ASTM_F_1831_-_17.pdf

Designation:F183117Standard Specification forCranial Traction Tongs and Halo External SpinalImmobilization Devices1This standard is issued under the fixed designation F1831;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last revision.A number in parentheses indicates the year of last reapproval.Asuperscript epsilon()indicates an editorial change since the last revision or reapproval.1.Scope*1.1 This specification covers standards a manufacturer shallmeet in the designing,manufacturing,testing,labeling,anddocumenting of halo and tong external spinal immobilizationdevices,but it is not to be construed as production methods,quality control techniques,manufacturers lot criteria,or clini-cal recommendations.1.2 This specification represents the best currently availabletest procedures at this time and is a minimum safety andperformance standard.1.3 This specification covers only those halo and tongdevices intended for use on humans for therapeutic purposes.This specification assumes the user is well-trained in theprocedures and maintenance of halo and tong application andhas the ability to determine if an abnormality is treatable bythese procedures.1.4 This specification describes those devices commonlyknown as halo external fixation devices and what is known ascranial traction tongs.1.5 Cranial traction tongs and halo devices are used toachieve and maintain optimal spinal alignment,in order toenhance fusion and decrease neurological deficit.1.6 Monitoring the progress of treatment after application ofthese devices is important,this should be done in accordancewith the manufacturers recommendation and guidelines per-taining to the specific device.1.7 The values stated in both inch-pound and SI units are tobe regarded separately as the standard.The values given inparentheses are for information only.1.8 The following precautionary statement pertains only tothe test method portions,Sections 10 13:This standard doesnot purport to address all of the safety concerns,if any,associated with its use.It is the responsibility of the user of thisstandard to establish appropriate safety and health practicesand determine the applicability of regulatory limitations priorto use.1.9 This international standard was developed in accor-dance with internationally recognized principles on standard-ization established in the Decision on Principles for theDevelopment of International Standards,Guides and Recom-mendations issued by the World Trade Organization TechnicalBarriers to Trade(TBT)Committee.2.Referenced Documents2.1 ASTM Standards:2F2052 Test Method for Measurement of Magnetically In-duced Displacement Force on Medical Devices in theMagnetic Resonance EnvironmentF2119 Test Method for Evaluation of MR Image Artifactsfrom Passive ImplantsF2182 Test Method for Measurement of Radio FrequencyInduced Heating On or Near Passive Implants DuringMagnetic Resonance ImagingF2213 Test Method for Measurement of Magnetically In-duced Torque on Medical Devices in the Magnetic Reso-nance EnvironmentF2503 Practice for Marking Medical Devices and OtherItems for Safety in the Magnetic Resonance Environment2.2 IEC Standard:IEC 601-1 Medical Electrical Equipment33.Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 cranial traction tonga device providing weightedcervical traction to a patient through invasive attachment to theskull.This traction instrument is indicated for closed reductionof a cervical spine injury(that is,fracture or dislocation).3.1.1.1 adjustable tonga cranial traction tong that adjustsfor size,pin positioning,or pin pressure.1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibility ofSubcommittee F04.31 on Neurosurgical Standards.Current edition approved June 1,2017.Published July 2017.Originally approvedin 1997.Last previous edition approved in 2014 as F1831 97(2014).DOI:10.1520/F1831-17.2For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Service at serviceastm.org.For Annual Book of ASTMStandards volume information,refer to the standards Document Summary page onthe ASTM website.3Available from American National Standards Institute(ANSI),25 W.43rd St.,4th Floor,New York,NY 10036,http:/www.ansi.org.*A Summary of Changes section appears at the end of this standardCopyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United StatesThis international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for theDevelopment of International Standards,Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade(TBT)Committee.1 3.1.1.2 one-piece tonga rigid,single-piece,semicircularcranial traction tong designed to accommodate a minimum oftwo skull pins for m