ASTM F1264-03(2012)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
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Designation:F1264 −03(Reapproved 2012)
Standard Specification and Test Methods for
Intramedullary Fixation Devices
This standard is issued under the fixed designation F1264; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope 2. Referenced Documents
2.1 ASTM Standards:
1.1 This specification is intended to provide a characteriza-
A214/A214MSpecification for Electric-Resistance-Welded
tion of the design and mechanical function of intramedullary
Carbon Steel Heat-Exchanger and Condenser Tubes
fixation devices (IMFDs), specify labeling and material
A450/A450MSpecification for General Requirements for
requirements, provide test methods for characterization of
Carbon and Low Alloy Steel Tubes
IMFD mechanical properties, and identify needs for further
D790Test Methods for Flexural Properties of Unreinforced
development of test methods and performance criteria. The
and Reinforced Plastics and Electrical Insulating Materi-
ultimate goal is to develop a standard which defines perfor-
als
mance criteria and methods for measurement of performance-
E4Practices for Force Verification of Testing Machines
related mechanical characteristics of IMFDs and their fixation
E691Practice for Conducting an Interlaboratory Study to
to bone. It is not the intention of this specification to define
Determine the Precision of a Test Method
levels of performance or case-specific clinical performance of
F86Practice for Surface Preparation and Marking of Metal-
these devices, as insufficient knowledge to predict the conse-
lic Surgical Implants
quencesoftheuseofanyofthesedevicesinindividualpatients
F138 Specification for Wrought 18Chromium-14Nickel-
for specific activities of daily living is available. It is not the
2.5MolybdenumStainlessSteelBarandWireforSurgical
intention of this specification to describe or specify specific
Implants (UNS S31673)
designs for IMFDs.
F339 Specification for Cloverleaf Intramedullary Pins
(Withdrawn 1998)
1.2 This specification describes IMFDs for surgical fixation
F383Practice for Static Bend and Torsion Testing of In-
of the skeletal system. It provides basic IMFD geometrical
tramedullary Rods (Withdrawn 1996)
definitions, dimensions, classification, and terminology; label-
F565PracticeforCareandHandlingofOrthopedicImplants
ing and material specifications; performance definitions; test
and Instruments
methods and characteristics determined to be important to
F1611Specification for Intramedullary Reamers
in-vivo performance of the device.
2.2 AMS Standard:
1.3 This specification includes four standard test methods:
AMS 5050SteelTubing, Seamless, 0.15 Carbon, Maximum
1.3.1 Static Four-Point Bend Test Method—Annex A1 and
Annealed
2.3 SAE Standard:
1.3.2 Static Torsion Test Method—Annex A2.
SAE J524Seamless Low-Carbon SteelTubingAnnealed for
1.3.3 Bending Fatigue Test Method—Annex A3.
Bending and Flaring
1.3.4 Test Method for Bending Fatigue of IMFD Locking
Screws—Annex A4.
3. Terminology
1.4 A rationale is given in Appendix X1. 3.1 Definitions for Geometric:
3.1.1 closed section, n—any cross section perpendicular to
1.5 The values stated in SI units are to be regarded as
thelongitudinalaxisofasolidIMFDorhollowIMFDinwhich
standard. No other units of measurement are included in this
there is no discontinuity of the outer wall.
standard.
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
This specification is under the jurisdiction of ASTM Committee F04 on Standards volume information, refer to the standard’s Document Summary page on
Medical and Surgical Materials and Devices and is the direct responsibility of the ASTM website.
Subcommittee F04.21 on Osteosynthesis. The last approved version of this historical standard is referenced on
Current edition approved May 1, 2012. Published June 2012. Originally www.astm.org.
´2 4
approved in 1989. Last previous edition approved in 2007 as F1264–03 (2007) . Available from Society of Automotive Engineers (SAE), 400 Commonwealth
DOI: 10.1520/F1264-03R12. Dr., Warrendale, PA 15096-0001, http://www.sae.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F1264−03 (2012)
3.1.1.1 Discussion—To orient the IMFD for testing and for 3.2.5 no load motion—relative motion between the IMFD
insertion, the desired relationship of any irregularities, andthebonethatoccurswithnoelasticstraininthedeviceand
asymetries, and so forth, to the sagittal and coronal planes no (or minimal) change in load. (See Note 1.)
should be described for the intended applications. 3.2.6 structural stiffness, n—the maximum slope of the
3.1.2 IMFD curvature, n—dimensions of size and locations elastic portion of the load-displacement curve as defined and
of arcs of the curvature, or mathematical description of the measured according to the test conducted.
curvature, or other quantitative descriptions to which the 3.2.6.1 Discussion—For bending in a specified plane, this
curvature is manufactured along with tolerances.
termisdefinedanddeterminedinthestaticfour-pointbendtest
described in Annex A1.
