ASTM F1264-03(2007)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: F 1264 – 03 (Reapproved 2007)
Standard Specification and Test Methods for
Intramedullary Fixation Devices
This standard is issued under the fixed designation F 1264; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (e) indicates an editorial change since the last revision or reapproval.
1. Scope A 214/A 214M Specification for Electric-Resistance-
Welded Carbon Steel Heat-Exchanger and Condenser
1.1 This specification is intended to provide a characteriza-
Tubes
tion of the design and mechanical function of intramedullary
A 450/A 450M Specification for General Requirements for
fixationdevices(IMFDs)specifylabelingandmaterialrequire-
Carbon, Ferritic Alloy, and Austenitic Alloy Steel Tubes
ments, provide test methods for characterization of IMFD
D 790 TestMethodsforFlexuralPropertiesofUnreinforced
mechanical properties and identify needs for further develop-
and Reinforced Plastics and Electrical Insulating Materials
ment of test methods and performance criteria. The ultimate
E4 Practices for Force Verification of Testing Machines
goal is to develop a standard which defines performance
E 691 Practice for Conducting an Interlaboratory Study to
criteria and methods for measurement of performance-related
Determine the Precision of a Test Method
mechanicalcharacteristicsofIMFDsandtheirfixationtobone.
F86 Practice for Surface Preparation and Marking of Me-
It is not the intention of this specification to define levels of
tallic Surgical Implants
performance or case-specific clinical performance of these
F 138 Specification for Wrought 18Chromium-14Nickel-
devices, as insufficient knowledge is available to predict the
2.5Molybdenum Stainless Steel Bar and Wire for Surgical
consequences of the use of any of these devices in individual
Implants (UNS S31673)
patients for specific activities of daily living. It is not the
F 339 Specification for Cloverleaf Intramedullary Pins
intention of this specification to describe or specify specific
F 383 Practice for Static Bend and Torsion Testing of
designs for IMFDs.
Intramedullary Rods
1.2 This specification describes IMFDs for surgical fixation
F 565 Practice for Care and Handling of Orthopedic Im-
of the skeletal system. It provides basic IFMD geometrical
plants and Instruments
definitions, dimensions, classification, and terminology; label-
F 1611 Specification for Intramedullary Reamers
ing and material specifications; performance definitions; test
2.2 AMS Standard:
methods and characteristics determined to be important to
AMS5050 SteelTubing,Seamless,0.15Carbon,Maximum
in-vivo performance of the device.
Annealed
1.3 This specification includes four standard test methods:
2.3 SAE Standard:
1.3.1 Static Four-Point Bend Test Method—Annex A1 and
SAEJ524 SeamlessLow-CarbonSteelTubingAnnealedfor
1.3.2 Static Torsion Test Method—Annex A2.
Bending and Flaring
1.3.3 Bending Fatigue Test Method—Annex A3.
1.3.4 Test Method for Bending Fatigue of IMFD Locking
3. Terminology
Screws—Annex A4.
3.1 Definitions for Geometric:
1.4 A rationale is given in Appendix X1.
3.1.1 closed section, n—any cross section perpendicular to
1.5 The values stated in SI units are to be regarded as the
thelongitudinalaxisofasolidIMFDorhollowIMFDinwhich
standard.
there is no discontinuity of the outer wall. To orient the IMFD
2. Referenced Documents for testing and for insertion, the desired relationship of any
irregularities, asymetries, and so forth, to the sagittal and
2.1 ASTM Standards:
coronal planes should be described for the intended applica-
tions.
3.1.2 IMFD curvature, n—dimensions of size and locations
This specification is under the jurisdiction of ASTM Committee F04 on
of arcs of the curvature, or mathematical description of the
Medical and Surgical Materials and Devices and is the direct responsibility of
curvature, or other quantitative descriptions to which the
Subcommittee F04.21 on Osteosynthesis.
Current edition approved Oct. 1, 2007. Published October 2007. Originally
approved in 1989. Last previous edition approved in 2003 as F 1264 – 03.
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 Withdrawn.
Standards volume information, refer to the standard’s Document Summary page on Available from Society of Automotive Engineers (SAE), 400 Commonwealth
the ASTM website. 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.
F 1264 – 03 (2007)
curvature is manufactured along with tolerances. To orient the specifiedplane,thistermisdefinedanddeterminedinthestatic
IMFD for testing and for insertion, the desired relationship of four-point bend test described in Annex A1.
the curvature to the sagittal and coronal planes should be
3.2.7 ultimate strength, n—the maximum force parameter
described for the intended applications.
