ASTM F1831-2017 Standard Specification for Cranial Traction Tongs and Halo External Spinal Immobilization Devices《颅骨牵引钳和晕轮外部脊椎固定装置的标准规格》.pdf

1、Designation: F1831 97 (Reapproved 2014)F1831 17Standard 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

2、 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 Scope*1.1 This specification covers standards a manufacturer shall meet in the designing,

3、manufacturing, testing, labeling, anddocumenting of halo and tong external spinal immobilization devices, but it is not to be construed as production methods, qualitycontrol techniques, manufacturers lot criteria, or clinical recommendations.1.2 This specification represents the best currently avail

4、able test procedures at this time and is a minimum safety andperformance standard.1.3 This specification covers only those halo and tong devices intended for use on humans for therapeutic purposes. Thisspecification assumes the user is well-trained in the procedures and maintenance of halo and tong

5、application and has the abilityto 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 cranialtraction tongs.1.5 Cranial traction tongs and halo devices are used to achieve an

6、d maintain optimal spinal alignment, in order to enhance fusionand decrease neurological deficit.1.6 Monitoring the progress of treatment after application of these devices is important, this should be done in accordance withthe manufacturers recommendation and guidelines pertaining to the specific

7、device.1.7 The values stated in both inch-pound and SI units are to be regarded separately as the standard. The values given inparentheses 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 s

8、tandard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibilityof the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatorylimitations prior to use.1.9 This international stan

9、dard was developed in accordance with internationally recognized principles on standardizationestablished in the Decision on Principles for the Development of International Standards, Guides and Recommendations issuedby the World Trade Organization Technical Barriers to Trade (TBT) Committee.2. Refe

10、renced Documents2.1 ASTM Standards:2F2052 Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the MagneticResonance EnvironmentF2119 Test Method for Evaluation of MR Image Artifacts from Passive ImplantsF2182 Test Method for Measurement of Radio Frequency Ind

11、uced Heating On or Near Passive Implants During MagneticResonance ImagingF2213 Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic ResonanceEnvironment1 This specification is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and

12、Devices and is the direct responsibility of SubcommitteeF04.31 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 asF1831 97(2006).97(2014). DOI: 10.1520/F1831-97R14.1

13、0.1520/F1831-17.2 For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at serviceastm.org. For Annual Book of ASTM Standardsvolume information, refer to the standards Document Summary page on the ASTM website.This document is not an ASTM standard and is

14、intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Becauseit 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 c

15、urrent versionof the standard as published by ASTM is to be considered the official document.*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 States1F2503 Practice for Marking M

16、edical Devices and Other Items 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 weighted cervical traction to a patient through invasi

17、ve attachment to the skull.This traction instrument is indicated for closed reduction of a cervical spine injury (that is, fracture or dislocation).3.1.1.1 adjustable tonga cranial traction tong that adjusts for size, pin positioning, or pin pressure.3.1.1.2 one-piece tonga rigid, single-piece, semi

18、circular cranial traction tong designed to accommodate a minimum of twoskull pins for mounting the device to the patients head below the equator.3.1.2 halo devicean external fixator for cervical stabilization that fastens by invasive means to a patients skull, and maintainsthe position of the skull

19、in relation to the thoracic area of the patient.3.1.3 halo ringthe portion of the halo device that fastens by invasive means to a patients skull below the head equator.3.1.3.1 closed loop halo ringa halo ring incorporating a closed loop anywhere in the design for purposes of structural integritywhen

20、 the ring is in use. This type of ring has multiple positioning options for the selection of pin sites and is mounted to the headwith multiple skull pins.3.1.3.2 head equatorthe greatest circumference of the head in the coronal aspect.3.1.3.3 open loop halo ringa halo ring with a posterior opening,

21、such that the part does not incorporate a closed loop anywherein the design for structural integrity. This ring has multiple position options for the selection of pin sites and is mounted to the headwith multiple skull pins.3.1.4 halo superstructurea rigid external framework used to maintain positio

