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Scope

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, define the geometric characteristics, 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 standard 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 standard 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.

1.4.2 Standard Test Method for Determining the Bending Fatigue Properties Of Metallic Bone Plates - Annex A2.

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

1.6 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 Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)

To find similar documents by ASTM Volume:

13.01 (Medical and Surgical Materials and Devices)

To find similar documents by classification:

11.040.40 (Implants for surgery, prosthetics and orthotics Including pacemakers Ophthalmic implants, see 11.040.70)

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