ASTM F382-99(2003)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.
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 standard 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 standard 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.
1.5 Unless otherwise indicated, the values stated in SI units shall be regarded as the 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.
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Designation: F 382 – 99 (Reapproved 2003)
Standard Specification and Test Method for
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 (e) indicates an editorial change since the last revision or reapproval.
e NOTE—Editorial changes were made throughout in December 2004.
1. Scope 2. Referenced Documents
1.1 Thisspecificationandtestmethodisintendedtoprovide 2.1 ASTM Standards:
a comprehensive reference for bone plates used in the surgical F 67 Specification for Unalloyed Titanium for Surgical
internal fixation of the skeletal system. The standard estab- Implant Applications
lishes consistent methods to classify, define the geometric F 75 SpecificationforCobalt-28Chromium-6Molybdenum
characteristics, and performance characteristics of bone plates. Alloy Castings and Casting Alloy for Surgical Implants
The standard also presents a catalog of standard specifications (UNS R30075)
that specify material; labeling and handling requirements; and F 86 Practice for Surface Preparation and Marking of Me-
standard test methods for measuring performance related tallic Surgical Implants
mechanical characteristics determined to be important to the in F 90 Specification for Wrought Cobalt-20Chromium-
vivo performance of bone plates. 15Tungsten-10Nickel Alloy for Surgical Implant Applica-
1.2 It is not the intention of the standard to define levels of tions (UNS R56401)
performance or case-specific clinical performance for bone F 136 Specification for Wrought Titanium-6Aluminum-
plates, as insufficient knowledge is available to predict the 4Vanadium ELI (Extra Low Interstitial)Alloy for Surgical
consequences or their use in individual patients for specific Implant Applications (UNS R56401)
activities of daily living. Futhermore, it is not the intention of F 138 Specification for Wrought 18Chromium-14Nickel-
the standard to describe or specify specific designs for bone 2.5Molybdenum Stainless Steel Bar and Wire for Surgical
plates used in the surgical internal fixation of the skeletal Implants (UNS S31673)
system. F 139 Specification for Wrought 18Chromium-14Nickel-
1.3 This document may not be appropriate for all types of 2.5Molybdenum Stainless Steel Sheet and Strip for Surgi-
bone plates. The user is cautioned to consider the appropriate- cal Implants (UNS S31673)
ness of the standard in view of a particular bone plate and its F 543 Specification and Test Methods for Metallic Medical
potential application. Bone Screws
1.4 This document includes the following test methods used F 565 Practice for Care and Handling of Orthopedic Im-
in determining the following bone plate mechanical perfor- plants and Instruments
mance characteristics. F 620 Specification for Alpha Plus Beta Titanium Alloy
1.4.1 Standard Test Method for Single Cycle Bend Testing Forgings for Surgical Implants
of Metallic Bone Plates—Annex A1. F 621 SpecificationforStainlessSteelForgingsforSurgical
1.4.2 Standard Test Method for Determining the Bending Implants
Fatigue Properties Of Metallic Bone Plates—Annex A2. F 983 Practice for Permanent Marking of Orthopaedic Im-
1.5 Unless otherwise indicated, the values stated in SI units plant Components
shall be regarded as the standard. F 1295 Specification for Wrought Titanium-6Aluminum-
1.6 This standard does not purport to address all of the 7Niobium Alloy for Surgical Implant Applications
safety concerns, if any, associated with its use. It is the F 1314 Wrought Nitrogen Strengthened-22Chromium-
responsibility of the user of this standard to establish appro- 12.5Nickel-5Manganese-2.5Molybdenum Stainless Steel
priate safety and health practices and determine the applica- Bar and Wire for Surgical Implants (UNS S20910)
bility of regulatory limitations prior to use. F 1472 Specification for Alpha Plus Beta Titanium Alloy
This test method is under the jurisdiction ofASTM Committee F04 on Medical
and Surgical Materials and Devices and is the direct responsibility of Subcommittee For referenced ASTM standards, visit the ASTM website, www.astm.org, or
F04.21 on Osteosynthesis. contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Current edition approved Apr. 10, 2003. Published May 2003. Originally Standards volume information, refer to the standard’s Document Summary page on
approved in 1973. Last previous edition approved in 1999 as F 382 – 99. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
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F 382 – 99 (2003)
Forgings for Surgical Implants 3.1.5 bone plate width, w (mm)—thelineardimensionofthe
F 1713 Specification for Wrought Titanium-13Niobium- bone plate measured perpendicular to both the length and
13Zirconium Alloy for Surgical Implant Applications thickness axes as shown in Fig. 2.