22、ning of the skull and cervical spine in relationto the thoracic and lumbar spine. Connects the halo ring to halo vest.3.1.4.1 halo superstructure adjustment mechanismscomponents that allow adjustment of angles and distances between ringand uprights or vest and uprights.3.1.4.2 transverse bara rigid

23、horizontal component of the halo superstructure.3.1.4.3 upright bara rigid vertical component of the halo superstructure.3.1.4.4 vest attachment mechanismattaches inferiorly to the halo superstructure and connects to vest shell, maintainspositioning of the halo superstructure in relation to the vest

24、 shell.3.1.4.5 vest platepart of the superstructure attached to the vest shell to provide a stable mounting point for the vest attachmentmechanisms.3.1.5 halo vesta body-orthosis that serves as a mounting point for the halo and superstructure.3.1.5.1 C.P.R. accessmechanism in vest or superstructure

25、to allow quick access to patients chest for cardiopulmonaryresuscitation (C.P.R.).3.1.5.2 vest linerpadding worn inside of halo vest shell and against the skin which distributes the pressure of the vest shellagainst the skin.3.1.5.3 vest shellrigid portion of body orthosis.3.1.6 skull pina rigid dev

26、ice used to invasively anchor the halo ring or cranial traction tongs to the skull at selected mountingpoints.3.1.6.1 adjustable skull pin(1) a pin that is force controlled by a mechanical mechanism, that is, spring-loaded pressure pin.(2) a solid threaded pin that maintains pressure and fixation ag

27、ainst the skull through application of a calibrated torque.3.1.6.2 fixed skull pina pin that is mounted directly to a tong structure requiring a drilled skull hole for positioning andfixation. Pressure is not adjusted directly through the pin.3.1.7 traction bail (traction hoop)a device that may be a

28、ttached to the halo ring to facilitate the application of weightedlongitudinal traction.4. Conformance4.1 Presently, this specification is voluntary and not by law. A manufacturer may label a product as conforming to thisspecification only if the product indeed meets all the requirements of this spe

29、cification.3 Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http:/www.ansi.org.F1831 1725. Classification5.1 Halo External FixatorTypically a complete system consisting of the halo ring, skull pins, vest and superstructure. Theuniqueness o

30、f this system is its ability to provide self-contained cervical stabilization.5.2 Cranial Traction TongsEither a rigid single-piece, semicircular device or an adjustable device. Both designs haveaccommodations for at least two skull pins to be mounted to the skull. Typically designed to be fitted ov

31、er the top of the head andused for weighted cervical reduction or bed traction, or both, in the supine (bed restricted) patient.6. Magnetic Resonance Imaging Compatibility Requirements6.1 These halo external fixator and cranial traction tong magnetic resonance imaging (MRI) compatibility requirement

32、s areintended to protect the patient from harm during MRI imaging procedures.6.2 Manufacturers shall be responsible for testing the MRI safety and efficacy of the device.6.2.1 Test MethodsSee SectionsSection 13 1513.7. Mechanical Integrity7.1 The purpose of this requirement is to ensure the user and

33、 the patient that the halo external fixator or cranial traction tongs,or both, are capable of withstanding the externally imposed conditions normally encountered during the useful life of the device.7.2 Cranial Traction Tongs Mechanical Integrity:7.2.1 The cranial traction tongs and any of its compo

34、nents must be manufactured from a material that provides suitable rigidsupport to the skull pins and any other attached components including the traction weights.7.2.2 Cranial traction tong pins shall be sufficiently strong to resist at least two times the normal maximum static loads that maybe enco

35、untered during normal wear.7.2.3 The cranial traction tongs and its components shall be resistant to deformation and sufficiently rigid such that pin positionand pressure on the skull can be maintained at maximum manufacturers specified pin pressures.7.2.4 Adjustable skull pins shall be calibrated w

