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ASTM International - ASTM F1264-16e1

Standard Specification and Test Methods for Intramedullary Fixation Devices

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Organization: ASTM International
Publication Date: 1 May 2016
Status: active
Page Count: 19
ICS Code (Implants for surgery, prosthetics and orthotics): 11.040.40
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... View More

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.

Document History

May 1, 2016
Standard Specification and Test Methods for Intramedullary Fixation Devices
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...
ASTM F1264-16e1
May 1, 2016
Standard Specification and Test Methods for Intramedullary Fixation Devices
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...
November 1, 2014
Standard Specification and Test Methods for Intramedullary Fixation Devices
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...
May 1, 2012
Standard Specification and Test Methods for Intramedullary Fixation Devices
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...
October 1, 2007
Standard Specification and Test Methods for Intramedullary Fixation Devices
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...
October 1, 2007
Standard Specification and Test Methods for Intramedullary Fixation Devices
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...
October 1, 2007
Standard Specification and Test Methods for Intramedullary Fixation Devices
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...
April 10, 2003
Standard Specification and Test Methods for Intramedullary Fixation Devices
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...
December 10, 2001
Standard Specification and Test Methods for Intramedullary Fixation Devices
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...
December 10, 2001
Standard Specification and Test Methods for Intramedullary Fixation Devices
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...
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