1. Scope 1.1 This guide specifies the method to measure the in-vivo wear of explanted Metal-on-Metal (MoM) acetabular cups and femoral heads using a dimensional change method. This guide is applicable to both Large Head Metal on Metal (LHMoM) (Modular) and resurfacing MoM hip systems. 1.2 This guide covers the measurement of linear and volumetric wear using a Coordinate Measuring Machine (CMM) and linear wear using an Out of Roundness (OOR) Machine. 1.3 This guide is intended as an extension to ASTM F 561- 05a as a Stage II nondestructive test. 1.4 This standard may involve hazardous materials, operations and equipment. As a precautionary measure, explanted devices should be sterilized or minimally disinfected by an appropriate means that does not adversely affect the implant or the associated tissue that may be the subject to subsequent analysis. A detailed discussion of precautions to be used in handling human tissues can be found in ISO 12891-1. 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.
Keywordswear; form; linear wear; volumetric wear;
The title and scope are in draft form and are under development within this ASTM Committee.Back to Top
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