3.1.2.1 Discussion—To orient the IMFD for testing and for
insertion, the desired relationship of the curvature to the 3.2.7 ultimate strength, n—maximum force parameter (for
sagittalandcoronalplanesshouldbedescribedfortheintended
example, load, moment, torque, stress, and so forth) which the
applications. structure can support, defined and measured according to the
3.1.3 IMFD diameter, n—diameter of the circumscribed test conducted.
3.2.8 N—a variable representing a specified number of
circle that envelops the IMFDs’cross section when measured
along the IMFDs’ working length. If the diameter is not cycles.
constant along the working length, then the site of measure-
ment should be indicated. 4. Classification
3.1.4 IMFD length, n—length of a straight line between the
4.1 ThefollowingIMFDsmaybeusedsingly,multiply,and
most proximal and distal ends of the IMFD.
with or without attached supplemental fixation.
3.1.5 open section, n—any cross section perpendicular to
4.2 Types of IMFDs: solid cross section, hollow cross
the longitudinal axis of a hollow IMFD in which there is a
section (open, closed, combination).
discontinuity of the outer wall.
3.1.5.1 Discussion—To orient the IMFD for testing and 4.3 IntendedapplicationoruseforparticularIMFDdesigns:
insertion, the desired relationship of the discontinuity to the
4.3.1 Preferred Orientation:
sagittalandcoronalplanesshouldbedescribedfortheintended
4.3.1.1 Right versus left,
applications.
4.3.1.2 Sagittal versus coronal plane,
3.1.6 potential critical stress concentrator (CSC), n—any
4.3.1.3 Proximal versus distal, and
change in section modulus, material property, discontinuity, or
4.3.1.4 Universal or multiple options.
other feature of a design expected to cause a concentration of
4.3.2 Preferred Anatomic Location:
stress in a region of the IMFD expected to be highly stressed
4.3.2.1 Specific bone,
under the normal anticipated loading conditions.
4.3.2.2 Proximal versus distal versus midshaft, and
3.1.7 working length, n—length of uniform cross section of
4.3.2.3 Universal or multiple options.
the IMFD intended to obtain some type of fit to the medullary
4.3.3 Preferred Use Limited to Specific Procedures:
canal in the area of the diaphysis.
4.3.3.1 Acute care of fractures,
3.1.8 tolerance, n—acceptable deviations from the nominal
(a) Specific types,
size of any dimension describing the IMFD.
(b) Specific locations,
3.2 Definitions—Mechanical/Structural:
4.3.3.2 Reconstructive procedures, and
3.2.1 bending compliance, n—reciprocal of the stiffness of
4.3.3.3 Universal or multiple options.
the IMFD under a bending load in a specified plane as defined
and determined in the static four-point bend test described in
5. Material
Annex A1.
5.1 All IMFDs are made of materials that have an ASTM
3.2.2 fatigue strength at N cycles, n—the maximum cyclic
standard shall meet those requirements given in the ASTM
forceparameter(forexample,load,moment,torque,stress,and
standards (2.1).
so forth) for a given load ratio, which produces device
structural damage or meets some other failure criterion in no
6. Performance Considerations and Test Methods
lessthanNcyclesasdefinedandmeasuredaccordingtothetest
6.1 Cross Section Dimensional Tolerances affect matching
conducted.
thebonepreparationinstruments(thatis,reamers)totheIMFD
3.2.3 failure strength, n—the force parameter (for example,
diameter, and fit the fixation of IMFDs in the bone.
load,moment,torque,stress,andsoforth)requiredtomeetthe
6.1.1 Terminology related to sizing of IMFD devices and
failure criteria, as defined and measured according to the test
instruments is provided in Terminology F1611.
conducted. (See Note 1.)
6.2 Longitudinal Contour Tolerances (along with bending
NOTE 1—No present testing standard exists related to this term for
IMFDs. compliance) affect the fit and fixation of IMFDs in the bone.
3.2.4 yield strength, n—the force parameter (for example, 6.3 FatigueStrengthaffectsthechoiceofimplantincasesin
load, moment, torque, stress, and so forth) which initiates which delayed healing is anticipated (that is, infected
permanent deformation as defined and measured according to nonunions, allografts, segmental loss, multiple trauma, and so
the test conducted. forth).
F1264−03 (2012)
6.3.1 ThefatiguestrengthorfatiguelivesorbothforIMFDs 7.5.2 Catalog number,
subjectedtocyclebendingforcesshallbedeterminedusingthe 7.5.3 Lot or serial number,
cyclic bending fatigue test method described in Annex A3. 7.5.4 IMFD diameter (3.1.3), and
6.3.2 The fatigue strength or fatigue lives or both for IMFD 7.5.5 IMFD length (3.1.4).
locking screws subjected to cyclic bending forces shall be
7.6 Care for and handle IMFDs in accordance with Practice
determined using the cyclic bending fatigue test method for
F565.
locking screws described in Annex A4.
