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harmonization in glycohemoglobin (GHB) testing, the process by which GHB test results among laboratories are made comparable to a common reference Project: C44
| harmonization 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
| harmonization achievement of equivalent measured quantity values (within clinically meaningful limits) for human samples examined for a stated measurand among 2 or more in vitro diagnostic 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 (ISO 21151) 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–International System of Units (SI)–traceable standardization, in which the calibration of 2 or more in vitro diagnostic medical devices is traceable to an international harmonization protocol that defines the highest level of metrological traceability for the stated measurand, but with no traceability to SI (ISO 21151); NOTE 3: “Harmonized” is the condition in which harmonization (equivalence among quantity values) is achieved among 2 or more in vitro diagnostic medical devices (ISO 21151); NOTE 4: Harmonization is one of the calibration hierarchy models described in ISO 17511 to achieve metrologically traceable quantity values for human samples (ISO 21151). Alternate Term: harmonized Project: H20, EP32
| international harmonization protocol standardization process implemented by an international organization to achieve equivalence among measured quantity values for 2 or more in vitro diagnostic medical devices intended for examination of the same measurand for cases in which there are no higher-order reference measurement procedures and no fit-for-purpose certified reference materials or international conventional calibrators (ISO 21151) NOTE 1: A harmonization protocol can be used to achieve standardization of measured values for a stated measurand when there are no other higher-order reference system components that are suitable for use (ISO 21151); NOTE 2: A harmonization protocol defines the highest level of metrological traceability for the stated measurand (ISO 21151). Alternate Term: harmonization protocol Project: EP32, H20
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