F04.31 - Neurosurgical Standards

ABSTRACT
This specification covers compositional, physical performance, and packaging requirements of preformed cranioplasty plates for covering skull defects. This specification does not cover toxicity nor biocompatibility of the material. Cranioplasty shall be fabricated in a variety of dimensions to accommodate various sized skull defects and shall contain multiple perforations. Cranioplasty plates shall conform to materials, manufacturing, packaging, and labeling requirements of this specification.
SCOPE
1.1 This specification covers preformed cranioplasty plates which do not require further alteration for covering skull defects. This specification covers compositional and physical performance and packaging requirements, but does not cover toxicity nor biocompatibility of the materials.  
1.2 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

SIGNIFICANCE AND USE
4.1 This practice provides minimum requirements for the ensurance of safety and efficacy. It provides a common language whereby the function of these surgical implants is described.
SCOPE
1.1 This practice covers requirements for the evaluation and specification of implantable shunts as related to resistance to flow, direction of flow, materials, radiopacity, mechanical properties, finish, sterility, and labeling of shunt assemblies.  
1.2 Devices to which this practice is applicable include, but are not limited to, those that are temporarily implanted to effect external drainage; or permanently implanted to effect shunting of fluid from a cerebral ventricle, a cyst, the subarachnoid space to the peritoneal cavity, the venous circulation, or some other suitable internal delivery site, and intracranial bypass.  
1.3 Limitations—Although this practice includes a standard test method for the evaluation of pressure/flow characteristics of shunts or shunt components, it does not include specific pressure/flow requirements.  
1.4 The following components that individually or in combination comprise shunt assemblies are considered to be within the scope of this practice: catheters (such as atrial, peritoneal, ventricular), connectors, implantable accessory devices (such as antisiphon devices and reservoirs), valved catheters, and valves.
Note 1: The standards in Section 2 contain provisions that, through reference in this text, constitute provisions of this practice. At the time of publication, the editions indicated are valid. All standards are subject to revision, and parties to agreements based on this practice are encouraged to investigate the possibility of applying the most recent editions of the standards indicated below. Devices or components, or both, whose structures are comparable to that outlined in these standards are acceptable.  
1.5 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

SCOPE
1.1 This practice covers recommended procedures for handling of neurosurgical intracranial aneurysm clips and the clip appliers (instruments).  
1.2 This practice is intended to inform hospital receiving personnel, central supply personnel, operating room personnel, and other individuals who will handle intracranial aneurysm clips and the instruments related thereto of recommended care and handling procedures to prevent damage of intracranial aneurysm clips and instruments.  
1.3 Handling and packaging procedures for the product are not a part of this practice and are covered in other practices.  
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

ABSTRACT
This specification covers the minimum safety and performance standards that a manufacturer should meet with regards to the design, manufacture, testing, labeling, and documentation of cranial traction tongs and halo external spinal immobilization devices intended for use on humans for therapeutic purposes. It is, however, not to be construed as production methods, quality control techniques, manufacturer's lot criteria, or clinical recommendations for such. Requirements to which the devices shall be tested on and conform accordingly to are magnetic resonance imaging (MRI) compatibility, mechanical integrity, design performance, induced current flow, and current induced heating.
SCOPE
1.1 This specification covers standards a manufacturer shall meet in the designing, manufacturing, testing, labeling, and documenting of halo and tong external spinal immobilization devices, but it is not to be construed as production methods, quality control techniques, manufacturer's lot criteria, or clinical recommendations.  
1.2 This specification represents the best currently available test procedures at this time and is a minimum safety and performance standard.  
1.3 This specification covers only those halo and tong devices intended for use on humans for therapeutic purposes. This specification assumes the user is well-trained in the procedures and maintenance of halo and tong application and has the ability to determine if an abnormality is treatable by these procedures.  
1.4 This specification describes those devices commonly known as halo external fixation devices and what is known as cranial traction tongs.  
1.5 Cranial traction tongs and halo devices are used to achieve and maintain optimal spinal alignment, in order to enhance fusion and decrease neurological deficit.  
1.6 Monitoring the progress of treatment after application of these devices is important, this should be done in accordance with the manufacturer's recommendation and guidelines pertaining to the specific device.  
1.7 The values stated in both inch-pound and SI units are to be regarded separately as the standard. The values given in parentheses are for information only.  
1.8 The following precautionary statement pertains only to the test method portions, Sections 10 – 13:  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.  
1.9 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

