ASTM F382-14
Standard Specification and Test Method for Metallic Bone Plates
- Standard No.
- ASTM F382-14
- Release Date
- 2014
- Published By
- American Society for Testing and Materials (ASTM)
- Status
- Replace By
- ASTM F382-17
- Latest
- ASTM F382-17
- Scope
- A2.5 Significance and Use
A2.5.1 This test method establishes a uniform four-point bending fatigue test to characterize and compare the fatigue performance of different bone plate designs. This test method may be used to determine a fatigue life of the bone plate at either a specific maximum bending moment or over a range of maximum bending moment conditions. Alternatively, the test method may be used to estimate a bone plate's fatigue strength for a specified number of fatigue cycles.
A2.5.2 This test method utilizes a simplified bone plate load model that may not be exactly representative of the in-situ loading configuration. The user should note that the test results generated by this test method can not be used to directly predict the in vivo performance of the bone plate being tested. The data generated from this test method can be used to conduct relative comparisons of different bone plate designs.
A2.5.3 This test method may not be appropriate for all types of implant applications. The user is cautioned to consider the appropriateness of the method in view of the devices being tested and their potential application.
A2.5.4 This test method assumes that the bone plate is manufactured from a material that exhibits linear-elastic material behavior. Therefore, the method is not applicable for testing bone plates made from materials that exhibit non-linear elastic behavior.
A2.5.5 This test method is restricted to the testing of bone plates within the lnear-elastic range of the material. . Therefore, the test method is not applicable for testing bone plates under conditions that would approach or exceed the bending strength of the bone plate being tested.
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.
ASTM F382-14 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 F1295 Standard Specification for Wrought Titanium-6 Aluminum-7 Niobium Alloy for Surgical Implant Applications (UNS R56700)
- ASTM F1314 Standard 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)
- ASTM F136 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant Applications
- ASTM F138 Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)
- ASTM F139 Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Sheet and Strip for Surgical Implants (UNS S31673)
- ASTM F1472 Standard Specification for Wrought Titanium -6Aluminum -4Vanadium Alloy (UNS R56400) for Surgical Implant Applications
- ASTM F1713 Standard Specification for Wrought Titanium-13Niobium-13Zirconium Alloy for Surgical Implant Applications
- ASTM F543 Standard Specification and Test Methods for Metallic Medical Bone Screws
- ASTM F565 Standard Practice for Care and Handling of Orthopedic Implants and Instruments
- ASTM F620 Standard Specification for Titanium Alloy Forgings for Surgical Implants in the Alpha Plus Beta Condition
- ASTM F621 Standard Specification for Stainless Steel Forgings for Surgical Implants
- ASTM F67 Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)
- ASTM F75 Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075)
- ASTM F86 Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants
- ASTM F90 Standard Specification for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy for Surgical Implant Applications (UNS R30605)
- 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 F382-14 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
