本文件规定了国际机构实施的协议要求，以在没有参考测量程序和无适用认证标准物质或国际常规校准器的情况下，在两个或多个IVD MDs之间实现相同测量的等效结果。在这种情况下，协调协议规定了所述被测量物的最高计量可追溯性水平。 本文件适用于存在认证标准物质或国际常规校准器，但不适合使用的情况，例如，它们不能与人体样本互换。 注:本文件阐述了第5节中所述分配值和测量值的可追溯性。 6在ISO 17511:2020中。

This document specifies requirements for a protocol implemented by an international body to achieve equivalent results among two or more IVD MDs for the same measurand for cases where there are no reference measurement procedures and no fit-for-purpose certified reference materials or international conventional calibrators. In this case, the harmonisation protocol defines the highest level of metrological traceability for the stated measurand. This document can be applied in cases when certified reference materials or international conventional calibrators exist but are not fit-for-purpose because, for example, they are not commutable with human samples. NOTE This document addresses one case of traceability of assigned and measured values described in 5.6 in ISO 17511:2020.