ASTM F382-99
(Test Method)Standard Specification and Test Method for Metallic Bone Plates
Standard Specification and Test Method for Metallic Bone Plates
SCOPE
1.1 This test method covers static bend testing of metallic bone plates for strength, equivalent bending stiffness, and ductility.
1.2 The values stated in SI units are to be regarded as the standard. The inch-pound units given in parentheses are for information only.
1.3 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.
General Information
Relations
Standards Content (Sample)
NOTICE: This standard has either been superceded and replaced by a new version or discontinued.
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Designation: F 382 – 99
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.
1. Scope F 67 Specification for Unalloyed Titanium for Surgical
Implant Applications
1.1 This standard is intended to provide a comprehensive
F 75 Specification for Cast Cobalt-Chromium-Molybdenum
reference for bone plates used in the surgical internal fixation
Alloy for Surgical Implant Applications
of the skeletal system. The standard establishes consistent
F 86 Practice for Surface Preparation and Marking of Me-
methods to classify, define the geometric characteristics, and
tallic Surgical Implants
performance characteristics of bone plates. The standard also
F 90 Specification for Wrought Cobalt-Chromium-
presents a catalog of standard specifications that specify
Tungsten-Nickel Alloy for Surgical Implant Applications
material; labeling and handling requirements; and standard test
F 136 Specification for Wrought Titanium 6Al-4V ELI
methods for measuring performance related mechanical char-
Alloy for Surgical Implant Applications
acteristics determined to be important to the in vivo perfor-
F 138 Specification for Stainless Steel Bars and Wire for
mance of bone plates.
Surgical Implants (Special Quality)
1.2 It is not the intention of the standard to define levels of
F 139 Specification for Stainless Steel Sheet and Strip for
performance or case-specific clinical performance for bone
Surgical Implants (Special Quality)
plates, as insufficient knowledge is available to predict the
F 543 Specification for Cortical Bone Screws
consequences or their use in individual patients for specific
F 565 Practice for Care and Handling of Orthopedic Im-
activities of daily living. Futhermore, it is not the intention of
plants and Instruments
the standard to describe or specify specific designs for bone
F 620 Specification for Titanium 6Al-ELI Alloy Forgings
plates used in the surgical internal fixation of the skeletal
for Surgical Implants
system.
F 621 Specification for Stainless Steel Forgings for Surgical
1.3 This standard may not be appropriate for all types of
Implants
bone plates. The user is cautioned to consider the appropriate-
F 983 Practice for Permanent Marking of Orthopaedic Im-
ness of the standard in view of a particular bone plate and its
plant Components
potential application.
F 1295 Wrought Titanium - 6 Aluminum - 7 Niobium Alloy
1.4 This standard includes the following test methods used
for Surgical Implant Applications
in determining the following bone plate mechanical perfor-
F 1314 Wrought Nitrogen Strengthened - 22 Chromium -
mance characteristics.
12.5 Nickel - 5 Manganese - 2.5 Molybdenum Stainless
1.4.1 Standard Test Method for Single Cycle Bend Testing
Steel Bar and Wire for Surgical Implants
of Metallic Bone Plates - Annex A1.
F 1472 Wrought Titanium Ti-6Al-4V Alloy for Surgical
1.4.2 Standard Test Method for Determining the Bending
Implant Applications
Fatigue Properties Of Metallic Bone Plates - Annex A2.
F 1713 Standard Specification for Wrought Titanium 13Nb-
1.5 Unless otherwise indicated, the values stated in SI units
13Zr Alloy for Surgical Implant Applications
shall be regarded as the standard.
2.2 ISO Standard:
1.6 This standard does not purport to address all of the
FDIS 14602 Non-active surgical implants—Implants for
safety concerns, if any, associated with its use. It is the
Osteosynthesis particular requirements.
responsibility of the user of this standard to establish appro-
priate safety and health practices and determine the applica-
3. Terminology
bility of regulatory limitations prior to use.
3.1 Definitions—Geometric:
2. Referenced Documents 3.1.1 auto compression—a type of bone plate that by its
design can generate a compressive force between adjacent
2.1 ASTM Standards:
unconnected bone fragments through the use of one or more
ramped holes or another type of slot geometry. This ramp or
This test method is under the jurisdiction of ASTM Committee F-4 on Medical
and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.21 on Osteosynthesis. Annual Book of ASTM Standards, Vol 13.01.
