ASTM F382-17
Standard Specification and Test Method for Metallic Bone Plates

Standard No.

ASTM F382-17

Release Date

2017

Published By

American Society for Testing and Materials (ASTM)

Latest

ASTM F382-17

Scope

1.1 This specification and test method is intended to provide a comprehensive reference for metallic 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, health and environmental practices and determine the applicability of regulatory limitations prior to use. 1.8 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

ASTM F382-17 Referenced Document

• ASTM E122 Standard Practice for Calculating Sample Size to Estimate, With a Specified Tolerable Error, the Average for Characteristic of a Lot or Process
• ASTM F2503 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
• ASTM F565 Standard Practice for Care and Handling of Orthopedic Implants and Instruments
• ASTM F983 Standard Practice for Permanent Marking of Orthopaedic Implant Components
• ISO 14602 Non-active surgical implants - Implants for osteosynthesis - Particular requirements
• ISO 9585 Implants for surgery; determination of bending strength and stiffness of bone plates

ASTM F382-17 history

• 2017 ASTM F382-17 Standard Specification and Test Method for Metallic Bone Plates
• 2014 ASTM F382-14 Standard Specification and Test Method for Metallic Bone Plates
• 1999 ASTM F382-99(2008)e1 Standard Specification and Test Method for Metallic Bone Plates
• 1999 ASTM F382-99(2008) Standard Specification and Test Method for Metallic Bone Plates
• 1999 ASTM F382-99(2003)e1 Standard Specification and Test Method for Metallic Bone Plates
• 1999 ASTM F382-99(2003) Standard Specification and Test Method for Metallic Bone Plates
• 1999 ASTM F382-99 Standard Specification and Test Method for Metallic Bone Plates