2.2 ISO Standard: 3.1.6 contouring—the manipulation and bending of a bone
FDIS 14602 Non-active surgical implants—Implants for plate, either pre-operatively or intra-operatively, to match the
Osteosynthesis particular requirements. anatomic geometry of the intended fixation location.
3.1.7 crescent section—a bone plate cross-section shape
3. Terminology
(perpendicular to the long axis of the bone plate) where the
3.1 Definitions—Geometric: thickness is not constant along the section. Typically the
3.1.1 auto compression—a type of bone plate that by its
section is thickest along the bone plate’s centerline and tapers
design can generate a compressive force between adjacent to a smaller thickness at the bone plate’s edges (see Fig. 1b).
unconnected bone fragments through the use of one or more
3.1.8 uniform width—referring to a bone plate where the
ramped holes or another type of slot geometry. This ramp or width is constant along the bone plate’s length.
slot geometry contacts the underside of the screw head, and
3.2 Definitions—Mechanical/Structural:
induces compressive force as the screw is inserted and tight-
3.2.1 bending stiffness, K (N/mm)— of a bone plate, the
ened to the bone plate. maximum slope of the linear elastic portion of the load versus
3.1.2 bone plate—a metallic device with two or more holes
load-point displacement curve for a bone plate when tested
or slot(s), or both, and a cross section that consists of at least according to the test method of Annex A1.
two dimensions (width and thickness) which generally are not
3.2.2 bending strength (N-m)— of a bone plate, the bending
the same in magnitude. The device is intended to provide moment necessary to produce a 0.2 % offset displacement in
alignment and fixation of two or more bone sections, primarily
the bone plate when tested as described in Annex A1.
byspanningthefractureordefect.Thedeviceistypicallyfixed 3.2.3 bending structural stiffness, El (N-m )—of a bone
to the bone through the use of bone screws or cerclage wire.A
plate, the bone plate’s normalized effective bending stiffness
partial list of general types of bone plates is given in Section that takes into consideration the effects of the test setup’s
4.1.
FIG. 1 Bone Plate Cross-sections
3.1.3 bone plate length, L (mm)—the linear dimension of configurationwhentestedaccordingtothemethoddescribedin
the bone plate measured along the longitudinal axis as illus- Annex A1.
trated in Fig. 2.
3.2.4 fatigue life, n—The number of loading cycles of a
3.1.4 bone plate thickness, b (mm)—the linear dimension of
specified character that a given specimen sustains before
the bone plate measured parallel to the screw hole axis as
failure of a specified nature occurs.
shown in Fig. 1a, 1b, and Fig. 2. For a bone plate with a
3.2.5 fatigue strength at N cycles—Anestimateofthecyclic
crescent section, the thickness is measured at the thickest point
forcing parameter (for example, load, moment, torque, stress,
along the section.
and so on) at a given load ratio, for which 50 % of the
specimens within a given sample population would be ex-
Available from International Standards Organization, Rue de Varembe, Case pected to survive N loading cycles.
Postale 56, CH-1211, Geneva 20, Switzerland.
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F 382 – 99 (2003)
FIG. 2 Bone Plate Dimensions
4. Classification 5. Marking, Packaging, Labeling, and Handling
4.1 Bone plates used in general orthopaedic surgery can be 5.1 Dimensions of bone plates should be designated by the
categorized into general types according to the following standard definitions given in Section 3.1.
classifications.
5.2 Bone plates shall be marked using a method specified in
4.1.1 cloverleaf plate—aboneplatethathasonethree-lobed accordance with either Practice F 983 or ISO 14602.
end which contains screw holes.
5.3 Markings on bone plates shall identify the manufacturer
4.1.2 cobra head plate—a bone plate that has one flared or distributor and shall be made away from the most highly
stressed areas, where possible.
triangular or trapezoidal end which contains multiple screw
holes or slots, or both.This type of bone plate is often used for
5.4 Packaging shall be adequate to protect the bone plates
hip arthrodesis.
during shipment.
