ASTM F384-00
(Specification)Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices
Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices
SCOPE
1.1 This standard is intended to provide a comprehensive reference for angled devices used in the surgical internal fixation of the skeletal system. This standard establishes consistent methods to classify and define the geometric and performance characteristics of angled devices. This standard also presents a catalog of standard specifications that specify material and labeling and handling requirements, and standard test methods for measuring performance related mechanical characteristics determined to be important to the in vivoperformance of angled devices.
1.2 It is not the intention of this standard to define levels of performance of case-specific clinical performance for angled devices, as insufficient knowledge is available to predict the consequences of their use in individual patients for specific activities of daily living. Futhermore, it is not the intention of this standard to describe or specify specific designs for angled devices used in the surgical internal fixation of the skeletal system.
1.3 This standard may not be appropriate for all types of angled devices. The user is cautioned to consider the appropriateness of this standard in view of a particular angled device and its potential application.
1.4 This standard includes the following test methods used in determining the following angled device mechanical performance characteristics:
1.4.1 Standard test method for single cycle compression bend testing of metallic angled orthopedic fracture fixation devices (see Annex A1).
1.4.2 Standard test method for determining the bending fatigue properties of metallic angled orthopedic fracture fixation devices (see Annex A2).
1.5 Unless otherwise indicated, the values stated in SI units shall be regarded as the standard.
Note 1--There is currently no ISO standard that is either similar to equivalent to this standard.
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Designation: F 384 – 00
Standard Specifications and Test Methods for
Metallic Angled Orthopedic Fracture Fixation Devices
This standard is issued under the fixed designation F 384; 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 2. Referenced Documents
1.1 This standard is intended to provide a comprehensive 2.1 ASTM Standards:
reference for angled devices used in the surgical internal E4 Practices for Force Verification of Testing Machines
fixation of the skeletal system. This standard establishes E8 Test Methods for Tension Testing of Metallic Materi-
consistent methods to classify and define the geometric and als
performance characteristics of angled devices. This standard E 122 Practice for Choice of Sample Size to Estimate the
also presents a catalog of standard specifications that specify Average Quality of a Lot or Process
material and labeling and handling requirements, and standard F67 Specification for Unalloyed Titanium for Surgical
test methods for measuring performance related mechanical Implant Applications
characteristics determined to be important to the in vivoperfor- F75 SpecificationforCobalt-28Chromium-6Molybdenum
mance of angled devices. Casting Alloy and Cast Products for Surgical Implants
1.2 It is not the intention of this standard to define levels of (UNS R30075)
performance of case-specific clinical performance for angled F90 Specification for Wrought Cobalt-20 Chromium-15
devices, as insufficient knowledge is available to predict the Tungsten-10 Nickel Alloy for Surgical Implant Applica-
consequences of their use in individual patients for specific tions (R30605)
activities of daily living. Futhermore, it is not the intention of F 136 Specification for Wrought Titanium-6 Aluminum-4
this standard to describe or specify specific designs for angled Vanadium ELI (Extra Low Interstitial) Alloy (UNS
devices used in the surgical internal fixation of the skeletal R56401) for Surgical Implant Applications
system. F 138 Specification for Wrought-18 Chromium-14 Nickel-
1.3 This standard may not be appropriate for all types of 2.5 Molybdenum Stainless Steel Bar and Wire for Surgical
angled devices. The user is cautioned to consider the appro- Implants (UNS S31673)
priateness of this standard in view of a particular angled device F 139 Specification for Wrought-18 Chromium-14 Nickel-
and its potential application. 2.5 Molybdenum Stainless Steel Sheet and Strip for Sur-
1.4 This standard includes the following test methods used gical Implants (UNS S31673)
in determining the following angled device mechanical perfor- F 382 Specification and Test Methods for Metallic Bone
mance characteristics: Plates
1.4.1 Standard test method for single cycle compression F 543 Specification for Metallic Medical Bone Screws
bend testing of metallic angled orthopedic fracture fixation F 565 Practice for Care and Handling of Orthopedic Im-
devices (see Annex A1). plants and Instruments
1.4.2 Standard test method for determining the bending F 620 Specification for Titanium-6 Aluminum-4 Vanadium
fatigue properties of metallic angled orthopedic fracture fixa- ELl Alloy Forgings for Surgical Implants (UNS R56401)
tion devices (see Annex A2). F 621 Specification for Stainless Steel Forgings for Surgical
1.5 Unless otherwise indicated, the values stated in SI units Implants
shall be regarded as the standard. F 983 Practice for Permanent Marking of Orthopedic Im-
plant Components
NOTE 1—There is currently no ISO standard that is either similar to
F 1295 Specification for Wrought Titanium-6 Aluminum-7
equivalent to this standard.
Niobium Alloy for Surgical Implant Applications (UNS
R56700)
These specifications and test methods are under the jurisdiction of ASTM
Committee F04 on Medical and Surgical Materials and Devices and are the direct
responsibility of Subcommittee F04.21 on Osteosynthesis. Annual Book of ASTM Standards. Vol 03.01.
