ASTM F1264-16e1
(Specification)Standard Specification and Test Methods for Intramedullary Fixation Devices
Standard Specification and Test Methods for Intramedullary Fixation Devices
SIGNIFICANCE AND USE
A1.4 Significance and Use
A1.4.1 This test method describes a static bending test to determine the bending stiffness and bending strength of the central and uniform portions of an IMFD.
A1.4.2 This test method may not be appropriate for all types of implant applications (that is, in proximal or distal extremity of an IMFD where screw holes exist). The user is cautioned to consider the appropriateness of the method in view of the devices being tested and their potential applications.
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 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 IMFD 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 Multiple test methods are included in this standard. However, the user is not necessarily obligated to test using all of the described methods. Instead, the user should only select, with justification, test methods that are appropriate for a particular device design. This may be only a subset of the herein described test methods.
1.4 This specification includes four standard test methods:
1.4.1 Static Four-Point Bend Test Method—Annex A1 and
1.4.2 Static Torsion Test Method—Annex A2.
1.4.3 Bending Fatigue Test Method—Annex A3.
1.4.4 Test Method for Bending Fatigue of IMFD Locking Screws—Annex A4.
1.5 A rationale is given in Appendix X1.
1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
General Information
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Standards Content (Sample)
This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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Designation: F1264 −16
Standard Specification and Test Methods for
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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.
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ε NOTE—Editorial changes were made throughout in November 2016.
1. Scope 1.5 A rationale is given in Appendix X1.
1.1 This specification is intended to provide a characteriza-
1.6 The values stated in SI units are to be regarded as
tion of the design and mechanical function of intramedullary
standard. No other units of measurement are included in this
fixation devices (IMFDs), specify labeling and material
standard.
requirements, provide test methods for characterization of
IMFD mechanical properties, and identify needs for further
2. Referenced Documents
development of test methods and performance criteria. The
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ultimate goal is to develop a standard which defines perfor- 2.1 ASTM Standards:
mance criteria and methods for measurement of performance- A214/A214MSpecification for Electric-Resistance-Welded
related mechanical characteristics of IMFDs and their fixation
Carbon Steel Heat-Exchanger and Condenser Tubes
to bone. It is not the intention of this specification to define
A450/A450MSpecification for General Requirements for
levels of performance or case-specific clinical performance of
Carbon and Low Alloy Steel Tubes
these devices, as insufficient knowledge to predict the conse-
D790Test Methods for Flexural Properties of Unreinforced
quencesoftheuseofanyofthesedevicesinindividualpatients
and Reinforced Plastics and Electrical Insulating Materi-
for specific activities of daily living is available. It is not the
als
intention of this specification to describe or specify specific
E4Practices for Force Verification of Testing Machines
designs for IMFDs.
E691Practice for Conducting an Interlaboratory Study to
1.2 This specification describes IMFDs for surgical fixation Determine the Precision of a Test Method
of the skeletal system. It provides basic IMFD geometrical F86Practice for Surface Preparation and Marking of Metal-
definitions, dimensions, classification, and terminology; label-
lic Surgical Implants
ing and material specifications; performance definitions; test
F138 Specification for Wrought 18Chromium-14Nickel-
methods and characteristics determined to be important to
2.5MolybdenumStainlessSteelBarandWireforSurgical
in-vivo performance of the device.
Implants (UNS S31673)
F339 Specification for Cloverleaf Intramedullary Pins
1.3 Multiple test methods are included in this standard.
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However, the user is not necessarily obligated to test using all (Withdrawn 1998)
F383Practice for Static Bend and Torsion Testing of In-
of the described methods. Instead, the user should only select,
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with justification, test methods that are appropriate for a tramedullary Rods (Withdrawn 1996)
particular device design. This may be only a subset of the F565PracticeforCareandHandlingofOrthopedicImplants
herein described test methods.
and Instruments
F1611Specification for Intramedullary Reamers
1.4 This specification includes four standard test methods:
F2503Practice for Marking Medical Devices and Other
1.4.1 Static Four-Point Bend Test Method—Annex A1 and
Items for Safety in the Magnetic Resonance Environment
1.4.2 Static Torsion Test Method—Annex A2.
F2809Terminology Relating to Medical and Surgical Mate-
1.4.3 Bending Fatigue Test Method—Annex A3.
rials and Devices
1.4.4 Test Method for Bending Fatigue of IMFD Locking
Screws—Annex A4.
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This specification is under the jurisdiction of ASTM Committee F04 on For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Medical and Surgical Materials and Devices and is the direct responsibility of contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Subcommittee F04.21 on Osteosynthesis. Standards volume information, refer to the standard’s Document Summary page on
Current edition approved May 1, 2016. Published June 2016. Originally the ASTM website.
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approved in 1989. Last previous edition approved in 2014 as F1264–14. DOI: The last approved version of this historical standard is referenced on
10.1520/F1264-16E01. www.astm.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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F1264 − 16
2.2 AMS Standard: failure criteria, as defined and measured according
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