1、Designation: F1264 03 (Reapproved 2012)Standard Specification and Test Methods forIntramedullary Fixation Devices1This standard is issued under the fixed designation F1264; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year o
2、f 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. Scope1.1 This specification is intended to provide a characteriza-tion of the design and mechanical function of intramedullar
3、yfixation devices (IMFDs), specify labeling and material re-quirements, 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 performancecri
4、teria 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 to predict the conseque
5、ncesof the use of any of these devices in individual patients forspecific activities of daily living is available. 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 prov
6、ides basic IMFD 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 metho
7、ds: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 a
8、sstandard. No other units of measurement are included in thisstandard.2. Referenced Documents2.1 ASTM Standards:2A214/A214M Specification for Electric-Resistance-WeldedCarbon Steel Heat-Exchanger and Condenser TubesA450/A450M Specification for General Requirements forCarbon and Low Alloy Steel Tubes
9、D790 Test Methods for Flexural Properties of Unreinforcedand Reinforced Plastics and Electrical Insulating MaterialsE4 Practices for Force Verification of Testing MachinesE691 Practice for Conducting an Interlaboratory Study toDetermine the Precision of a Test MethodF86 Practice for Surface Preparat
10、ion and Marking of Me-tallic Surgical ImplantsF138 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for SurgicalImplants (UNS S31673)F339 Specification for Cloverleaf Intramedullary Pins3F383 Practice for Static Bend and Torsion Testing ofIntramedullary Rods3F
11、565 Practice for Care and Handling of Orthopedic Im-plants and InstrumentsF1611 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. Terminol
12、ogy3.1 Definitions for Geometric: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 May 1, 2012. Published June 2012. Originallyapproved in
13、1989. Last previous edition approved in 2007 as F1264 03 (2007)2.DOI: 10.1520/F1264-03R12.2For 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 Sum
14、mary page onthe ASTM website.3Withdrawn. The last approved version of this historical standard is referencedon www.astm.org.4Available from Society of Automotive Engineers (SAE), 400 CommonwealthDr., Warrendale, PA 15096-0001, http:/www.sae.org.1Copyright ASTM International, 100 Barr Harbor Drive, P
15、O Box C700, West Conshohocken, PA 19428-2959, United States.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.3.1.1.1 DiscussionTo orient the IMFD for testing and forinsertion, the desired
16、 relationship of any irregularities, asyme-tries, and so forth, to the sagittal and coronal planes should bedescribed for the intended applications.3.1.2 IMFD curvature, ndimensions of size and locationsof arcs of the curvature, or mathematical description of thecurvature, or other quantitative desc
17、riptions to which thecurvature is manufactured along with tolerances.3.1.2.1 DiscussionTo orient the IMFD for testing and forinsertion, the desired relationship of the curvature to thesagittal and coronal planes should be described for the intendedapplications.3.1.3 IMFD diameter, ndiameter of the c
18、ircumscribedcircle that envelops the IMFDs cross section when measuredalong the IMFDs working length. If the diameter is notconstant along the working length, then the site of measure-ment should be indicated.3.1.4 IMFD length, nlength of a straight line between themost proximal and distal ends of t
19、he 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.3.1.5.1 DiscussionTo orient the IMFD for testing andinsertion, the desired relationship of the discontinuity to thesagittal and coronal planes shou
20、ld be described for the intendedapplications.3.1.6 potential critical stress concentrator (CSC), nanychange in section modulus, material property, discontinuity, orother feature of a design expected to cause a concentration ofstress in a region of the IMFD expected to be highly stressedunder the nor
21、mal anticipated loading conditions.3.1.7 working length, nlength of uniform cross section ofthe IMFD intended to obtain some type of fit to the medullarycanal in the area of the diaphysis.3.1.8 tolerance, nacceptable deviations from the nominalsize of any dimension describing the IMFD.3.2 Definition
22、sMechanical/Structural:3.2.1 bending compliance, nreciprocal of the stiffness ofthe IMFD under a bending load in a specified plane as definedand determined in the static four-point bend test described inAnnex A1.3.2.2 fatigue strength at N cycles, nthe maximum cyclicforce parameter (for example, loa
23、d, moment, torque, stress, andso forth) for a given load ratio, which produces devicestructural damage or meets some other failure criterion in noless than N cycles as defined and measured according to the testconducted.3.2.3 failure strength, nthe force parameter (for example,load, moment, torque,
24、stress, and so forth) required to meet thefailure criteria, as defined and measured according to the testconducted. (See Note 1.)NOTE 1No present testing standard exists related to this term forIMFDs.3.2.4 yield strength, nthe force parameter (for example,load, moment, torque, stress, and so forth)
