ASTM F1831-1997(2006) 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范》.pdf

1、Designation: F 1831 97 (Reapproved 2006)Standard Specification forCranial Traction Tongs and Halo External SpinalImmobilization Devices1This standard is issued under the fixed designation F 1831; the number immediately following the designation indicates the year oforiginal adoption or, in the case

2、of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon (e) indicates an editorial change since the last revision or reapproval.1. Scope1.1 This specification covers standards a manufacturer shallmeet in the designing, manufacturing

3、, 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 proc

4、edures 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 andh

5、as 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

6、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 valu

7、es 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 10-15 of this specification:This standard does not purport to ad

8、dress all of the safetyconcerns, if any, associated with its use. It is the responsibilityof the user of this standard to establish appropriate safety andhealth practices and determine the applicability of regulatorylimitations prior to use.2. Referenced Documents2.1 IEC Standard:IEC 601-1 Medical E

9、lectrical Equipment23. 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 (tha

10、t is, fracture or dislocation).3.1.1.1 adjustable tonga cranial traction tong that adjustsfor size, pin positioning, or pin pressure.3.1.1.2 one-piece tonga rigid, single-piece, semicircularcranial traction tong designed to accommodate a minimum oftwo skull pins for mounting the device to the patien

11、ts headbelow the equator.3.1.2 halo devicean external fixator for cervical stabiliza-tion that fastens by invasive means to a patients skull, andmaintains the position of the skull in relation to the thoracicarea of the patient.3.1.3 halo ringthe portion of the halo device that fastensby invasive me

12、ans to a patients skull below the head equator.3.1.3.1 closed loop halo ringa halo ring incorporating aclosed loop anywhere in the design for purposes of structuralintegrity when the ring is in use. This type of ring has multiplepositioning options for the selection of pin sites and is mountedto the

13、 head with multiple skull pins.3.1.3.2 head equatorthe greatest circumference of thehead in the coronal aspect3.1.3.3 open loop halo ringa halo ring with a posterioropening, such that the part does not incorporate a closed loopanywhere in the design for structural integrity. This ring hasmultiple po

14、sition options for the selection of pin sites and ismounted to the head with multiple skull pins.3.1.4 halo superstructurea rigid external framework usedto maintain positioning of the skull and cervical spine inrelation to the thoracic and lumbar spine. Connects the haloring to halo vest.1This speci

15、fication is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Material and Devices and is the direct responsibility ofSubcommittee F04.31 on Neurosurgical Standards.Current edition approved March 1, 2006. Published April 2006. Originallyapproved in 1997. Last previous edition appro

16、ved in 1997 as F 1831 97.2Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.3.1.4.1 halo superstructure adjustment mechanisms com

17、-ponents that allow adjustment of angles and distances betweenring and uprights or vest and uprights.3.1.4.2 transverse bara rigid horizontal component of thehalo superstructure.3.1.4.3 upright bara rigid vertical component of the halosuperstructure.3.1.4.4 vest attachment mechanismattaches inferior

18、ly tothe halo superstructure and connects to vest shell, maintainspositioning of the halo superstructure in relation to the vestshell.3.1.4.5 vest platepart of the superstructure attached to thevest shell to provide a stable mounting point for the vestattachment mechanisms.3.1.5 halo vesta body-orth

19、osis that serves as a mountingpoint for the halo and superstructure.3.1.5.1 C.P.R. accessmechanism in vest or superstructureto allow quick access to patients chest for cardiopulmonaryresuscitation (C.P.R.).3.1.5.2 vest linerpadding worn inside of halo vest shelland against the skin which distributes

20、 the pressure of the vestshell against the skin.3.1.5.3 vest shellrigid portion of body orthosis.3.1.6 skull pina rigid device used to invasively anchor thehalo ring or cranial traction tongs to the skull at selectedmounting points.3.1.6.1 adjustable skull pin(1) a pin that is force con-trolled by a

21、 mechanical mechanism, that is, spring-loadedpressure pin. (2) a solid threaded pin that maintains pressureand fixation against the skull through application of a cali-brated torque.3.1.6.2 fixed skull pina pin that is mounted directly to atong structure requiring a drilled skull hole for positionin

22、g andfixation. Pressure is not adjusted directly through the pin.3.1.7 traction bail (traction hoop)a device that may beattached to the halo ring to facilitate the application ofweighted longitudinal traction.4. Conformance4.1 Presently, this specification is voluntary and not by law.A manufacturer

23、may label a product as conforming to thisspecification only if the product indeed meets all the require-ments of this specification.5. Classification5.1 Halo External FixatorTypically a complete systemconsisting of the halo ring, skull pins, vest and superstructure.The uniqueness of this system is i

24、ts 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 tothe skull. Typically designed to be fitted over the top of thehea

25、d and used for weighted cervical reduction or bed traction,or both, in the supine (bed restricted) patient.6. Magnetic Resonance Imaging CompatibilityRequirements6.1 These halo external fixator and cranial traction tongmagnetic resonance imaging (MRI) compatibility requirementsare intended to protec

26、t the patient from harm during MRIimaging procedures.6.2 Manufacturers shall be responsible for testing the MRIsafety and efficacy of the device.6.2.1 Test MethodsSee Sections 13-15.7. Mechanical Integrity7.1 The purpose of this requirement is to ensure the user andthe patient that the halo external

27、 fixator or cranial tractiontongs, or both, are capable of withstanding the externallyimposed conditions normally encountered during the useful lifeof the device.7.2 Cranial Traction Tongs Mechanical Integrity:7.2.1 The cranial traction tongs and any of its componentsmust be manufactured from a mate

28、rial that provides suitablerigid support to the skull pins and any other attached compo-nents including the traction weights.7.2.2 Cranial traction tong pins shall be sufficiently strong toresist at least two times the normal maximum static loads thatmay be encountered during normal wear.7.2.3 The c

