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.
