ASTM F1829-98(2009)
(Test Method)Standard Test Method for Static Evaluation of the Glenoid Locking Mechanism in Shear
Standard Test Method for Static Evaluation of the Glenoid Locking Mechanism in Shear
SIGNIFICANCE AND USE
This test method can be used to describe the effects of materials, manufacturing, and design variables on the performance of metal-backed glenoid prostheses locking mechanisms to resist static shear loading.
The glenoid component is used in shoulder replacements and should conform to the criteria specified in Specification F 1378.
The loading of metal-backed glenoid prostheses in vivo will, in general, differ from the loading defined in this test method. The results obtained here cannot be used to directly predict in vivo performance. However, this test method is designed to allow for comparisons between different metal backed glenoid locking mechanism designs, when tested under similar circumstances.
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 materials being tested and their potential application.
In order for the test data on metal-backed glenoid components to be comparable, reproducible, and capable of being correlated among laboratories, it is essential that uniform procedures be established.
SCOPE
1.1 This test method covers a method for determining the static shear disassembly force of modular glenoid components used in shoulder prostheses. It is intended to be used as a design validation and for comparison with other prostheses.
1.2 This test method covers modular glenoid components comprised of a separate articular insert and backing. The insert and backing can be fabricated from any combination of the following materials: metal alloys, polymeric materials, composite materials.
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
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 appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
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Designation: F1829 − 98(Reapproved 2009)
Standard Test Method for
Static Evaluation of Glenoid Locking Mechanism in Shear
This standard is issued under the fixed designation F1829; 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 3.1.3 glenoid backing—the metallic or composite material
prosthetic portion of a multiple piece glenoid component that
1.1 This test method covers a method for determining the
attaches to the scapula.
static shear disassembly force of modular glenoid components
used in shoulder prostheses. It is intended to be used as a
3.1.4 glenoid component—the prosthetic portion that re-
design validation and for comparison with other prostheses.
places the glenoid fossa of the scapula and articulates with the
natural humeral head or a prosthetic replacement.
1.2 This test method covers modular glenoid components
comprised of a separate articular insert and backing. The insert
4. Significance and Use
and backing can be fabricated from any combination of the
following materials: metal alloys, polymeric materials, com-
4.1 This test method can be used to describe the effects of
posite materials.
materials, manufacturing, and design variables on the perfor-
1.3 The values stated in SI units are to be regarded as mance of metal-backed glenoid prostheses locking mecha-
standard. No other units of measurement are included in this
nisms to resist static shear loading.
standard.
4.2 The glenoid component is used in shoulder replace-
1.4 This standard does not purport to address all of the
ments and should conform to the criteria specified in Specifi-
safety concerns, if any, associated with its use. It is the
cation F1378.
responsibility of the user of this standard to establish appro-
4.3 The loading of metal-backed glenoid prostheses in vivo
priate safety and health practices and determine the applica-
will, in general, differ from the loading defined in this test
bility of regulatory limitations prior to use.
method. The results obtained here cannot be used to directly
2. Referenced Documents
predict in vivo performance. However, this test method is
designed to allow for comparisons between different metal
2.1 ASTM Standards:
backed glenoid locking mechanism designs, when tested under
E4 Practices for Force Verification of Testing Machines
similar circumstances.
F1378 Specification for Shoulder Prostheses
4.4 This test method may not be appropriate for all types of
3. Terminology
implant applications. The user is cautioned to consider the
3.1 Definitions:
appropriateness of the method in view of the materials being
3.1.1 articular insert—the polymeric prosthetic portion of a
tested and their potential application.
multiple piece glenoid component that articulates with the
4.5 In order for the test data on metal-backed glenoid
humeral head.
components to be comparable, reproducible, and capable of
3.1.2 “d”—offset distance from the edge of the glenoid
being correlated among laboratories, it is essential that uniform
backing locking mechanism to the centerline of the point of
procedures be established.
load application on the articular insert as shown in Fig. 1 and
Fig. 2.
5. Apparatus
5.1 The test fixture shall be constructed so that the line of
This test method is under the jurisdiction ofASTM Committee F04 on Medical
load application is parallel to the intended axis of the implant
and Surgical Materials and Devices and is the direct responsibility of Subcommittee
(that is, inferior to superior or anterior to posterior).
F04.22 on Arthroplasty.
Current edition approved Feb. 1, 2009. Published March 2009. Originally
approved in 1997. Last previous edition approved in 2003 as F1829 – 98(2003).
6. Equipment
DOI: 10.1520/F1829-98R09.
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
6.1 The tests will be performed on either mechanical or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
hydraulic load frames with adequate load capacity and that
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. meet the criteria of Practices E4.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F1829 − 98 (2009)
FIG. 1 Schematic of Static Glenoid Locking Strength Inferior-to-Superior Direction
FIG. 2 Schematic of Static Glenoid Locking Strength Anterior-to-Posterior Direction
7. Sampling 8.2 Glenoid backing test components may either be in the
form of the final implant or may be a simplified model with the
7.1 Aminimum of five samples with the load oriented in the
exact locking mechanism to be used on the final implant. The
inferior-to-superior direction shall be tested per device.
materials and surface shall be representative of implant quality
7.2 Aminimum of five samples with the load oriented in the
products. All manufacturing processes (including heat treat-
anterior-to-posterior direction shall be tested per device.
ment) should be followed.
8. Sample and Test Specimen
8.3 All components should be sterilized according to the
8.1 All articular insert test components shall be representa- manufacturer’s recommendations, if that process could affect
tive of final manufactured implant quality products. the results.
F1829 − 98 (2009)
8.4 A new articular insert shoul
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