Standard Specification and Test Method for Metallic Bone Plates
|Publication Date:||1 November 2014|
|ICS Code (Implants for surgery, prosthetics and orthotics):||11.040.40|
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.
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.
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.
This document includes the following test methods used in determining the following bone plate mechanical performance characteristics:
Standard Test Method for Single Cycle Bend Testing of Metallic Bone Plates-Annex A1, and
Standard Test Method for Determining the Bending Fatigue Properties Of Metallic Bone Plates-Annex A2.
The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
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.
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.