Current edition approved October 10, 1999. Published December 1999. Origi- Available from International Standards Organization, Rue de Varembe, Case
nally published as F 382–73. Last previous edition F 382–98a. Postale 56, CH-1211, Geneva 20, Switzerland.
Copyright © ASTM, 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959, United States.
NOTICE: This standard has either been superceded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
F 382
slot geometry contacts the underside of the screw head, and 3.2.2 bending strength (N-m)— of a bone plate, the bending
induces compressive force as the screw is inserted and tight- moment necessary to produce a 0.2 % offset displacement in
ened to the bone plate. the bone plate when tested as described in Annex A1.
3.1.2 bone plate—a metallic device with two or more holes 3.2.3 bending structural stiffness, El (N-m )—of a bone
and/or slot(s) and a cross section that consists of at least two plate, the bone plate’s normalized effective bending stiffness
dimensions (width and thickness) which generally are not the that takes into consideration the effects of the test setup’s
same in magnitude. The device is intended to provide align- configuration when tested according to the method described in
ment and fixation of two or more bone sections, primarily by Annex A1.
spanning the fracture or defect. The device is typically fixed to 3.2.4 fatigue life, n—The number of loading cycles of a
the bone through the use of bone screws or cerclage wire. A specified character that a given specimen sustains before
partial list of general types of bone plates is given in Section failure of a specified nature occurs.
4.1. 3.2.5 fatigue strength at N cycles—An estimate of the cyclic
3.1.3 bone plate length, L (mm)—the linear dimension of forcing parameter (for example, load, moment, torque, stress,
the bone plate measured along the longitudinal axis as illus- and so on) at a given load ratio, for which 50 % of the
trated in Fig. 2. specimens within a given sample population would be ex-
3.1.4 bone plate thickness, b (mm)—the linear dimension of pected to survive N loading cycles.
the bone plate measured parallel to the screw hole axis as
4. Classification
shown in Fig. 1a, 1b, and Fig. 2. For a bone plate with a
crescant section, the thickness is measured at the thickest point 4.1 Bone plates used in general orthopaedic surgery can be
along the section. categorized into general types according to the following
3.1.5 bone plate width, w (mm)—the linear dimension of the classifications.
bone plate measured perpendicular to both the length and 4.1.1 cloverleaf plate—a bone plate that has one three-lobed
thickness axes as shown in Fig. 2. end which contains screw holes.
3.1.6 contouring—the manipulation and bending of a bone 4.1.2 cobra head plate—a bone plate that has one flared
plate, either pre-operatively or intra-operatively, to match the triangular or trapezoidal end which contains multiple screw
anatomic geometry of the intended fixation location. holes and/or slots. This type of bone plate is often used for hip
3.1.7 crescent section—a bone plate cross-section shape arthrodesis.
(perpendicular to the long axis of the bone plate) where the 4.1.3 reconstruction plate—a bone plate that does not have
thickness is not constant along the section. Typically the a uniform width, but usually has a smaller cross-section
section is thickest along the bone plate’s centerline and tapers between the screw holes or slots. The reduced cross-section
to a smaller thickness at the bone plate’s edges (see Fig. 1b). between screw holes/slots facilitates contouring the bone plate
3.1.8 uniform width—referring to a bone plate where the in several planes. Reconstruction plates are often used in
width is constant along the bone plate’s length. fractures of the pelvis and acetabulum.
3.2 Definitions—Mechanical/Structural: 4.1.4 straight plate—a bone plate with uniform width and a
3.2.1 bending stiffness, K (N/mm)— of a bone plate, the straight longitudinal axis. Straight plates are often used for
maximum slope of the linear elastic portion of the load versus fractures of the diaphysis of long bones.
load-point displacement curve for a bone plate when tested 4.1.5 tubular plate—a bone plate whose cross-section re-
according to the test method of Annex A1. sembles a portion of a tube, and which has a constant thickness
FIG. 1 Bone Plate Cross-sections
NOTICE: This standard has either been superceded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
F 382
FIG. 2 Bone Plate Dimensions
or a crescent section. Tubular plates are often used for fractures 5.6 Bone plates should be cared for and handled in accor-
of the smaller long bones (that is, radius, ulna, fibula). dance with Practice F 565, as appropriate.
