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ASTM F 1266 Document Information:
Title
Standard Performance Specification for Cerebral Stereotactic Instruments
ASTM International
Publication Date:
Nov 24, 1989
Scope:
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.
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.
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.
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:
Thalamotomy for parkinsonism and other types of tremor,
Electrode implantation for epilepsy,
Needle or magnetic insertion, or both, for aneurysm
thrombosis,
Thalamic or subthalamic operations for dystonia,
Thalamic or subthalamic operations for involuntary movements
such as chorea or hemiballismus,
Ablation of deep cerebellar nuclei for spasticity,
Cingulotomy and thalamic or subthalamic surgery for pain,
Mesencephalotomy or tractotomy for pain,
Ablations of subcortical temporal lobe structures for treatment
of epilepsy,
Psychosurgical procedures,
Implantation of depth stimulating electrodes for pain,
Insertion of forceps or needle for obtaining biopsy
specimens,
Foreign body removal,
Implantation of radioactive material, and
Biopsy or treatment of tumors.
This standard does not purport to address all of the safety
concerns, if any, associated with its use. It is the responsibility
of the user of this standard to establish appropriate safety and
health practices and determine the applicability of regulatory
limitations prior to use.
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