ASTM F1264-2003(2007) Standard Specification and Test Methods for Intramedullary Fixation Devices《髓内固定器械的标准规范和试验方法》.pdf

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1、Designation: F 1264 03 (Reapproved 2007)Standard Specification and Test Methods forIntramedullary Fixation Devices1This standard is issued under the fixed designation F 1264; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year

2、 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 is intended to provide a characteriza-tion of the design and mechanical function of intramedul

3、laryfixation devices (IMFDs) specify labeling and material require-ments, provide test methods for characterization of IMFDmechanical properties and identify needs for further develop-ment of test methods and performance criteria. The ultimategoal is to develop a standard which defines performancecr

4、iteria and methods for measurement of performance-relatedmechanical characteristics of IMFDs and their fixation to bone.It is not the intention of this specification to define levels ofperformance or case-specific clinical performance of thesedevices, as insufficient knowledge is available to predic

5、t theconsequences of the use of any of these devices in individualpatients for specific activities of daily living. It is not theintention of this specification to describe or specify specificdesigns for IMFDs.1.2 This specification describes IMFDs for surgical fixationof the skeletal system. It pro

6、vides basic IFMD geometricaldefinitions, dimensions, classification, and terminology; label-ing and material specifications; performance definitions; testmethods and characteristics determined to be important toin-vivo performance of the device.1.3 This specification includes four standard test meth

7、ods:1.3.1 Static Four-Point Bend Test MethodAnnex A1 and1.3.2 Static Torsion Test MethodAnnex A2.1.3.3 Bending Fatigue Test MethodAnnex A3.1.3.4 Test Method for Bending Fatigue of IMFD LockingScrewsAnnex A4.1.4 A rationale is given in Appendix X1.1.5 The values stated in SI units are to be regarded

8、as thestandard.2. Referenced Documents2.1 ASTM Standards:2A 214/A 214M Specification for Electric-Resistance-Welded Carbon Steel Heat-Exchanger and CondenserTubesA 450/A 450M Specification for General Requirements forCarbon, Ferritic Alloy, and Austenitic Alloy Steel TubesD 790 Test Methods for Flex

9、ural Properties of Unreinforcedand Reinforced Plastics and Electrical Insulating MaterialsE4 Practices for Force Verification of Testing MachinesE 691 Practice for Conducting an Interlaboratory Study toDetermine the Precision of a Test MethodF86 Practice for Surface Preparation and Marking of Me-tal

10、lic Surgical ImplantsF 138 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for SurgicalImplants (UNS S31673)F 339 Specification for Cloverleaf Intramedullary Pins3F 383 Practice for Static Bend and Torsion Testing ofIntramedullary Rods3F 565 Practice for Care

11、 and Handling of Orthopedic Im-plants and InstrumentsF 1611 Specification for Intramedullary Reamers2.2 AMS Standard:AMS 5050 Steel Tubing, Seamless, 0.15 Carbon, MaximumAnnealed42.3 SAE Standard:SAE J524 Seamless Low-Carbon Steel TubingAnnealed forBending and Flaring43. Terminology3.1 Definitions f

12、or Geometric:3.1.1 closed section, nany cross section perpendicular tothe longitudinal axis of a solid IMFD or hollow IMFD in whichthere is no discontinuity of the outer wall. To orient the IMFDfor testing and for insertion, the desired relationship of anyirregularities, asymetries, and so forth, to

13、 the sagittal andcoronal planes should be described for the intended applica-tions.3.1.2 IMFD curvature, ndimensions of size and locationsof arcs of the curvature, or mathematical description of thecurvature, or other quantitative descriptions to which the1This specification is under the jurisdictio

14、n of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibility ofSubcommittee F04.21 on Osteosynthesis.Current edition approved Oct. 1, 2007. Published October 2007. Originallyapproved in 1989. Last previous edition approved in 2003 as F 1264 03.2For referenced

15、 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.3Withdrawn.4Available from Society of Automotive Engineers (SAE), 400 Common

16、wealthDr., Warrendale, PA 15096-0001, http:/www.sae.org.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.curvature is manufactured along with tolerances. To orient theIMFD for testing and for insertion, the desired relationship ofthe

17、curvature to the sagittal and coronal planes should bedescribed for the intended applications.3.1.3 IMFD diameter, nThe diameter of the circum-scribed circle, which envelops the IMFDs cross section whenmeasured along the IMFDs working length. If the diameter isnot constant along the working length,

18、then the site ofmeasurement should be indicated.3.1.4 IMFD length, nthe length of a straight line betweenthe most proximal and distal ends of the IMFD.3.1.5 open section, nany cross section perpendicular tothe longitudinal axis of a hollow IMFD in which there is adiscontinuity of the outer wall. To

