ASTM F1541-2002(2007) Standard Specification and Test Methods for External Skeletal Fixation Devices《骨骼外部固定器设备的标准规范和试验方法》.pdf

1、Designation: F 1541 02 (Reapproved 2007)Standard Specification and Test Methods forExternal Skeletal Fixation Devices1This standard is issued under the fixed designation F 1541; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the y

2、ear 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 provides a characterization of thedesign and mechanical function of external skeletal fixat

3、iondevices (ESFDs), test methods for characterization of ESFDmechanical properties, and identifies needs for further devel-opment of test methods and performance criteria. The ultimategoal is to develop a specification, which defines performancecriteria and methods for measurement of performance-rel

4、atedmechanical characteristics of ESFDs and their fixation to bone.It is not the intention of this specification to define levels ofperformance or case-specific clinical performance of the de-vices, as insufficient knowledge is available to predict theconsequences of the use of any of these devices

5、in individualpatients for specific activities of daily living. Furthermore, it isnot the intention of this specification to describe or specifyspecific designs for ESFDs.1.2 This specification describes ESFDs for surgical fixationof the skeletal system. It provides basic ESFD geometricaldefinitions,

6、 dimensions, classification, and terminology; mate-rial specifications; performance definitions; test methods; andcharacteristics determined to be important to the in-vivoperformance of the device.1.3 This specification includes a terminology and classifi-cation annex and five standard test method a

7、nnexes as follows:1.3.1 Classification of External FixatorsAnnex A1.1.3.2 Test Method for External Skeletal FixatorConnectorsAnnex A2.1.3.3 Test Method for Determining In-Plane CompressiveProperties of Circular Ring or Ring Segment BridgeElementsAnnex A3.1.3.4 Test Method for External Skeletal Fixat

8、or JointsAnnex A4.1.3.5 Test Method for External Skeletal Fixator Pin Anchor-age ElementsAnnex A5.1.3.6 Test Method for External Skeletal FixatorSubassembliesAnnex A6.1.3.7 Test Method for External Skeletal Fixator/ConstructsSubassembliesAnnex A7.1.4 A rationale is given in Appendix X1.1.5 The value

9、s stated in SI units are to be regarded as thestandard.1.6 The following safety hazards caveat pertains only to thetest method portions (Annex A2-Annex A6):1.7 This standard does not purport to address all of thesafety concerns, if any, associated with its use. It is theresponsibility of the user of

10、 this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.2. Referenced Documents2.1 ASTM Standards:2A 938 Test Method for Torsion Testing of WireD 790 Test Methods for Flexural Properties of Unreinforcedand Reinforce

11、d Plastics and Electrical Insulating MaterialsE4 Practices for Force Verification of Testing MachinesF 67 Specification for Unalloyed Titanium, for SurgicalImplant Applications (UNS R50250, UNS R50400, UNSR50550, UNS R50700)F 90 Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy f

12、or Surgical Implant Applica-tions (UNS R30605)F 136 Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for SurgicalImplant Applications (UNS R56401)F 138 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for SurgicalImplan

13、ts (UNS S31673)F 366 Specification for Fixation Pins and WiresF 543 Specification and Test Methods for Metallic MedicalBone ScrewsF 544 Reference Chart for Pictorial Cortical Bone ScrewClassification3F 1058 Specification for Wrought 40Cobalt-20Chromium-16Iron-15Nickel-7Molybdenum Alloy Wire and Stri

14、p forSurgical Implant Applications (UNS R30003 and UNSR30008)1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibility ofSubcommittee F04.21 on Osteosynthesis.Current edition approved June 15, 2007. Published Jun

15、e 2007. Originallypublished as F 1541 94. Last previous edition approved in 2002 as F 1541 02.2For 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

16、 Summary page onthe ASTM website.3Withdrawn.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.F 1264 Specification and Test Methods for IntramedullaryFixation DevicesF 1472 Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy f

17、or Surgical Implant Applications (UNSR56400)F 1713 Specification for Wrought Titanium-13Niobium-13Zirconium Alloy for Surgical Implant Applications(UNS R58130)3. Terminology3.1 DefinitionsThe definitions of terms relating to exter-nal fixators are described in Annex A1.4. Classification4.1 External

18、skeletal fixators are modular devices assembledfrom component elements.4.2 Test methods can address individual elements, for ex-ample, anchorage elements, bridge elements; subassemblies ofelements, for example, connectors, joints, ring elements; or theentire fixator.4.3 Tests of an entire assembled

