Work Item
ASTM WK38566
New Practice for Measuring Metal Ions in Blood Samples from Total Joint Arthroplasty Patients
1. Scope
1.1 This practice is to help standardize the methodology for the analysis of metal ion content in blood of patients with total joint replacements. The metal ions of interest are typically Co, Cr, and Ti. It is desirable to standardize the methodology for the analysis of metal ion content in blood 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 throughout the standard shall be in SI units. 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.
Keywords
musculoskeletal 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
Rationale
None Provided
The title and scope are in draft form and are under development within this ASTM Committee.
Work Item Status
Date Initiated: 08-01-2012
Technical Contact: Leslie Gilbertson
Item: 001
Ballot: F04.22 (12-03)
Status: Will Reballot Item
Item: 016
Ballot: F04 (15-04)
Status: Will Reballot Item
Item: 003
Ballot: F04.22 (15-05)
Status: Will Reballot Item
Item: 001
Ballot: F04.22 (16-04)
Status: Will Reballot Item
Item: 003
Ballot: F04.22 (17-04)
Status: Negative Votes Need Resolution