(for example, load, moment, torque, stress, and so forth) which
3.1.3 IMFD diameter, n—The diameter of the circum-
the structure can support defined and measured according to
scribed circle, which envelops the IMFDs’ cross section when
the test conducted.
measured along the IMFDs’ working length. If the diameter is
3.2.8 N—a variable representing a specified number of
not constant along the working length, then the site of
cycles.
measurement should be indicated.
3.1.4 IMFD length, n—the length of a straight line between
4. Classification
the most proximal and distal ends of the IMFD.
4.1 The following IMFDs may be used singly, multiply, and
3.1.5 open section, n—any cross section perpendicular to
with or without attached supplemental fixation.
the longitudinal axis of a hollow IMFD in which there is a
4.2 Types of IMFDs: solid cross section, hollow cross
discontinuity of the outer wall. To orient the IMFD for testing
section (open, closed, combination).
and insertion, the desired relationship of the discontinuity to
4.3 IntendedapplicationoruseforparticularIMFDdesigns:
the sagittal and coronal planes should be described for the
4.3.1 Preferred Orientation:
intended applications.
3.1.6 potential critical stress concentrator (CSC), n—any 4.3.1.1 Right versus left,
change in section modulus, material property, discontinuity, or
4.3.1.2 Sagittal versus coronal plane,
other feature of a design expected to cause a concentration of
4.3.1.3 Proximal versus distal, and
stress that is located in a region of the IMFD expected to be
4.3.1.4 Universal or multiple options.
highly stressed under the normal anticipated loading condi-
4.3.2 Preferred Anatomic Location:
tions.
4.3.2.1 Specific bone,
3.1.7 working length, n—a length of uniform cross section
4.3.2.2 Proximal versus distal versus midshaft, and
of the IMFD intended to obtain some type of fit to the
4.3.2.3 Universal or multiple options.
medullary canal in the area of the diaphysis.
4.3.3 Preferred Use Limited to Specific Procedures:
3.1.8 tolerance—the acceptable deviations from the nomi-
4.3.3.1 Acute care of fractures,
nal size of any dimension describing the IMFD.
3.2 Definitions—Mechanical/Structural:
(a) Specific types,
3.2.1 bending compliance, n—the reciprocal of the stiffness
(b) Specific locations,
of the IMFD under a bending load in a specified plane as
4.3.3.2 Reconstructive procedures, and
defined and determined in the static four-point bend test
4.3.3.3 Universal or multiple options.
described in Annex A1.
3.2.2 fatigue strength at N cycles, n—the maximum cyclic
5. Material
forceparameter(forexample,load,moment,torque,stress,and
5.1 All IMFDs are made of materials that have an ASTM
so forth) for a given load ratio, which produces device
standard shall meet those requirements given in the ASTM
structural damage or meets some other failure criterion in no
standards (2.1).
lessthanNcyclesasdefinedandmeasuredaccordingtothetest
conducted.
6. Performance Considerations and Test Methods
3.2.3 failure strength, n—the force parameter (for example,
load, moment, torque, stress, and so forth) required to meet the
6.1 Cross Section Dimensional Tolerances affect matching
failure criteria defined and measured according to the test
thebonepreparationinstruments(thatis,reamers)totheIMFD
conducted.
diameter, and fit the fixation of IMFDs in the bone.
3.2.4 yield strength, n—the force parameter (for example,
6.1.1 Terminology related to sizing of IMFD devices and
load, moment, torque, stress, and so forth) which initiates
instruments is provided in Terminology F 1611.
permanent deformation as defined and measured according to
6.2 Longitudinal Contour Tolerances (along with bending
the test conducted.
compliance) affect the fit and fixation of IMFDs in the bone.
3.2.5 no load motion—some devices have a degree of free
6.3 FatigueStrengthaffectsthechoiceofimplantincasesin
motion at fixation points which allows relative motion to occur
which delayed healing is anticipated (that is, infected non-
between the device and the bone with no elastic strain in the
unions, allografts, segmental loss, multiple trauma, and so
device and no (or minimal) change in load. This is termed “no
forth).
load motion.”
