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Description of ASTM-F382 2014ASTM F382-14Historical Standard: Standard Specification and Test Method for Metallic Bone PlatesASTM F382Scope 1.1 This specification and test method is intended to provide a comprehensive reference for bone plates used in the surgical internal fixation of the skeletal system. The standard establishes consistent methods to classify and define the geometric and performance characteristics of bone plates. The standard also presents a catalog of standard specifications that specify material; labeling and handling requirements; and standard test methods for measuring performance related mechanical characteristics determined to be important to the in vivo performance of bone plates. 1.2 It is not the intention of the standard to define levels of performance or case-specific clinical performance for bone plates, as insufficient knowledge is available to predict the consequences or their use in individual patients for specific activities of daily living. Futhermore, it is not the intention of the standard to describe or specify specific designs for bone plates used in the surgical internal fixation of the skeletal system. 1.3 This document may not be appropriate for all types of bone plates. The user is cautioned to consider the appropriateness of the standard in view of a particular bone plate and its potential application. 1.4 This document includes the following test methods used in determining the following bone plate mechanical performance characteristics: 1.4.1 Standard Test Method for Single Cycle Bend Testing of Metallic Bone Plates—Annex A1, and 1.4.2 Standard Test Method for Determining the Bending Fatigue Properties Of Metallic Bone Plates—Annex A2. 1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.6 Multiple test methods are included in this standard. However, it must be noted that the user is not obligated to test using all of the described methods. Instead, the user should only select test methods that are appropriate for a particular device design. In most instances, only a subset of the herein described test methods will be required. 1.7 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use. Keywords bend testing—surgical implants; fatigue test; bone plate; orthopedic medical devices—bone plates; surgical devices; test methods—surgical implants; ICS Code ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics) DOI: 10.1520/F0382-14 The following editions for this book are also available...
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About ASTMASTM International, formerly known as the American Society for Testing and Materials (ASTM), is a globally recognized leader in the development and delivery of international voluntary consensus standards. Today, some 12,000 ASTM standards are used around the world to improve product quality, enhance safety, facilitate market access and trade, and build consumer confidence. ASTM’s leadership in international standards development is driven by the contributions of its members: more than 30,000 of the world’s top technical experts and business professionals representing 150 countries. Working in an open and transparent process and using ASTM’s advanced electronic infrastructure, ASTM members deliver the test methods, specifications, guides, and practices that support industries and governments worldwide. |
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