ASTM F1264-03(2007)e2

This document is not anASTM standard and is intended only to provide the user of anASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
´2
Designation:F1264–01 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 (´) indicates an editorial change since the last revision or reapproval.
´ NOTE—Editorial changes were made throughout in December 2008.
´ NOTE—Units information was editorially corrected in August 2009.
1. 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 is available. 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 IFMDIMFD geometrical
definitions,dimensions,classification,andterminology;labelingandmaterialspecifications;performancedefinitions;testmethods
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.
1.5The values stated in SI units are to be regarded as the standard.
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
2. Referenced Documents
2.1 ASTM Standards:
A 214/A 214M Specification for Electric-Resistance-Welded Carbon Steel Heat-Exchanger and Condenser Tubes
A 450/A 450M SpecificationforGeneralRequirementsforCarbon,FerriticAlloy,CarbonandAusteniticLowAlloySteelTubes
D 790 Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials
E4 Practices for Force Verification of Testing Machines
E 691 Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
F86 Practice for Surface Preparation and Marking of Metallic Surgical Implants
F 138 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants
(UNS S31673)
F 339 Specification for Cloverleaf Intramedullary Pins
F 383 Practice for Static Bend and Torsion Testing of Intramedullary Rods
F 565 Practice for Care and Handling of Orthopaedic Implants and Instruments
F 1611 Specification for Intramedullary Reamers
2.2 AMS Standard:
This specification is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.21 on Osteosynthesis.
Current edition approved Dec. 10, 2001. Published April 2002. Originally published as F1264–89. Last previous edition F1264–00.
Current edition approved Oct. 1, 2007. Published October 2007. Originally approved in 1989. Last previous edition approved in 2003 as F 1264 – 03.
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at service@astm.org. For Annual Book ofASTM Standards
, Vol 08.01.volume information, refer to the standard’s Document Summary page on the ASTM website.
Withdrawn.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
´2
F 1264 – 03 (2007)
AMS 5050 Steel Tubing, Seamless, 0.15 Carbon, Maximum Annealed
2.3 SAE Standard:
SAE J524 Seamless Low-Carbon Steel Tubing Annealed for Bending and Flaring
3. Terminology
3.1 Definitions for Geometric:
3.1.1 closedsection,n—anycrosssectionperpendiculartothelongitudinalaxisofasolidIMFDorhollowIMFDinwhichthere
is no discontinuity of the outer wall.
3.1.1.1 Discussion—To orient the IMFD for testing and for insertion, the desired relationship of any irregularities, asymetries,
and so forth, to the sagittal and coronal planes should be described for the intended applications.
3.1.2 IMFD curvature, n—dimensions of size and locations of arcs of the curvature, or mathematical description of the
curvature, or other quantitative descriptions to which the curvature is manufactured along with tolerances.
3.1.2.1 Discussion—To orient the IMFD for testing and for insertion, the desired relationship of the curvature to the sagittal and
coronal planes should be described for the intended applications.
3.1.3 IMFD diameter, n—The diameter —diameter of the circumscribed circle, whichcircle that envelops the IMFDs’IMFDs’
cross section when measured along the IMFDs’IMFDs’working length. If the diameter is not constant along the working length,
then the site of measurement should be indicated.
3.1.4 IMFD length, n—the length—length of a straight line between the most proximal and distal ends of the IMFD.
3.1.5 open section, n—any cross section perpendicular to the longitudinal axis of a hollow IMFD in which there is a
discontinuity of the outer wall.
3.1.5.1 Discussion—ToorienttheIMFDfortestingandinsertion,thedesiredrelationshipofthediscontinuitytothesagittaland
coronal planes should be described for the intended applications.
3.1.6 potential critical stress concentrator (CSC), n—any change in section modulus, material property, discontinuity, or other
featureofadesignexpectedtocauseaconcentrationofstressthatislocatedinaregionoftheIMFDexpectedtobehighlystressed
under the normal anticipated loading conditions.
3.1.7 working length, n—a length—length of uniform cross section of the IMFD intended to obtain some type of fit to the
medullary canal in the area of the diaphysis.
