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ASTM-F1831:2006 Edition

ASTM-F1831:2006 Edition

$40.63

F1831-97(2006) Standard Specification for Cranial Traction Tongs and Halo External Spinal Immobilization Devices

Published By Publication Date Number of Pages
ASTM 2006 10
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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.

PDF Catalog

PDF Pages PDF Title
1 Scope
Referenced Documents
Terminology
2 Conformance
Classification
Magnetic Resonance Imaging Compatibility Requirements
Mechanical Integrity
3 Performance Requirements
Disclosures, Labeling, and Documentation
4 Test Method for Mechanical Integrity of Cranial Traction Tongs
FIG. 1
5 Test Method for Mechanical Integrity of Halo Rings and Attachment Bails
FIG. 2
7 Test Method for Mechanical Integrity of Halo Superstructures
FIG. 3
8 Test Method for Calculation of Induced Current Flow of Halo External Fixators or Cranial Traction Tongs, or Both
Test Method for Experimental Documentation of Current Induced Heating in Halo External Fixators or Cranial Traction Tongs, or Both, During Magnetic Resonance Imaging
FIG. 4
9 Optional Test Method for Clinical Evaluation of MR Compatibility of Halo External Fixators or Cranial Traction Tongs
FIG. 5
FIG. 6
10 Keywords

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