GSO ISO 21151:2022
体外诊断医疗器械 建立分配给校准器和人体样本的值的计量可追溯性的国际协调协议的要求

In vitro diagnostic medical devices — Requirements for international harmonisation protocols establishing metrological traceability of values assigned to calibrators and human samples

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标准号

GSO ISO 21151:2022

发布

2022年

发布单位

GSO

当前最新

GSO ISO 21151:2022

 

 

适用范围

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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