ASTM F1719-96(2008)

Standard Specification for Image-Interactive Stereotactic and Localization Systems (Withdrawn 2017)

ABSTRACT
This specification covers the different types, appropriate applicability, and safety and sterilizability requirements that pertain to 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. 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.
SIGNIFICANCE AND USE
The following uses of imaging-guided stereotactic surgery have been documented in the literature, and are presented as examples. This list is not inclusive of all the techniques presently being used, and certainly does not reflect nor intend to impede the development of new techniques in the future:
Biopsy of intracranial tissue,
Implantation of radioisotopes by various techniques,
Aspiration of cysts,
Aspiration of abcesses,
Instillation of therapeutic agents, including antibiotics, chemotherapeutic agents, tissue, drugs, and neurotransmitters,
Insertion of electrodes for recording of electrical activity or impedance,
Insertion of probes for lesion production in functional neurosurgery,
Insertion of electrodes for stimulation,
Aspiration of hematomas,
Resection of mass lesions,
Laser vaporization or removal of intracranial tissue,
Guidance of externally delivered radiation therapy,
Adjunct to open surgical procedures,
Placement of catheters into ventricles, cysts, and so forth, and
Hyperthermia.
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, co...

General Information

• Status: Withdrawn
• Publication Date: 31-Jan-2008
• Withdrawal Date: 16-Jul-2017
• ICS: 11.040.99 - Other medical equipment
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.31 - Neurosurgical Standards

Relations

• Replaces: ASTM F1719-96(2002) - Standard Specification for Image-Interactive Stereotactic and Localization Systems
• Effective Date: 01-Feb-2008

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: F1719 −96 (Reapproved 2008)
Standard Specification for
1
Image-Interactive Stereotactic and Localization Systems
This standard is issued under the fixed designation F1719; 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 General Types of Imaging that May Be Used With
Stereotactic Systems—Currently employed imaging modalities
1.1 This specification covers the combined use of stereot-
used in imaging-guided stereotactic systems include
actic instruments or systems with imaging techniques, to direct
radiography, angiography, computed tomography, magnetic
a diagnostic or therapeutic modality into a specific target
resonance imaging, ultrasound, biplane and multiplane digital
within the brain, based on localization information derived
subtraction angiography, and positron emission scanning.
from such imaging techniques.
However, it is recognized that other modalities may be inter-
1.2 For the purpose of this specification, a stereotactic
faced with currently available and future stereotactic systems
instrument or system is a guiding, aiming, or viewing device
and that new imaging modalities may evolve in the future.
used in human neurosurgery for the purpose of manually
Standards for imaging devices will be dealt with in documents
directing a system or treating modality to a specific point
concerning such devices, and will not be addressed herein.
within the brain by radiographic, imaging, or other visualiza-
tion or identification of landmarks or targets or lesions. 1.5 General types of diagnostic modalities include biopsy
instruments, cannulas, endoscopes, electrodes, or other such
1.3 Definition of Stereotactic Imaging Systems—Types of
instruments.Therapeuticmodalitiesinclude,butarenotlimited
imaging-guided systems all require three components: an
to, heating, cooling, irradiation, laser, injection, tissue
imaging system, a stereotactic frame, or other physical device
transplantation, mechanical or ultrasonic disruption, and any
to identify the position of a point in space, and a method to
modality ordinarily used in cerebrospinal surgery.
relate image-generated coordinates to frame or device coordi-
nates. See Performance Specification F1266. The imaging
1.6 Probe—Any system or modality directed by stereotactic
technique must reliably and reproducibly generate data con-
techniques, including mechanical or other probe, a device that
cerning normal or abnormal anatomic structures, or both, that
is inserted into the brain or points to a target, and stereotacti-
can interface with the coordinate system of the stereotactic
cally directed treatment or diagnostic modality.
frame or other stereotactic system. The imaging-guided sys-
tems must allow accurate direction of therapeutic, viewing or NOTE1—Examplespresentedthroughoutthisspecificationarelistedfor
clarity only; that does not imply that use should be restricted to the
diagnostic modalities to a specific point or volume or along a
procedures or examples listed.
specific trajectory within the brain or often accurate estimation
of structure size and location allowing biopsy, resection,
1.7 Robot—A power-driven servo-controlled system for
vaporization, implantation, aspiration, or other manipulation,
controlling and advancing a probe according to a predeter-
or combination thereof. The standards of accuracy,
mined targeting program.
reproducibility, and safety must be met for the imaging
1.8 Digitizer—A device that is directed to indicate the
modality, the stereotactic system, and the method of interface
position of a probe or point in stereotactic or other coordinates.
between the two, and for the system as a whole. The mechani-
cal parts of the imaging modality and the stereotactic system
1.9 Frameless System—A system that does not require a
should be constructed to allow maximal interaction with
stereotactic frame, that identifies and localizes a point or
minimal interference with each other, to minimize imaging
volume in space by means of data registration, and a method to
artifactanddistortion,andminimizepotentialcontaminationof
relatethatpointorvolumetoitsrepresentationderivedfroman
the surgical field.
imaging system.
1.10 The values stated in SI units are to be regarded as the
standard.
1
This specification is under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devices and is the direct responsibility of
1.11 Thefollowingprecautionarycaveatpertainsonlytothe
Subcommittee F04.31 on Neurosurgical Standards.
test method portion, Section 3, of this specification: This
Current edition approved Feb. 1, 2008. Publi
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