5. Marking, Packaging, Labeling, and Handling 6. Materials
5.1 Dimensions of bone plates should be designated by the 6.1 All bone plates made of materials which have an ASTM
standard definitions given in Section 3.1. committee F04 standard designation shall meet those require-
5.2 Bone plates shall be marked using a method specified in ments given in the ASTM standards. A majority of materials
accordance with either ASTM F 983 or ISO 14602. having ASTM specifications can be found in the list of
5.3 Markings on bone plates shall identify the manufacturer referenced ASTM standards of Section 2.1.
or distributor and shall be made away from the most highly 6.2 Bone plates of forged specification F 136 shall meet the
stressed areas, where possible. requirements of specification F 620.
5.4 Packaging shall be adequate to protect the bone plates 6.3 Bone plates of forged specification F 138 shall meet the
during shipment.
requirements of specification F 621.
5.5 Package labeling for bone plates shall include when
7. General Requirements and Performance
possible the following information:
Considerations
5.5.1 Manufacturer and Product Name,
5.5.2 Catalog number, 7.1 geometric considerations—bone plates that are intended
5.5.3 Lot or serial number, to be used with bone screws shall have design features (screw
5.5.4 Material and, where applicable, its associated ASTM holes or slots) that conform or appropriately fit the correspond-
specification designation number, ing bone screw.
5.5.5 Number of screw holes, 7.2 bending properties—a critical characteristic of bone
5.5.6 Bone plate width, plates for orthopedic applications since the bone plate provides
5.5.7 Bone plate length, the primary means of stabilizing the bone fragments. Addition-
5.5.8 Bone plate thickness, and ally, the bending stiffness of the bone plate may directly affect
5.5.9 ASTM specification designation number. the rate and ability of healing.
NOTICE: This standard has either been superceded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
F 382
7.2.1 The relevant bending properties (bending stiffness, 8. Keywords
bending structural stiffness, and bending strength) shall be
8.1 bend testing - surgical implants; fatigue test; bone plate;
determined using the standard test method of Annex A1.
orthopedic medical devices - bone plates; surgical devices; test
7.2.2 Determine the relevant bending fatigue properties
methods - surgical implants
according to the methods described in Annex A2.
ANNEXES
A1. STANDARD TEST METHOD FOR SINGLE CYCLE BEND TESTING OF METALLIC BONE PLATES
A1.1 Scope:
A1.1.1 This test method describes methods for single cycle
bend testing in order to determine intrinsic, structural proper-
ties of metallic bone plates. The test method measures the
bending stiffness, bending structural stiffness, and bending
strength of bone plates.
A1.1.2 This standard is intended to provide a means of
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
FIG. A1.1 Diagram Illustrating Methods For Determining Bending
responsibility of the user of this standard to establish appro-
Properties of Bone Plates
priate safety and health practices and determine the applica-
bility of regulatory limitations prior to use.
stiffness that takes into consideration the effects of the test
NOTE A1.1—There is currently an ISO standard (ISO 9585 - Implants
setup’s configuration. For this test method the bending struc-
for Surgery - Determination of Bending Strength and Stiffness of Bone
tural stiffness is determined from the single cycle bending
Plates) that is similar, but not equivalent to this standard test method.
response of the bone plate and the testing configuration.
A1.2 Referenced Documents:
A1.3.1.4 bending stiffness, K (N/mm)—of a bone plate, the
A1.2.1 ASTM Standards: maximum slope of the linear elastic portion of the load versus
E 4 Practices for Load Verification of Testing Machines load-point curve when tested as described in section A1.8. (See
E 122 Practice for Choice of Sample Size to Estimate the the slope of line Om in Fig. A1.1).
Average Quality of a Lot or Process A1.3.1.5 bone plate width, w (mm)—the width of the bone
plate as shown in Fig. A1.3.
A1.3 Terminology:
A1.3.1.6 center span, a (mm)—the distance between the
two loading rollers as shown in Fig. A1.2.
A1.3.1 Definitions:
A1.3.1.7 fracture load, F (N)—the applied load at the
A1.3.1.1 0.2 % offset displacement, q (mm)—permanent
max
time when the bone plate fractures.
deformation equal to 0.2 % of the center loading span distance.
A1.3.1.8 loading span, h (mm)—the distance between the
(point B in Fig. A1.1).
loading roller and the nearest support as shown in Fig. A1.2.
A1.3.1.2 bending strength (N-m)—of a bone plat
...
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