ASTM F1266-89(2008)
(Specification)Standard Performance Specification for Cerebral Stereotactic Instruments (Withdrawn 2017)
Standard Performance Specification for Cerebral Stereotactic Instruments (Withdrawn 2017)
SIGNIFICANCE AND USE
The purpose of a stereotactic apparatus is to guide the advance of an electrode or other probe accurately and in a controlled fashion to a given point in space, relative to the apparatus, to the stereotactic target. Thus, when the apparatus is attached to the skull, the electrode or probe can be advanced to a given geographical point within the cranial cavity, near the base of the skull or in the spinal canal.
As generally employed, the ventricles or cavities within the brain or other neurosurgical landmarks are identified roentgenographically by other means and, by consulting an atlas or other table, the mean distance and direction between the visualized landmark and a given anatomical target are measured. The electrode or probe is then inserted to the stereotactic target, that is, the point in space which is calculated from the distance and direction between the visualized landmark and the desired target in relation to the coordinate system of the stereotactic apparatus.
It is recognized that there is considerable anatomical variability in the size and shape of the central nervous system so that the target point that is identified from the atlas or table is only approximate. Usually, where possible, physiological verification may also be obtained. One must distinguish between the anatomical accuracy, which is inexact because of the variability of brains, and the mechanical accuracy, which is a function of the precision of the stereotactic instrument.
The requirements set forth herein are concerned only with the mechanical accuracy of stereotactic instruments. It is also recognized that once minimum standards for mechanical accuracy have been obtained, increased mechanical precision will not necessarily lead to increased anatomical precision.
SCOPE
1.1 This specification covers stereotactic instruments used by neurosurgeons to assist in the placement of probes, such as cannulae, needles, forceps, or electrodes or to direct radiation into brain regions or anatomical targets that are not visible on the surface. The general location of these regions is determined by measurements from landmarks visualized by X ray or other means, such measurements being based on atlases derived from anatomical studies and autopsy. Because of the anatomical variability, more precise location in any single patient may be determined by physiological responses in that patient. The degree of success in stereotactic surgery depends upon the experience of the surgeon as well as the precision of the stereotactic instrument. Nevertheless, minimum standards of accuracy for stereotactic instruments that are within the range of variability of human anatomy must be maintained.
1.2 For the purpose of this specification, a stereotactic instrument is a guiding device used in human neurosurgery for the purpose of directing an instrument or treating modality to a specific point within the brain by radiographic or other visualization of landmarks.
1.3 Stereotactic instruments must be constructed to afford the surgeon reliably reproducible accuracy in placing instruments into target areas. Proper positioning of the probe is often verified by X rays to control errors in calculation and to correct deflection of the probe during insertion. Physiological parameters may be used to further define the optimal target.
1.4 At the present time, stereotactic instruments are used most frequently, but not exclusively in the following operations. The list is presented only to present examples and should not be construed to restrict advances or developments of new procedures. For some applications it is not required to hit a point in space, but to hit a volume or make a lesion within a mass. For that purpose, devices other than those covered by this specification may be employed, but should be restricted to such uses:
1.4.1 Thalamotomy for parkinsonism and other types of tremor,
1.4.2 Electrode implantation for epilepsy,
1.4....
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Standards Content (Sample)
NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation:F1266 −89(Reapproved 2008)
Standard Performance Specification for
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Cerebral Stereotactic Instruments
This standard is issued under the fixed designation F1266; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope 1.4.1 Thalamotomy for parkinsonism and other types of
tremor,
1.1 This specification covers stereotactic instruments used
1.4.2 Electrode implantation for epilepsy,
by neurosurgeons to assist in the placement of probes, such as
1.4.3 Needle or magnetic insertion, or both, for aneurysm
cannulae, needles, forceps, or electrodes or to direct radiation
thrombosis,
into brain regions or anatomical targets that are not visible on
1.4.4 Thalamic or subthalamic operations for dystonia,
the surface.The general location of these regions is determined
1.4.5 Thalamic or subthalamic operations for involuntary
by measurements from landmarks visualized by X ray or other
movements such as chorea or hemiballismus,
means, such measurements being based on atlases derived
1.4.6 Ablation of deep cerebellar nuclei for spasticity,
from anatomical studies and autopsy. Because of the anatomi-
1.4.7 Cingulotomy and thalamic or subthalamic surgery for
cal variability, more precise location in any single patient may
pain,
be determined by physiological responses in that patient. The
1.4.8 Mesencephalotomy or tractotomy for pain,
degree of success in stereotactic surgery depends upon the
1.4.9 Ablations of subcortical temporal lobe structures for
experience of the surgeon as well as the precision of the
treatment of epilepsy,
stereotactic instrument. Nevertheless, minimum standards of
1.4.10 Psychosurgical procedures,
accuracy for stereotactic instruments that are within the range
1.4.11 Implantation of depth stimulating electrodes for pain,
of variability of human anatomy must be maintained.
1.4.12 Insertion of forceps or needle for obtaining biopsy
1.2 For the purpose of this specification, a stereotactic
specimens,
instrument is a guiding device used in human neurosurgery for
1.4.13 Foreign body removal,
the purpose of directing an instrument or treating modality to
1.4.14 Implantation of radioactive material, and
a specific point within the brain by radiographic or other
1.4.15 Biopsy or treatment of tumors.
visualization of landmarks.
1.5 This standard does not purport to address all of the
1.3 Stereotactic instruments must be constructed to afford
safety concerns, if any, associated with its use. It is the
the surgeon reliably reproducible accuracy in placing instru-
responsibility of the user of this standard to establish appro-
ments into target areas. Proper positioning of the probe is often
priate safety and health practices and determine the applica-
verified by X rays to control errors in calculation and to correct
bility of regulatory limitations prior to use.
deflection of the probe during insertion. Physiological param-
eters may be used to further define the optimal target.
2. Referenced Documents
1.4 At the present time, stereotactic instruments are used
2.1 NFPA Standard:
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most frequently, but not exclusively in the following opera-
NFPA 99 Health Care Facilities Code (56A and 76B-T)
tions.The list is presented only to present examples and should
2.2 UL Standard:
not be construed to restrict advances or developments of new
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UL 544 Electrical, Medical, and Dental Equipment
procedures. For some applications it is not required to hit a
point in space, but to hit a volume or make a lesion within a
3. Terminology
mass. For that purpose, devices other than those covered by
3.1 Descriptions of Terms—The following descriptions of
this specification may be employed, but should be restricted to
terms are for the purposes of this specification only. Other
such uses:
nomenclature may be used throughout the literature and by
various manufacturers:
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This specification is under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devices and is the direct responsibility of
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Subcommittee F04.31 on Neurosurgical Standards. Available from National Fire Protection Association (NFPA), 1 Batterymarch
Current edition approved Feb. 1, 2008. Published March 2008. Originally Park, Quincy, MA 02169-7471, http://www.nfpa.org.
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approved in 1989. Last previous edition approved in 2002 as F1266 – 89 (2002). Available from Underwriters Laboratories (UL), 333 Pfingsten Rd.,
DOI: 10.1520/F1266-89R08. Northbrook, IL 60062-2096, http://www.ul.com.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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