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。购买本文件时可获得的所有当前修订均包含在购买本文件中。

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.All current amendments available at time of purchase are included with the purchase of this document.