ASTM F382-99(2008)e1
(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 PlatesAnnex A1.
1.4.2 Standard Test Method for Determining the...
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Designation:F382 −99(Reapproved 2008)
Standard Specification and Test Method for
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.
ε NOTE—Units information was editorially corrected in August 2009.
1. Scope 1.6 This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the
1.1 Thisspecificationandtestmethodisintendedtoprovide
responsibility of the user of this standard to establish appro-
a comprehensive reference for bone plates used in the surgical
priate safety and health practices and determine the applica-
internal fixation of the skeletal system. The standard estab-
bility of regulatory limitations prior to use.
lishes consistent methods to classify, define the geometric
characteristics, and performance characteristics of bone plates.
2. Referenced Documents
The standard also presents a catalog of standard specifications
2.1 ASTM Standards:
that specify material; labeling and handling requirements; and
F67 Specification for Unalloyed Titanium, for Surgical Im-
standard test methods for measuring performance related
plant Applications (UNS R50250, UNS R50400, UNS
mechanical characteristics determined to be important to the in
R50550, UNS R50700)
vivo performance of bone plates.
F75 Specification for Cobalt-28 Chromium-6 Molybdenum
1.2 It is not the intention of the standard to define levels of
Alloy Castings and Casting Alloy for Surgical Implants
performance or case-specific clinical performance for bone
(UNS R30075)
plates, as insufficient knowledge is available to predict the
F86 Practice for Surface Preparation and Marking of Metal-
consequences or their use in individual patients for specific
lic Surgical Implants
activities of daily living. Futhermore, it is not the intention of
F90 Specification for Wrought Cobalt-20Chromium-
the standard to describe or specify specific designs for bone
15Tungsten-10NickelAlloy for Surgical ImplantApplica-
plates used in the surgical internal fixation of the skeletal
tions (UNS R30605)
system.
F136 Specification for Wrought Titanium-6Aluminum-
4Vanadium ELI (Extra Low Interstitial)Alloy for Surgical
1.3 This document may not be appropriate for all types of
Implant Applications (UNS R56401)
bone plates. The user is cautioned to consider the appropriate-
F138 Specification for Wrought 18Chromium-14Nickel-
ness of the standard in view of a particular bone plate and its
2.5Molybdenum Stainless Steel Bar andWire for Surgical
potential application.
Implants (UNS S31673)
1.4 This document includes the following test methods used
F139 Specification for Wrought 18Chromium-14Nickel-
in determining the following bone plate mechanical perfor-
2.5Molybdenum Stainless Steel Sheet and Strip for Sur-
mance characteristics.
gical Implants (UNS S31673)
1.4.1 Standard Test Method for Single Cycle Bend Testing
F543 Specification and Test Methods for Metallic Medical
of Metallic Bone Plates—Annex A1.
Bone Screws
1.4.2 Standard Test Method for Determining the Bending
F565 PracticeforCareandHandlingofOrthopedicImplants
Fatigue Properties Of Metallic Bone Plates—Annex A2.
and Instruments
F620 Specification for TitaniumAlloy Forgings for Surgical
1.5 The values stated in SI units are to be regarded as
Implants in the Alpha Plus Beta Condition
standard. No other units of measurement are included in this
F621 Specification for Stainless Steel Forgings for Surgical
standard.
Implants
F983 Practice for Permanent Marking of Orthopaedic Im-
plant Components
This specification and test method is under the jurisdiction ofASTM Commit-
tee F04 on Medical and Surgical Materials and Devices and is the direct
responsibility of Subcommittee F04.21 on Osteosynthesis. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Current edition approved Nov. 1, 2008. Published November 2008. Originally contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
ε1
approved in 1973. Last previous edition approved in 2003 as F382 – 99(2003) . Standards volume information, refer to the standard’s Document Summary page on
DOI: 10.1520/F0382-99R08E01. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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F382−99 (2008)
FIG. 1Bone Plate Cross-sections
F1295 Specification for Wrought Titanium-6Aluminum- to the bone through the use of bone screws or cerclage wire.A
7Niobium Alloy for Surgical Implant Applications (UNS partial list of general types of bone plates is given in Section
R56700) 4.1.
F1314 Specification for Wrought Nitrogen Strengthened 22
3.1.3 bone plate length, L(mm)—thelineardimensionofthe
Chromium–13 Nickel–5 Manganese–2.5 Molybdenum
boneplatemeasuredalongthelongitudinalaxisasillustratedin
Stainless Steel Alloy Bar and Wire for Surgical Implants
Fig. 2.
