ASTM F1831-17
(Specification)Standard Specification for Cranial Traction Tongs and Halo External Spinal Immobilization Devices
Standard Specification for Cranial Traction Tongs and Halo External Spinal Immobilization Devices
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.
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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.
Designation: F1831 −17
Standard Specification for
Cranial Traction Tongs and Halo External Spinal
1
Immobilization Devices
This standard is issued under the fixed designation F1831; 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* standard to establish appropriate safety and health practices
and determine the applicability of regulatory limitations prior
1.1 This specification covers standards a manufacturer shall
to use.
meet in the designing, manufacturing, testing, labeling, and
1.9 This international standard was developed in accor-
documenting of halo and tong external spinal immobilization
dance with internationally recognized principles on standard-
devices, but it is not to be construed as production methods,
ization established in the Decision on Principles for the
quality control techniques, manufacturer’s lot criteria, or clini-
Development of International Standards, Guides and Recom-
cal recommendations.
mendations issued by the World Trade Organization Technical
1.2 This specification represents the best currently available
Barriers to Trade (TBT) Committee.
test procedures at this time and is a minimum safety and
performance standard.
2. Referenced Documents
2
1.3 This specification covers only those halo and tong 2.1 ASTM Standards:
devices intended for use on humans for therapeutic purposes.
F2052 Test Method for Measurement of Magnetically In-
This specification assumes the user is well-trained in the duced Displacement Force on Medical Devices in the
procedures and maintenance of halo and tong application and
Magnetic Resonance Environment
has the ability to determine if an abnormality is treatable by F2119 Test Method for Evaluation of MR Image Artifacts
these procedures.
from Passive Implants
F2182 Test Method for Measurement of Radio Frequency
1.4 This specification describes those devices commonly
Induced Heating On or Near Passive Implants During
known as halo external fixation devices and what is known as
Magnetic Resonance Imaging
cranial traction tongs.
F2213 Test Method for Measurement of Magnetically In-
1.5 Cranial traction tongs and halo devices are used to
duced Torque on Medical Devices in the Magnetic Reso-
achieve and maintain optimal spinal alignment, in order to
nance Environment
enhance fusion and decrease neurological deficit.
F2503 Practice for Marking Medical Devices and Other
1.6 Monitoringtheprogressoftreatmentafterapplicationof
Items for Safety in the Magnetic Resonance Environment
these devices is important, this should be done in accordance
2.2 IEC Standard:
3
with the manufacturer’s recommendation and guidelines per-
IEC 601-1 Medical Electrical Equipment
taining to the specific device.
3. Terminology
1.7 The values stated in both inch-pound and SI units are to
3.1 Definitions of Terms Specific to This Standard:
be regarded separately as the standard. The values given in
3.1.1 cranial traction tong—a device providing weighted
parentheses are for information only.
cervical traction to a patient through invasive attachment to the
1.8 The following precautionary statement pertains only to
skull. This traction instrument is indicated for closed reduction
the test method portions, Sections10–13: This standard does
of a cervical spine injury (that is, fracture or dislocation).
not purport to address all of the safety concerns, if any,
3.1.1.1 adjustable tong—a cranial traction tong that adjusts
associated with its use. It is the responsibility of the user of this
for size, pin positioning, or pin pressure.
1 2
This specification is under the jurisdiction of ASTM Committee F04 on For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Medical and Surgical Materials and Devices and is the direct responsibility of contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Subcommittee F04.31 on Neurosurgical Standards. Standards volume information, refer to the standard’s Document Summary page on
CurrenteditionapprovedJune1,2017.PublishedJuly2017.Originallyapproved the ASTM website.
3
in 1997. Last previous edition approved in 2014 as F1831 – 97(2014). DOI: Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
10.1520/F1831-17. 4th Floor, New York, NY 10036, http://www.ansi.org.
*A Summary of Changes section appears at the end of this standard
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
...
This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: F1831 − 97 (Reapproved 2014) F1831 − 17
Standard Specification for
Cranial Traction Tongs and Halo External Spinal
1
Immobilization Devices
This standard is issued under the fixed designation F1831; 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 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 – 1315 of this specification-
::This 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.
2. Referenced Documents
2
2.1 ASTM Standards:
F2052 Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic
Resonance Environment
F2119 Test Method for Evaluation of MR Image Artifacts from Passive Implants
F2182 Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic
Resonance Imaging
F2213 Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance
Environment
1
This specification is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.31 on Neurosurgical Standards.
Current edition approved Oct. 1, 2014June 1, 2017. Published November 2014July 2017. Originally approved in 1997. Last previous edition approved in 20062014 as
F1831 – 97(2006).97(2014). DOI: 10.1520/F1831-97R14.10.1520/F1831-17.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
*A Summary of Changes section appears at the end of this standard
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F1831 − 17
F2503 Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
2.2 IEC Standard:
3
IEC 601-1 Medical Electrical Equipment
3. Terminology
3.1 Definitions of Terms Specific to This Standard:
3.1.1 cranial traction tong—a device providing weighted cervical traction to a patient through invasive attachment to the skull.
This traction instrument is indicat
...
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