ASTM F1264-00
(Specification)Standard Specification and Test Methods for Intramedullary Fixation Devices
Standard Specification and Test Methods for Intramedullary Fixation Devices
SCOPE
1.1 This specification is intended to provide a characterization of the design and mechanical function of intramedullary fixation devices (IMFDs) specify labeling and material requirements, provide test methods for characterization of IMFD mechanical properties and identify needs for further development of test methods and performance criteria. The ultimate goal is to develop a standard which defines performance criteria and methods for measurement of performance-related mechanical characteristics of IMFDs and their fixation to bone. It is not the intention of this specification to define levels of performance or case-specific clinical performance of these devices, as insufficient knowledge is available to predict the consequences of the use of any of these devices in individual patients for specific activities of daily living. It is not the intention of this specification to describe or specify specific designs for IMFDs.
1.2 This specification describes IMFDs for surgical fixation of the skeletal system. It provides basic IFMD geometrical definitions, dimensions, classification, and terminology; labeling and material specifications; performance definitions; test methods and characteristics determined to be important to in-vivo performance of the device.
1.3 This specification includes four standard test methods;
1.3.1 Static Four-Point Bend Test Method—Annex A1 and
1.3.2 Static Torsion Test Method—Annex A2.
1.3.3 Bending Fatigue Test Method—Annex A3.
1.3.4 Test Method for Bending Fatigue of IMFD Locking Screws—Annex A4.
1.4 A rationale is given in Appendix X1.
1.5 The values stated in SI units are to be regarded as the standard.
General Information
Relations
Standards Content (Sample)
NOTICE: This standard has either been superseded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
Designation: F 1264 – 00
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 Carbon, Ferritic Alloy, and Austenitic Alloy Steel Tubes
D 790 Test Methods for Flexural Properties of Unreinforced
1.1 This specification is intended to provide a characteriza-
and Reinforced Plastics and Electrical Insulating Materi-
tion of the design and mechanical function of intramedullary
als
fixation devices (IMFDs) specify labeling and material require-
E 4 Practices for Force Verification of Testing Machines
ments, provide test methods for characterization of IMFD
E 691 Practice for Conducting an Interlaboratory Study to
mechanical properties and identify needs for further develop-
Determine the Precision of a Test Method
ment of test methods and performance criteria. The ultimate
F 86 Practice for Surface Preparation and Marking of Me-
goal is to develop a standard which defines performance
tallic Surgical Implants
criteria and methods for measurement of performance-related
F 138 Specification for Wrought-18 Chromium-14 Nickel-
mechanical characteristics of IMFDs and their fixation to bone.
12.5 Molybdenum Stainless Steel Bar and Wire for Surgi-
It is not the intention of this specification to define levels of
cal Implants (UNS S31673)
performance or case-specific clinical performance of these
6,7
F 339 Specification for Cloverleaf Intramedullary Pins
devices, as insufficient knowledge is available to predict the
F 383 Practice for Static Bend and Torsion Testing of
consequences of the use of any of these devices in individual
Intramedullary Rods
patients for specific activities of daily living. It is not the
F 565 Practice for Care and Handling of Orthopaedic Im-
intention of this specification to describe or specify specific
plants and Instruments
designs for IMFDs.
F 1611 Terminology for Sizing of IMFDs for Application to
1.2 This specification describes IMFDs for surgical fixation
Reamed Diaphyseal Bone and Associated Instrumentation
of the skeletal system. It provides basic IFMD geometrical
2.2 AMS Standard:
definitions, dimensions, classification, and terminology; label-
AMS 5050 Steel Tubing, Seamless, 0.15 Carbon, Maxi-
ing and material specifications; performance definitions; test
mum Annealed
methods and characteristics determined to be important to
2.3 SAE Standard:
in-vivo performance of the device.
SAE J524 Seamless Low-Carbon Steel Tubing Annealed
1.3 This specification includes four standard test methods:
for Bending and Flaring
1.3.1 Static Four-Point Bend Test Method—Annex A1, and
1.3.2 Static Torsion Test Method—Annex A2.
3. Terminology
1.3.3 Bending Fatigue Test Method—Annex A3.
3.1 Definitions for Geometric:
1.3.4 Test Method for Bending Fatigue of IMFD Locking
3.1.1 closed section, n—any cross section perpendicular to
Screws—Annex A4.
the longitudinal axis of a solid IMFD, or hollow IMFD where
1.4 A Rationale is given in Appendix X1.
there is no discontinuity of the outer wall. In order to orient the
1.5 The values stated in SI units are to be regarded as the
IMFD for testing and for insertion, the desired relationship of
standard.
any irregularities, asymetries, etc., to the sagittal and coronal
2. Referenced Documents planes should be described for the intended applications.
3.1.2 IMFD curvature, n—dimensions of size and locations
2.1 ASTM Standards:
of arcs of the curvature, or mathematical description of the
A 214/A 214M Specification for Electric-Resistance-
curvature, or other quantitative descriptions to which the
Welded Carbon Steel Heat Exchanger and Condenser
2 curvature is manufactured along with tolerances. In order to
Tubes
A 450/A 450M Specification for General Requirements for
Annual Book of ASTM Standards, Vol 03.01.
