ASTM F382-17
(Specification)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 Significance and Use
A2.5.1 This 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 fatigue life of the bone plate at either a specific maximum bending moment or over a range of maximum bending moment conditions. Alternatively, the test method may be used to estimate a bone plate's fatigue strength for a specified number of fatigue cycles.
A2.5.2 This 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 lnear-elastic range of the material. . 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 and define the geometric 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, and
1.4...
General Information
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Standards Content (Sample)
This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation: F382 − 17
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. A number in parentheses indicates the year of last reapproval. A superscript
epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope using all of the described methods. Instead, the user should
only select test methods that are appropriate for a particular
1.1 This specification and test method is intended to provide
device design. In most instances, only a subset of the herein
a comprehensive reference for metallic bone plates used in the
described test methods will be required.
surgical internal fixation of the skeletal system. The standard
1.7 This standard does not purport to address all of the
establishes consistent methods to classify and define the
safety concerns, if any, associated with its use. It is the
geometric and performance characteristics of bone plates. The
responsibility of the user of this standard to establish appro-
standard also presents a catalog of standard specifications that
priate safety, health, and environmental practices and deter-
specify material; labeling and handling requirements; and
mine the applicability of regulatory limitations prior to use.
standard test methods for measuring performance related
1.8 This international standard was developed in accor-
mechanical characteristics determined to be important to the in
dance with internationally recognized principles on standard-
vivo performance of bone plates.
ization established in the Decision on Principles for the
1.2 It is not the intention of the standard to define levels of
Development of International Standards, Guides and Recom-
performance or case-specific clinical performance for bone
mendations issued by the World Trade Organization Technical
plates, as insufficient knowledge is available to predict the
Barriers to Trade (TBT) Committee.
consequences or their use in individual patients for specific
activities of daily living. Futhermore, it is not the intention of
2. Referenced Documents
the standard to describe or specify specific designs for bone
2
2.1 ASTM Standards:
plates used in the surgical internal fixation of the skeletal
E122 Practice for Calculating Sample Size to Estimate, With
system.
Specified Precision, the Average for a Characteristic of a
1.3 This document may not be appropriate for all types of
Lot or Process
bone plates. The user is cautioned to consider the appropriate-
F565 Practice for Care and Handling of Orthopedic Implants
ness of the standard in view of a particular bone plate and its
and Instruments
potential application.
F983 Practice for Permanent Marking of Orthopaedic Im-
1.4 This document includes the following test methods used plant Components
in determining the following bone plate mechanical perfor-
F2503 Practice for Marking Medical Devices and Other
mance characteristics: Items for Safety in the Magnetic Resonance Environment
3
1.4.1 Standard Test Method for Single Cycle Bend Testing
2.2 ISO Standard:
of Metallic Bone Plates—Annex A1, and
ISO 9585 Implants for Surgery—Determination of Bending
1.4.2 Standard Test Method for Determining the Bending
Strength and Stiffness of Bone Plates
Fatigue Properties Of Metallic Bone Plates—Annex A2.
ISO 14602 Non-active surgical implants—Implants for Os-
teosynthesis particular requirements.
1.5 The values stated in SI units are to be regarded as
standard. No other units of measurement are included in this
3. Terminology
standard.
3.1 Definitions—Geometric:
1.6 Multiple test methods are included in this standard.
3.1.1 auto compression—a type of bone plate that by its
However, it must be noted that the user is not obligated to test
design can generate a compressive force between adjacent
1 2
This specification and test method is under the jurisdiction of ASTM Commit- For referenced ASTM standards, visit the ASTM website, www.astm.org, or
tee F04 on Medical and Surgical Materials and Devices and is the direct contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
responsibility of Subcommittee F04.21 on Osteosynthesis. Standards volume information, refer to the standard’s Document Summary page on
Current edition approved Sept. 1, 2017. Published October 2017. Originally the ASTM website.
3
approved in 1973. Last previous edition approved in 2014 as F382 – 14. DOI: Available from American National Standards Institute (ANSI), 25 W. 43rd St.,
10.1520/F0382-17. 4th Floor, New York, NY 10036, http://www
...
This document is not an ASTM standard and is intended only to provide the user of an ASTM 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.
Designation: F382 − 14 F382 − 17
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. A number in parentheses indicates the year of last reapproval. A superscript
epsilon (´) indicates an editorial change since the last revision or reapproval.
1. 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 and define the geometric 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, and
1.4.2 Standard Test Method for Determining the Bending Fatigue Properties Of Metallic Bone Plates—Annex A2.
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.6 Multiple test methods are included in this standard. However, it must be noted that the user is not obligated to test using
all of the described methods. Instead, the user should only select test methods that are appropriate for a particular device design.
In most instances, only a subset of the herein described test methods will be required.
1.7 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 safety, health and healthenvironmental practices and determine the
applicability of regulatory limitations prior to use.
1.8 This international standard was developed in accordance with internationally recognized principles on standardization
established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued
by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
2. Referenced Documents
2
2.1 ASTM Standards:
E122 Practice for Calculating Sample Size to Estimate, With Specified Precision, the Average for a Characteristic of a Lot or
Process
F67 Specification for Unalloyed Titanium, 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
1
This specification and test method is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of
Subcommittee F04.21 on Osteosynthesis.
Current edition approved Nov. 1, 2014Sept. 1, 2017. Published January 2014October 2017. Originally approved in 1973. Last previous edition approved in 20082014 as
ε1
F382 – 99 (2008)F382 – 14. . DOI: 10.1520/F0382-14.10.1520/F0382-17.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM 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
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F382 − 17
FIG. 1 Bone Plate Cross-sections
F90 Spec
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