ASTM F384-17
Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices

Standard No.

ASTM F384-17

Release Date

2017

Published By

American Society for Testing and Materials (ASTM)

Latest

ASTM F384-17

Scope

1.1 These specifications and test methods provide a comprehensive reference for angled devices used in the surgical internal fixation of the skeletal system. This standard establishes consistent methods to classify and define the geometric and performance characteristics of angled devices. This 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 angled devices. 1.2 It is not the intention of this standard to define levels of performance or case-specific clinical performance for angled devices, as insufficient knowledge is available to predict the consequences of their use in individual patients for specific activities of daily living. Futhermore, this standard does not describe or specify specific designs for angled devices used in the surgical internal fixation of the skeletal system. 1.3 This standard may not be appropriate for all types of angled devices. The user is cautioned to consider the appropriateness of this standard in view of a particular angled device and its potential application. NOTE 1—This standard is not intended to address intramedullary hip screw nails or other angled devices without a sideplate. 1.4 This standard includes the following test methods used in determining the following angled device mechanical performance characteristics: 1.4.1 Standard test method for single cycle compression bend testing of metallic angled orthopedic fracture fixation devices (see Annex A1). 1.4.2 Standard test method for determining the bending fatigue properties of metallic angled orthopedic fracture fixation devices (see 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. NOTE 2—There is currently no ISO standard that is either similar to equivalent to this standard. 1.6 Multiple test methods are included in this standard. However, the user is not necessarily obligated to test using all of the described methods. Instead, the user should only select, with justification, test methods that are appropriate for a particular device design. This may be only a subset of the herein described test methods. 1.7 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 F384-17 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 E4 Standard Practices for Force Verification of Testing Machines
• ASTM E8 Standard Test Methods for Tension Testing of Metallic Materials
• 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)*， 2019-12-01 Update
• 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 F2503 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment*， 2023-04-01 Update
• ASTM F382 Standard Specification and Test Method for Metallic Bone Plates
• ASTM F565 Standard Practice for Care and Handling of Orthopedic Implants and Instruments*， 2021-04-01 Update
• ASTM F620 Standard Specification for Titanium Alloy Forgings for Surgical Implants in the Alpha Plus Beta Condition*， 2020-02-01 Update
• 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)*， 2017-03-01 Update
• ASTM F75 Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075)
• 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*， 2018-02-01 Update
• ISO 14602 Non-active surgical implants - Implants for osteosynthesis - Particular requirements
• ISO 5835 Implants for surgery; metal bone screws with hexagonal drive connection, spherical under-surface of head, asymmetrical thread; dimensions
• ISO 5836 Implants for surgery; metal bone plates; holes corresponding to screws with asymmetrical thread and spherical under-surface
• ISO 9268 Implants for surgery; metal bone screws with conical under-surface of head; dimensions
• ISO 9269 Implants for surgery; metal bone plates; holes and slots corresponding to screws with conical under-surface

ASTM F384-17 history

• 2017 ASTM F384-17 Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices
• 2012 ASTM F384-12 Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices
• 2006 ASTM F384-06(2011) Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices
• 2006 ASTM F384-06e1 Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices
• 2006 ASTM F384-06 Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices
• 2000 ASTM F384-00 Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices