1.1 This guide specifies a method to estimate the in-vivo material loss from the conical 22 femoral head / stem junction from explanted modular hip prosthesis. This guide is applicable to 23 any modular hip with any articulating bearing material, stem material and conical taper size. 24 1.2 This guide covers the measurement of depth of material loss and volume of material loss 25 and taper geometry using a Roundness Machine and Coordinate Measuring Machine (CMM). 26 1.3 This standard may involve hazardous materials, operations and equipment. As a 27 precautionary measure, explanted devices should be sterilized or minimally disinfected by an 28 appropriate means that does not adversely affect the implant or the associated tissue that may be 29 X XXXX 2 the subject of subsequent analysis. A detailed discussion of precautions to be used in handling 30 human tissues can be found in ISO 12891-1. This standard does not purport to address all of the 31 safety concerns if any, associated with its use. It is the responsibility of the user of this standard 32 to establish appropriate safety and health practices and determine the applicability of regulatory 33 limitations prior to use.
The title and scope are in draft form and are under development within this ASTM Committee.Back to Top