrently employed imaging modalitiesusedinimaging-guidedstereotacticsystemsincluderadiography,angiography,computed tomography,magneticresonance imaging,ultrasound,biplane and multiplane digitalsubtraction angiography,and positron emission scanning.However,it is recognized that other modalities may be inter-faced with currently available and future stereotactic systemsand that new imaging modalities may evolve in the future.Standards for imaging devices will be dealt with in documentsconcerning such devices,and will not be addressed herein.1.5 General types of diagnostic modalities include biopsyinstruments,cannulas,endoscopes,electrodes,or other suchinstruments.Therapeutic modalities include,but are not limitedto,heating,cooling,irradiation,laser,injection,tissuetransplantation,mechanical or ultrasonic disruption,and anymodality ordinarily used in cerebrospinal surgery.1.6 ProbeAny system or modality directed by stereotactictechniques,including mechanical or other probe,a device thatis inserted into the brain or points to a target,and stereotacti-cally directed treatment or diagnostic modality.NOTE1Examples presented throughout this specification are listed forclarity only;that does not imply that use should be restricted to theprocedures or examples listed.1.7 RobotA power-driven servo-controlled system forcontrolling and advancing a probe according to a predeter-mined targeting program.1.8 DigitizerA device that is directed to indicate theposition of a probe or point in stereotactic or other coordinates.1.9 Frameless SystemA system that does not require astereotactic frame,that identifies and localizes a point orvolume in space by means of data registration,and a method torelate that point or volume to its representation derived from animaging system.1.10 The values stated in SI units are to be regarded as thestandard.1.11 The following precautionary caveat pertains only to thetest method portion,Section 3,of this specification:Thisstandard does not purport to address all of the safety concerns,if any,associated with its use.It is the responsibility of the user1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibility ofSubcommittee F04.31 on Neurosurgical Standards.Current edition approved Feb.1,2008.Published March 2008.Originallyapproved in 1996.Last previous edition approved in 2002 as F1719 96(2002).DOI:10.1520/F1719-96R08.Copyright ASTM International,100