SIGNIFICANCE AND USE
4.1 This practice provides minimum requirements for the ensurance of safety and efficacy. It provides a common language whereby the function of these surgical implants is described.
SCOPE
1.1 This practice covers requirements for the evaluation and specification of implantable shunts as related to resistance to flow, direction of flow, materials, radiopacity, mechanical properties, finish, sterility, and labeling of shunt assemblies.  
1.2 Devices to which this practice is applicable include, but are not limited to, those that are temporarily implanted to effect external drainage; or permanently implanted to effect shunting of fluid from a cerebral ventricle, a cyst, the subarachnoid space to the peritoneal cavity, the venous circulation, or some other suitable internal delivery site, and intracranial bypass.  
1.3 Limitations—Although this practice includes a standard test method for the evaluation of pressure/flow characteristics of shunts or shunt components, it does not include specific pressure/flow requirements.  
1.4 The following components, that individually or in combination comprise shunt assemblies, are considered to be within the scope of this practice: catheters (such as atrial, peritoneal, ventricular), connectors, implantable accessory devices (such as antisiphon devices and reservoirs), valved catheters and valves.  
1.5 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.
Note 1: The following standards contain provisions that, through reference in this text, constitute provisions of this practice. At the time of publication, the editions indicated are valid. All standards are subject to revision, and parties to agreements based on this practice are encouraged to investigate the possibility of applying the most recent editions of the standards indicated below. Devices or components, or both, whose structures are comparable to that outlined in these standards are acceptable.

ABSTRACT
This specification covers the minimum safety and performance standards that a manufacturer should meet with regards to the design, manufacture, testing, labeling, and documentation of cranial traction tongs and halo external spinal immobilization devices intended for use on humans for therapeutic purposes. It is, however, not to be construed as production methods, quality control techniques, manufacturer's lot criteria, or clinical recommendations for such. Requirements to which the devices shall be tested on and conform accordingly to are magnetic resonance imaging (MRI) compatibility, mechanical integrity, design performance, induced current flow, and current induced heating.
SCOPE
1.1 This specification covers standards a manufacturer shall meet in the designing, manufacturing, testing, labeling, and documenting of halo and tong external spinal immobilization devices, but it is not to be construed as production methods, quality control techniques, manufacturer's lot criteria, or clinical recommendations.  
1.2 This specification represents the best currently available test procedures at this time and is a minimum safety and performance standard.  
1.3 This specification covers only those halo and tong devices intended for use on humans for therapeutic purposes. This specification assumes the user is well-trained in the procedures and maintenance of halo and tong application and has the ability to determine if an abnormality is treatable by these procedures.  
1.4 This specification describes those devices commonly known as halo external fixation devices and what is known as cranial traction tongs.  
1.5 Cranial traction tongs and halo devices are used to achieve and maintain optimal spinal alignment, in order to enhance fusion and decrease neurological deficit.  
1.6 Monitoring the progress of treatment after application of these devices is important, this should be done in accordance with the manufacturer's recommendation and guidelines pertaining to the specific device.  
1.7 The values stated in both inch-pound and SI units are to be regarded separately as the standard. The values given in parentheses are for information only.  
1.8 The following precautionary statement pertains only to the test method portions Sections 10 – 15 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.

SCOPE
1.1 This practice covers recommended procedures for handling of neurosurgical intracranial aneurysm clips and the clip appliers (instruments).  
1.2 This practice is intended to inform hospital receiving personnel, central supply personnel, operating room personnel, and other individuals who will handle intracranial aneurysm clips and the instruments related thereto of recommended care and handling procedures to prevent damage of intracranial aneurysm clips and instruments.  
1.3 Handling and packaging procedures for the product are not a part of this practice and are covered in other practices.

