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ASTM F1829-98

(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

SCOPE
1.1 This practice 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 regarded as the 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.

General Information

Status
Historical
Publication Date
09-Apr-1998
ICS
11.040.40 - Implants for surgery, prosthetics and orthotics
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.22 - Arthroplasty
Current Stage
Ref Project

Relations

Replaced By
ASTM F1829-98(2003) - Standard Test Method for Static Evaluation of the Glenoid Locking Mechanism in Shear
Effective Date
10-Apr-1998

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ASTM F1829-98 - Standard Test Method for Static Evaluation of the Glenoid Locking Mechanism in Shear
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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn. Contact
ASTM International (www.astm.org) for the latest information.
Designation: F 1829 – 98
AMERICAN SOCIETY FOR TESTING AND MATERIALS
100 Barr Harbor Dr., West Conshohocken, PA 19428
Reprinted from the Annual Book of ASTM Standards. Copyright ASTM
Standard Test Method for
Static Evaluation of the Glenoid Locking Mechanism in
1
Shear
This standard is issued under the fixed designation F 1829; 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 3.1.4 glenoid component—the prosthetic portion that re-
places the glenoid fossa of the scapula and articulates with the
1.1 This practice covers a method for determining the static
natural humeral head or a prosthetic replacement.
shear disassembly force of modular glenoid components used
in shoulder prostheses. It is intended to be used as a design
4. Significance and Use
validation and for comparison with other prostheses.
4.1 This test method can be used to describe the effects of
1.2 This test method covers modular glenoid components
materials, manufacturing, and design variables on the perfor-
comprised of a separate articular insert and backing. The insert
mance of metal backed glenoid prostheses locking mechanisms
and backing can be fabricated from any combination of the
to resist static shear loading.
following materials: metal alloys, polymeric materials, com-
4.2 The glenoid component is used in shoulder replace-
posite materials.
ments and should conform to the criteria specified in Specifi-
1.3 The values stated in SI units are regarded as the
cation F 1378.
standard.
4.3 The loading of metal backed glenoid prostheses in vivo
1.4 This standard does not purport to address all of the
will, in general, differ from the loading defined in this test
safety concerns, if any, associated with its use. It is the
method. The results obtained here can not be used to directly
responsibility of the user of this standard to establish appro-
predict in vivo performance. However, this test method is
priate safety and health practices and determine the applica-
designed to allow for comparisons between different metal
bility of regulatory limitations prior to use.
backed glenoid locking mechanism designs, when tested under
2. Referenced Documents similar circumstances.
4.4 This test method may not be appropriate for all types of
2.1 ASTM Standards:
2
implant applications. The user is cautioned to consider the
E 4 Practices for Force Verification of Testing Machines
3
appropriateness of the method in view of the materials being
F 1378 Specification for Shoulder Prosthesis
tested and their potential application.
3. Terminology
4.5 In order for the test data on metal backed glenoid
components to be comparable, reproducible, and capable of
3.1 Definitions:
being correlated among laboratories, it is essential that uniform
3.1.1 articular insert—the polymeric prosthetic portion of a
procedures be established.
multiple piece glenoid component that articulates with the
humeral head.
5. Apparatus
3.1.2 “d”—offset distance from the edge of the glenoid
5.1 The test fixture shall be constructed so that the line of
backing locking mechanism to the centerline of the point of
load application is parallel to the intended axis of the implant
load application on the articular insert as shown in Fig. 1 and
(that is, inferior to superior or anterior to posterior).
Fig. 2.
3.1.3 glenoid backing—the metallic or composite material
6. Equipment
prosthetic portion of a multiple piece glenoid component that
6.1 The tests will be performed on either mechanical or
attaches to the scapula.
hydraulic load frames with adequate load capacity and that
meet the criteria of Practices E 4.
1
This practice is under the jurisdiction of ASTM Committee F-4 on Medical and
7. Sampling
Surgical Materials and Devicesand is the direct responsibility of Subcommittee
F04.22on Arthroplasty.
7.1 A minimum of five samples with the load oriented in the
Current edition approved April 10, 1998. Published March 1999. Originally
inferior to superior direction shall be tested per device.
published as F 1829 - 97. Last previous edition F 1829 - 97.
2
7.2 A minimum of five samples with the load oriented in the
Annual Book of ASTM Standards, Vol 03.01.
3
Annual Book of ASTM Standards, Vol 13.01.
1

---------------------- Page: 1 ----------------------
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 1829
FIG. 1 Schematic of Static Glenoid Locking Strength Inferior to Superior Direction
FIG. 2 Schematic of Static Glenoid Locking Strength Anterior to Posterior Direction
...

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1.7 This document is a guide. As defined by ASTM in their “Form and Style for ASTM Standards” book in section C15.2, “A standard guide is a compendium of information or series of options that does not recommend a specific course of action. Guides are intended ...

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5.1 The current hip simulator wear test standards (ISO 14242-1 or ISO 14242-3) stipulate only one load waveform and one set of articulation motions. There is a need for more versatile and rigorous wear test regimes, but the knowledge of what represents realistic high demand wear test features is limited. More research is clearly needed before a standard that defines what a representative high demand wear test should include can be written. The objective of this guide is to advise researchers on the possible high demand wear test features that should be included in evaluation of hard-on-hard articulations.  
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5.3 All the test features, both conventional and high demand, could have interactive effects on the wear of the components.
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1.1 The objective of this guide is to advise researchers on the possible high demand wear test features that should be included in evaluation of hard-on-hard articulations. This guide makes suggestions for high demand test features that may need to be added to an overall wear test regime. Device articulating components manufactured from other metallic alloys, ceramics, or with coated or elementally modified surfaces without significant clinical use could possibly be evaluated with this guide. However, such materials may include risks and failure mechanisms that are not addressed in this guide.  
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A1.1 Significance and Use
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1.6 This standard may involve the use of hazardous materials, operations, and equipment. 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
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