ASTM F1264-2003(2007)e2 Standard Specification and Test Methods for Intramedullary Fixation Devices《髓内固定器械的机械性能要求的标准规范》.pdf

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1、Designation: F 1264 03 (Reapproved 2007)2Standard 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 yea

2、r 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.1NOTEEditorial changes were made throughout in December 2008.2NOTEUnits information was editorially corrected in August 2009.

3、1. Scope1.1 This specification is intended to provide a characteriza-tion of the design and mechanical function of intramedullaryfixation devices (IMFDs), specify labeling and material re-quirements, provide test methods for characterization of IMFDmechanical properties, and identify needs for furth

4、er develop-ment of test methods and performance criteria. The ultimategoal is to develop a standard which defines performancecriteria and methods for measurement of performance-relatedmechanical characteristics of IMFDs and their fixation to bone.It is not the intention of this specification to defi

5、ne levels ofperformance or case-specific clinical performance of thesedevices, as insufficient knowledge to predict the consequencesof 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

6、or specify specificdesigns for IMFDs.1.2 This specification describes IMFDs for surgical fixationof the skeletal system. It provides basic IMFD geometricaldefinitions, dimensions, classification, and terminology; label-ing and material specifications; performance definitions; testmethods and charact

7、eristics determined to be important toin-vivo performance of the device.1.3 This specification includes four standard test methods: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 Fati

8、gue 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 asstandard. No other units of measurement are included in thisstandard.2. Referenced Documents2.1 ASTM Standards:2A 214/A 214M Specification for Electric-Resistance-Welded C

9、arbon Steel Heat-Exchanger and CondenserTubesA 450/A 450M Specification for General Requirements forCarbon and Low Alloy Steel TubesD 790 Test Methods for Flexural Properties of Unreinforcedand Reinforced Plastics and Electrical Insulating MaterialsE4 Practices for Force Verification of Testing Mach

10、inesE 691 Practice for Conducting an Interlaboratory Study toDetermine the Precision of a Test MethodF86 Practice for Surface Preparation and Marking of Me-tallic Surgical ImplantsF 138 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for SurgicalImplants (UNS

11、 S31673)F 339 Specification for Cloverleaf Intramedullary Pins3F 383 Practice for Static Bend and Torsion Testing ofIntramedullary Rods3F 565 Practice for Care and Handling of Orthopedic Im-plants and InstrumentsF 1611 Specification for Intramedullary Reamers2.2 AMS Standard:AMS 5050 Steel Tubing, S

12、eamless, 0.15 Carbon, MaximumAnnealed42.3 SAE Standard:SAE J524 Seamless Low-Carbon Steel TubingAnnealed forBending and Flaring43. Terminology3.1 Definitions for Geometric:1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the dire

13、ct 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 ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Servi

14、ce 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 CommonwealthDr., Warrendale, PA 15096-0001, http:/www.sae.org.1Copyright ASTM Internationa

15、l, 100 Barr Harbor Drive, PO 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 an

16、d forinsertion, the desired 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,

17、 or other quantitative descriptions 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 d

18、iameter, ndiameter of the circumscribedcircle 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 pr

19、oximal 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.3.1.5.1 DiscussionTo orient the IMFD for testing andinsertion, the desired relationship of the discontinuity to thesagit

20、tal and coronal planes should 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 h

21、ighly stressedunder the normal 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 describ

22、ing the IMFD.3.2 DefinitionsMechanical/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

23、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 noless than N cycles as defined and measured according to the testconducted.3.2.3 failure strength, nthe force parameter (for exa

24、mple,load, moment, torque, 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, tor

25、que, stress, and so forth) 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 st

26、iffness, nthe maximum slope 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 streng

27、th, nmaximum force parameter (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,

28、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 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 P

29、roximal 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 Universal or multiple options.4.3.3 Preferred Use Limited to Specific Procedures:4.3.3.1 Acute care of fractures,(a) Spec

30、ific 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 shall meet those requirements given in the ASTMstandards (2.1).6. Performance Considerations and Test Methods6.1 Cros

31、s 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 related to sizing of IMFD devices andinstruments is provided in Terminology F 1611.6.2 Longitudinal Contour Tolerances

32、(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 is, infected non-unions, allografts, segmental loss, multiple trauma, and soforth).F 1264 03 (2007)226.3.1 The fat

33、igue 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 fatigue lives or both for IMFDlocking screws subjected to cyclic bending forces shall bedetermined usi

34、ng the cyclic bending fatigue 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,

35、 noncompliant patient,and so forth).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

36、or secondary healing) depending 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 subje

37、cted to pure torsionshall be determined 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 oc

38、cur inthe extraction device before 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 specif

39、ied in accordancewith Practice 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

40、.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 handle IMFDs in accordance with PracticeF 565.8. Means for Insertion and Extraction8.1 For IMFDs that are to be extracted using a hook device,th

41、e 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 the dimen-sions shown in Fig. 2.9. Keywords9.1 bend testing; definitions; extraction; fatigue test; frac-ture fixation; implants; intramedullary

42、 fixation devices; ortho-paedic 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

43、.78FIG. 2 Dimensions of Extractor HookF 1264 03 (2007)23ANNEXES(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 (

44、IMFDs) for surgical fixation ofthe 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 sp

45、ecifically to testIMFD designs that 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 IMF

46、Ds that are used to fixonly a short 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 devic

47、ewith bone or other biologic materials.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 inte

48、nded to serve as a qualityassurance 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 vie

49、w of the devices beingtested, the 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