ASTM F382-14
(Specification)Standard Specification and Test Method for Metallic Bone Plates
Standard Specification and Test Method for Metallic Bone Plates
ABSTRACT
This specification and test method establishes the consistent methods for classifying, and defining the geometric and performance characteristics of five types (cloverleaf, cobra head, reconstruction, straight, and tubular) of metallic bone plates used in the surgical internal fixation of the skeletal system. Also presented here are catalogs of standard specifications for material, labeling, and handling requirements, and standard test methods for measuring performance related mechanical (single cycle bend and bend fatigue) characteristics determined to be important to the in vivo performance of bone plates. This neither defines the levels of performance or case-specific clinical performance for bone plates, nor describes specific designs for bone plates.
SIGNIFICANCE AND USE
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.
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 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.
1.4 This document 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, and
1.4...
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Designation:F382 −14
Standard Specification and Test Method for
1
Metallic Bone Plates
ThisstandardisissuedunderthefixeddesignationF382;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginal
adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.Asuperscript
epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope using all of the described methods. Instead, the user should
only select test methods that are appropriate for a particular
1.1 Thisspecificationandtestmethodisintendedtoprovide
device design. In most instances, only a subset of the herein
a comprehensive reference for bone plates used in the surgical
described test methods will be required.
internal fixation of the skeletal system. The standard estab-
1.7 This standard does not purport to address all of the
lishes consistent methods to classify and define the geometric
safety concerns, if any, associated with its use. It is the
and performance characteristics of bone plates. The standard
responsibility of the user of this standard to establish appro-
also presents a catalog of standard specifications that specify
priate safety and health practices and determine the applica-
material; labeling and handling requirements; and standard test
bility of regulatory limitations prior to use.
methods for measuring performance related mechanical char-
acteristics determined to be important to the in vivo perfor-
2. Referenced Documents
mance of bone plates.
2
2.1 ASTM Standards:
1.2 It is not the intention of the standard to define levels of
E122 PracticeforCalculatingSampleSizetoEstimate,With
performance or case-specific clinical performance for bone
Specified Precision, the Average for a Characteristic of a
plates, as insufficient knowledge is available to predict the
Lot or Process
consequences or their use in individual patients for specific
F67 Specification for Unalloyed Titanium, for Surgical Im-
activities of daily living. Futhermore, it is not the intention of
plant Applications (UNS R50250, UNS R50400, UNS
the standard to describe or specify specific designs for bone
R50550, UNS R50700)
plates used in the surgical internal fixation of the skeletal
F75 Specification for Cobalt-28 Chromium-6 Molybdenum
system.
Alloy Castings and Casting Alloy for Surgical Implants
1.3 This document may not be appropriate for all types of
(UNS R30075)
bone plates. The user is cautioned to consider the appropriate-
F86 Practice for Surface Preparation and Marking of Metal-
ness of the standard in view of a particular bone plate and its
lic Surgical Implants
potential application.
F90 Specification for Wrought Cobalt-20Chromium-
1.4 This document includes the following test methods used 15Tungsten-10NickelAlloy for Surgical ImplantApplica-
in determining the following bone plate mechanical perfor- tions (UNS R30605)
mance characteristics: F136 Specification for Wrought Titanium-6Aluminum-
1.4.1 Standard Test Method for Single Cycle Bend Testing 4Vanadium ELI (Extra Low Interstitial)Alloy for Surgical
of Metallic Bone Plates—Annex A1, and Implant Applications (UNS R56401)
1.4.2 Standard Test Method for Determining the Bending F138 Specification for Wrought 18Chromium-14Nickel-
Fatigue Properties Of Metallic Bone Plates—Annex A2. 2.5Molybdenum Stainless Steel Bar andWire for Surgical
Implants (UNS S31673)
1.5 The values stated in SI units are to be regarded as
F139 Specification for Wrought 18Chromium-14Nickel-
standard. No other units of measurement are included in this
2.5Molybdenum Stainless Steel Sheet and Strip for Sur-
standard.
gical Implants (UNS S31673)
1.6 Multiple test methods are included in this standard.
F543 Specification and Test Methods for Metallic Medical
However, it must be noted that the user is not obligated to test
Bone Screws
F565 PracticeforCareandHandlingofOrthopedicImplants
and Instruments
1
This specification and test method is under the jurisdiction ofASTM Commit-
tee F04 on Medical and Surgical Materials and Devices and is 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 Nov. 1, 2014. Published January 2014. Originally contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
ε1
approved in 1973. Last previous edition approved in 2008 as F382 – 99 (2008) . Standards volume information, refer to the standard’s Document Summary page on
DOI: 10.1520/F0382-14. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F382−14
FIG. 1Bone Plate Cross-sections
F620 Specification for TitaniumAlloy Forgings for Surgical 3.1.2 bone
...
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.
´1
Designation: F382 − 99 (Reapproved 2008) F382 − 14
Standard Specification and Test Method for
1
Metallic Bone Plates
This standard is issued under the fixed designation F382; 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
ε NOTE—Units information was editorially corrected in August 2009.
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, classify and 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 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.
1.4 This document includes the following test methods used in determining the following bone plate mechanical performance
characteristics. characteristics:
1.4.1 Standard Test Method for Single Cycle Bend Testing of Metallic Bone Plates—Annex A1., and
1.4.2 Standard Test Method for Determining the Bending Fatigue Properties Of Metallic Bone Plates—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.
1.6 Multiple test methods are included in this standard. However, it must be noted that the user is not obligated to test using
all of the described methods. Instead, the user should only select test methods that are appropriate for a particular device design.
In most instances, only a subset of the herein described test methods will be required.
1.7 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
2
2.1 ASTM Standards:
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)
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)
1
This specification and test method is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of
Subcommittee F04.21 on Osteosynthesis.
Current edition approved Nov. 1, 2008Nov. 1, 2014. Published November 2008January 2014. Originally approved in 1973. Last previous edition approved in 20032008
ε1
as F382 – 99 (2008)(2003) . DOI: 10.1520/F0382-99R08E01.10.1520/F0382-14.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at service@astm.org. 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 ----------------------
F382 − 14
FIG. 1 Bone Plate Cross-sections
F136 Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surg
...
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