ASTM-F1820 › Standard Test Method for Determining the Forces for Disassembly of Modular Acetabular Devices
The following bibliographic material is provided to assist you with your purchasing decision:
Scope
1.1 This test method covers a standard methodology by which to measure the attachment strength between the modular acetabular shell and liner. Although the methodology described does not replicate physiological loading conditions, it has been described as a means of comparing the integrity of various locking mechanisms.
1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.4 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.
Significance and Use
5.1 This test method is intended to assess the locking strength of the acetabular liner in a modular acetabular shell when subjected to three different force application conditions.
5.2 This test method may not be appropriate for all implant applications. The user is cautioned to consider the appropriateness of the method in view of the materials and design being tested and their potential application.
5.3 While these test methods may be used to measure the force required to disengage modular acetabular devices, comparison of such data for various device designs must take into consideration the size of the implant and the type of locking mechanism evaluated. The location of the locking mechanism relative to the load application may be dependent upon the size and design of the acetabular device. In addition, the locking mechanism itself may vary with size, particularly if the design is circumferential in nature (for example, a larger diameter implant would have a greater area of acetabular shell and liner interface than a small diameter implant).
5.4 Material failure is possible before locking mechanism failure during either push-out or offset pull-out/lever-out conditions. This is due to the possibility that the shear strength of the material may be exceeded before the locking mechanism is fully tested.
Keywords
acetabular component; arthroplasty; disassembly; lever-out; offset pull-out; torque disassembly;
To find similar documents by ASTM Volume:
13.01 (Medical and Surgical Materials and Devices)
To find similar documents by classification:
This document comes with our free Notification Service, good for the life of the document.
This document is available in either Paper or PDF format.
Customers who bought this document also bought:
ASTM-A276Standard Specification for Stainless Steel Bars and Shapes
ASTM-E18
Standard Test Methods for Rockwell Hardness of Metallic Materials
ASTM-D4169
Standard Practice for Performance Testing of Shipping Containers and Systems
Document Number
ASTM-F1820-22
Revision Level
2022 EDITION
Status
Current
Modification Type
Revision
Publication Date
March 18, 2022
Document Type
Test Method
Page Count
8 pages
Committee Number
F04.22