19、orient the IMFD for testingand insertion, the desired relationship of the discontinuity tothe sagittal and coronal planes should be described for theintended applications.3.1.6 potential critical stress concentrator (CSC), nanychange in section modulus, material property, discontinuity, orother feat

20、ure of a design expected to cause a concentration ofstress that is located in a region of the IMFD expected to behighly stressed under the normal anticipated loading condi-tions.3.1.7 working length, na length of uniform cross sectionof the IMFD intended to obtain some type of fit to themedullary ca

21、nal in the area of the diaphysis.3.1.8 tolerancethe acceptable deviations from the nomi-nal size of any dimension describing the IMFD.3.2 DefinitionsMechanical/Structural:3.2.1 bending compliance, nthe reciprocal of the stiffnessof the IMFD under a bending load in a specified plane asdefined and det

22、ermined in the static four-point bend testdescribed in Annex A1.3.2.2 fatigue strength at N cycles, nthe maximum cyclicforce parameter (for example, load, moment, torque, stress, andso forth) for a given load ratio, which produces devicestructural damage or meets some other failure criterion in nole

23、ss than N cycles as defined and measured according to the testconducted.3.2.3 failure strength, nthe force parameter (for example,load, moment, torque, stress, and so forth) required to meet thefailure criteria defined and measured according to the testconducted.53.2.4 yield strength, nthe force par

24、ameter (for example,load, moment, torque, stress, and so forth) which initiatespermanent deformation as defined and measured according tothe test conducted.3.2.5 no load motionsome devices have a degree of freemotion at fixation points which allows relative motion to occurbetween the device and the

25、bone with no elastic strain in thedevice and no (or minimal) change in load. This is termed “noload motion.”53.2.6 structural stiffness, nthe maximum slope of theelastic portion of the load-displacement curve as defined andmeasured according to the test conducted. For bending in aspecified plane, th

26、is term is defined and determined in the staticfour-point bend test described in Annex A1.3.2.7 ultimate strength, nthe maximum force parameter(for example, load, moment, torque, stress, and so forth) whichthe structure can support defined and measured according tothe test conducted.3.2.8 Na variabl

27、e representing a specified number ofcycles.4. Classification4.1 The following IMFDs may be used singly, multiply, andwith or without attached supplemental fixation.4.2 Types of IMFDs: solid cross section, hollow crosssection (open, closed, combination).4.3 Intended application or use for particular

28、IMFD designs:4.3.1 Preferred Orientation:4.3.1.1 Right versus left,4.3.1.2 Sagittal versus coronal plane,4.3.1.3 Proximal versus distal, and4.3.1.4 Universal or multiple options.4.3.2 Preferred Anatomic Location:4.3.2.1 Specific bone,4.3.2.2 Proximal versus distal versus midshaft, and4.3.2.3 Univers

29、al or multiple options.4.3.3 Preferred Use Limited to Specific Procedures:4.3.3.1 Acute care of fractures,(a) Specific types,(b) Specific locations,4.3.3.2 Reconstructive procedures, and4.3.3.3 Universal or multiple options.5. Material5.1 All IMFDs are made of materials that have an ASTMstandard sha

30、ll meet those requirements given in the ASTMstandards (2.1).6. Performance Considerations and Test Methods6.1 Cross Section Dimensional Tolerances affect matchingthe bone preparation instruments (that is, reamers) to the IMFDdiameter, and fit the fixation of IMFDs in the bone.6.1.1 Terminology relat

31、ed to sizing of IMFD devices andinstruments is provided in Terminology F 1611.6.2 Longitudinal Contour Tolerances (along with bendingcompliance) affect the fit and fixation of IMFDs in the bone.46.3 Fatigue Strength affects the choice of implant in cases inwhich delayed healing is anticipated (that

32、is, infected non-unions, allografts, segmental loss, multiple trauma, and soforth).6.3.1 The fatigue strength or fatigue lives or both for IMFDssubjected to cycle bending forces shall be determined using thecyclic bending fatigue test method described in Annex A3.6.3.2 The fatigue strength or fatigu

33、e lives or both for IMFDlocking screws subjected to cyclic bending forces shall bedetermined using the cyclic bending fatigue test method forlocking screws described in Annex A4.5No present testing standard exists related to this term for IMFDs.F 1264 03 (2007)26.4 Bending Strength affects the choic

34、e of implant in whichload sharing is minimized or loading is severe or both (that is,with distal or proximal locking, subtrochanteric fractures,comminuted fracture, segmental loss, noncompliant patient,and so forth).6.4.1 Yield, failure, and ultimate strength for IMFDs sub-jected to bending in a sin

