ASTM F1719-96(2002)
(Specification)Standard Specification for Image-Interactive Stereotactic and Localization Systems
Standard Specification for Image-Interactive Stereotactic and Localization Systems
SCOPE
1.1 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.
1.2 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.
1.3 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.
1.4 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.
1.5 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.
1.6 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.
1.7 Robot—A power-driven servo-controlled system for controlling and advancing a probe according to a predetermined targeting program.
1.8 Digitizer—A device that is directed to indicate the position of a probe or point in stereotactic or other coordinates.
1.9 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.
1.10 The values stated in SI ...
General Information
Relations
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: F 1719 – 96 (Reapproved 2002)
Standard Specification for
1
Image-Interactive Stereotactic and Localization Systems
This standard is issued under the fixed designation F 1719; 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 used in imaging-guided stereotactic systems include radiogra-
phy, angiography, computed tomography, magnetic resonance
1.1 This specification covers the combined use of stereotac-
imaging, ultrasound, biplane and multiplane digital subtraction
tic instruments or systems with imaging techniques, to direct a
angiography, and positron emission scanning. However, it is
diagnostic or therapeutic modality into a specific target within
recognized that other modalities may be interfaced with
the brain, based on localization information derived from such
currentlyavailableandfuturestereotacticsystemsandthatnew
imaging techniques.
imaging modalities may evolve in the future. Standards for
1.2 For the purpose of this specification, a stereotactic
imaging devices will be dealt with in documents concerning
instrument or system is a guiding, aiming, or viewing device
such devices, and will not be addressed herein.
used in human neurosurgery for the purpose of manually
1.5 General types of diagnostic modalities include biopsy
directing a system or treating modality to a specific point
instruments, cannulas, endoscopes, electrodes, or other such
within the brain by radiographic, imaging, or other visualiza-
instruments.Therapeuticmodalitiesinclude,butarenotlimited
tion or identification of landmarks or targets or lesions.
to, heating, cooling, irradiation, laser, injection, tissue trans-
1.3 Definition of Stereotactic Imaging Systems—Types of
plantation, mechanical or ultrasonic disruption, and any mo-
imaging-guided systems all require three components: an
dality ordinarily used in cerebrospinal surgery.
imaging system, a stereotactic frame, or other physical device
1.6 Probe—Any system or modality directed by stereotactic
to identify the position of a point in space, and a method to
techniques, including mechanical or other probe, a device that
relate image-generated coordinates to frame or device coordi-
is inserted into the brain or points to a target, and stereotacti-
nates. See Performance Specification F 1266. The imaging
cally directed treatment or diagnostic modality.
technique must reliably and reproducibly generate data con-
cerning normal or abnormal anatomic structures, or both, that
NOTE 1—Examples presented throughout this specification are listed
can interface with the coordinate system of the stereotactic for clarity only; that does not imply that use should be restricted to the
procedures or examples listed.
frame or other stereotactic system. The imaging-guided sys-
tems must allow accurate direction of therapeutic, viewing or
1.7 Robot—A power-driven servo-controlled system for
diagnostic modalities to a specific point or volume or along a
controlling and advancing a probe according to a predeter-
specific trajectory within the brain or often accurate estimation
mined targeting program.
of structure size and location allowing biopsy, resection,
1.8 Digitizer—A device that is directed to indicate the
vaporization, implantation, aspiration, or other manipulation,
position of a probe or point in stereotactic or other coordinates.
or combination thereof. The standards of accuracy, reproduc-
1.9 Frameless System—A system that does not require a
ibility, and safety must be met for the imaging modality, the
stereotactic frame, that identifies and localizes a point or
stereotactic system, and the method of interface between the
volume in space by means of data registration, and a method to
two,andforthesystemasawhole.Themechanicalpartsofthe
relatethatpointorvolumetoitsrepresentationderivedfroman
imaging modality and the stereotactic system should be con-
imaging system.
structed to allow maximal interaction with minimal interfer-
1.10 The values stated in SI units are to be regarded as the
ence with each other, to minimize imaging artifact and distor-
standard.
tion, and minimize potential contamination of the surgical
1.11 Thefollowingprecautionarycaveatpertainsonlytothe
field.
test method portion, Section 3, of this specification: This
1.4 General Types of Imaging that May Be Used With
standard does not purport to address all of the safety concerns,
Stereotactic Systems—Currently employed imaging modalities
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 applicabil
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.