Current edition approved Nov. 10, 2000. Published February 2001. Originally Annual Book of ASTM Standards. Vol 14.02.
published as F 384 - 73. Last previous edition F 384 - 99.
Annual Book of ASTM Standards. Vol 13.01.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
F384–00
F 1314 Specification for Wrought Nitrogen
Strengthened-22 Chromium-12.5 Nickel-5 Manganese -2.5
Molybdenum Stainless Steel Bar and Wire for Surgical
Implants
F 1472 Specification for Wrought Titanium-6 Aluminum-4
Vanadium Alloy for Surgical Implant Applications (UNS
R56400)
F 1713 SpecificationforWroughtTitanium-13Niobium-13
Zirconium Alloy for Surgical Implant Applications
2.2 ISO Standards:
ISO 5835 Implants for Surgery - Metal Bone Screws with
HexagonalDriveConnection-SphericalUnderSurfaceof
FIG. 2 Diagram Illustrating Blade Plate Angled Devices
Head, Asymmetrical Thread
ISO 5836 Implants for Surgery - Metal Bone Plates - Holes
3.1.4 barrel length, L , n— the distance from the free end
Corresponding to Screws with Asymmetrical Thread and BR
of the barrel to the interior vertex of the barrel/sideplate
Spherical Under Surface
junction (see Fig. 1).
ISO 9268 Implants for Surgery - Metal Bone Screws with
3.1.5 blade, n—the portion of an angled device which
Conical Under-Surface of Head - Dimensions
transmits the off axis loading of the anatomical loading
ISO 9269 Implants for Surgery - Metal Bone Plates - Holes
condition to the sideplate portion of the angled device (see Fig.
and Slots Corresponding to Screws with Conical Under-
2).
Surface
3.1.6 blade length, L , n—the distance from the free end
ISO14602 Non-active Surgical Implants– Implants for Os-
BD
ofthebladetotheinteriorvertexoftheblade/sideplatejunction
teosynthesis – Particular Requirements
(see Fig. 2).
3.1.7 lag screw, n—that component of a compression hip
screw angled device which is threaded into the metaphyses and
transmits the off axis load to the sideplate through the barrel
(see Fig. 1).
3.1.8 lag screw length, n—the straight line distance mea-
sured between the proximal and distal ends of the lag screw
(see Fig. 1).
3.1.9 sideplate, n—that portion of the angle device gener-
ally aligned with the bone’s long axis which attaches to the
bone via bone screws (see Fig. 1 and Fig. 2).
3.1.10 sideplate length, L, n—the distance from the free end
of the sideplate to the interior vertex of the barrel/sideplate
junction, shown in Fig. 1 and Fig. 2.
3.1.11 sideplate thickness, b, n—the thickness of the side-
plate as shown in Fig. 1 and Fig. 2.
3.1.12 sideplate width, w, n—the width of the sideplate as
shown in Fig. 1 and Fig. 2.
FIG. 1 Diagram Illustrating Compression Hip Screw Angled
3.1.13 thread diameter, n—the maximum outside diameter
Devices
of the lag screw (see Fig. 1).
3.1.14 thread length, n—the straight line distance measured
between the tip and thread runout positions of the screw (see
3. Terminology
Fig. 1).
3.1 Definitions: Geometric
3.2 Definitions: Mechanical/Structure:
3.1.1 angle, n—defined at either the barrel/sideplate or
3.2.1 bending strength, n— of the sideplate, the bending
blade/sideplate junction (see Fig. 1 and Fig. 2).
moment necessary to produce a 0.2 % offset displacement in
3.1.2 angled device, n—aclassoforthopedicdevicesforthe
the sideplate when tested as described in Annex A1 of
fixation of fractures in the methaphyseal areas of long bones
Specification and Test Methods F 382.
that has a component aligned at an angle to the bone’s long
3.2.2 bending structural stiffness, El , n—of the sideplate,
e
axis.
the sideplate’s normalized effective bending stiffness that takes
3.1.3 barrel, n—the portion of an angled device which
into consideration the effects of the test setup’s configuration
captures the lag screw (see Fig. 1).
when tested according to the method described inAnnexA1 of
Specification and Test Methods F 382.
3.2.3 compression bending stiffness, (K), n—of a device, the
maximum slope of the linear elastic portion of the load versus
Available form American National Standards Institute, 11 W. 42nd St., New
York, NY 10036. displacement curve, when tested as described in Annex A1.
F384–00
3.2.4 compression bending strength, n—of a device, the 5.5.8 Sideplate width,
bending moment necessary to produce a 0.2 % offset displace- 5.5.9 Sideplate length,
ment in the device when tested as described in Annex A1. 5.5.10 Sideplate thickness,
3.2.5 fatigue strength at N cycles, n—an estimate of the 5.5.11 Screw hole size, and
cyclic forcing parameter, for example, load, moment, torque, 5.5.12 ASTM specification designation number.
stress, etc., at a given load ratio, for which 50 % of the 5.6 Bone plates should be cared for and handled in accor-
specimens within a given sample population would be ex- dance with Practice F 565, as appropriate.
pected to survive N loading cycles.
