ASTM F1266-89(2002)
(Specification)Standard Performance Specification for Cerebral Stereotactic Instruments
Standard Performance Specification for Cerebral Stereotactic Instruments
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,
1.4.3 Needle or magnetic insertion, or both, for aneurysm thrombosis,
1.4.4 Thalamic or subthalamic operations for dystonia,
1.4.5 Thalamic or subthalamic operations for involuntary movements such as chorea or hemiballismus,
1.4.6 Ablation of deep cerebellar nuclei for spasticity,
1.4.7 Cingulotomy and thalamic or subthalamic surgery for pain,
1.4.8 Mesencephalotomy or tractotomy for pain,
1.4.9 Ablations of subcortical temporal lobe structures for treatment 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 biopsy specimens,
1.4.13 Foreign body removal,
1.4.14 Implantation of radioactive material, and
1.4.15 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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Designation: F 1266 – 89 (Reapproved 2002)
Standard Performance Specification for
1
Cerebral Stereotactic Instruments
This standard is issued under the fixed designation F 1266; 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 (e) indicates an editorial change since the last revision or reapproval.
1. Scope 1.4.3 Needle or magnetic insertion, or both, for aneurysm
thrombosis,
1.1 This specification covers stereotactic instruments used
1.4.4 Thalamic or subthalamic operations for dystonia,
by neurosurgeons to assist in the placement of probes, such as
1.4.5 Thalamic or subthalamic operations for involuntary
cannulae, needles, forceps, or electrodes or to direct radiation
movements such as chorea or hemiballismus,
into brain regions or anatomical targets that are not visible on
1.4.6 Ablation of deep cerebellar nuclei for spasticity,
the surface.The general location of these regions is determined
1.4.7 Cingulotomy and thalamic or subthalamic surgery for
by measurements from landmarks visualized by X ray or other
pain,
means, such measurements being based on atlases derived
1.4.8 Mesencephalotomy or tractotomy for pain,
from anatomical studies and autopsy. Because of the anatomi-
1.4.9 Ablations of subcortical temporal lobe structures for
cal variability, more precise location in any single patient may
treatment of epilepsy,
be determined by physiological responses in that patient. The
1.4.10 Psychosurgical procedures,
degree of success in stereotactic surgery depends upon the
1.4.11 Implantation of depth stimulating electrodes for pain,
experience of the surgeon as well as the precision of the
1.4.12 Insertion of forceps or needle for obtaining biopsy
stereotactic instrument. Nevertheless, minimum standards of
specimens,
accuracy for stereotactic instruments that are within the range
1.4.13 Foreign body removal,
of variability of human anatomy must be maintained.
1.4.14 Implantation of radioactive material, and
1.2 For the purpose of this specification, a stereotactic
1.4.15 Biopsy or treatment of tumors.
instrument is a guiding device used in human neurosurgery for
1.5 This standard does not purport to address all of the
the purpose of directing an instrument or treating modality to
safety concerns, if any, associated with its use. It is the
a specific point within the brain by radiographic or other
responsibility of the user of this standard to establish appro-
visualization of landmarks.
priate safety and health practices and determine the applica-
1.3 Stereotactic instruments must be constructed to afford
bility of regulatory limitations prior to use.
the surgeon reliably reproducible accuracy in placing instru-
ments into target areas. Proper positioning of the probe is often
2. Referenced Documents
verified by X rays to control errors in calculation and to correct
2.1 NFPA Standard:
deflection of the probe during insertion. Physiological param-
2
NFPA 99 Health Care Facilities Code (56A and 76B-T)
eters may be used to further define the optimal target.
2.2 UL Standard:
1.4 At the present time, stereotactic instruments are used
3
UL 544 Electrical, Medical, and Dental Equipment
most frequently, but not exclusively in the following opera-
tions.The list is presented only to present examples and should
3. Terminology
not be construed to restrict advances or developments of new
3.1 Descriptions of Terms—The following descriptions of
procedures. For some applications it is not required to hit a
terms are for the purposes of this specification only. Other
point in space, but to hit a volume or make a lesion within a
nomenclature may be used throughout the literature and by
mass. For that purpose, devices other than those covered by
various manufacturers:
this specification may be employed, but should be restricted to
3.1.1 anatomical accuracy—the reliability or accuracy with
such uses:
which the tip of a probe can be introduced into a given
1.4.1 Thalamotomy for parkinsonism and other types of
anatomical target. Because of anatomical variability, a given
tremor,
anatomical structure or anatomical target may vary relative to
1.4.2 Electrode implantation for epilepsy,
1 2
This specification is under the jurisdiction of ASTM Committee F04 on Available from National Fire Protection Association (NFPA), 1 Batterymarch
Medical and Surgical Materials and Devices and is the direct responsibility of Park, Quincy, MA 02269-9101.
3
Subcommittee F04.31 on Neurosurgical Standards. Available from Underwriters Laboratories (UL), Corporate Progress, 333
Current edition approved Nov. 24, 1989. Published January 1990. Pfingsten Rd., Northbrook, IL 60062.
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