ASTM F384-17

Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices

SIGNIFICANCE AND USE
A2.5 Significance and Use
A2.5.1 The test method establishes a uniform cantilever bending fatigue test to characterize and compare the fatigue performance of different angled device designs. This test method may be used to determine the fatigue life of an angled device at either a specific or over a range of maximum bending moment conditions. Additionally, this test method may be alternatively used to estimate the fatigue strength of an angled device for a specified number of fatigue cycles.
A2.5.2 The test method utilizes a simplified angled device cantilever bending 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 angled device being tested. The data generated from this test method can be used to conduct relative comparisons of different angled device 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 angled device is manufactured from a material that exhibits linear-elastic material behavior; therefore, this test method is not applicable for testing angled devices made from materials that exhibit nonlinear elastic behavior.
A2.5.5 This test method is restricted to the testing of angled devices within the linear-elastic range of the material; therefore, this test method is not applicable for testing angled devices under conditions that would approach or exceed the bending strength of the angled device being tested.
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 se...

General Information

• Status: Published
• Publication Date: 31-Jan-2017
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.21 - Osteosynthesis

Relations

• Refers: ASTM F382-14 - Standard Specification and Test Method for Metallic Bone Plates
• Effective Date: 01-Nov-2014
• Refers: ASTM F67-13(2017) - Standard Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)
• Effective Date: 01-Mar-2017
• Refers: ASTM F1314-18 - 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)
• Effective Date: 01-Feb-2018
• Refers: ASTM F983-86(2018) - Standard Practice for Permanent Marking of Orthopaedic Implant Components
• Effective Date: 01-Feb-2018
• Refers: ASTM E1942-98(2018)e1 - Standard Guide for Evaluating Data Acquisition Systems Used in Cyclic Fatigue and Fracture Mechanics Testing
• Effective Date: 01-Jun-2018
• Refers: ASTM F138-19 - Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)
• Effective Date: 01-Dec-2019
• Refers: ASTM F139-19 - Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Sheet and Strip for Surgical Implants (UNS S31673)
• Effective Date: 01-Dec-2019
• Refers: ASTM F620-11(2015) - Standard Specification for Titanium Alloy Forgings for Surgical Implants in the Alpha Plus Beta Condition
• Effective Date: 01-Dec-2015
• Refers: ASTM F620-20 - Standard Specification for Titanium Alloy Forgings for Surgical Implants in the Alpha Plus Beta Condition
• Effective Date: 01-Feb-2020
• Refers: ASTM E1823-20 - Standard Terminology Relating to Fatigue and Fracture Testing
• Effective Date: 01-Feb-2020
• Refers: ASTM E4-14 - Standard Practices for Force Verification of Testing Machines
• Effective Date: 01-Jun-2014

Standards Content (Sample)