ABSTRACT
This specification covers compositional, physical performance, and packaging requirements of preformed cranioplasty plates for covering skull defects. This specification does not cover toxicity nor biocompatibility of the material. Cranioplasty shall be fabricated in a variety of dimensions to accommodate various sized skull defects and shall contain multiple perforations. Cranioplasty plates shall conform to materials, manufacturing, packaging, and labeling requirements of this specification.
SCOPE
1.1 This specification covers preformed cranioplasty plates which do not require further alteration for covering skull defects. This specification covers compositional and physical performance and packaging requirements, but does not cover toxicity nor biocompatibility of the materials.

ABSTRACT
This specification covers compositional, physical performance, and packaging requirements of preformed cranioplasty plates for covering skull defects. This specification does not cover toxicity nor biocompatibility of the material. Cranioplasty shall be fabricated in a variety of dimensions to accommodate various sized skull defects and shall contain multiple perforations. Cranioplasty plates shall conform to materials, manufacturing, packaging, and labeling requirements of this specification.
SCOPE
1.1 This specification covers preformed cranioplasty plates which do not require further alteration for covering skull defects. This specification covers compositional and physical performance and packaging requirements, but does not cover toxicity nor biocompatibility of the materials.

SCOPE
1.1 This practice covers recommended procedures for handling of neurosurgical intracranial aneurysm clips and the clip appliers (instruments).
1.2 This practice is intended to inform hospital receiving personnel, central supply personnel, operating room personnel, and other individuals who will handle intracranial aneurysm clips and the instruments related thereto of recommended care and handling procedures to prevent damage of intracranial aneurysm clips and instruments.
1.3 Handling and packaging procedures for the product are not a part of this practice and are covered in other practices.

SIGNIFICANCE AND USE
This practice provides minimum requirements for the ensurance of safety and efficacy. It provides a common language whereby the function of these surgical implants is described.
SCOPE
1.1 This practice covers requirements for the evaluation and specification of implantable shunts as related to resistance to flow, direction of flow, materials, radiopacity, mechanical properties, finish, sterility, and labeling of shunt assemblies.
1.2 Devices to which this practice is applicable include, but are not limited to, those that are temporarily implanted to effect external drainage; or permanently implanted to effect shunting of fluid from a cerebral ventricle, a cyst, the subarachnoid space to the peritoneal cavity, the venous circulation, or some other suitable internal delivery site, and intracranial bypass.
1.3 Limitations Although this practice includes a standard test method for the evaluation of pressure/flow characteristics of shunts or shunt components, it does not include specific pressure/flow requirements.
1.4 The following components, that individually or in combination comprise shunt assemblies, are considered to be within the scope of this practice: catheters (such as atrial, peritoneal, ventricular), connectors, implantable accessory devices (such as antisiphon devices and reservoirs), valved catheters and valves.
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.Note 1
The following standards contain provisions that, through reference in this text, constitute provisions of this practice. At the time of publication, the editions indicated are valid. All standards are subject to revision, and parties to agreements based on this practice are encouraged to investigate the possibility of applying the most recent editions of the standards indicated below. Devices or components, or both, whose structures are comparable to that outlined in these standards are acceptable.
1.5 This test method provides the procedure and acceptance criteria upon which a judgment of acceptable radiopacity can be based and labeling claims substantiated.

