DIN Standards Committee Health Technologies
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
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
Order from DIN Media