25、which initiatespermanent deformation as defined and measured according tothe test conducted.3.2.5 no load motionrelative motion between the IMFDand the bone that occurs with no elastic strain in the device andno (or minimal) change in load. (See Note 1.)3.2.6 structural stiffness, nthe maximum slope
26、 of theelastic portion of the load-displacement curve as defined andmeasured according to the test conducted.3.2.6.1 DiscussionFor bending in a specified plane, thisterm is defined and determined in the static four-point bend testdescribed in Annex A1.3.2.7 ultimate strength, nmaximum force paramete
27、r (forexample, load, moment, torque, stress, and so forth) which thestructure can support, defined and measured according to thetest conducted.3.2.8 Na variable representing a specified number ofcycles.4. Classification4.1 The following IMFDs may be used singly, multiply, andwith or without attached
28、 supplemental fixation.4.2 Types of IMFDs: solid cross section, hollow crosssection (open, closed, combination).4.3 Intended application or use for particular 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
29、.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 Universal 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 loc
30、ations,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 shall meet those requirements given in the ASTMstandards (2.1).6. Performance Considerations and Test Methods6.1 Cross Section Dimensional Toler
31、ances affect matchingthe bone preparation instruments (that is, reamers) to the IMFDdiameter, and fit the fixation of IMFDs in the bone.6.1.1 Terminology related to sizing of IMFD devices andinstruments is provided in Terminology F1611.6.2 Longitudinal Contour Tolerances (along with bendingcomplianc
32、e) 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 is, infected non-unions, allografts, segmental loss, multiple trauma, and soforth).F1264 03 (2012)26.3.1 The fatigue strength or fatigue lives
33、 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 fatigue lives or both for IMFDlocking screws subjected to cyclic bending forces shall bedetermined using the cyclic bending fatigue
34、test method forlocking screws described in Annex A4.6.4 Bending Strength affects the choice 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 f
35、orth).6.4.1 Yield, failure, and ultimate strength for IMFDs sub-jected to bending in a single 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) dependin
36、g uponthe fracture type (transverse, oblique, and so forth).6.5.1 Bending structural stiffness 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 d
37、etermined using the static torsion test methoddescribed in Annex A2.6.6 No-Load Axial and Torsional Motion Allowed in De-vices Using Secondary Attached Fixation affects degree ofmotion at the fracture site. (See Note 1.)6.7 Extraction SystemMechanical failures should occur inthe extraction device be
38、fore they occur in the IMFD. Thisprevents the need to remove the IMFD without proper tools.(See Note 1.)7. Marking, Packaging, Labeling, 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
39、 F86.7.3 Use the markings on the IMFD to identify the manufac-turer or distributor. Mark away from the most highly stressedareas 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 na
40、me,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 handle IMFDs in accordance with PracticeF565.8. Means for Insertion and Extraction8.1 For IMFDs that are to be extracted using a hook device,the following requirements apply:
41、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 the dimen-sions shown in Fig. 2.9. Keywords9.1 bend testing; definitions; extraction; fatigue test; frac-ture fixation; implants; intramedullary fixation devices; ortho-paedic
42、 medical device; performance; surgical devices; termi-nology; test methods; torsion test; traumaIMFD Diameter,mmHook SizeSlot Length, L,mmSlot Width, W,mm6, 7 2 9.53 1.918 and larger 1 9.53 3.23FIG. 1 Dimensions of Extractor Hook SlotHook Size Hook Width, A,mm1 3.052 1.78FIG. 2 Dimensions of Extract
43、or HookF1264 03 (2012)3ANNEXES(Mandatory Information)A1. TEST 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 ofth
44、e skeletal system. This test method includes bend testing in avariety of planes relative to the major anatomic planes. Thepurpose is to measure bending strength and bending stiffnessintrinsic to the design and materials of IMFDs.A1.1.2 This test method is designed specifically to testIMFD designs th
45、at have a well-defined working length (WL)ofuniform 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 sho
46、rt portion of the diaphysis of any of the long bonesor 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 mate
47、rials.A1.1.4 This test method is not intended to define case-specific clinical performance of these devices, as insufficientknowledge to predict the consequences of the use of any ofthese devices in individual patients is available.A1.1.5 This test method is not intended to serve as a qualityassuran
48、ce document, and thus, statistical sampling techniquesfor 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
49、 material of their manufacture, and their potentialapplications.A1.1.7 The values stated in SI units are to be regarded asstandard. No other units of measurement are included in thisstandard.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, nreciprocal
