1. 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.

2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.

ASTM Standards

E4 Practices for Force Verification of Testing Machines

E467 Practice for Verification of Constant Amplitude Dynamic Forces in an Axial Fatigue Testing System

E1823 Terminology Relating to Fatigue and Fracture Testing

E1942 Guide for Evaluating Data Acquisition Systems Used in Cyclic Fatigue and Fracture Mechanics Testing

F67 Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)

F75 Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075)

F86 Practice for Surface Preparation and Marking of Metallic Surgical Implants

F90 Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications (UNS R30605)

F136 Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)

F138 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)

F139 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Sheet and Strip for Surgical Implants (UNS S31673)

F543 Specification and Test Methods for Metallic Medical Bone Screws

F565 Practice for Care and Handling of Orthopedic Implants and Instruments

F620 Specification for Titanium Alloy Forgings for Surgical Implants in the Alpha Plus Beta Condition

F621 Specification for Stainless Steel Forgings for Surgical Implants

F983 Practice for Permanent Marking of Orthopaedic Implant Components

F1295 Specification for Wrought Titanium-6Aluminum-7Niobium Alloy for Surgical Implant Applications (UNS R56700)

F1314 Specification for Wrought Nitrogen Strengthened 22 Chromium - 13 Nickel - 5 Manganese - 2.5 Molybdenum Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S20910)

F1472 Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400)

F1713 Specification for Wrought Titanium-13Niobium-13Zirconium Alloy for Surgical Implant Applications (UNS R58130)

ISO Standard

Keywords

bend testing surgical implants; fatigue test; bone plate; orthopedic medical devices bone plates; surgical devices; test methods surgical implants; Bend testing--surgical materials; Bone implant materials/applications--specifications; Ductility--metals/alloys; Four-point bending; Metallic bone plates; Orthopaedic medical devices (bone)--specifications; Orthopaedic medical devices (bone plates); Testing methods--surgical implants;

ICS Code

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

DOI: 10.1520/F0382-99R03E01

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