ASTM F1264-2014 Standard Specification and Test Methods for Intramedullary Fixation Devices《髓内固定器械的标准规格和试验方法》.pdf

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1、Designation: F1264 14Standard 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 of last revision. A

2、 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 intramedullaryfixation devices

3、(IMFDs), specify labeling and materialrequirements, provide test methods for characterization ofIMFD mechanical properties, and identify needs for furtherdevelopment of test methods and performance criteria. Theultimate goal is to develop a standard which defines perfor-mance criteria and methods fo

4、r measurement of performance-related mechanical characteristics of IMFDs and their fixationto bone. It is not the intention of this specification to definelevels of performance or case-specific clinical performance ofthese devices, as insufficient knowledge to predict the conse-quences of the use of

5、 any of these devices in individual patientsfor specific 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 provides basic IMFD g

6、eometricaldefinitions, 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 Multiple test methods are included in this standard.However, the user

7、 is not necessarily obligated to test using allof the described methods. Instead, the user should only select,with justification, test methods that are appropriate for aparticular device design. This may be only a subset of theherein described test methods.1.4 This specification includes four standa

8、rd test methods:1.4.1 Static Four-Point Bend Test MethodAnnex A1 and1.4.2 Static Torsion Test MethodAnnex A2.1.4.3 Bending Fatigue Test MethodAnnex A3.1.4.4 Test Method for Bending Fatigue of IMFD LockingScrewsAnnex A4.1.5 A rationale is given in Appendix X1.1.6 The values stated in SI units are to

9、be regarded asstandard. 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 Allo

10、y Steel TubesD790 Test Methods for Flexural Properties of Unreinforcedand Reinforced Plastics and Electrical Insulating Materi-alsE4 Practices for Force Verification of Testing MachinesE691 Practice for Conducting an Interlaboratory Study toDetermine the Precision of a Test MethodF86 Practice for Su

11、rface Preparation and Marking of Metal-lic Surgical ImplantsF138 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for SurgicalImplants (UNS S31673)F339 Specification for Cloverleaf Intramedullary Pins(Withdrawn 1998)3F383 Practice for Static Bend and Torsion T

12、esting of In-tramedullary Rods (Withdrawn 1996)3F565 Practice for Care and Handling of Orthopedic Implantsand InstrumentsF1611 Specification for Intramedullary ReamersF2809 Terminology Relating to Medical and Surgical Mate-rials and Devices2.2 AMS Standard:AMS 5050 Steel Tubing, Seamless, 0.15 Carbo

13、n, MaximumAnnealed42.3 SAE Standard:SAE J524 Seamless Low-Carbon Steel Tubing Annealed forBending and Flaring41This 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.Curr

14、ent edition approved Nov. 1, 2014. Published March 2015. Originallyapproved in 1989. Last previous edition approved in 2012 as F1264 03 (2012).DOI: 10.1520/F1264-14.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Bo

15、ok of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.3The last approved version of this historical standard is referenced onwww.astm.org.4Available from Society of Automotive Engineers (SAE), 400 CommonwealthDr., Warrendale, PA 15096-0001, http:/www

16、.sae.org.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States13. Terminology3.1 Definitions for Geometric:3.1.1 closed section, nany cross section perpendicular tothe longitudinal axis of a solid or hollow IMFD in which thereis no disconti

17、nuity of the outer wall.3.1.1.1 DiscussionTo orient the IMFD for testing and forinsertion, the desired relationship of any irregularities,asymmetries, and so forth, to the sagittal and coronal planes forthe intended applications should be described.3.1.2 IMFD curvature, ndimensions of size and locat

18、ionsof arcs of the curvature, or mathematical description of thecurvature, 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 co

19、ronal planes for the intended applications shouldbe described.3.1.3 IMFD diameter, ndiameter of the circumscribedcircle that envelops the IMFDs cross section when measuredalong its working length. If the diameter is not constant alongthe working length, then the site of measurement should beindicate

20、d.3.1.4 IMFD length, nlength of a straight line between themost 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.3.1.5.1 DiscussionTo orient the IMFD for testing andin

21、sertion, the desired relationship of the discontinuity to thesagittal and coronal planes for the intended applications shouldbe described.3.1.6 potential critical stress concentrator (CSC), nanychange in section modulus, material property, discontinuity, orother feature of a design expected to cause

