ASTM F1264-2016e1 Standard Specification and Test Methods for Intramedullary Fixation Devices《髓内固定装置的标准规格和试验方法》.pdf

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1、Designation: F1264 161Standard 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.

2、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 November 2016.1. Scope1.1 This specification is intended to provide a characteriza-tion of the des

3、ign and mechanical function of intramedullaryfixation devices (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

4、 a standard which defines perfor-mance criteria and methods for 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 ins

5、ufficient knowledge to predict the conse-quences of the use of 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 sur

6、gical fixationof the skeletal system. It provides 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 Multipl

7、e test methods are included in this standard.However, the user 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 desc

8、ribed test methods.1.4 This specification includes four standard 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

9、given in Appendix X1.1.6 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:2A214/A214M Specification for Electric-Resistance-WeldedCarbon Steel Heat-Exchanger and Condenser TubesA450/A450M

10、 Specification for General Requirements forCarbon and Low Alloy 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

11、 toDetermine the Precision of a Test MethodF86 Practice for Surface 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 Pi

12、ns(Withdrawn 1998)3F383 Practice for Static Bend and Torsion Testing of In-tramedullary Rods (Withdrawn 1996)3F565 Practice for Care and Handling of Orthopedic Implantsand InstrumentsF1611 Specification for Intramedullary ReamersF2503 Practice for Marking Medical Devices and OtherItems for Safety in

13、 the Magnetic Resonance EnvironmentF2809 Terminology Relating to Medical and Surgical Mate-rials and Devices1This 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.Curren

14、t edition approved May 1, 2016. Published June 2016. Originallyapproved in 1989. Last previous edition approved in 2014 as F1264 14. DOI:10.1520/F1264-16E01.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of AS

15、TMStandards 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.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United StatesThis in

16、ternational standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT)

17、Committee.12.2 AMS Standard:AMS 5050 Steel Tubing, Seamless, 0.15 Carbon, MaximumAnnealed42.3 SAE Standard:SAE J524 Seamless Low-Carbon Steel Tubing Annealed forBending and Flaring43. Terminology3.1 Definitions for Geometric:3.1.1 closed section, nany cross section perpendicular tothe longitudinal a

18、xis of a solid or hollow IMFD in which thereis no discontinuity 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 des

19、cribed.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 thecurvature is manufactured along with tolerances.3.1.2.1 DiscussionTo orient the IMFD for testing and forinsertion, the d

20、esired relationship of the curvature to thesagittal and coronal 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 work

21、ing length, then the site of measurement should beindicated.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 w

22、all.3.1.5.1 DiscussionTo orient the IMFD for testing andinsertion, 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, di

23、scontinuity, orother feature of a design expected to cause 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 le

24、ngth, nlength of uniform cross section ofthe IMFD intended 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 dete

25、rmined in the static four-point bend test described inAnnex 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 sta

26、ndard exists related to this term forIMFDs.3.2.3 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 noless than N cycles as d

27、efined and measured according to the testconducted.3.2.4 Na 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,

28、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 strength, nmaxi

29、mum force parameter (forexample, load, moment, torque, stress, 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

30、 defined and measured according tothe test conducted.4. Classification4.1 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

31、 designs:4.2.1 Preferred Orientation:4.2.1.1 Right versus 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 o

32、r multiple options.4.2.3 Preferred Use Limited to Specific Procedures:4.2.3.1 Acute care of fractures,(1) Specific types,(2) 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

33、those requirements given in the ASTMstandard (2.1).4Available from Society of Automotive Engineers (SAE), 400 CommonwealthDr., Warrendale, PA 15096-0001, http:/www.sae.org.F1264 16126. Performance Considerations and Test Methods6.1 Cross Section Dimensional Tolerances affect matchingthe bone prepara

34、tion 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 Longitudinal Contour Tolerances (along with bendingcompliance) affect the fit and fixation of IMFDs in the bone.

35、46.3 Fatigue Strength affects the choice of implant in cases inwhich delayed healing is anticipated (that is, infectednonunions, 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 determine

36、d 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 bedetermined using the cyclic bending fatigue test method forlocking screws in Annex A4.6.4 Bending Strength affects the choic

37、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

38、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 primary or secondary healing, depending upon thefracture type (transverse, oblique, and so forth).6.5.1 Bending structural stiffness for

39、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 Torsional

40、 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 before they occur in the IMFD. Thisprevents the need to remove the IMFD without proper tools.(See Not

41、e 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 accordancewith Practice F86.7.3 Use the markings on the IMFD to identify the manufac-turer or distributor. Mark away fro

42、m 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: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

43、 IMFD length (3.1.4).7.6 IMFDs should be cared for and handled in accordancewith Practice F565.7.7 See Practice F2503 to identify potential hazards pro-duced by interactions between the device and the MR environ-ment and for terms that may be used to label the device forsafety in the MR environment.

44、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 the dimen-sions shown in Fig. 2.9. Keywords9.1

45、 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 Length, L,mmSlot Width, W,mm6, 7 2 9.53 1.918

46、 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 Extractor HookF1264 1613ANNEXES(Mandatory Information)A1. TEST METHOD FOR STATIC FOUR-POINT BEND TESTA1.1. ScopeA1.1.1 This test method describes methods for static four-point be

47、nd testing of intrinsic, structural properties of in-tramedullary fixation devices (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 stiffnessi

48、ntrinsic 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)ofuniform open or closed cross section throughout the majorityof its length (WL 10 diameter) and shall be applied to thefull length of the di

49、aphysis 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 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 orother 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