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.
Designation: F384 − 17
Standard Specifications and Test Methods for
1
Metallic Angled Orthopedic Fracture Fixation Devices
This standard is issued under the fixed designation F384; the number immediately following the designation indicates the year of original
adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A superscript
epsilon (´) indicates an editorial change since the last revision or reapproval.
NOTE 2—There is currently no ISO standard that is either similar to
1. Scope
equivalent to this standard.
1.1 These specifications and test methods provide a com-
1.6 Multiple test methods are included in this standard.
prehensive reference for angled devices used in the surgical
However, the user is not necessarily obligated to test using all
internal fixation of the skeletal system. This standard estab-
of the described methods. Instead, the user should only select,
lishes consistent methods to classify and define the geometric
with justification, test methods that are appropriate for a
and performance characteristics of angled devices. This stan-
particular device design. This may be only a subset of the
dard also presents a catalog of standard specifications that
herein described test methods.
specify material, labeling, and handling requirements, and
1.7 This international standard was developed in accor-
standard test methods for measuring performance related
dance with internationally recognized principles on standard-
mechanical characteristics determined to be important to the in
ization established in the Decision on Principles for the
vivo performance of angled devices.
Development of International Standards, Guides and Recom-
1.2 It is not the intention of this standard to define levels of
mendations issued by the World Trade Organization Technical
performance or case-specific clinical performance for angled
Barriers to Trade (TBT) Committee.
devices, as insufficient knowledge is available to predict the
consequences of their use in individual patients for specific
2. Referenced Documents
activities of daily living. Futhermore, this standard does not
2
2.1 ASTM Standards:
describe or specify specific designs for angled devices used in
E4 Practices for Force Calibration and Verification of Test-
the surgical internal fixation of the skeletal system.
ing Machines
1.3 This standard may not be appropriate for all types of
E8 Test Methods for Tension Testing of Metallic Materials
angled devices. The user is cautioned to consider the appro-
[Metric] E0008_E0008M
priateness of this standard in view of a particular angled device
E122 Practice for Calculating Sample Size to Estimate, With
and its potential application.
Specified Precision, the Average for a Characteristic of a
NOTE 1—This standard is not intended to address intramedullary hip
Lot or Process
screw nails or other angled devices without a sideplate.
F67 Specification for Unalloyed Titanium, for Surgical Im-
1.4 This standard includes the following test methods used
plant Applications (UNS R50250, UNS R50400, UNS
in determining the following angled device mechanical perfor-
R50550, UNS R50700)
mance characteristics:
F75 Specification for Cobalt-28 Chromium-6 Molybdenum
1.4.1 Standard test method for single cycle compression
Alloy Castings and Casting Alloy for Surgical Implants
bend testing of metallic angled orthopedic fracture fixation
(UNS R30075)
devices (see Annex A1).
F90 Specification for Wrought Cobalt-20Chromium-
1.4.2 Standard test method for determining the bending
15Tungsten-10Nickel Alloy for Surgical Implant Applica-
fatigue properties of metallic angled orthopedic fracture fixa-
tions (UNS R30605)
tion devices (see Annex A2).
F136 Specification for Wrought Titanium-6Aluminum-
1.5 The values stated in SI units are to be regarded as 4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical
standard. No other units of measurement are included in this Implant Applications (UNS R56401)
standard. F138 Specification for Wrought 18Chromium-14Nickel-
2.5Molybdenum Stainless Steel Bar and Wire for Surgical
Implants (UNS S31673)
1
These specifications and test methods are under the jurisdiction of ASTM
Committee F04 on Medical and Surgical Materials and Devices and are the direct
2
responsibility of Subcommittee F04.21 on Osteosynthesis. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Current edition approved Feb. 1, 2017. Published March 2017. Originally contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
approved in 1973. Last previous edition approved in 2012 as F384 – 12. DOI: Standards volume information, refer to the s
...

This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: F384 − 12 F384 − 17
Standard Specifications and Test Methods for
1
Metallic Angled Orthopedic Fracture Fixation Devices
This standard is issued under the fixed designation F384; the number immediately following the designation indicates the year of original
adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A superscript
epsilon (´) indicates an editorial change since the last revision or reapproval.
1. 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.
2. Referenced Documents
2
2.1 ASTM Standards:
E4 Practices for Force Verification of Testing Machines
E8 Test Methods for Tension Testing of Metallic Materials
E122 Practice for Calculating Sample Size to Estimate, With Specified Precision, the Average for a Characteristic of a Lot or
Process
F67 Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS
R50700)
1
These specifications and test methods are under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and are the direct responsibility
of Subcommittee F04.21 on Osteosynthesis.
Current edition approved May 15, 2012Feb. 1, 2017. Published June 2012March 2017. Originally approved in 1973. Last previous edition approved in 20112012 as
F384 – 06 (2011).F384 – 12. DOI: 10.1520/F0384-12.10.1520/F0384-17.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

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F384 − 17
FIG. 1 Diagram Illustrating Compression Hip Screw Angled Devices
F75 Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Cas
...