4.1.3 reconstruction plate—a bone plate that does not have
5.5 Package labeling for bone plates shall include when
a uniform width, but usually has a smaller cross-section
possible the following information:
between the screw holes or slots. The reduced cross-section
5.5.1 Manufacturer and Product Name,
between screw holes/slots facilitates contouring the bone plate
5.5.2 Catalog number,
in several planes. Reconstruction plates are often used in
5.5.3 Lot or serial number,
fractures of the pelvis and acetabulum.
5.5.4 Material and, where applicable, its associated ASTM
4.1.4 straight plate—a bone plate with uniform width and a
specification designation number,
straight longitudinal axis. Straight plates are often used for
5.5.5 Number of screw holes,
fractures of the diaphysis of long bones.
5.5.6 Bone plate width,
4.1.5 tubular plate—a bone plate whose cross-section re-
5.5.7 Bone plate length,
semblesaportionofatube,andwhichhasaconstant thickness
5.5.8 Bone plate thickness, and
oracrescentsection.Tubularplatesareoftenusedforfractures
of the smaller long bones (that is, radius, ulna, fibula). 5.5.9 ASTM specification designation number.
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F 382 – 99 (2003)
5.6 Bone plates should be cared for and handled in accor- 7.2 bending properties—a critical characteristic of bone
dance with Practice F 565, as appropriate. plates for orthopedic applications since the bone plate provides
the primary means of stabilizing the bone fragments.Addition-
6. Materials
ally, the bending stiffness of the bone plate may directly affect
6.1 All bone plates made of materials which have anASTM
the rate and ability of healing.
committee F04 standard designation shall meet those require-
7.2.1 The relevant bending properties (bending stiffness,
ments given in the ASTM standards. A majority of materials
bending structural stiffness, and bending strength) shall be
having ASTM specifications can be found in the list of
determined using the standard test method of Annex A1.
referenced ASTM standards of Section 2.1.
7.2.2 Determine the relevant bending fatigue properties
6.2 Bone plates of forged Specification F 136 shall meet the
according to the methods described in Annex A2.
requirements of specification F 620.
6.3 Bone plates of forged Specification F 138 shall meet the
requirements of specification F 621. 8. Keywords
8.1 bendtesting—surgicalimplants;fatiguetest;boneplate;
7. General Requirements and Performance
Considerations orthopedicmedicaldevices—boneplates;surgicaldevices;test
methods—surgical implants
7.1 geometric considerations—boneplatesthatareintended
to be used with bone screws shall have design features (screw
holes or slots) that conform or appropriately fit the correspond-
ing bone screw.
ANNEXES
A1. STANDARD TEST METHOD FOR SINGLE CYCLE BEND TESTING OF METALLIC BONE PLATES
A1.1 Scope: A1.3.1.1 0.2 % offset displacement, q (mm)—permanent
deformationequalto0.2 %ofthecenterloadingspandistance.
A1.1.1 This test method describes methods for single cycle
(point B in Fig. A1.1).
bend testing in order to determine intrinsic, structural proper-
A1.3.1.2 bending strength (N-m)—of a bone plate, the
ties of metallic bone plates. The test method measures the
bending moment necessary to produce a 0.2 % offset displace-
bending stiffness, bending structural stiffness, and bending
mentintheboneplatewhentestedasdescribedinSectionA1.8
strength of bone plates.
(the bending moment corresponding to point D in Fig. A1.1.).
A1.1.2 This test method is intended to provide a means of
If the bone plate fractures before the proof point is attained the
mechanically characterize different bone plate designs. It is not
bending strength shall be defined as the bending moment at
the intention of this standard to define levels of performance
fracture.
for bone plates as insufficient knowledge is available to predict
A1.3.1.3 bending structural stiffness, (EI ) (N-m )—of a
e
the consequences of the use of particular bone plate designs.
bone plate, the bone plate’s normalized effective bending
A1.1.3 Units—The values stated in SI units are to be
stiffness that takes into consideration the effects of the test
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 :
E 4 Practices for Load Verification of Testing Machines
E 122 Practice for Choice of Sample Size to Estimate the
Average Quality of a Lot or Process
A1.3 Terminology:
FIG. A1.1 Diagram Illustrating Methods For Determining Bending
A1.3.1 Definitions: Properties of Bone Plates
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F 382 – 99 (2003)
setup’s configuration. For this test method, the bending struc-
tural stiffness is determined from the single cycle bending
response of the bone plate and the testing configuration.
A1.3.1.4 bending stiffness, K (N/mm)—of a bone plate, the
maximum slope of the linear elastic portion of the load versus
...
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