ASTM_F_1266_-_89_2008.pdf

Designation:F126689(Reapproved 2008)Standard Performance Specification forCerebral Stereotactic Instruments1This standard is issued under the fixed designation F1266;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 stereotactic instruments usedby neurosurgeons to assist in the placement of probes,such ascannulae,needles,forceps,or electrodes or to direct radiationinto brain regions or anatomical targets that are not visible onthe surface.The general location of these regions is determinedby measurements from landmarks visualized by X ray or othermeans,such measurements being based on atlases derivedfrom anatomical studies and autopsy.Because of the anatomi-cal variability,more precise location in any single patient maybe determined by physiological responses in that patient.Thedegree of success in stereotactic surgery depends upon theexperience of the surgeon as well as the precision of thestereotactic instrument.Nevertheless,minimum standards ofaccuracy for stereotactic instruments that are within the rangeof variability of human anatomy must be maintained.1.2 For the purpose of this specification,a stereotacticinstrument is a guiding device used in human neurosurgery forthe purpose of directing an instrument or treating modality toa specific point within the brain by radiographic or othervisualization of landmarks.1.3 Stereotactic instruments must be constructed to affordthe surgeon reliably reproducible accuracy in placing instru-ments into target areas.Proper positioning of the probe is oftenverified by X rays to control errors in calculation and to correctdeflection of the probe during insertion.Physiological param-eters may be used to further define the optimal target.1.4 At the present time,stereotactic instruments are usedmost frequently,but not exclusively in the following opera-tions.The list is presented only to present examples and shouldnot be construed to restrict advances or developments of newprocedures.For some applications it is not required to hit apoint in space,but to hit a volume or make a lesion within amass.For that purpose,devices other than those covered bythis specification may be employed,but should be restricted tosuch uses:1.4.1 Thalamotomy for parkinsonism and other types oftremor,1.4.2 Electrode implantation for epilepsy,1.4.3 Needle or magnetic insertion,or both,for aneurysmthrombosis,1.4.4 Thalamic or subthalamic operations for dystonia,1.4.5 Thalamic or subthalamic operations for involuntarymovements such as chorea or hemiballismus,1.4.6 Ablation of deep cerebellar nuclei for spasticity,1.4.7 Cingulotomy and thalamic or subthalamic surgery forpain,1.4.8 Mesencephalotomy or tractotomy for pain,1.4.9 Ablations of subcortical temporal lobe structures fortreatment of epilepsy,1.4.10 Psychosurgical procedures,1.4.11 Implantation of depth stimulating electrodes for pain,1.4.12 Insertion of forceps or needle for obtaining biopsyspecimens,1.4.13 Foreign body removal,1.4.14 Implantation of radioactive material,and1.4.15 Biopsy or treatment of tumors.1.5 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 NFPA Standard:NFPA 99 Health Care Facilities Code(56A and 76B-T)22.2 UL Standard:UL 544 Electrical,Medical,and Dental Equipment33.Terminology3.1 Descriptions of TermsThe following descriptions ofterms are for the purposes of this specification only.Othernomenclature may be used throughout the literature and byvarious manufacturers:1This 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 1989.Last previous edition approved in 2002 as F1266 89(2002).DOI:10.1520/F1266-89R08.2Available from National Fire Protection Association(NFPA),1 BatterymarchPark,Quincy,MA 02169-7471,http:/www.nfpa.org.3Available from Underwriters Laboratories(UL),333 Pfingsten Rd.,Northbrook,IL 60062-2096,http:/.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 3.1.1 anatomical accuracythe reliability or accuracy withwhich the tip of a probe can be introduced into a givenanatomical target.Because of anatomical variability,a givenanatomical structure or anatomical target may vary relative tothe position of the reference atlas position of that structure.Consequently,it is not possible to relate the reliability of astereo