AAMI and ISO standards were updated and additional ASTM standards were added to the list of standards that pertained to this document. Additional information regarding how to perform Analyte validation was provided in the document to help the readers understand the requirements for validation. Other options for protein and hemoglobin assay were added to the standards for detection of analytes after a cleaning validation.
Date Initiated: 08-12-2021
Technical Contact: Alpa Patel
Item: 002
Ballot: F04.15 (22-01)
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Ballot: F04 (22-05)
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Item: 000
Ballot:
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Item: 003
Ballot: F04.15 (23-01)
Status: Negative Votes Need Resolution