Abstract

This document specifies requirements for certified reference materials (CRM) and the content of their supporting documentation for them to be considered of higher metrological order according to ISO 17511. It is applicable to CRMs classifiable as primary measurement standards, secondary measurement standards, and international conventional calibrators that function either as calibrators or trueness control materials. This document also provides requirements on how data shall be collected for value determination and how to present the assigned value and its measurement uncertainty. This document applies to CRMs with assigned values of differential or rational quantities. For nominal properties and ordinal quantities, see Annex A.

Begin

2023-04-21

WI

00140150

Planned document number

DIN EN ISO 15194

Project number

17600009

Responsible national committee

NA 176-08-08 AA - Quality management in medical laboratories  

Responsible european committee

CEN/TC 140/WG 3 - Quality management in the medical laboratory  

Responsible international committee

ISO/TC 212/WG 2 - Reference systems  

draft standard

In vitro diagnostic medical devices - Requirements for certified reference materials and the content of supporting documentation (ISO/DIS 15194:2023); German and English version prEN ISO 15194:2023
2024-02
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previous edition(s)

In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified reference materials and the content of supporting documentation (ISO 15194:2009); German version EN ISO 15194:2009
2009-10

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