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BS EN ISO 17511:2021

In vitro diagnostic medical devices. Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples

standard by British Standard / European Standard / International Organization for Standardization , 06/07/2021

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Full Description

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.

Product Details

Published:: 06/07/2021
ISBN(s):: 9780539011258
Number of Pages:: 70
File Size:: 1 file , 6 MB
Product Code(s):: 30378310, 30378310, 30378310
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