ASTM F1264-16
(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 (i.e., 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.
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Designation:F1264 −16
Standard Specification and Test Methods for
1
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.
1. Scope 1.6 The values stated in SI units are to be regarded as
standard. No other units of measurement are included in this
1.1 This specification is intended to provide a characteriza-
standard.
tion of the design and mechanical function of intramedullary
fixation devices (IMFDs), specify labeling and material
2. Referenced Documents
requirements, provide test methods for characterization of
2
IMFD mechanical properties, and identify needs for further 2.1 ASTM Standards:
development of test methods and performance criteria. The A214/A214MSpecification for Electric-Resistance-Welded
ultimate goal is to develop a standard which defines perfor- Carbon Steel Heat-Exchanger and Condenser Tubes
mance criteria and methods for measurement of performance- A450/A450MSpecification for General Requirements for
related mechanical characteristics of IMFDs and their fixation Carbon and Low Alloy Steel Tubes
to bone. It is not the intention of this specification to define D790Test Methods for Flexural Properties of Unreinforced
levels of performance or case-specific clinical performance of and Reinforced Plastics and Electrical Insulating Materi-
these devices, as insufficient knowledge to predict the conse- als
quencesoftheuseofanyofthesedevicesinindividualpatients E4Practices for Force Verification of Testing Machines
E691Practice for Conducting an Interlaboratory Study to
for specific activities of daily living is available. It is not the
intention of this specification to describe or specify specific Determine the Precision of a Test Method
F86Practice for Surface Preparation and Marking of Metal-
designs for IMFDs.
lic Surgical Implants
1.2 This specification describes IMFDs for surgical fixation
F138 Specification for Wrought 18Chromium-14Nickel-
of the skeletal system. It provides basic IMFD geometrical
2.5MolybdenumStainlessSteelBarandWireforSurgical
definitions, dimensions, classification, and terminology; label-
Implants (UNS S31673)
ing and material specifications; performance definitions; test
F339 Specification for Cloverleaf Intramedullary Pins
methods and characteristics determined to be important to
3
(Withdrawn 1998)
in-vivo performance of the device.
F383Practice for Static Bend and Torsion Testing of In-
3
1.3 Multiple test methods are included in this standard.
tramedullary Rods (Withdrawn 1996)
However, the user is not necessarily obligated to test using all
F565PracticeforCareandHandlingofOrthopedicImplants
of the described methods. Instead, the user should only select,
and Instruments
with justification, test methods that are appropriate for a
F1611Specification for Intramedullary Reamers
particular device design. This may be only a subset of the
F2503Practice for Marking Medical Devices and Other
herein described test methods.
Items for Safety in the Magnetic Resonance Environment
F2809Terminology Relating to Medical and Surgical Mate-
1.4 This specification includes four standard test methods:
1.4.1 Static Four-Point Bend Test Method—Annex A1 and rials and Devices
1.4.2 Static Torsion Test Method—Annex A2.
2.2 AMS Standard:
1.4.3 Bending Fatigue Test Method—Annex A3.
AMS 5050SteelTubing, Seamless, 0.15 Carbon, Maximum
4
1.4.4 Test Method for Bending Fatigue of IMFD Locking
Annealed
Screws—Annex A4.
1.5 A rationale is given in Appendix X1.
2
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
1
This specification is under the jurisdiction of ASTM Committee F04 on Standards volume information, refer to the standard’s Document Summary page on
Medical and Surgical Materials and Devices and is the direct responsibility of the ASTM website.
3
Subcommittee F04.21 on Osteosynthesis. The last approved version of this historical standard is referenced on
Current edition approved May 1, 2016. Published June 2016. Originally www.astm.org.
4
approved in 1989. Last previous edition approved in 2014 as F1264–14. DOI: Available from Society of Automotive Engineers (SAE), 400 Commonwealth
10.1520/F1264-16. 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
1
---------------------- Page: 1 ----------------------
F1264−16
2.3 SAE Standard: so forth) for a given load ratio, which produces device
SAE J524Seamless Low-Car
...
This document is not an ASTM standard and is intended only to provide the user of an ASTM 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.
Designation: F1264 − 14 F1264 − 16
Standard Specification and Test Methods for
1
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. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
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 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.
2. Referenced Documents
2
2.1 ASTM Standards:
A214/A214M Specification for Electric-Resistance-Welded Carbon Steel Heat-Exchanger and Condenser Tubes
A450/A450M Specification for General Requirements for Carbon and Low Alloy Steel Tubes
D790 Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials
E4 Practices for Force Verification of Testing Machines
E691 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
F138 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants
(UNS S31673)
3
F339 Specification for Cloverleaf Intramedullary Pins (Withdrawn 1998)
3
F383 Practice for Static Bend and Torsion Testing of Intramedullary Rods (Withdrawn 1996)
F565 Practice for Care and Handling of Orthopedic Implants and Instruments
1
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 Nov. 1, 2014May 1, 2016. Published March 2015June 2016. Originally approved in 1989. Last previous edition approved in 20122014 as
F1264 – 03 (2012).F1264 – 14. DOI: 10.1520/F1264-14.10.1520/F1264-16.
2
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 Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
3
The last approved version of this historical standard is referenced on www.astm.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F1264 − 16
F1611 Specification for Intramedullary Reamers
F2503 Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
...
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