8. Means for Insertion and Extraction
6.4 Bending Strength affects the choice of implant in which
load sharing is minimized or loading is severe or both (that is, 8.1 For IMFDs that are to be extracted using a hook device,
with distal or proximal locking, subtrochanteric fractures, the following requirements apply:
comminuted fracture, segmental loss, noncompliant patient, 8.1.1 The slot at the end of the IMFD shall have the
and so forth). dimensions shown in Fig. 1.
6.4.1 Yield, failure, and ultimate strength for IMFDs sub-
jected to bending in a single plane shall be determined using
the static four-point bend test method described in AnnexA1.
6.5 Bending and Torsional Stiffness may affect the type and
rateofhealing(primaryorsecondaryhealing)dependingupon
the fracture type (transverse, oblique, and so forth).
6.5.1 Bending structural stiffness for IMFDs subjected to
bending in a single plane shall be determined using the static
four-point bend test method described in Annex A1. IMFD Diameter, Slot Length, L, Slot Width, W,
Hook Size
mm mm mm
6.5.2 TorsionalstiffnessforIMFDssubjectedtopuretorsion
6, 7 2 9.53 1.91
shall be determined using the static torsion test method
8 and larger 1 9.53 3.23
described in Annex A2.
FIG. 1Dimensions of Extractor Hook Slot
6.6 No-Load Axial and Torsional Motion Allowed in De-
vices Using Secondary Attached Fixation affects degree of
8.1.2 The hook used for extraction shall have the dimen-
motion at the fracture site. (See Note 1.)
sions shown in Fig. 2.
6.7 Extraction System—Mechanicalfailuresshouldoccurin
the extraction device before they occur in the IMFD. This
prevents the need to remove the IMFD without proper tools.
(See Note 1.)
7. Marking, Packaging, Labeling, and Handling
7.1 Dimensions of IMFDs should be designated by the
standard definitions given in 3.1.
Hook Size Hook Width, A,mm
7.2 Mark IMFDs using a method specified in accordance
1 3.05
2 1.78
with Practice F86.
7.3 Use the markings on the IMFD to identify the manufac-
FIG. 2Dimensions of Extractor Hook
turer or distributor. Mark away from the most highly stressed
areas where possible.
9. Keywords
7.4 PackagingshallbeadequatetoprotecttheIMFDduring
9.1 bend testing; definitions; extraction; fatigue test; frac-
shipment.
ture fixation; implants; intramedullary fixation devices; ortho-
7.5 Include the following on package labeling for IMFDs:
paedic medical device; performance; surgical devices; termi-
7.5.1 Manufacturer and product name, nology; test methods; torsion test; trauma
F1264−03 (2012)
ANNEXES
(Mandatory Information)
A1. TEST METHOD FOR STATIC FOUR-POINT BEND TEST METHOD
A1.1 Scope A1.2.1.2.1 Discussion—Failure may be defined by perma-
nent deformation, breakages, or buckling.
A1.1.1 This test method describes methods for static four-
A1.2.1.3 bending moment to yield, n—moment which pro-
point bend testing of intrinsic, structural properties of in-
tramedullary fixation devices (IMFDs) for surgical fixation of ducesplasticdeformationasdefinedbythe0.2%strainoff-set
method from the load-displacement curve.
theskeletalsystem.Thistestmethodincludesbendtestingina
variety of planes relative to the major anatomic planes. The
A1.2.1.4 bending structural stiffness, n—resistance to bend-
purpose is to measure bending strength and bending stiffness
ing of an IMFD tested in accordance with the procedures of
intrinsic to the design and materials of IMFDs.
A1.5.1, normalized to the cross-sectional properties of the
workinglengthwithoutregardtothelengthofIMFDtested,by
A1.1.2 This test method is designed specifically to test
the calculations described inA1.5.1.8 (the effective EI for the
IMFDdesignsthathaveawell-definedworkinglength(WL)of
e
region tested).
uniform open or closed cross section throughout the majority
of its length (WL ≥ 10× diameter) and is to be applied to the
A1.2.1.5 fixture/device compliance, n—measurement of the
full length of the diaphysis of a femur, tibia, humerus, radius,
combined compliance of the IMFD on the test fixture with
or ulna. This is not applicable to IMFDs that are used to fix
co-aligned load-support points (such as A1.6.2). This value is
only a short portion of the diaphysis of any of the long bones
dependent upon IMFD orientation, load direction and load and
or the diaphysis of small bones such as the metacarpals,
support spans.
metatarsals, phalanges, and so forth.
A1.2.1.6 ultimate bending moment, n—momentatthemaxi-
A1.1.3 This test method is not intended to test the e
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