3.2.6 fatigue life, N, n—the number of loading cycles of a
6. Materials
specified character that a given specimen sustains before
6.1 All angled devices made of materials which can be
failure of a specified nature occurs.
purchased to an ASTM specification shall meet those require-
ments given in the ASTM specification. Such specification
4. Classification
include: F67, F75, F90, F 139, F 543, F 1295, F 1314,
4.1 Angled devices used in general orthopedic surgery
F 1472, and F 1713.
represent a subset of bone plates. Angled devices are mainly
6.2 Angled devices of forged Specification F 136 shall meet
used in the treatment of fractures in the metaphyseal areas of
the requirements of Specification F 620.
long bones. Angled devices can be categorized into general
6.3 Angled devices of forged Specification F 138 shall meet
types according to the following classifications:
the requirements of Specification F 621.
4.1.1 Blade Plate— an angled device where the component
of the device that is oriented at an angle from the long axis of
7. General Requirements and Performance
the bone is fixed relative to the sideplate; this component often
Considerations
is shaped like a blade to achieve fixation into the metaphyses
7.1 Geometric Considerations—For angled devices that are
(see Fig. 2), and
intendedtobeusedwithbonescrewsthatconformtoISO 5835
4.1.2 Compression Hip Screw—an angled device where the
or ISO 9268, the screw holes shall correspond to the dimen-
component of the device which is oriented at a angle from the
sions and tolerances of ISO 5836 or ISO 9269, respectively.
long axis of the bone is free to translate relative to the sideplate
7.2 Bending Properties—Bending properties are a critical
through a barrel; this component often achieves fixation into
characteristic of angled devices for orthopedic applications
the metaphyses through the use of deep threads (see Fig. 1).
since the plate provides the primary means of stabilizing the
5. Marking, Packaging, Labeling and Handling bone fragments. Additionally, the bending stiffness of the
angled device may directly affect the rate and ability of
5.1 Dimensions of angled devices should be designated by
healing.
the standard definitions given in 3.1.
7.2.1 The relevant compression bending properties (com-
5.2 Angled devices shall be marked using a method speci-
pression bending stiffness and compression bending strength)
fied in accordance with either Practice F 983 or ISO 14602.
of the device shall be determined using Annex A1.
5.3 Markings on angled devices shall identify the manufac-
7.2.2 The relevant bending properties (bending stiffness,
tureordistributorandshallbemadeawayfromthemosthighly
bending structural stiffness and bending strength) of the
stressed areas, where possible.
sideplate shall be determined using the Annex A1 of Specifi-
5.4 Packagingshallbeadequatetoprotecttheangleddevice
cation and Test Methods F 382.
during shipment.
7.2.3 Determine the relevant angled device bending fatigue
5.5 Package labeling for angled devices shall include when
properties according to the methods described in Annex A2.
possible the following information;
7.2.4 Determine the relevant side plate bending fatigue
5.5.1 Manufacturer and product name,
properties according to the methods described in Annex A2 of
5.5.2 Catalog number,
Specification and Test Methods F 382.
5.5.3 Lot or serial number,
5.5.4 Material and, where applicable, its associated ASTM
8. Keywords
specification designation number,
5.5.5 Device angle, 8.1 angled devices; bend testing; blade plate; compression
5.5.6 Barrel (blade) length, hip screw; fatigue test; orthopedic medical devices; surgical
5.5.7 Number of screw holes, devices; surgical implants
F384–00
ANNEXES
(Mandatory Information)
A1. STANDARD TEST METHOD FOR SINGLE CYCLE COMPRESSION BEND TESTING OF METALLIC ANGLED
ORTHOPEDIC FRACTURE FIXATION DEVICES
A1.1 Scope A1.3.1.1 0.2 % offset displacement, q, n—permanent defor-
mation (mm) equal to 0.2 % of the lever arm length (see point
A1.1.1 This test method describes methods for single cycle
Bin Fig. A1.1).
bend testing for determining intrinsic, structural properties of
A1.3.1.2 compression bending stiffness, K, n—of an angled
metallic angled orthopedic fracture fixation devices. The test
device, the maximum slope (N/m) of the linear elastic portion
method measures the angled device’s compression bending
of the load versus displacement curve, when tested as de-
stiffness and compression bending strength.
scribed in A1.8. (See the slope of line 0m in Fig. A1.1).
A1.1.2 This test method is intended to provide a means to
A1.3.1.3 compression bending strength, n—of an angled
mechanically characterize different angled device designs. It is
device, the bending moment (N - m) necessary to produce a
not the intention of this test method to define levels of
0.2 % offset displacement in the angled device when tested as
performance for angled devices, as insufficient knowledge is
described inA1.8 (the bending moment corresponding to point
available to predict the consequences of the use of particular
Pin Fig.A1.1). If the angled device fractures before the proof
angled device designs.
load is attained, the compression bending strength shall be
A1.1.3 This test method is designed to provide flexibility in
defined as the bending moment at fracture.
the testing configuration so that a range of clinical failure
A1.3.1.4 fracture load, F , n— the applied load (N) at the
modes for the angled fixation devices (for example, sideplate,
max
time when the angled device fractures.
lag screw, and barrel fractures) can be evaluated.
A1.
...
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