ABSTRACT
This specification covers the minimum safety and performance standards that a manufacturer should meet with regards to the design, manufacture, testing, labeling, and documentation of cranial traction tongs and halo external spinal immobilization devices intended for use on humans for therapeutic purposes. It is, however, not to be construed as production methods, quality control techniques, manufacturer's lot criteria, or clinical recommendations for such. Requirements to which the devices shall be tested on and conform accordingly to are magnetic resonance imaging (MRI) compatibility, mechanical integrity, design performance, induced current flow, and current induced heating.
SCOPE
1.1 This specification covers standards a manufacturer shall meet in the designing, manufacturing, testing, labeling, and documenting of halo and tong external spinal immobilization devices, but it is not to be construed as production methods, quality control techniques, manufacturer's lot criteria, or clinical recommendations.
1.2 This specification represents the best currently available test procedures at this time and is a minimum safety and performance standard.
1.3 This specification covers only those halo and tong devices intended for use on humans for therapeutic purposes. This specification assumes the user is well-trained in the procedures and maintenance of halo and tong application and has the ability to determine if an abnormality is treatable by these procedures.
1.4 This specification describes those devices commonly known as halo external fixation devices and what is known as cranial traction tongs.
1.5 Cranial traction tongs and halo devices are used to achieve and maintain optimal spinal alignment, in order to enhance fusion and decrease neurological deficit.
1.6 Monitoring the progress of treatment after application of these devices is important, this should be done in accordance with the manufacturer's recommendation and guidelines pertaining to the specific device.
1.7 The values stated in both inch-pound and SI units are to be regarded separately as the standard. The values given in parentheses are for information only.
1.8 The following precautionary statement pertains only to the test method portions Sections 10-15 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.

SCOPE
1.1 This practice covers requirements for the evaluation and specification of implantable shunts as related to resistance to flow, direction of flow, materials, radiopacity, mechanical properties, finish, sterility, and labeling of shunt assemblies.
1.2 Devices to which this practice is applicable include, but are not limited to, those that are temporarily implanted to effect external drainage; or permanently implanted to effect shunting of fluid from a cerebral ventricle, a cyst, the subarachnoid space to the peritoneal cavity, the venous circulation, or some other suitable internal delivery site, and intracranial bypass.
1.3 Limitations-- Although this practice includes a standard test method for the evaluation of pressure/flow characteristics of shunts or shunt components, it does not include specific pressure/flow requirements.
1.4 The following components, that individually or in combination comprise shunt assemblies, are considered to be within the scope of this practice: catheters (such as atrial, peritoneal, ventricular), connectors, implantable accessory devices (such as antisiphon devices and reservoirs), valved catheters and valves.
1.5 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.Note 1--The following standards contain provisions that, through reference in this text, constitute provisions of this practice. At the time of publication, the editions indicated are valid. All standards are subject to revision, and parties to agreements based on this practice are encouraged to investigate the possibility of applying the most recent editions of the standards indicated below. Devices or components, or both, whose structures are comparable to that outlined in these standards are acceptable.

SCOPE
1.1 This specification covers requirements for the disclosure of specific characteristics of screw-type adjustable clamps that are designed for the gradual permanent occlusion of carotid arteries. These devices consist of an implantable portion and an externally projecting removable screwdriver (see Fig. 1).  
1.2 The following precautionary caveat pertains only to the test method portion, Section 5, of this specification: This standard does not purport to address all of the safety problems, 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.

SCOPE
1.1 This specification covers preformed cranioplasty plates which do not require further alteration for covering skull defects. This specification covers compositional and physical performance and packaging requirements, but does not cover toxicity nor biocompatibility of the materials.

SCOPE
1.1 This practice covers recommended procedures for handling of neurosurgical intracranial aneurysm clips and the clip appliers (instruments).  
1.2 This practice is intended to inform hospital receiving personnel, central supply personnel, operating room personnel, and other individuals who will handle intracranial aneurysm clips and the instruments related thereto of recommended care and handling procedures to prevent damage of intracranial aneurysm clips and instruments.  
1.3 Handling and packaging procedures for the product are not a part of this practice and are covered in other practices.

SCOPE
1.1 This specification covers preformed cranioplasty plates that allow alteration for covering skull defects.

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.
1.5 This standard may involve hazardous materials, operations, and equipment. This standard does not purport to address all of the safety problems 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.

SCOPE
1.1 This practice covers recommended procedures for handling neurosurgical implants and instruments.  
1.2 This practice is intended to inform hospital receiving personnel, central supply personnel, operating room personnel, and other individuals who will handle neurosurgical implants and instruments of recommended care and handling procedures to prevent damage of neurosurgical implants and instruments.