36、ith force indicators.7.2.5 Test MethodSee Section 10.7.3 Halo Skull Pin Mechanical Integrity:7.3.1 Halo skull pins shall be sufficiently strong to resist at least two times the normal maximum static and dynamic loads thatmay be encountered during normal use.7.3.2 Test MethodSee Section 11.7.4 Halo R

37、ing Mechanical Integrity:7.4.1 The halo ring shall be manufactured from a material that provides suitable rigid support to the attached skull pins andsuperstructure.7.4.2 The halo ring shall be resistant to deformation and sufficiently rigid such that pin position and pressure on the skull canbe mai

38、ntained at maximum manufacturers specified pin pressures.7.4.3 Test MethodSee Section 11.7.5 Halo Superstructure Assemblies Mechanical Integrity:7.5.1 A new halo external fixator device must be able to maintain structural integrity under normal physical loading when thesystem is fully assembled.7.5.

39、2 All mechanical components of the superstructure assembly must maintain rigidity and functional integrity throughout theuseful life of the product.7.5.3 Test MethodSee Section 12.7.6 Halo Vest Assembly Mechanical Integrity:7.6.1 The halo vest assembly must provide a stable platform for rigid attach

40、ment of the superstructure.7.6.2 The halo vest must provide an adjustable means of rigid fixation to the upper body of the patient.8. Performance Requirements8.1 The purpose of these requirements is to ensure that a halo external fixator or cranial tongs shall meet the minimumperformance requirement

41、s as originally designed. The halo and tongs device requirements should not vary from procedure toprocedure provided they are used and maintained according to the manufacturers recommendation.8.2 Halo External Fixator Performance Requirements:8.2.1 All mechanical fixation components will be manufact

42、ured out of corrosion resistant materials.8.2.2 All components shall be manufactured out of materials capable of providing functional integrity over the useful life of thedevice.8.2.3 The manufacturer will be responsible to maintain adequate mechanical test data or equivalent clinical data in regard

43、 tothe suitability of design, useful life and diagnostic imaging compatibility of the system.F1831 1738.2.4 The manufacturer will be responsible for supplying materials that are sterilizable by the manufacturers recommendedsterilization techniques.8.3 Halo Pin Performance Requirements:8.3.1 All port

44、ions of the skull pin that are in constant physical contact with the patients skin shall be manufactured frombiologically compatible material.8.3.2 All halo skull pins shall be supplied with a method for locking the pin in place in the halo ring.8.4 Halo Ring Performance RequirementsThe manufacturer

45、 will be responsible for providing a ring assembly that allows forthe following:8.4.1 The halo ring shall be able to easily and rigidly attach to the superstructure.8.4.2 The halo ring shall be able to easily accept a minimum of four halo skull pins.8.5 Halo Superstructure Assembly Performance Requi

46、rements:8.5.1 The halo vest and superstructure assemblies shall be able to be easily attached and detached from the halo ring with theappropriate tools.8.6 Halo Vest Performance Requirements:8.6.1 The vest material shall be trimmable and moldable with the appropriate tools to allow the medical perso

47、nnel to providesuitable adaptability to the various anatomies encountered.8.6.2 The manufacturer will provide suitable vest liner materials to maintain a substrate between the vest shell and the skin.These lining materials shall be free of any chemicals or toxins, or both, that could cause an allerg

48、ic response in the average patient.8.6.3 The halo vest shall have a vest attachment mechanism whereby the halo superstructure is suitably attached via theappropriate tools or mechanism.8.6.4 The halo vest shall allow rapid and complete access to the chest in the event of a cardiac emergency to allow

49、 access tothe chest for C.P.R.8.7 Halo Tools Performance RequirementsAll halo adjustment tools supplied by the manufacturer shall consistently performin the manner to which they were designed throughout the useful life of the product or as indicated by the manufacturersrecommendations.8.8 Cranial Traction Tongs Performance Requirements:8.8.1 All mechanical fixation components will be manufactured out of corrosion resistant materials.8.8.2 All components shall be manufactured out of materials capable of providing functional integrit