标准编号：ISO 21151:2020
中文名称：体外诊断医疗设备 对校准器和人体样本所赋值的计量溯源性的国际协调协议的要求
英文名称：In vitro diagnostic medical devices — Requirements for international harmonisation protocols establishing metrological traceability of values assigned to calibrators and human samples
发布日期：2020-05
标准范围
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.
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