3.1.8 tolerance—the acceptable, n—acceptable deviations from the nominal size of any dimension describing the IMFD.
3.2 Definitions—Mechanical/Structural:
3.2.1 bending compliance, n—the reciprocal—reciprocal of the stiffness of the IMFD under a bending load in a specified plane
as defined and determined in the static four-point bend test described in Annex A1.
3.2.2 fatigue strength at N cycles, n—the maximum cyclic force parameter (for example, load, moment, torque, stress, and so
forth)foragivenloadratio,whichproducesdevicestructuraldamageormeetssomeotherfailurecriterioninnolessthan Ncycles
as defined and measured according to the test conducted.
3.2.3 failure strength, n—the force parameter (for example, load, moment, torque, stress, and so forth) required to meet the
failure criteria defined and measured according to the test conducted. —the force parameter (for example, load, moment, torque,
stress, and so forth) required to meet the failure criteria, as defined and measured according to the test conducted. (See Note 1.)
NOTE 1—No present testing standard exists related to this term for IMFDs.
3.2.4 yield strength, n—the force parameter (for example, load, moment, torque, stress, and so forth) which initiates permanent
deformation as defined and measured according to the test conducted.
3.2.5 no load motion—some devices have a degree of free motion at fixation points which allows relative motion to occur
between the device and the bone with no elastic strain in the device and no (or minimal) change in load. This is termed “no load
motion.” —relative motion between the IMFD and the bone that occurs with no elastic strain in the device and no (or minimal)
change in load. (See Note 1.)
3.2.6 structural stiffness, n—the maximum slope of the elastic portion of the load-displacement curve as defined and measured
according to the test conducted.
3.2.6.1 Discussion—For bending in a specified plane, this term is defined and determined in the static four-point bend test
described in Annex A1.
3.2.7 ultimate strength, n—themaximum—maximumforceparameter(forexample,load,moment,torque,stress,andsoforth)
which the structure can support, defined and measured according to the test conducted.
3.2.8 N—a variable representing a specified number of cycles.
4. Classification
4.1 The following IMFDs may be used singly, multiply, and with or without attached supplemental fixation.
Annual Book of ASTM Standards, Vol 14.02.
Available from Society of Automotive Engineers (SAE), 400 Commonwealth Dr., Warrendale, PA 15096-0001, http://www.sae.org.
´2
F 1264 – 03 (2007)
4.2 Types of IMFDs: solid cross section, hollow cross section (open, closed, combination).
4.3 Intended application or use for particular IMFD designs:
4.3.1 Preferred Orientation:
4.3.1.1 Right versus left,
4.3.1.2 Sagittal versus coronal plane,
4.3.1.3 Proximal versus distal, and
4.3.1.4 Universal or multiple options.
4.3.2 Preferred Anatomic Location:
4.3.2.1 Specific bone,
4.3.2.2 Proximal versus distal versus midshaft, and
4.3.2.3 Universal or multiple options.
4.3.3 Preferred Use Limited to Specific Procedures:
4.3.3.1 Acute care of fractures,
(a) Specific types,
(b) Specific locations,
4.3.3.2 Reconstructive procedures, and
4.3.3.3 Universal or multiple options.
5. Material
5.1 All IMFDs are made of materials that have an ASTM International standard shall meet those requirements given in the
ASTM International standards (2.1).
6. Performance Considerations and Test Methods
6.1 Cross Section Dimensional Tolerances affect matching the bone preparation instruments (that is, reamers) to the IMFD
diameter, and fit the fixation of IMFDs in the bone.
6.1.1 Terminology related to sizing of IMFD devices and instruments is provided in Terminology F 1611.
6.2 Longitudinal Contour Tolerances (along with bending compliance) affect the fit and fixation of IMFDs in the bone.
6.3 Fatigue Strength affects the choice of implant in cases in which delayed healing is anticipated (that is, infected nonunions,
allografts, segmental loss, multiple trauma, and so forth).
6.3.1 The fatigue strength or fatigue lives or both for IMFDs subjected to cycle bending forces shall be determined using the
cyclic bending fatigue test method described in Annex A3.
