本文件规定了必要的技术要求和文件，以建立IVD MDs测量量的校准器、真实性控制材料和人体样本的计量溯源性。人体样本是针对每个IVD MD规定的拟测量样本。人体样本数量值的计量溯源性延伸至最高可用参考系统组件，理想情况下延伸至RMP和认证参考材料（CRM）。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 technical requirements and documentation necessary to establish metrological traceability of values assigned to calibrators, trueness control materials and human samples for quantities measured by IVD MDs. The human samples are those intended to be measured, as specified for each IVD MD. Metrological traceability of values for quantities in human samples extends to the highest available reference system component, ideally to RMPs and certified reference materials (CRMs).All current amendments available at time of purchase are included with the purchase of this document.