35、gle plane shall be determined usingthe static four-point bend test method described in Annex A1.6.5 Bending and Torsional Stiffness may affect the type andrate of healing (primary or secondary healing) depending uponthe fracture type (transverse, oblique, and so forth).6.5.1 Bending structural stiff

36、ness for IMFDs subjected tobending in a single plane shall be determined using the staticfour-point bend test method described in Annex A1.6.5.2 Torsional stiffness for IMFDs subjected to pure torsionshall be determined using the static torsion test methoddescribed in Annex A2.6.6 No-Load Axial and

37、Torsional Motion Allowed in De-vices Using Secondary Attached Fixation affects degree ofmotion at the fracture site.56.7 Extraction SystemMechanical failures should occur inthe extraction device before they occur in the IMFDpreventsneed to remove IMFD without proper tools.57. Marking, Packaging, Lab

38、eling, and Handling7.1 Dimensions of IMFDs should be designated by thestandard definitions given in 3.1.7.2 Mark IMFDs using a method specified in accordancewith Practice F86.7.3 Use the markings on the IMFD to identify the manufac-turer or distributor and mark away from the most highlystressed area

39、s where possible.7.4 Packaging shall be adequate to protect the IMFD duringshipment.7.5 Include the following on package labeling for IMFDs:7.5.1 Manufacturer and product name,7.5.2 Catalog number,7.5.3 Lot or serial number,7.5.4 IMFD diameter (3.1.3), and7.5.5 IMFD length (3.1.4).7.6 Care for and h

40、andle IMFDs in accordance with PracticeF 565.8. Means for Insertion and Extraction8.1 For IMFDs that are to be extracted using a hook device,the following requirements apply:8.1.1 The slot at the end of the IMFD shall have thedimensions shown in Fig. 1.8.1.2 The hook used for extraction shall have t

41、he dimen-sions shown in Fig. 2.9. Keywords9.1 bend testing; definitions; extraction; fatigue test; frac-ture fixation; implants; intramedullary fixation devices; ortho-paedic medical device; performance; surgical devices; termi-nology; test methods; torsion test; traumaIMFD Diameter,mmHook SizeSlot

42、Length, L,mm (in.)Slot Width, W,mm (in.)6, 7 2 9.53 (0.375) 1.91 (0.075)8 and larger 1 9.53 (0.375) 3.23 (0.127)FIG. 1 Dimensions of Extractor Hook SlotHook Size Hook Width, A, mm (in.)1 3.05 (0.120)2 1.78 (0.070)FIG. 2 Dimensions of Extractor HookF 1264 03 (2007)3ANNEXES(Mandatory Information)A1. T

43、EST METHOD FOR STATIC FOUR-POINT BEND TEST METHODA1.1 ScopeA1.1.1 This test method describes methods for static four-point bend testing of intrinsic, structural properties of in-tramedullary fixation devices (IMFDs) for surgical fixation ofthe skeletal system. This test method includes bend testing

44、in avariety of planes defined relative to the major anatomic planes.The purpose is to measure bending strength and bendingstiffness intrinsic to the design and materials of IMFDs.A1.1.2 This test method is designed specifically to testIMFD designs that have a well-defined working length (WL)ofunifor

45、m open or closed cross section throughout the majorityof its length (WL $ 103 diameter) and is to be applied to thefull length of the diaphysis of a femur, tibia, humerus, radius,or ulna. This is not applicable to IMFDs that are used to fixonly a short portion of the diaphysis of any of the long bon

46、esor the diaphysis of small bones such as the metacarpals,metatarsals, phalanges, and so forth.A1.1.3 This test method is not intended to test the extrinsicproperties of any IMFD, that is, the interaction of the devicewith bone or other biologic materials.A1.1.4 This test method is not intended to d

47、efine case-specific clinical performance of these devices, as insufficientknowledge is available to predict the consequences of the useof any of these devices in individual patients.A1.1.5 This test method is not intended to serve as a qualityassurance document, and thus, statistical sampling techni

48、quesfor batches from production of IMFDs are not addressed.A1.1.6 This test method may not be appropriate for all typesof implant applications. The user is cautioned to consider theappropriateness of the method in view of the devices beingtested, the material of their manufacture, and their potentia

49、lapplications.A1.1.7 The values stated in SI units are to be regarded as thestandard.A1.1.8 This standard 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. TerminologyA1.2.1 Definitions:A1.2.1.1 bending compliance, nthe reciprocal of the stiff-ness of the IMFD under a bending load in a specified plane(1/EIefor the IMFD, y/F for the syst