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ASTM F 1719 Document Information:
Title
Standard Specification for Image-Interactive Stereotactic and Localization Systems
ASTM International
Publication Date:
Jun 10, 1996
Scope:
This specification covers the combined use of stereotactic
instruments or systems with imaging techniques, to direct a
diagnostic or therapeutic modality into a specific target within
the brain, based on localization information derived from such
imaging techniques.
For the purpose of this specification, a stereotactic instrument
or system is a guiding, aiming, or viewing device used in human
neurosurgery for the purpose of manually directing a system or
treating modality to a specific point within the brain by
radiographic, imaging, or other visualization or identification of
landmarks or targets or lesions.
Definition of Stereotactic Imaging Systems—Types of
imaging-guided systems all require three components: an imaging
system, a stereotactic frame, or other physical device to identify
the position of a point in space, and a method to relate
image-generated coordinates to frame or device coordinates. See
Performance Specification F 1266. The imaging technique must
reliably and reproducibly generate data concerning normal or
abnormal anatomic structures, or both, that can interface with the
coordinate system of the stereotactic frame or other stereotactic
system. The imaging-guided systems must allow accurate direction of
therapeutic, viewing or diagnostic modalities to a specific point
or volume or along a specific trajectory within the brain or often
accurate estimation of structure size and location allowing biopsy,
resection, vaporization, implantation, aspiration, or other
manipulation, or combination thereof. The standards of accuracy,
reproducibility, and safety must be met for the imaging modality,
the stereotactic system, and the method of interface between the
two, and for the system as a whole. The mechanical parts of the
imaging modality and the stereotactic system should be constructed
to allow maximal interaction with minimal interference with each
other, to minimize imaging artifact and distortion, and minimize
potential contamination of the surgical field.
General Types of Imaging that May Be Used With Stereotactic
Systems—Currently employed imaging modalities used in
imaging-guided stereotactic systems include radiography,
angiography, computed tomography, magnetic resonance imaging,
ultrasound, biplane and multiplane digital subtraction angiography,
and positron emission scanning. However, it is recognized that
other modalities may be interfaced with currently available and
future stereotactic systems and that new imaging modalities may
evolve in the future. Standards for imaging devices will be dealt
with in documents concerning such devices, and will not be
addressed herein.
General types of diagnostic modalities include biopsy
instruments, cannulas, endoscopes, electrodes, or other such
instruments. Therapeutic modalities include, but are not limited
to, heating, cooling, irradiation, laser, injection, tissue
transplantation, mechanical or ultrasonic disruption, and any
modality ordinarily used in cerebrospinal surgery.
Probe—Any system or modality directed by stereotactic
techniques, including mechanical or other probe, a device that is
inserted into the brain or points to a target, and stereotactically
directed treatment or diagnostic modality.
NOTE 1—Examples presented throughout this specification are
listed for clarity only; that does not imply that use should be
restricted to the procedures or examples listed.
Robot—A power-driven servo-controlled system for
controlling and advancing a probe according to a predetermined
targeting program.
Digitizer—A device that is directed to indicate the
position of a probe or point in stereotactic or other
coordinates.
Frameless System—A system that does not require a
stereotactic frame, that identifies and localizes a point or volume
in space by means of data registration, and a method to relate that
point or volume to its representation derived from an imaging
system.
The values stated in SI units are to be regarded as the
standard.
The following precautionary caveat pertains only to the test
method portion, Section 3, of this specification: 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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