SCOPE
1.1 This specification covers standards a manufacturer shall meet in the designing, manufacturing, testing, labeling, and documenting of halo and tong external spinal immobilization devices, but it is not to be construed as production methods, quality control techniques, manufacturer's lot criteria, or clinical recommendations.
1.2 This specification represents the best currently available test procedures at this time and is a minimum safety and performance standard.
1.3 This specification covers only those halo and tong devices intended for use on humans for therapeutic purposes. This specification assumes the user is well-trained in the procedures and maintenance of halo and tong application and has the ability to determine if an abnormality is treatable by these procedures.
1.4 This specification describes those devices commonly known as halo external fixation devices and what is known as cranial traction tongs.
1.5 Cranial traction tongs and halo devices are used to achieve and maintain optimal spinal alignment, in order to enhance fusion and decrease neurological deficit.
1.6 Monitoring the progress of treatment after application of these devices is important, this should be done in accordance with the manufacturer's recommendation and guidelines pertaining to the specific device.
1.7 The values stated in both inch-pound and SI units are to be regarded separately as the standard. The values given in parentheses are for information only.
1.8 The following precautionary statement pertains only to the test method portions Sections 10-15 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.

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 ...

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.

SCOPE
1.1 This practice covers recommended procedures for handling of neurosurgical intracranial aneurysm clips and the clip appliers (instruments).
1.2 This practice is intended to inform hospital receiving personnel, central supply personnel, operating room personnel, and other individuals who will handle intracranial aneurysm clips and the instruments related thereto of recommended care and handling procedures to prevent damage of intracranial aneurysm clips and instruments.
1.3 Handling and packaging procedures for the product are not a part of this practice and are covered in other practices.

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.

SCOPE
1.1 This specification covers requirements for the disclosure of specific characteristics of screw-type adjustable clamps that are designed for the gradual permanent occlusion of carotid arteries. These devices consist of an implantable portion and an externally projecting removable screwdriver (see Fig. 1).
1.2 The following precautionary caveat pertains only to the test method portion, Section 5, 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.

SCOPE
1.1 This practice covers recommended procedures for handling neurosurgical implants and instruments.
1.2 This practice is intended to inform hospital receiving personnel, central supply personnel, operating room personnel, and other individuals who will handle neurosurgical implants and instruments of recommended care and handling procedures to prevent damage of neurosurgical implants and instruments.

SCOPE
1.1 This specification covers preformed cranioplasty plates which do not require further alteration for covering skull defects. This specification covers compositional and physical performance and packaging requirements, but does not cover toxicity nor biocompatibility of the materials.

SCOPE
1.1 This practice covers recommended procedures for handling neurosurgical implants and instruments.
1.2 This practice is intended to inform hospital receiving personnel, central supply personnel, operating room personnel, and other individuals who will handle neurosurgical implants and instruments of recommended care and handling procedures to prevent damage of neurosurgical implants and instruments.
WITHDRAWN RATIONALE
This practice covered recommended procedures for handling neurosurgical implants and instruments.
Formerly under the jurisdiction of Committee F04 on Medical and Surgical Materials and Devices, this practice was withdrawn in July 2017 in accordance with section 10.6.3 of the Regulations Governing ASTM Technical Committees, which requires that standards shall be updated by the end of the eighth year since the last approval date.

SIGNIFICANCE AND USE
The purpose of a stereotactic apparatus is to guide the advance of an electrode or other probe accurately and in a controlled fashion to a given point in space, relative to the apparatus, to the stereotactic target. Thus, when the apparatus is attached to the skull, the electrode or probe can be advanced to a given geographical point within the cranial cavity, near the base of the skull or in the spinal canal.
As generally employed, the ventricles or cavities within the brain or other neurosurgical landmarks are identified roentgenographically by other means and, by consulting an atlas or other table, the mean distance and direction between the visualized landmark and a given anatomical target are measured. The electrode or probe is then inserted to the stereotactic target, that is, the point in space which is calculated from the distance and direction between the visualized landmark and the desired target in relation to the coordinate system of the stereotactic apparatus.
It is recognized that there is considerable anatomical variability in the size and shape of the central nervous system so that the target point that is identified from the atlas or table is only approximate. Usually, where possible, physiological verification may also be obtained. One must distinguish between the anatomical accuracy, which is inexact because of the variability of brains, and the mechanical accuracy, which is a function of the precision of the stereotactic instrument.
The requirements set forth herein are concerned only with the mechanical accuracy of stereotactic instruments. It is also recognized that once minimum standards for mechanical accuracy have been obtained, increased mechanical precision will not necessarily lead to increased anatomical precision.
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....