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 locking screws described in Annex A4.
6.4 Bending Strength affects the choice of implant in which load 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 subjected 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 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 Devices Using Secondary Attached Fixation affects degree of motion at
the fracture site. affects degree of motion at the fracture site. (See Note 1.)
6.7 Extraction System—Mechanical failures should occur in the extraction device before they occur in the IMFD—prevents
need to remove IMFD without proper tools. —Mechanical failures should occur in 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.
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 manufacturer or distributor and markdistributor. 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,
7.5.2 Catalog number,
7.5.3 Lot or serial number,
´2
F 1264 – 03 (2007)
7.5.4 IMFD diameter (3.1.3), and
7.5.5 IMFD length (3.1.4).
7.6 Care for and handle IMFDs in accordance with Practice F 565.
8. Means for Insertion and Extraction
8.1 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 the dimensions shown in Fig. 1.
IMFD Diameter, Slot Length, L, Slot Width, W,
Hook Size
mm mm (in.) mm (in.)
IMFD Diameter, Slot Length, L, Slot Width, W,
Hook Size
mm mm mm
6, 7 2 9.53 (0.375) 1.91 (0.075)
6, 7 2 9.53 1.91
8 and larger 1 9.53 (0.375) 3.23 (0.127)
8 and larger 1 9.53 3.23
FIG. 1 Dimensions of Extractor Hook Slot
8.1.2 The hook used for extraction shall have the dimensions shown in Fig. 2.
Hook Size Hook Width, A, mm (in.)
Hook Size Hook Width, A,mm
1 3.05 (0.120)
1 3.05
2 1.78 (0.070)
2 1.78
FIG. 2 Dimensions of Extractor Hook
9. Keywords
9.1 bend testing; definitions; extraction; fatigue test; fracture fixation; implants; intramedullary fixation devices; orthopaedic
medical device; performance; surgical devices; terminology; test methods; torsion test; trauma
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F 1264 – 03 (2007)
ANNEXES
(Mandatory Information)
A1. TEST METHOD FOR STATIC FOUR-POINT BEND TEST METHOD
A1.1 Scope
A1.1.1 This test method describes methods for static four-point bend testing of intrin
...

This document is not anASTM standard and is intended only to provide the user of anASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
´1 ´1
Designation: F 1264 – 03 (Reapproved 2007) F 1264 – 03 (2007) ´2
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 (´) indicates an editorial change since the last revision or reapproval.
´ NOTE—Editorial changes were made throughout in December 2008.
—Editorial changes were made throughout in December 2008.
´ NOTE—Units information was editorially corrected in August 2009.
1. 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
performanceofthesedevices,asinsufficientknowledgetopredicttheconsequencesoftheuseofanyofthesedevicesinindividual
patients for specific activities of daily living is available. 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 IMFD geometrical
definitions,dimensions,classification,andterminology;labelingandmaterialspecifications;performancedefinitions;testmethods
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.
1.5The values stated in SI units are to be regarded as standard. The values given in parentheses are mathematical conversions
to inch-pound units that are provided for information only and are not considered standard.
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
2. Referenced Documents
2.1 ASTM Standards:
A 214/A 214M Specification for Electric-Resistance-Welded Carbon Steel Heat-Exchanger and Condenser Tubes
A 450/A 450M Specification for General Requirements for Carbon and Low Alloy Steel Tubes
D 790 Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials
E4 Practices for Force Verification of Testing Machines
E 691 Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
F86 Practice for Surface Preparation and Marking of Metallic Surgical Implants
F 138 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants
(UNS S31673)
F 339 Specification for Cloverleaf Intramedullary Pins
F 383 Practice for Static Bend and Torsion Testing of Intramedullary Rods
F 565 Practice for Care and Handling of Orthopedic Implants and Instruments
F 1611 Specification for Intramedullary Reamers
This specification is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of 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 referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at service@astm.org. For Annual Book ofASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
Withdrawn.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
´2
2.2 AMS Standard:
AMS 5050 Steel Tubing, Seamless, 0.15 Carbon, Maximum Annealed
2.3 SAE Standard:
SAE J524 Seamless Low-Carbon Steel Tubing Annealed for Bending and Flaring
3. Terminology
3.1 Definitions for Geometric:
3.1.1 closedsection,n—anycrosssectionperpendiculartothelongitudinalaxisofasolidIMFDorhollowIMFDinwhichthere
is no discontinuity of the outer wall.
