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ASTM F384-00

Historical Revision

Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices

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1.1 This standard is intended to provide a comprehensive reference for angled devices used in the surgical internal fixation of the skeletal system. This standard establishes consistent methods to classify and define the geometric and performance characteristics of angled devices. This standard also presents a catalog of standard specifications that specify material and labeling and handling requirements, and standard test methods for measuring performance related mechanical characteristics determined to be important to the in vivoperformance of angled devices.

1.2 It is not the intention of this standard to define levels of performance of case-specific clinical performance for angled devices, as insufficient knowledge is available to predict the consequences of their use in individual patients for specific activities of daily living. Futhermore, it is not the intention of this standard to describe or specify specific designs for angled devices used in the surgical internal fixation of the skeletal system.

1.3 This standard may not be appropriate for all types of angled devices. The user is cautioned to consider the appropriateness of this standard in view of a particular angled device and its potential application.

1.4 This standard includes the following test methods used in determining the following angled device mechanical performance characteristics:

1.4.1 Standard test method for single cycle compression bend testing of metallic angled orthopedic fracture fixation devices (see Annex A1).

1.4.2 Standard test method for determining the bending fatigue properties of metallic angled orthopedic fracture fixation devices (see Annex A2).

1.5 Unless otherwise indicated, the values stated in SI units shall be regarded as the standard.

Note 1--There is currently no ISO standard that is either similar to equivalent to this standard.


SDO ASTM: ASTM International
Document Number F384
Publication Date Nov. 10, 2000
Language en - English
Page Count 11
Revision Level 00
Supercedes
Committee F04.21
Publish Date Document Id Type View
Aug. 15, 2024 F0384-24 Revision
Feb. 1, 2017 F0384-17 Revision
May 15, 2012 F0384-12 Revision
Jan. 15, 2006 F0384-06E01 Revision
Jan. 15, 2006 F0384-06 Revision
Nov. 10, 2000 F0384-00 Revision
June 1, 2011 F0384-06R11 Reaffirmation