6.3.1 ThefatiguestrengthorfatiguelivesorbothforIMFDs
3.2.6 structural stiffness, n—the maximum slope of the
subjected to cycle bending forces shall be determined using the
elastic portion of the load-displacement curve as defined and
cyclic bending fatigue test method described in Annex A3.
measured according to the test conducted. For bending in a
6.3.2 The fatigue strength or fatigue lives or both for IMFD
locking screws subjected to cyclic bending forces shall be
determined using the cyclic bending fatigue test method for
No present testing standard exists related to this term for IMFDs. locking screws described in Annex A4.
F 1264 – 03 (2007)
6.4 Bending Strength affects the choice of implant in which 8. Means for Insertion and Extraction
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 Annex A1.
6.5 Bending and Torsional Stiffness may affect the type and
rate of healing (primary or secondary healing) depending upon
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.
6.5.2 TorsionalstiffnessforIMFDssubjectedtopuretorsion
IMFD Diameter, Slot Length, L, Slot Width, W,
Hook Size
mm mm (in.) mm (in.)
shall be determined using the static torsion test method
6, 7 2 9.53 (0.375) 1.91 (0.075)
described in Annex A2.
8 and larger 1 9.53 (0.375) 3.23 (0.127)
6.6 No-Load Axial and Torsional Motion Allowed in De-
vices Using Secondary Attached Fixation affects degree of FIG. 1 Dimensions of Extractor Hook Slot
motion at the fracture site.
6.7 Extraction System—Mechanicalfailuresshouldoccurin
8.1.2 The hook used for extraction shall have the dimen-
the extraction device before they occur in the IMFD—prevents
sions shown in Fig. 2.
need to remove IMFD without proper tools.
7. Marking, Packaging, Labeling, and Handling
7.1 Dimensions of IMFDs should be designated by the
standard definitions given in 3.1.
7.2 Mark IMFDs using a method specified in accordance
with PracticeF86.
7.3 Use the markings on the IMFD to identify the manufac-
turer or distributor and mark away from the most highly
Hook Size Hook Width, A, mm (in.)
stressed areas where possible.
1 3.05 (0.120)
7.4 Packaging shall be adequate to protect the IMFD during
2 1.78 (0.070)
shipment.
7.5 Include the following on package labeling for IMFDs:
FIG. 2 Dimensions of Extractor Hook
7.5.1 Manufacturer and product name,
7.5.2 Catalog number,
9. Keywords
7.5.3 Lot or serial number,
7.5.4 IMFD diameter (3.1.3), and 9.1 bend testing; definitions; extraction; fatigue test; frac-
7.5.5 IMFD length (3.1.4). ture fixation; implants; intramedullary fixation devices; ortho-
7.6 Care for and handle IMFDs in accordance with Practice paedic medical device; performance; surgical devices; termi-
F 565. nology; test methods; torsion test; trauma
F 1264 – 03 (2007)
ANNEXES
(Mandatory Information)
A1. TEST METHOD FOR STATIC FOUR-POINT BEND TEST METHOD
A1.1 Scope A1.2.1.3 bending moment to yield, n—the moment which
produces plastic deformation as defined by the 0.2 % strain
A1.1.1 This test method describes methods for static four-
off-set method from the load-displacement curve.
point bend testing of intrinsic, structural properties of in-
A1.2.1.4 bending structural stiffness, n—the resistance to
tramedullary fixation devices (IMFDs) for surgical fixation of
bending of an IMFD tested in accordance with the procedures
the skeletal system. This test method includes bend testing in a
of A1.5.1, normalized to the cross-sectional properties of the
variety of planes defined relative to the major anatomic planes.
workinglengthwithoutregardtothelengthofIMFDtested,by
The purpose is to measure bending strength and bending
the calculations described inA1.5.1.8 (the effective EI for the
stiffness intrinsic to the design and materials of IMFDs.
e
region tested).
A1.1.2 This test method is designed specifically to test
IMFD designs that have a well-defined working length (WL)of A1.2.1.5 fixture/device compliance, n—a measurement of
uniform open or closed cross section throughout the majority the combined compliance of the IMFD on the test fixture with
of its length (WL$ 103 diameter) and is to be applied to the co-aligned load-support points (such as A1.6.2). This value is
full length of the diaphysis of a femur, tibia, humerus, radius, dependent upon IMFD orientation, load direction and load and
or ulna. This is not applicable to IMFDs that are used to fix support spans.
only a short portion of the diaphysis of any of the long bones
A1.2.1.6 ultimate bending moment, n—the moment at the
or the diaphysis of small bones such as the metacarpals,
maximum or ultimate load as measured on the load-
metatarsals, phalanges, and so forth.
displacement curve for any test in accordance wi
...