29、ranial traction tongs and its components shall beresistant to deformation and sufficiently rigid such that pinposition and pressure on the skull can be maintained atmaximum manufacturers specified pin pressures.7.2.4 Adjustable skull pins shall be calibrated with forceindicators.7.2.5 Test MethodSee

30、 Section 10.7.3 Halo Skull Pin Mechanical Integrity:7.3.1 Halo skull pins shall be sufficiently strong to resist atleast two times the normal maximum static and dynamic loadsthat may be encountered during normal use.7.3.2 Test MethodSee Section 11.7.4 Halo Ring Mechanical Integrity:7.4.1 The halo ri

31、ng shall be manufactured from a materialthat provides suitable rigid support to the attached skull pinsand superstructure.7.4.2 The halo ring shall be resistant to deformation andsufficiently rigid such that pin position and pressure on theskull can be maintained at maximum manufacturers specifiedpi

32、n 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 tomaintain structural integrity under normal physical loadingwhen the system is fully assembled.7.5.2 All mechanical components of the superstruct

33、ure as-sembly must maintain rigidity and functional integrity through-out the useful 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 platformfor rigid attachment of the superstructure.7.6.2 The halo ve

34、st must provide an adjustable means ofrigid fixation to the upper body of the patient.F 1831 97 (2006)28. Performance Requirements8.1 The purpose of these requirements is to ensure that ahalo external fixator or cranial tongs shall meet the minimumperformance requirements as originally designed. The

35、 halo andtongs device requirements should not vary from procedure toprocedure provided they are used and maintained according tothe manufacturers recommendation.8.2 Halo External Fixator Performance Requirements:8.2.1 All mechanical fixation components will be manufac-tured out of corrosion resistan

36、t materials.8.2.2 All components shall be manufactured out of materi-als capable of providing functional integrity over the useful lifeof the device.8.2.3 The manufacturer will be responsible to maintainadequate mechanical test data or equivalent clinical data inregard to the suitability of design,

37、useful life and diagnosticimaging compatibility of the system.8.2.4 The manufacturer will be responsible for supplyingmaterials that are sterilizable by the manufacturers recom-mended sterilization techniques.8.3 Halo Pin Performance Requirements:8.3.1 All portions of the skull pin that are in const

38、antphysical contact with the patients skin shall be manufacturedfrom biologically compatible material.8.3.2 All halo skull pins shall be supplied with a method forlocking the pin in place in the halo ring.8.4 Halo Ring Performance RequirementsThe manufac-turer will be responsible for providing a rin

39、g assembly thatallows for the following:8.4.1 The halo ring shall be able to easily and rigidly attachto the superstructure.8.4.2 The halo ring shall be able to easily accept a minimumof four halo skull pins.8.5 Halo Superstructure Assembly Performance Require-ments:8.5.1 The halo vest and superstru

40、cture assemblies shall beable to be easily attached and detached from the halo ring withthe appropriate tools.8.6 Halo Vest Performance Requirements:8.6.1 The vest material shall be trimmable and moldablewith the appropriate tools to allow the medical personnel toprovide suitable adaptability to the

41、 various anatomies encoun-tered.8.6.2 The manufacturer will provide suitable vest linermaterials to maintain a substrate between the vest shell and theskin. These lining materials shall be free of any chemicals ortoxins, or both, that could cause an allergic response in theaverage patient.8.6.3 The

42、halo vest shall have a vest attachment mechanismwhereby the halo superstructure is suitably attached via theappropriate tools or mechanism.8.6.4 The halo vest shall allow rapid and complete access tothe chest in the event of a cardiac emergency to allow access tothe chest for C.P.R.8.7 Halo Tools Pe

43、rformance RequirementsAll halo ad-justment tools supplied by the manufacturer shall consistentlyperform in the manner to which they were designed throughoutthe useful life of the product or as indicated by the manufac-turers recommendations.8.8 Cranial Traction Tongs Performance Requirements:8.8.1 A

44、ll mechanical fixation components will be manufac-tured out of corrosion resistant materials.8.8.2 All components shall be manufactured out of materi-als capable of providing functional integrity over the useful lifeof the device.8.8.3 The manufacturer will be responsible to maintainadequate mechani

45、cal test data or equivalent clinical data inregard to the suitability of design, useful life and diagnosticimaging compatibility of the system.8.8.4 The manufacturer will be responsible for supplyingmaterials that are sterilizable by the manufacturers recom-mended sterilization techniques.8.8.5 The

46、cranial traction tongs must permit attachment ofcables and other necessary hardware.8.9 Cranial Traction Tongs Pin Performance Requirements:8.9.1 All tong pins must be supplied by the manufacturerwith a method of locking.8.9.2 Any portion of the tong pin that is in direct contactwith the patients sk

47、in shall be manufactured from biologicallycompatible materials.9. Disclosures, Labeling, and Documentation9.1 These requirements are intended to ensure a manufac-turers written dissemination of all necessary information thatallow a user to determine properly a halo external fixator orcranial tractio

48、n tongs (and all of their related accessories)function, application and limitation. These disclosures, label-ing and documentation requirements also ensure clear identi-fication of the product and make available all pertinent data auser may require. A manufacturer may label his product asconforming

49、to this standard only if the product fulfills all of therequirements listed in this specification.9.2 DisclosuresA manufacturer shall disclose each speci-fication listed where applicable.9.2.1 Single Patient Use StatementA manufacturer ofhalo external fixation systems or cranial traction tongs shallprovide a warning statement to inform the user that the deviceis guaranteed for single patient use only.9.2.2 SterilizationA disclosure statement that states ex-actly which items of the halo external fixator and the cranialtraction tongs and th