22、 a concentration ofstress in a region of the IMFD expected to be highly stressedunder the normal anticipated loading conditions.3.1.7 tolerance, nacceptable deviations from the nominalsize of any dimension describing the IMFD.3.1.8 working length, nlength of uniform cross section ofthe IMFD intended

23、 to obtain some type of fit to the medullarycanal in the area of the diaphysis.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 inAnne

24、x A1.3.2.2 failure strength, nthe force parameter (for example,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.3.2.3 fatigue s

25、trength 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 noless than N cycles as defined and measured according to the testconducted.3.2.4 N

26、a variable representing a specified number ofcycles.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 of theelastic portion of the load-displ

27、acement 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 parameter (forexample, load, moment, torque, str

28、ess, and so forth) which thestructure can support, defined and measured according to thetest conducted.3.2.8 yield strength, nthe force parameter (for example,load, moment, torque, stress, and so forth) which initiatespermanent deformation as defined and measured according tothe test conducted.4. Cl

29、assification4.1 The following IMFDs may be used singly, multiply, andwith or without attached supplemental fixation: solid crosssection, hollow cross section (open, closed, or a combination).4.2 Intended application or use for particular IMFD designs:4.2.1 Preferred Orientation:4.2.1.1 Right versus

30、left,4.2.1.2 Sagittal versus coronal plane,4.2.1.3 Proximal versus distal, and4.2.1.4 Universal or multiple options.4.2.2 Preferred Anatomic Location:4.2.2.1 Specific bone,4.2.2.2 Proximal versus distal versus midshaft, and4.2.2.3 Universal or multiple options.4.2.3 Preferred Use Limited to Specific

31、 Procedures:4.2.3.1 Acute care of fractures,(a) Specific types,(b) Specific locations,4.2.3.2 Reconstructive procedures, and4.2.3.3 Universal or multiple options.5. Material5.1 All IMFDs made of materials that have an ASTMstandard shall meet those requirements given in the ASTMstandards (2.1).6. Per

32、formance Considerations and Test Methods6.1 Cross Section Dimensional Tolerances affect matchingthe bone preparation instruments (that is, reamers) to the IMFDdiameter, and the IMFD in the bone.6.1.1 Terminology related to sizing of IMFD devices andinstruments is provided in Specification F1611.6.2

33、Longitudinal Contour Tolerances (along with bendingcompliance) affect the fit and fixation of IMFDs in the bone.4F1264 1426.3 Fatigue Strength affects the choice of implant in cases inwhich delayed healing is anticipated (that is, infectednonunions, allografts, segmental loss, multiple trauma, and s

34、oforth).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 in Annex A3.6.3.2 The fatigue strength or fatigue lives or both for IMFDlocking screws subjected to cyclic bending forces shall bedet

35、ermined using the cyclic bending fatigue test method forlocking screws 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

36、, 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 primary or secon

37、dary healing, depending upon thefracture 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

38、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 occur inth

39、e 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 IMFDs should be marked using a method in

40、 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 The following shall be included on package labeling forIMFDs:

41、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 IMFDs should be cared for and handled in accordancewith Practice F565.8. Means for Insertion and Extraction8.1 For IMFDs that are to be extracted using a

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

43、intramedullary 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,

44、 A,mm1 3.052 1.78FIG. 2 Dimensions of Extractor HookF1264 143ANNEXES(Mandatory Information)A1. TEST METHOD FOR STATIC FOUR-POINT BEND TESTA1.1. ScopeA1.1.1 This test method describes methods for static four-point bend testing of intrinsic, structural properties of in-tramedullary fixation devices (I

45、MFDs) 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 spe

46、cifically to testIMFD designs that have a well-defined working length (WL)ofuniform open or closed cross section throughout the majorityof its length (WL 10 diameter) and shall be applied to thefull length of the diaphysis of a femur, tibia, humerus, radius,or ulna. This is not applicable to IMFDs t

47、hat 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 (that is, the interaction of the device with bone orot

48、her biologic materials), of any IMFD.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 intend

49、ed 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 view of the devices beingtested, the material of their manufacture, and their potentialapplications.A1.1.7 This test method is intended to evaluate the bendingstrength or bending stiffness of the working length of theIMFD, and may not be appropriate for all si