3.1.1.1 Discussion—To orient the IMFD for testing and for insertion, the desired relationship of any irregularities, asymetries,
and so forth, to the sagittal and coronal planes should be described for the intended applications.
3.1.2 IMFD curvature, n—dimensions of size and locations of arcs of the curvature, or mathematical description of the
curvature, or other quantitative descriptions to which the curvature is manufactured along with tolerances.
3.1.2.1 Discussion—To orient the IMFD for testing and for insertion, the desired relationship of the curvature to the sagittal and
coronal planes should be described for the intended applications.
3.1.3 IMFD diameter, n—diameter of the circumscribed circle that envelops the IMFDs’ cross section when measured along
the IMFDs’ working length. If the diameter is not constant along the working length, then the site of measurement should be
indicated.
3.1.4 IMFD length, n—length of a straight line between the most proximal and distal ends of the IMFD.
3.1.5 open section, n—any cross section perpendicular to the longitudinal axis of a hollow IMFD in which there is a
discontinuity of the outer wall.
3.1.5.1 Discussion—ToorienttheIMFDfortestingandinsertion,thedesiredrelationshipofthediscontinuitytothesagittaland
coronal planes should be described for the intended applications.
3.1.6 potential critical stress concentrator (CSC), n—any change in section modulus, material property, discontinuity, or other
feature of a design expected to cause a concentration of stress in a region of the IMFD expected to be highly stressed under the
normal anticipated loading conditions.
3.1.7 working length, n—length of uniform cross section of the IMFD intended to obtain some type of fit to the medullary canal
in the area of the diaphysis.
3.1.8 tolerance, n—acceptable deviations from the nominal size of any dimension describing the IMFD.
3.2 Definitions—Mechanical/Structural:
3.2.1 bending compliance, n—reciprocal of the stiffness of the IMFD under a bending load in a specified plane as defined and
determined in the static four-point bend test described in Annex A1.
3.2.2 fatigue strength at N cycles, n—the maximum cyclic force parameter (for example, load, moment, torque, stress, and so
forth)foragivenloadratio,whichproducesdevicestructuraldamageormeetssomeotherfailurecriterioninnolessthan Ncycles
as defined and measured according to the test conducted.
3.2.3 failure strength, n—the force parameter (for example, load, moment, torque, stress, and so forth) required to meet the
failure criteria, as defined and measured according to the test conducted. (See Note 1.)
NOTE 1—No present testing standard exists related to this term for IMFDs.
3.2.4 yield strength, n—the force parameter (for example, load, moment, torque, stress, and so forth) which initiates permanent
deformation as defined and measured according to the test conducted.
3.2.5 no load motion—relative motion between the IMFD and the bone that occurs with no elastic strain in the device and no
(or minimal) change in load. (See Note 1.)
3.2.6 structural stiffness, n—the maximum slope of the elastic portion of the load-displacement curve as defined and measured
according to the test conducted.
3.2.6.1 Discussion—For bending in a specified plane, this term is defined and determined in the static four-point bend test
described in Annex A1.
3.2.7 ultimate strength, n—maximum force parameter (for example, load, moment, torque, stress, and so forth) which the
structure can support, defined and measured according to the test conducted.
3.2.8 N—a variable representing a specified number of cycles.
4. Classification
4.1 The following IMFDs may be used singly, multiply, and with or without attached supplemental fixation.
4.2 Types of IMFDs: solid cross section, hollow cross section (open, closed, combination).
4.3 Intended application or use for particular IMFD designs:
4.3.1 Preferred Orientation:
Available from Society of Automotive Engineers (SAE), 400 Commonwealth Dr., Warrendale, PA 15096-0001, http://www.sae.org.
