ASTM F382-99(2008)
(Test Method)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
A2.5.1 The 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 bone plate's fatigue life at either a specific or over a range of maximum bending moment conditions. Additionally, the test method may be alternatively used to estimate a bone plate's fatigue strength for a specified number of fatigue cycles.
A2.5.2 The 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 materials' linear-elastic range. 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, 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.
1.4.1 Standard Test Method for Single Cycle Bend Testing of Metallic Bone Plates—Annex A1.
1.4.2 Standard Test Method for Determining th...
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Designation: F 382 – 99 (Reapproved 2008)
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.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope 2. Referenced Documents
2
1.1 Thisspecificationandtestmethodisintendedtoprovide 2.1 ASTM Standards:
a comprehensive reference for bone plates used in the surgical F67 Specification for Unalloyed Titanium, for Surgical
internal fixation of the skeletal system. The standard estab- Implant Applications (UNS R50250, UNS R50400, UNS
lishes consistent methods to classify, define the geometric R50550, UNS R50700)
characteristics, and performance characteristics of bone plates. F75 SpecificationforCobalt-28Chromium-6Molybdenum
The standard also presents a catalog of standard specifications Alloy Castings and Casting Alloy for Surgical Implants
that specify material; labeling and handling requirements; and (UNS R30075)
standard test methods for measuring performance related F86 Practice for Surface Preparation and Marking of Me-
mechanicalcharacteristicsdeterminedtobeimportanttothe in tallic Surgical Implants
vivo performance of bone plates. F 90 Specification for Wrought Cobalt-20Chromium-
1.2 It is not the intention of the standard to define levels of 15Tungsten-10Nickel Alloy for Surgical Implant Applica-
performance or case-specific clinical performance for bone tions (UNS R30605)
plates, as insufficient knowledge is available to predict the F136 Specification for Wrought Titanium-6Aluminum-
consequences or their use in individual patients for specific 4Vanadium ELI (Extra Low Interstitial)Alloy for Surgical
activities of daily living. Futhermore, it is not the intention of Implant Applications (UNS R56401)
the standard to describe or specify specific designs for bone F138 Specification for Wrought 18Chromium-14Nickel-
plates used in the surgical internal fixation of the skeletal 2.5Molybdenum Stainless Steel Bar and Wire for Surgical
system. Implants (UNS S31673)
1.3 This document may not be appropriate for all types of F139 Specification for Wrought 18Chromium-14Nickel-
bone plates. The user is cautioned to consider the appropriate- 2.5Molybdenum Stainless Steel Sheet and Strip for Surgi-
ness of the standard in view of a particular bone plate and its cal Implants (UNS S31673)
potential application. F543 Specification and Test Methods for Metallic Medical
1.4 Thisdocumentincludesthefollowingtestmethodsused Bone Screws
in determining the following bone plate mechanical perfor- F565 Practice for Care and Handling of Orthopedic Im-
mance characteristics. plants and Instruments
1.4.1 Standard Test Method for Single Cycle Bend Testing F620 Specification for Alpha Plus Beta Titanium Alloy
of Metallic Bone Plates—Annex A1. Forgings for Surgical Implants
1.4.2 Standard Test Method for Determining the Bending F621 SpecificationforStainlessSteelForgingsforSurgical
Fatigue Properties Of Metallic Bone Plates—Annex A2. Implants
1.5 The values stated in SI units are to be regarded as F983 Practice for Permanent Marking of Orthopaedic Im-
standard. The values given in parentheses are mathematical plant Components
conversions to inch-pound units that are provided for informa- F1295 Specification for Wrought Titanium-6Aluminum-
tion only and are not considered standard. 7Niobium Alloy for Surgical Implant Applications (UNS
1.6 This standard does not purport to address all of the R56700)
safety concerns, if any, associated with its use. It is the F1314 SpecificationforWroughtNitrogenStrengthened22
responsibility of the user of this standard to establish appro- Chromium−13Nickel−5Manganese−2.5Molybdenum
priate safety and health practices and determine the applica- Stainless Steel Alloy Bar and Wire for Surgical Implants
bility of regulatory limitations prior to use. (UNS S20910)
1
This specification and test method is under the jurisdiction ofASTM Commit-
2
tee F04 on Medical and Surgical Materials and Devices and is the direct For referenced ASTM standards, visit the ASTM website, www.astm.org, or
responsibility of Subcommittee F04.21 on Osteosynthesis. contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Current edition approved Nov. 1, 2008. Published November 2008. Originally Standards volume information, refer to the standard’s Document Summary page on
´1
approved in 1973. Last previous edition approved in 2003 as F 382–99(2003) . the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1
---------------------- Page: 1
...