19、fixator may include thefixator alone, or alternatively, the fixator as anchored to arepresentation of the bone(s) upon which it typically would bemounted in clinical usage.5. Materials5.1 All ESFDs made of materials that have an ASTMstandard shall meet those requirements given in ASTM Stan-dards lis

20、ted in 2.1.6. Performance Considerations and Test Methods6.1 Individual ComponentsThe anchorage pins throughwhich an ESFD is attached to a skeletal member or memberstypically experience high flexural, or torsional loads, or both.Often, the majority of the overall compliance of an ESFD is inits ancho

21、rage elements. A test method for evaluating themechanical performance of an ESFD anchorage element ineither of these loading modes is described in Annex A5.6.2 Subassemblies of Elements:6.2.1 The sites of junction between ESFD anchorage ele-ments, for example, pins, and bridge elements, for example,

22、rods, normally require specialized clamping or gripping mem-bers, known as connecting elements. Often, connecting ele-ments are subjected to high loads, especially moments, soadequacy of their intrinsic mechanical stiffness, or strength, orboth, is critical to overall fixator performance. A test met

23、hodfor evaluating the mechanical performance of ESFD connectorelements is described in Annex A2.6.2.2 ESFDs involving ring-type bridge elements are usedwidely both for fracture treatment and for distraction osteo-genesis. The anchorage elements in such fixators usually arewires or thin pins, which p

24、ass transverse to the bone long axisand which are tensioned deliberately to control the longitudinalstiffness of the fixator. Tensioning these wires or pins causesappreciable compressive load in the plane of the ring element.A test method for evaluating the mechanical performance ofESFD ring element

25、s in this loading mode is described inAnnexA3.6.2.3 The high loads often developed at ESFD junction sitesare of concern both because of potentially excessive elasticdeformation and because of potential irrecoverable deforma-tion. In addition to the connecting element itself (Annex A2),overall perfor

26、mance of the junction also depends on theinterface between the connecting element and the anchorage,or bridge elements, or both, which it grips. A test method forevaluating the overall strength, or stiffness, or both, at anexternal fixator joint, as defined inAnnexA1 as the connectingelement itself

27、plus its interface with the anchorage, or bridge,or both, elements, which it grips, is described in Annex A4.6.2.4 The modular nature of many ESFD systems affordsthe surgeon particularly great latitude as to configuration of theframe subassembly, as defined in Annex A1 as the bridgeelements plus the

28、 connecting elements used to join bridgeelements, but specifically excluding the anchorage elements.Since configuration of the frame subassembly is a majordeterminant of overall ESFD mechanical behavior, it is impor-tant to have procedures for unambiguously characterizingframe subassemblies, both ge

29、ometrically and mechanically.Test methodology suitable for that purpose is described inAnnex A6.6.3 Entire Assembled FixatorNo test methods are yetapproved for entire assembled fixators.7. Keywords7.1 anchorage element; bending; bridge element; connector;external skeletal fixation device; fracture f

30、ixation; joints;modularity; orthopedic medical device; osteosynthesis; ringelement; subassembly (frame); terminology; torsionF 1541 02 (2007)2ANNEXES(Mandatory Information)A1. CLASSIFICATION OF EXTERNAL SKELETAL FIXATORSA1.1 ScopeA1.1.1 This classification covers the definitions of basicterms and co

31、nsiderations for external skeletal fixation devices(ESFDs) and the mechanical analyses thereof.A1.1.2 It is not the intent of this classification to definelevels of acceptable performance or to make recommendationsconcerning the appropriate or preferred clinical usage of thesedevices.A1.1.3 This sta

32、ndard does not purport to address all of thesafety concerns, if any, associated with its use. It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.A1.2 Referenced DocumentsA1

33、.2.1 ASTM Standards:2F 366 Specification for Fixation Pins and WiresF 543 Specification and Test Methods for Metallic MedicalBone ScrewsF 544 Reference Chart for Pictorial Cortical Bone ScrewClassification3A1.3 BackgroundA1.3.1 ESFDs are in widespread use in orthopedic surgery,primarily for applicat

34、ions involving fracture fixation or limblengthening, or both. The mechanical demands placed on thesedevices often are severe. Clinical success usually depends onsuitable mechanical integration of the ESFD with the host boneor limb.A1.3.2 It is important, therefore, to have broadly acceptedterminolog