(UNS S20910)
3.1.4 bone plate thickness, b (mm)—the linear dimension of
F1472 Specification for Wrought Titanium-6Aluminum-
the bone plate measured parallel to the screw hole axis as
4VanadiumAlloy for Surgical ImplantApplications (UNS
shown in Fig. 1a, 1b, and Fig. 2. For a bone plate with a
R56400)
crescent section, the thickness is measured at the thickest point
F1713 Specification for Wrought Titanium-13Niobium-
along the section.
13Zirconium Alloy for Surgical Implant Applications
3.1.5 bone plate width, w (mm)—thelineardimensionofthe
(UNS R58130)
3 bone plate measured perpendicular to both the length and
2.2 ISO Standard:
thickness axes as shown in Fig. 2.
FDIS 14602 Non-activesurgicalimplants—ImplantsforOs-
3.1.6 contouring—the manipulation and bending of a bone
teosynthesis particular requirements.
plate, either pre-operatively or intra-operatively, to match the
3. Terminology anatomic geometry of the intended fixation location.
3.1.7 crescent section—a bone plate cross-section shape
3.1 Definitions—Geometric:
(perpendicular to the long axis of the bone plate) where the
3.1.1 auto compression—a type of bone plate that by its
thickness is not constant along the section. Typically the
design can generate a compressive force between adjacent
section is thickest along the bone plate’s centerline and tapers
unconnected bone fragments through the use of one or more
to a smaller thickness at the bone plate’s edges (see Fig. 1b).
ramped holes or another type of slot geometry. This ramp or
slot geometry contacts the underside of the screw head, and
3.1.8 uniform width—referring to a bone plate where the
induces compressive force as the screw is inserted and tight-
width is constant along the bone plate’s length.
ened to the bone plate.
3.2 Definitions—Mechanical/Structural:
3.1.2 bone plate—a metallic device with two or more holes
3.2.1 bending stiffness, K (N/mm)— of a bone plate, the
or slot(s), or both, and a cross section that consists of at least
maximum slope of the linear elastic portion of the load versus
two dimensions (width and thickness) which generally are not
load-point displacement curve for a bone plate when tested
the same in magnitude. The device is intended to provide
according to the test method of Annex A1.
alignment and fixation of two or more bone sections, primarily
3.2.2 bending strength (N-m)— of a bone plate, the bending
byspanningthefractureordefect.Thedeviceistypicallyfixed
moment necessary to produce a 0.2 % offset displacement in
the bone plate when tested as described in Annex A1.
3.2.3 bending structural stiffness, El (N-m )—of a bone
Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
4th Floor, New York, NY 10036, http://www.ansi.org. plate, the bone plate’s normalized effective bending stiffness
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F382−99 (2008)
FIG. 2Bone Plate Dimensions
that takes into consideration the effects of the test setup’s between the screw holes or slots. The reduced cross-section
configurationwhentestedaccordingtothemethoddescribedin between screw holes/slots facilitates contouring the bone plate
Annex A1. in several planes. Reconstruction plates are often used in
fractures of the pelvis and acetabulum.
3.2.4 fatigue life, n—The number of loading cycles of a
4.1.4 straight plate—a bone plate with uniform width and a
specified character that a given specimen sustains before
straight longitudinal axis. Straight plates are often used for
failure of a specified nature occurs.
fractures of the diaphysis of long bones.
3.2.5 fatigue strength at N cycles—An estimate of the cyclic
4.1.5 tubular plate—a bone plate whose cross-section re-
forcing parameter (for example, load, moment, torque, stress,
semblesaportionofatube, andwhichhas aconstantthickness
and so on) at a given load ratio, for which 50 % of the
oracrescentsection.Tubularplatesareoftenusedforfractures
specimens within a given sample population would be ex-
of the smaller long bones (that is, radius, ulna, fibula).
pected to survive N loading cycles.
5. Marking, Packaging, Labeling, and Handling
4. Classification
5.1 Dimensions of bone plates should be designated by the
4.1 Bone plates used in general orthopaedic surgery can be
standard definitions given in Section 3.1.
categorized into general types according to the following
classifications.
5.2 Bone plates shall be marked using a method specified in
4.1.1 cloverleaf plate—aboneplatethathasonethree-lobed
accordance with either Practice F983 or ISO 14602
end which contains screw holes.
FDIS 14602.
