1.1 There is a concern about the effect of metal implant corrosion and wear on the patient, particularly with metal-on-metal joint articulations and modular implant connections. It is desirable to standardize the methodology for the analysis of metal ion content in blood, other body fluids, and retrieved tissue using inductively coupled plasma mass spectrometry (ICP-MS) so that results from different laboratories will be comparable. 1.2 This practice also details the methods for handling and treatment of samples including digestion of samples and appropriate dilution techniques for ICP-MS use. The methods are applicable to retrieved samples for metal ion measurements via ICP-MS. 1.3 The values stated in SI units are to be regarded as the standard. No ther units of measurement are inclded 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.
Keywordsmusculoskeletal joint replacement; orthopedic device; metal-on-metal hip prosthesis; metal-on-metal total hip arthroplasty; modular acetabular system; cobalt-28 % chromium-6 % molybdenum alloy; metal ions, ICP-MS
The title and scope are in draft form and are under development within this ASTM Committee.Back to Top