ASTM F384-06e1

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

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 an angled device's fatigue life at either a specific or over a range of maximum bending moment conditions. Additionally, this test method may be alternatively used to estimate an angled device's fatigue strength 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 material's linear-elastic range; 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 of 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.  
A2.1.1 This test method describes methods for bending fatigue testing in order to determine intrinsic structural properties of metallic angled devices. The test method may be used to determine the fatigue life at a specific or o...

General Information

• Status: Historical
• Publication Date: 14-Jan-2006
• 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

• Replaces: ASTM F384-06 - Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices
• Effective Date: 15-Jan-2006
• Replaced By: ASTM F384-06(2011) - Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices
• Effective Date: 01-Jun-2011

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
´1
Designation: F384 – 06
Standard Specifications and Test Methods for
1
Metallic Angled Orthopedic Fracture Fixation Devices
ThisstandardisissuedunderthefixeddesignationF384;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginal
adoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscript
epsilon (´) indicates an editorial change since the last revision or reapproval.
1
´ NOTE—Units information was editorially corrected in August 2009.
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-
prehensive reference for angled devices used in the surgical
2. Referenced Documents
internal fixation of the skeletal system. This standard estab-
2
2.1 ASTM Standards:
lishes consistent methods to classify and define the geometric
E4 Practices for Force Verification of Testing Machines
and performance characteristics of angled devices. This stan-
E8 Test Methods for Tension Testing of Metallic Materials
dard also presents a catalog of standard specifications that
E122 Practice for Calculating Sample Size to Estimate,
specify material, labeling, and handling requirements, and
With Specified Precision, the Average for a Characteristic
standard test methods for measuring performance related
of a Lot or Process
mechanicalcharacteristicsdeterminedtobeimportanttothe in
F67 Specification for Unalloyed Titanium, for Surgical
vivo performance of angled devices.
Implant Applications (UNS R50250, UNS R50400, UNS
1.2 It is not the intention of this standard to define levels of
R50550, UNS R50700)
performance of case-specific clinical performance for angled
F75 Specification for Cobalt-28 Chromium-6 Molybdenum
devices, as insufficient knowledge is available to predict the
Alloy Castings and Casting Alloy for Surgical Implants
consequences of their use in individual patients for specific
(UNS R30075)
activities of daily living. Futhermore, this standard does not
F90 Specification for Wrought Cobalt-20Chromium-
describe or specify specific designs for angled devices used in
15Tungsten-10Nickel Alloy for Surgical Implant Applica-
the surgical internal fixation of the skeletal system.
tions (UNS R30605)
1.3 This standard may not be appropriate for all types of
F136 Specification for Wrought Titanium-6Aluminum-
angled devices. The user is cautioned to consider the appro-
4Vanadium ELI (Extra Low Interstitial)Alloy for Surgical
priatenessofthisstandardinviewofaparticularangleddevice
Implant Applications (UNS R56401)
and its potential application.
F138 Specification for Wrought 18Chromium-14Nickel-
NOTE 1—This standard is not intended to address intramedullary hip 2.5Molybdenum Stainless Steel Bar and Wire for Surgical
screw nails or other angled devices without a sideplate.
Implants (UNS S31673)
F139 Specification for Wrought 18Chromium-14Nickel-
1.4 This standard includes the following test methods used
2.5Molybdenum Stainless Steel Sheet and Strip for Surgi-
in determining the following angled device mechanical perfor-
cal Implants (UNS S31673)
mance characteristics:
F382 Specification and Test Method for Metallic Bone
1.4.1 Standard test method for single cycle compression
Plates
bend testing of metallic angled orthopedic fracture fixation
F543 Specification and Test Methods for Metallic Medical
devices (see Annex A1).
Bone Screws
1.4.2 Standard test method for determining the bending
F565 Practice for Care and Handling of Orthopedic Im-
fatigue properties of metallic angled orthopedic fracture fixa-
plants and Instruments
tion devices (see Annex A2).
F620 Specification for Alpha Plus Beta Titanium Alloy
1.5 The values stated in SI units are to be regarded as
Forgings for Surgical Implants
standard. No other units of measurement are included in this
F621 Specification for Stainless Steel Forgings for Surgical
standard.
Implants
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 Jan. 15, 2006. Published February 2006. Originally
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
approved in 1973. Last previous edition approved in 2000 as F384–00. DOI:
Standards volume information, refer to the standard’s Document Summary page on
10.1520/F0384-06E01.
the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

---------------------- Page: 1 ----------------------
´1
F384 – 06
FIG. 1 Diagram Illustrating Compression Hip Screw Angled Devices
F983 Practice for Permanent M
...