Annual Book of ASTM Standards, Vol 14.02.
This specification is under the jurisdiction of ASTM Committee F-4 on Medical
Annual Book of ASTM Standards, Vol 13.01.
and Surgical Materials and Devices and is the direct responsibility of Subcommittee Discontinued; see 1998 Annual Book of ASTM Standards, Vol 13.01.
F04.21 on Osteosynthesis. Discontinued; see 1996 Annual Book of ASTM Standards, Vol 13.01.
Current edition approved May 10, 2000. Published August 2000. Originally Available from the Society of Automotive Engineers, 400 Commonwealth Dr.,
published as F 1264 – 89. Last previous edition F 1264 – 99a. Warrendale, PA 15096.
2 9
Annual Book of ASTM Standards, Vol 08.01.
Copyright © ASTM, 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959, United States.
F 1264
orient the IMFD for testing and for insertion, the desired 3.2.7 ultimate strength, n—the maximum force parameter
relationship of the curvature to the sagittal and coronal planes (for example, load, moment, torque, stress, etc.) which the
should be described for the intended applications. structure can support defined and measured according to the
3.1.3 IMFD diameter, n—The diameter of the circum- test conducted.
scribed circle, which envelops the IMFDs’ cross section when 3.2.8 N—a variable representing a specified number of
measured along the IMFDs’ working length. If the diameter is cycles.
not constant along the working length, then the site of
4. Classification
measurement should be indicated.
4.1 The following IMFDs may be used singly, multiply,
3.1.4 IMFD length, n—the length of a straight line between
with or without attached supplemental fixation.
the most proximal and distal ends of the IMFD.
4.2 Types of IMFDs: solid cross section, hollow cross
3.1.5 open section, n—any cross section perpendicular to
section (open, closed, combination).
the longitudinal axis of a hollow IMFD where there is a
4.3 Intended application or use for particular IMFD designs:
discontinuity of the outer wall. In order to orient the IMFD for
4.3.1 Preferred Orientation:
testing and insertion, the desired relationship of the disconti-
4.3.1.1 Right versus left,
nuity to the sagittal and coronal planes should be described for
4.3.1.2 Sagittal versus coronal plane,
the intended applications.
4.3.1.3 Proximal versus distal, and
3.1.6 potential critical stress concentrator (CSC), n—any
4.3.1.4 Universal or multiple options.
change in section modulus, material property, discontinuity, or
4.3.2 Preferred Anatomic Location:
other feature of a design expected to cause a concentration of
4.3.2.1 Specific bone,
stress, which is located in a region of the IMFD expected to be
4.3.2.2 Proximal versus distal versus midshaft, and
highly stressed under the normal anticipated loading condi-
4.3.2.3 Universal or multiple options.
tions.
4.3.3 Preferred Use Limited to Specific Procedures:
3.1.7 working length, n—a length of uniform cross section
4.3.3.1 Acute care of fractures,
of the IMFD intended to obtain some type of fit to the
(a) Specific types,
medullary canal in the area of the diaphysis.
(b) Specific locations,
3.1.8 tolerance—the acceptable deviations from the nomi-
4.3.3.2 Reconstructive procedures, and
nal size of any dimension describing the IMFD.
4.3.3.3 Universal or multiple options.
3.2 Definitions—Mechanical/Structural:
3.2.1 bending compliance, n—the reciprocal of the stiffness 5. Material
of the IMFD under a bending load in a specified plane as
5.1 All IMFDs made of materials which have an ASTM
defined and determined in the static four-point bend test
standard shall meet those requirements given in the ASTM
described in Annex A1.
standards (2.1).
3.2.2 fatigue strength at N cycles, n—the maximum cyclic
6. Performance Considerations and Test Methods
force parameter (for example, load, moment, torque, stress,
6.1 Cross-Section Dimensional Tolerances affect matching
etc.,) for a given load ratio, which produces device structural
the bone preparation instruments (that is, reamers) to the IMFD
damage or meets some other failure criterion in no less than N
diameter, and fit the fixation of IMFDs in the bone.
cycles as defined and measured according to the test con-
6.1.1 Terminology related to sizing of IMFD devices and
ducted.
instruments is provided in Terminology F 1611.
3.2.3 failure strength, n—the force parameter (for example,
6.2 Longitudinal Contour Tolerances (along with bending
load, moment, torque, stress, etc.) required to meet the failure
compliance), affect the fit and fixation of IMFDs in the bone.
criteria defined and measured according to the test con-
6.3 Fatigue Strength, affects the choice of implant in cases
ducted.
where delayed healing is anticipated (that is, infected non-
3.2.4 yield strength, n—the force parameter (for example,
unions, allografts, segmental loss, multiple trauma, etc.).
load, moment, torque, stress, etc.) which initiates permanent
6.3.1 The fatigue strength or fatigue lives, or both for
deformation as defined and measured according to the test
IMFD’s subjected to cycle bending forces shall be determined
conducted.
using the cyclic bending fatigue test method described in
3.2.5 no load motion—some devices have a degree of free
Annex A3.
motion at fixation points which allows relative motion to occur
6.3.2 The fatigue strength or fatigue lives, or both, for
between the device and the bone with no elastic strain in the
IMFD locking screws subjected to cyclic bending forces shall
device and no (or minimal) change in load. This is termed “no
be determined using the cyclic bending fatigue test method for
load motion.”
locking screws described in Annex A4.