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:F382–99 (Reapproved 2003) Designation: F 382 – 99 (Reapproved 2008)
Standard Specification and Test Method for
1
Metallic Bone Plates
This standard is issued under the fixed designation F 382; 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—Editorial changes were made throughout in December 2004.
1. Scope
1.1 This specification and test method is intended to provide a comprehensive reference for bone plates used in the surgical
internalfixationoftheskeletalsystem.Thestandardestablishesconsistentmethodstoclassify,definethegeometriccharacteristics,
andperformancecharacteristicsofboneplates.Thestandardalsopresentsacatalogofstandardspecificationsthatspecifymaterial;
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.
1.4.2 Standard Test Method for Determining the Bending Fatigue Properties Of Metallic Bone Plates—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. The values given in parentheses are mathematical conversions
to inch-pound units that are provided for information only and are not considered standard.
1.6 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:
F67Specification for Unalloyed Titanium for Surgical Implant Applications 67 Specification for Unalloyed Titanium, for
Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)
F 75 Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS
R30075)
F 86 Practice for Surface Preparation and Marking of Metallic Surgical Implants
F 90 Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications (UNS
R56401) R30605)
F 136 Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant
Applications (UNS R56401)
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)
1
This specification and test method is under the jurisdiction ofASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of
Subcommittee F04.21 on Osteosynthesis.
Current edition approved Apr. 10, 2003.Nov. 1, 2008. Published May 2003.November 2008. Originally approved in 1973. Last previous edition approved in 19992003
´1
as F 382 – 99(2003) .
2
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM 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 ----------------------
F 382 – 99 (2008)
F 543 Specification and Test Method
...
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:F382–99 (Reapproved 2003) Designation: F 382 – 99 (Reapproved 2008)
Standard Specification and Test Method for
1
Metallic Bone Plates
This standard is issued under the fixed designation F 382; 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—Editorial changes were made throughout in December 2004.
1. Scope
1.1 This specification and test method is intended to provide a comprehensive reference for bone plates used in the surgical
internalfixationoftheskeletalsystem.Thestandardestablishesconsistentmethodstoclassify,definethegeometriccharacteristics,
andperformancecharacteristicsofboneplates.Thestandardalsopresentsacatalogofstandardspecificationsthatspecifymaterial;
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.
1.4.2 Standard Test Method for Determining the Bending Fatigue Properties Of Metallic Bone Plates—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. The values given in parentheses are mathematical conversions
to inch-pound units that are provided for information only and are not considered standard.
1.6 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:
F67 Specification for UnalloyedTitanium for Surgical ImplantApplicationsSpecification for UnalloyedTitanium, 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
R56401)R30605)
F 136 Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant
Applications (UNS R56401)
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)
1
This specification and test method is under the jurisdiction ofASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of
Subcommittee F04.21 on Osteosynthesis.
Current edition approved Apr. 10, 2003.Nov. 1, 2008. Published May 2003.November 2008. Originally approved in 1973. Last previous edition approved in 19992003
´1
as F 382 – 99(2003) .
2
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM 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 ----------------------
F 382 – 99 (2008)
F 543 Specification and Test Methods for Meta
...
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