4.1.2 cobra head plate—a bone plate that has one flared
5.3 Markings on bone plates shall identify the manufacturer
triangular or trapezoidal end which contains multiple screw
or distributor and shall be made away from the most highly
holes or slots, or both.This type of bone plate is often used for
stressed areas, where possible.
hip arthrodesis.
4.1.3 reconstruction plate—a bone plate that does not have 5.4 Packaging shall be adequate to protect the bone plates
a uniform width, but usually has a smaller cross-section during shipment.
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F382−99 (2008)
5.5 Package labeling for bone plates shall include when 6.3 Bone plates of forged Specification F138 shall meet the
possible the following information: requirements of Specification F621.
5.5.1 Manufacturer and Product Name,
7. General Requirements and Performance
5.5.2 Catalog number,
Considerations
5.5.3 Lot or serial number,
7.1 geometric considerations—bone plates that are intended
5.5.4 Material and, where applicable, its associated ASTM
specification designation number, to be used with bone screws shall have design features (screw
holes or slots) that conform or appropriately fit the correspond-
5.5.5 Number of screw holes,
ing bone screw.
5.5.6 Bone plate width,
5.5.7 Bone plate length,
7.2 bending properties—a critical characteristic of bone
5.5.8 Bone plate thickness, and
plates for orthopedic applications since the bone plate provides
5.5.9 ASTM specification designation number.
the primary means of stabilizing the bone fragments.
Additionally, the bending stiffness of the bone plate may
5.6 Bone plates should be cared for and handled in accor-
directly affect the rate and ability of healing.
dance with Practice F565, as appropriate.
7.2.1 The relevant bending properties (bending stiffness,
bending structural stiffness, and bending strength) shall be
6. Materials
determined using the standard test method of Annex A1.
6.1 All bone plates made of materials which have anASTM
7.2.2 Determine the relevant bending fatigue properties
committee F04 standard designation shall meet those require-
according to the methods described in Annex A2.
ments given in the ASTM standards. A majority of materials
having ASTM specifications can be found in the list of
8. Keywords
referenced ASTM standards of Section 2.1.
8.1 bendtesting—surgicalimplants;fatiguetest;boneplate;
6.2 Bone plates of forged Specification F136 shall meet the orthopedicmedicaldevices—boneplates;surgicaldevices;test
requirements of Specification F620. methods—surgical implants
ANNEXES
A1. STANDARD TEST METHOD FOR SINGLE CYCLE BEND TESTING OF METALLIC BONE PLATES
A1.1 Scope: E122 Practice for Choice of Sample Size to Estimate the
Average Quality of a Lot or Process
A1.1.1 This test method describes methods for single cycle
bend testing in order to determine intrinsic, structural proper-
A1.3 Terminology:
ties of metallic bone plates. The test method measures the
A1.3.1 Definitions:
bending stiffness, bending structural stiffness, and bending
A1.3.1.1 0.2 % offset displacement, q (mm)—permanent
strength of bone plates.
deformationequalto0.2 %ofthecenterloadingspandistance.
A1.1.2 This test method is intended to provide a means of
(point B in Fig. A1.1).
mechanically characterize different bone plate designs. It is not
the intention of this standard to define levels of performance
for bone plates as insufficient knowledge is available to predict
the consequences of the use of particular bone plate designs.
A1.1.3 Units—The values stated in SI units are to be
regarded as standard. No other units of measurement are
included in this standard.
A1.1.4 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 appro-
priate safety and health practices and determine the applica-
bility of regulatory limitations prior to use.
NOTE A1.1—There is currently an ISO standard (ISO 9585—Implants
for Surgery—Determination of Bending Strength and Stiffness of Bone
Plates) that is similar, but not equivalent to this test method.
A1.2 Referenced Documents:
A1.2.1 ASTM Standards : E4 Practices for Load Verifi-
FIG. A1.1Diagram Illustrating Methods For Determining Bending
cation of Testing Machines Properties of Bone Plates
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F382−99 (2008)
A1.3.1.2 bending strength (N-m)—of a bone plate, the
bending moment necessary to produce a 0.2 % offset displace-
ment in the bone plate when tested as described in Section
A1.8 (the bending moment corresponding to point D in Fig.
A1.1.). If the bone plate fractures before the proof point is
attained the bending strength shall be defined as the bending
moment at fracture.
A1.3.1.3 bending structural stiffness, (EI ) (N-m )—of a
e
bone plate, the bone plate’s normalized effective bending
stiffness that takes into consideration the effects of the test
setup’s configuration. For this test method, the bending struc-
FIG. A1.3Roller Profiling Requirements
tural s
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