ASTM F1264-01

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

• Status: Historical
• Publication Date: 09-Dec-2001
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.21 - Osteosynthesis

Relations

• Replaces: ASTM F1264-00 - Standard Specification and Test Methods for Intramedullary Fixation Devices
• Effective Date: 10-Dec-2001
• Replaced By: ASTM F1264-03 - Standard Specification and Test Methods for Intramedullary Fixation Devices
• Effective Date: 10-Apr-2003
• Referred By: ASTM F1541-17 - Standard Specification and Test Methods for External Skeletal Fixation Devices
• Effective Date: 10-Dec-2001
• Referred By: ASTM F1611-20 - Standard Specification for Intramedullary Reamers
• Effective Date: 10-Dec-2001

Standards Content (Sample)

NOTICE: This standard has either been superceded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
Designation: F 1264 – 01
Standard Specification and Test Methods for
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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 450/A 450M Specification for General Requirements for
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Carbon, Ferritic Alloy, and Austenitic Alloy Steel Tubes
1.1 This specification is intended to provide a characteriza-
D 790 Test Methods for Flexural Properties of Unreinforced
tion of the design and mechanical function of intramedullary
and Reinforced Plastics and Electrical Insulating Materi-
fixation devices (IMFDs) specify labeling and material require-
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als
ments, provide test methods for characterization of IMFD
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E 4 Practices for Force Verification of Testing Machines
mechanical properties and identify needs for further develop-
E 691 Practice for Conducting an Interlaboratory Study to
ment of test methods and performance criteria. The ultimate
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Determine the Precision of a Test Method
goal is to develop a standard which defines performance
F 86 Practice for Surface Preparation and Marking of Me-
criteria and methods for measurement of performance-related
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tallic Surgical Implants
mechanical characteristics of IMFDs and their fixation to bone.
F 138 Specification for Wrought 18 Chromium-14 Nickel-
It is not the intention of this specification to define levels of
2.5 Molybdenum Stainless Steel Bar and Wire for Surgical
performance or case-specific clinical performance of these
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Implants (UNS S31673)
devices, as insufficient knowledge is available to predict the
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F 339 Specification for Cloverleaf Intramedullary Pins
consequences of the use of any of these devices in individual
F 383 Practice for Static Bend and Torsion Testing of
patients for specific activities of daily living. It is not the
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Intramedullary Rods
intention of this specification to describe or specify specific
F 565 Practice for Care and Handling of Orthopaedic Im-
designs for IMFDs.
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plants and Instruments
1.2 This specification describes IMFDs for surgical fixation
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F 1611 Specification for Intramedullary Reamers
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, Maximum
ing and material specifications; performance definitions; test
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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 for
1.3 This specification includes four standard test methods:
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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 in which
1.4 A rationale is given in Appendix X1.
there is no discontinuity of the outer wall. To orient the IMFD
1.5 The values stated in SI units are to be regarded as the
for testing and for insertion, the desired relationship of any
standard.
irregularities, asymetries, and so forth, to the sagittal and
2. Referenced Documents coronal planes should be described for the intended applica-
tions.
2.1 ASTM Standards:
3.1.2 IMFD curvature, n—dimensions of size and locations
A 214/A 214M Specification for Electric-Resistance-
of arcs of the curvature, or mathematical description of the
Welded Carbon Steel Heat-Exchanger and Condenser
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curvature, or other quantitative descriptions to which the
Tubes
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Annual Book of ASTM Standards, Vol 03.01.
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This specification is under the jurisdiction of ASTM Committee F04 on Annual Book of ASTM Standards, Vol 14.02.
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Medical and Surgical Materials and Devices and is the direct responsibility of Annual Book of ASTM Standards, Vol 13.01.
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Subcommittee F04.21 on Osteosynthesis. Discontinued; see 1998 Annual Book of ASTM Standards, Vol 13.01.
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Current edition approved Dec. 10, 2001. Published April 2002. Originally Discontinued; see 1996 Annual Book of ASTM Standards, Vol 13.01.
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published as F 1264 – 89. Last previous edition F 1264 – 00. Available from the Society of Automotive Engineers, 400 Commonwealth Dr.,
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Annual Book of ASTM Standards, Vol 08.01. Warrendale, PA 15096.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
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