35、y and testing standards by which these devices canbe described and their mechanical behaviors measured.A1.3.3 Useful terminology and testing standards must takeinto account that the modular nature of most ESFDs deliber-ately affords a great deal of clinical latitude in configuring theassembled fixat

36、or.A1.4 Significance and UseA1.4.1 The purpose of this classification is to establish aconsistent terminology system by means of which these ESFDconfigurations can be classified. It is anticipated that a com-panion testing standard using this classification system willsubsequently be developed.A1.5

37、Basis of ClassificationA1.5.1 An assembled ESFD and the bone(s) or bone ana-log(s) to which it is affixed constitute a fixator-bone construct.A1.5.1.1 The assembled ESFD itself, apart from the hostbone, is termed the fixator assembly.A1.5.1.2 The individual parts (or modules of individualparts) from

38、 which the end user assembles the fixator are termedits elements.A1.5.2 An ESFD normally is configured to span a mechani-cal discontinuity in the host bone that otherwise would beunable to transmit one or more components of the appliedfunctional load successfully. This bony discontinuity is termedth

39、e mechanical defect.A1.5.3 Examples of mechanical defects are fracture sur-faces, interfragmentary callus, segmental bone gaps, articularsurfaces, neoplasms, and osteotomies.A1.5.4 Coordinate System(s)The relative positions of thebones or bone segments bordering the mechanical defectshould be descri

40、bed in terms of an orthogonal axis coordinatesystem (Fig. A1.1).A1.5.4.1 Where possible, coordinate axis directions shouldbe aligned perpendicular to standard anatomical planes, forexample, transverse (horizontal or axial), coronal (frontal), andsagittal (median).A1.5.4.2 Where possible, translation

41、 directions should beconsistent with standard clinical conventions, for example,ventral (anterior), dorsal (posterior), cranial (cephalad or supe-rior), caudal (inferior), lateral, or medial.A1.5.4.3 Rotation measurement conventions must followthe right-hand rule and, where possible, should be consi

42、stentwith standard clinical terminology, for example, right or leftlateral bending, flexion, extension, and torsion.A1.5.5 A base coordinate system (X, Y, Z) should be affixedto one of the bones or major bone segments bordering themechanical defect. This bone or bone segment is termed thebase segmen

43、t, Sb, and serves as a datum with respect to whichpertinent motion(s) of bone segments or fixator elements, orboth, can be referenced. Depending on context, Sbmay bedefined as being on either the proximal or the distal side of amechanical defect.A1.5.6 The other bone(s) or bone segment(s) bordering

44、themechanical defect, whose potential motion(s) with respect toSbis of interest, is termed the mobile segment(s), Sm.Ifnecessary, a local right-handed orthogonal coordinate system(x, y, z) may be embedded within the Sm(s).A1.5.7 Degrees of Freedom:Describing the position, or change in position, of S

45、mrelativeto Sbrequires specifying one or more independent variables.These variables will be termed positional degrees of freedom(P-DOF).A1.5.7.1 Depending on context, this may involve as manyas six variables (three translation and three orientation).A1.5.7.2 Also depending on context, P-DOFs may be

46、usedto describe motions of interest in various magnitude ranges.For example, P-DOFs may be used to describe one or morecomponents of visually imperceptible motion, for example,F 1541 02 (2007)3elastic flexure of a thick rod) or one or more components ofgrossly evident motion, such as, interfragmenta

47、ry motion at anunstable fracture site.A1.5.8 Application or adjustment of an ESFD normallyincludes an attempt to achieve or maintain a specific position ofSmrelative to Sb. The adjustability afforded by the ESFDdesign for this purpose, most commonly, fracture fragmentreduction, will be characterized

48、 in terms of adjustment degreesof freedom (A-DOF).A1.5.9 Some ESFDs are designed optionally to transmitselected components of loading or displacement across thedefect, usually by disengaging a locking mechanism. Thecomponent of motion of Smpermitted by such unlocking, oftengiven the clinical name “d

49、ynamization,” will be termed un-locked degrees of freedom (U-DOF).A1.5.9.1 Depending on the specifics of design, the motionpermitted in an unlocked degree of freedom may be opposedsubstantially and deliberately by a specific mechanism such asa spring or a cushion. Such an unlocked degree of freedom istermed a resisted unlocked degree of freedom.A1.5.9.2 Unlocked degrees of freedom in which motion isinduced actively by external energy input from devices asso-ciated with the fixator are termed actuated degrees of freedom.A1.5.9.3 An unlocked degree of freedom in which mo