3.2.6 structural stiffness, n—the maximum slope of the
6.4 Bending Strength, affects the choice of implant where
elastic portion of the load-displacement curve as defined and
load sharing is minimized or loading is severe, or both (that is,
measured according to the test conducted. For bending in a
with distal or proximal locking, subtrochanteric fractures,
specified plane this term is defined and determined in the static
comminuted fracture, segmental loss, non-compliant patient,
four-point bend test described in Annex A1.
etc.).
6.4.1 Yield, failure, and ultimate strength for IMFDs sub-
No present testing standard exists related to this term for IMFDs. jected to bending in a single plane shall be determined using
F 1264
the static four-point bend test method described in Annex A1. 8.1.1 The slot at the end of the IMFD shall have the
6.5 Bending and Torsional Stiffness, may affect the type and dimensions shown in Fig. 1.
rate of healing (primary or secondary healing) depending upon
the fracture type (transverse, oblique, etc.).
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 Torsional stiffness for IMFDs subjected to pure torsion
shall be determined using the static torsion test method
described in Annex A2.
6.6 No-Load Axial and Torsional Motion Allowed in De-
vices Using Secondary Attached Fixation, affects degree of
IMFD Diameter, Slot Length, L, Slot Width, W,
Hook Size
motion at the fracture site.
mm mm (in.) mm (in.)
6, 7 2 9.50 (0.375) 1.91 (0.075)
6.7 Extraction System, Mechanical Failures Should Occur
8 and larger 1 9.50 (0.375) 3.23 (0.127)
in the Extraction Device Before They Occur in the IMFD,
prevents need to remove IMFD without proper tools.
FIG. 1 Dimensions of Extractor Hook Slot
7. Marking, Packaging, Labeling, and Handling
8.1.2 The hook used for extraction shall have the dimen-
7.1 Dimensions of IMFDs should be designated by the
sions shown in Fig. 2.
standard definitions given in 3.1.
7.2 Mark IMFDs using a method specified in accordance
with Practice F 86.
7.3 Use the markings on the IMFD to identify the manufac-
turer or distributor and mark away from the most highly
stressed areas, where possible.
7.4 Packaging shall be adequate to protect the IMFD during
shipment.
7.5 Include the following on package labeling for IMFDs:
7.5.1 Manufacturer and product name,
Hook Size Hook Width, A, mm (in.)
7.5.2 Catalog number,
1 3.18 (0.120)
2 1.78 (0.070)
7.5.3 Lot or serial number,
7.5.4 IMFD diameter (3.1.3), and
FIG. 2 Dimensions of Extractor Hook
7.5.5 IMFD length (3.1.4).
7.6 Care for and handle IMFDs in accordance with Practice
9. Keywords
F 565.
9.1 bend testing; definitions; extraction; fatigue test; frac-
8. Means for Insertion and Extraction
ture fixation; implants; intramedullary fixation devices; ortho-
8.1 For IMFDs which are to be extracted using a hook paedic medical device; performance; surgical devices; termi-
nology; test methods; torsion test; trauma
device, the following requirements apply:
F 1264
ANNEXES
(Mandatory Information)
A1. TEST METHOD FOR STATIC FOUR-POINT BEND TEST METHOD
A1.1 Scope off-set method from the load-displacement curve.
A1.2.1.4 bending structural stiffness, n—the resistance to
A1.1.1 This test method describes methods for static four-
bending of an IMFD tested in accordance with the procedures
point bend testing of intrinsic, structural properties of in-
of A1.5.1, normalized to the cross-sectional properties of the
tramedullary fixation devices (IMFDs) for surgical fixation of
working length without regard to the length of IMFD tested, by
the skeletal system. This test method includes bend testing in a
the calculations described in A1.5.1.8 (the effective EI for the
e
variety of planes defined relative to the major anatomic planes.
region tested).
The purpose is to measure bending strength and bending
A1.2.1.5 fixture/device compliance, n—a measurement of
stiffness intrinsic to the design and materials of IMFDs.
the combined compliance of the IMFD on the test fixture with
A1.1.2 This test method is designed specifically to test
co-aligned load-support points (such as, A1.5.2). This value is
IMFD designs which have a well-defined working length (WL)
dependent upon IMFD orientation, load direction and load and
of uniform open or closed cross section throughout the
support spans.
majority of its length (WL $ 103 diameter), and is to be
A1.2.1.6 ultimate bending moment, n—the moment at the
applied to the full length of the diaphysis of a femur, tibia,
maximum or ultimate load as measured on the load-
humerus, radius or ulna. This is not applicable to IMFDs which
displacement curve for any test in accordance with A1.5.1.
are used to fix only a short portion of the diaphysis of any of
A1.2.2 Definitions of Terms Specific to This Standard:
the long bones, o
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.