´2
4.3.1.1 Right versus left,
4.3.1.2 Sagittal versus coronal plane,
4.3.1.3 Proximal versus distal, and
4.3.1.4 Universal or multiple options.
4.3.2 Preferred Anatomic Location:
4.3.2.1 Specific bone,
4.3.2.2 Proximal versus distal versus midshaft, and
4.3.2.3 Universal or multiple options.
4.3.3 Preferred Use Limited to Specific Procedures:
4.3.3.1 Acute care of fractures,
(a) Specific types,
(b) Specific locations,
4.3.3.2 Reconstructive procedures, and
4.3.3.3 Universal or multiple options.
5. Material
5.1 All IMFDs are made of materials that have anASTM standard shall meet those requirements given in theASTM standards
(2.1).
6. Performance Considerations and Test Methods
6.1 Cross Section Dimensional Tolerances affect matching the bone preparation instruments (that is, reamers) to the IMFD
diameter, and fit the fixation of IMFDs in the bone.
6.1.1 Terminology related to sizing of IMFD devices and instruments is provided in Terminology F 1611.
6.2 Longitudinal Contour Tolerances (along with bending compliance) affect the fit and fixation of IMFDs in the bone.
6.3 Fatigue Strength affects the choice of implant in cases in which delayed healing is anticipated (that is, infected nonunions,
allografts, segmental loss, multiple trauma, and so forth).
6.3.1 The fatigue strength or fatigue lives or both for IMFDs subjected to cycle bending forces shall be determined using the
cyclic bending fatigue test method described in Annex A3.
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 locking screws described in Annex A4.
6.4 Bending Strength affects the choice of implant in which load 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 subjected 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 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 Devices Using Secondary Attached Fixation affects degree of motion at
the fracture site. (See Note 1.)
6.7 Extraction System—Mechanical failures should occur in 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.
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 manufacturer or distributor. 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,
7.5.2 Catalog number,
7.5.3 Lot or serial number,
7.5.4 IMFD diameter (3.1.3), and
7.5.5 IMFD length (3.1.4).
7.6 Care for and handle IMFDs in accordance with Practice F 565.
´2
8. Means for Insertion and Extraction
8.1 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 the dimensions shown in Fig. 1.
IMFD Diameter, Slot Length, L, Slot Width, W,
Hook Size
mm mm (in.) mm (in.)
IMFD Diameter, Slot Length, L, Slot Width, W,
Hook Size
mm mm mm
6, 7 2 9.53 (0.375) 1.91 (0.075)
6, 7 2 9.53 1.91
8 and larger 1 9.53 (0.375) 3.23 (0.127)
8 and larger 1 9.53 3.23
FIG. 1 Dimensions of Extractor Hook Slot
8.1.2 The hook used for extraction shall have the dimensions shown in Fig. 2.
Hook Size Hook Width, A, mm (in.)
Hook Size Hook Width, A,mm
1 3.05 (0.120)
1 3.05
2 1.78 (0.070)
2 1.78
FIG. 2 Dimensions of Extractor Hook
9. Keywords
9.1 bend testing; definitions; extraction; fatigue test; fracture fixation; implants; intramedullary fixation devices; orthopaedic
medical device; performance; surgical devices; terminology; test methods; torsion test; trauma
´2
ANNEXES
(Mandatory Information)
A1. TEST METHOD FOR STATIC FOUR-POINT BEND TEST METHOD
A1.1 Scope
A1.1.1 This test method describes methods for static four-point bend testing of intrinsic, structural properties of intramedullary
fixation devices (IMFDs) for surgical fixation of the skeletal system. This test method includes bend testing in a variety of planes
relative to the major anatomic planes. The purpose is to measure bending strength and bending stiffness intrinsic to the design and
materials of IMFDs.
A1.1.2 This test method is designed specifically to test IMFD designs that have a well-defined working length (WL) of uniform
open or closed cross section throughout the majority of its length (WL$ 103 diameter) and is to be applied to the full length of
the diaphysis of a femur, tibia, humerus, radius, or ulna. This is not applicable to IMFDs that are used to fix only a short portion
of the diaphysis of any of the long bones or the diaphysis of small bones such as the metacarpals, metatarsals, phalanges, and
...