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ASTM F1264-03(2012)

Historical Reaffirmation

Standard Specification and Test Methods for Intramedullary Fixation Devices

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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 This specification includes four standard test methods:

1.3.1 Static Four-Point Bend Test MethodAnnex A1 and

1.3.2 Static Torsion Test MethodAnnex A2.

1.3.3 Bending Fatigue Test MethodAnnex A3.

1.3.4 Test Method for Bending Fatigue of IMFD Locking ScrewsAnnex A4.

1.4 A rationale is given in Appendix X1.

1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.


A2.4.1 This test method describes a static torsional test to determine the torsional stiffness of the central and uniform portion of an intramedullary fixation device.

A2.4.2 This test method may not be appropriate for all types of implant applications. The user is cautioned to consider the appropriateness of the method in view of the devices being tested and their potential application.

SDO ASTM: ASTM International
Document Number F1264
Publication Date May 1, 2012
Language en - English
Page Count 18
Revision Level 03(2012)
Supercedes
Committee F04.21
Publish Date Document Id Type View
Aug. 15, 2024 F1264-24 Revision
May 1, 2016 F1264-16E01 Revision
May 1, 2016 F1264-16 Revision
Nov. 1, 2014 F1264-14 Revision
Oct. 1, 2007 F1264-03R07E02 Revision
Oct. 1, 2007 F1264-03R07E01 Revision
April 10, 2003 F1264-03 Revision
Dec. 10, 2001 F1264-01 Revision
Dec. 10, 2001 F1264-00 Revision
May 1, 2012 F1264-03R12 Reaffirmation
Oct. 1, 2007 F1264-03R07 Reaffirmation