1.1This 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.
1.2This specification represents the best currently available test procedures at this time and is a minimum safety and performance standard.
1.3This 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.
1.4This specification describes those devices commonly known as halo external fixation devices and what is known as cranial traction tongs.
1.5Cranial traction tongs and halo devices are used to achieve and maintain optimal spinal alignment, in order to enhance fusion and decrease neurological deficit.
1.6Monitoring 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.
1.7The 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.
1.8The 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.
1.9This 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.