This document is not anASTM standard and is intended only to provide the user of anASTM 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.
´1
Designation:F384–00 Designation: F 384 – 06
Standard Specifications and Test Methods for
1
Metallic Angled Orthopedic Fracture Fixation Devices
This standard is issued under the fixed designation F 384; 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
´ NOTE—Units information was editorially corrected in August 2009.
1. Scope
1.1This standard is intended to1.1 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 and labelingmaterial, 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 of 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, it is not the intention of this standard todoes 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 Standardtestmethodforsinglecyclecompressionbendtestingofmetallicangledorthopedicfracturefixationdevices(see
Annex A1).
1.4.2 Standardtestmethodfordeterminingthebendingfatiguepropertiesofmetallicangledorthopedicfracturefixationdevices
(see Annex A2).
1.5Unless otherwise indicated, the values stated in SI units shall be regarded as the standard.
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
NOTE1—There 2—There is currently no ISO standard that is either similar to equivalent to this standard.
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
E 122 Practice for Choice of Sample Size to Estimate theAverage Quality of a Lot or Process Practice for Calculating Sample
Size to Estimate, With Specified Precision, the Average for a Characteristic of a Lot or Process
F67 Specification for UnalloyedTitanium for Surgical ImplantApplications Specification for UnalloyedTitanium, for Surgical
Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)
F75 Specification for Cobalt-28 Chromium-6 Molybdenum Casting Alloy Castings and Cast ProductsCasting Alloy for
Surgical Implants (UNS R30075)
F90 Specification for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy for Surgical Implant Applications
4
(R30605) Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications
(UNS R30605)
F 136 Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for
1
ThesespecificationsandtestmethodsareunderthejurisdictionofASTMCommitteeF04onMedicalandSurgicalMaterialsandDevicesandarethedirectresponsibility
of Subcommittee F04.21 on Osteosynthesis .
Current edition approved Nov. 10, 2000. Published February 2001. Originally published as F384-73. Last previous edition F384-99.
Current edition approved Jan. 15, 2006. Published February 2006. Originally approved in 1973. Last previous edition approved in 2000 as F 384 – 00.
2
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at [e-mail]. For Annual Book of ASTM Standards
. Vol 03.01.volume information, refer to the standard’s Document Summary page on the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive
...

This document is not anASTM standard and is intended only to provide the user of anASTM 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.
´1
Designation:F384–06 Designation: F 384 – 06
Standard Specifications and Test Methods for
1
Metallic Angled Orthopedic Fracture Fixation Devices
This standard is issued under the fixed designation F 384; 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
´ NOTE—Units information was editorially corrected in August 2009.
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 of 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 Standardtestmethodforsinglecyclecompressionbendtestingofmetallicangledorthopedicfracturefixationdevices(see
Annex A1).
1.4.2 Standardtestmethodfordeterminingthebendingfatiguepropertiesofmetallicangledorthopedicfracturefixationdevices
(see Annex A2).
1.5Unless otherwise indicated, the values stated in SI units shall be regarded as the standard.
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.
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
E 122 Practice for Calculating Sample Size to Estimate, With Specified Precision, theAverage for a Characteristic of a Lot or
Process
F67 SpecificationforUnalloyedTitanium,forSurgicalImplantApplications(UNSR50250,UNSR50400,UNSR50550,UNS
R50700)
F75 Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS
R30075)
F90 Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications (UNS
R30605)
F 136 Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant
Applications (UNS R56401)
1
ThesespecificationsandtestmethodsareunderthejurisdictionofASTMCommitteeF04onMedicalandSurgicalMaterialsandDevicesandarethedirectresponsibility
of Subcommittee F04.21 on Osteosynthesis .
Current edition approved Jan. 15, 2006. Published February 2006. Originally approved in 1973. Last previous edition approved in 2000 as F 384 – 00.
2
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM 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

---------------------- Page: 1 ----------------------
´1
F384–06
F 138 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants
(UNS S31673)
F 139 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Sheet and Strip for Surgical Implants
(UNS S31673)
F 382 Specification and Test Method for Metallic Bone Plates
F 543 Specification and Test Methods for Metallic
...