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in glycohemoglobin (GHB) testing, the process by which GHB test results among laboratories are made comparable to a common reference

Project: C44


an understanding so as to develop confidence in an acceptance of assessment using different approaches and a willingness to work towards convergence of these methods (WHO)

NOTE: Towards this end, harmonization will be addressed as a two-step process: in the short term, to increase/strive for worldwide understanding of various methods used; in the long term, to identify areas for convergence and work toward this convergence (WHO).


achievement of equivalent measured quantity values (within clinically meaningful limits) for human samples examined for a stated measurand among two or more in vitro diagnostic (IVD) medical devices by applying an international consensus protocol in their calibration hierarchies when fit for purpose higher-order reference materials or reference measurement procedures are not available

NOTE 1: Harmonization is a calibration hierarchy model used to achieve metrologically traceable quantity values for human samples (ISO 17511); NOTE 2: Harmonization is a special case of non-SI traceable standardization in which the calibration of two or more IVD medical devices is traceable to an international harmonization protocol that defines the highest level of metrological traceability for the stated measurand with no traceability to SI; NOTE 3: Harmonized is the condition in which harmonization (equivalence among quantity values) is achieved among two or more IVD medical devices (ISO 21151)

Project: EP32


the process of recognizing, understanding, and explaining differences while taking steps to achieve uniformity of results, or at a minimum, a means of conversion of results such that different groups can use the data obtained from assays interchangeably

Project: I/LA28


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