ABSTRACT
This specification covers requirements for the disclosure of specific characteristics of screw-type adjustable clamps that are designed for the gradual permanent occlusion of carotid arteries. These devices consist of an implantable portion and an externally projecting removable screwdriver. The manufacturer shall disclose the generic names of the materials used in the manufacture of the clamp, the advance ratio, pressure plate induced laceration of vessel, and slip resistance of the clamp.
SCOPE
1.1 This specification covers requirements for the disclosure of specific characteristics of screw-type adjustable clamps that are designed for the gradual permanent occlusion of carotid arteries. These devices consist of an implantable portion and an externally projecting removable screwdriver (see Fig. 1).
1.2 The following precautionary caveat pertains only to the test method portion, Section 5, 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.
WITHDRAWN RATIONALE
This specification covered requirements for the disclosure of specific characteristics of screw-type adjustable clamps that are designed for the gradual permanent occlusion of carotid arteries.
Formerly under the jurisdiction of Committee F04 on Medical and Surgical Materials and Devices, this specification was withdrawn in July 2017 in accordance with section 10.6.3 of the Regulations Governing ASTM Technical Committees, which requires that standards shall be updated by the end of the eighth year since the last approval date.

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...

ABSTRACT
This specification covers preformed cranioplasty plates that allow alteration of dimensions to fit a particular skull defect. Cranioplasty plates shall be manufactured from unalloyed titanium, wrought cobalt-20chromium-15tungsten-10nickel alloy, or wrought titanium-6aluminum-4vanadium extra low interstitial alloy with multiple perforations and in various dimensions, with the thickness and shape varying with need. The shape, in particular, may be altered by the neurosurgeon such as to contour it to conform to the normal configuration and symmetry of the skull at various defect sites. Should the plates require metallic sutures or screws as fasteners, they shall be of the same metallic composition as the cranioplasty plates.
SCOPE
1.1 This specification covers preformed cranioplasty plates that allow alteration for covering skull defects.
WITHDRAWN RATIONALE
This specification covers preformed cranioplasty plates that allow alteration for covering skull defects.
Formerly under the jurisdiction of Committee F04 on Medical and Surgical Materials and Devices, this specification was withdrawn in January 2011 in accordance with section 10.5.3.1 of the Regulations Governing ASTM Technical Committees, which requires that standards shall be updated by the end of the eighth year since the last approval date.

ABSTRACT
This specification covers the requirements for specific characteristics and appropriate test requirements for, and disclosure of self-closing aneurysm clips that are intended for permanent implantation. Miniatures of "microclips" that are not intended for the obliteration of aneurysms are excluded from this specification.
SCOPE
1.1 This specification covers requirements for the specific characteristics of self-closing aneurysm clips that are intended for permanent implantation. Appropriate test requirements are also included.
1.2 Since all of the properties that contribute to aneurysm clip performance may not be known, this specification is intended to reflect the state of our knowledge to date.
1.3 Miniatures of "microclips" that are not intended for the obliteration of aneurysms are excluded from this specification.
WITHDRAWN RATIONALE
This specification covers requirements for the specific characteristics of self-closing aneurysm clips that are intended for permanent implantation. Appropriate test requirements are also included.
Formerly under the jurisdiction of Committee F04 on Medical and Surgical Materials and Devices, this specification was withdrawn in March 2009 in accordance with section 10.5.3.1 of the Regulations Governing ASTM Technical Committees, which requires that standards shall be updated by the end of the eighth year since the last approval date.