DIN EN ISO 15194:2024-02
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 / Note: Date of issue 2024-01-05*Intended as replacement for DIN EN ISO 15194 (2009-10).
| Fecha edición: |
2024-02-01
En Vigor
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| Idiomas disponibles: | Alemán, Inglés |
| Resumen: | 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. |
| Keywords: | Biochemicals|Calibration materials|Certificates|Characterisations|Characteristics|Check material|Chemical analysis and testing|Classification|Classification systems|Common name|Definitions|Descriptions|Diagnosis|Evaluations|Human medicine|In vitro|Instructions for use|In-vitro diagnostic|Laboratories|Laboratory medicine|Lists|Matrices|Measured value|Measurement|Measuring systems|Measuring techniques|Medical sciences|Metrology|Numerical values|Parameters|Reference materials|Reference measuring methods|Reference methods|Samples|Size|Size measurement|Specification (approval)|Systemology|Terminology|Validation|Wear-quantity |
| ICS: | 11.100.10 - Sistemas de ensayo para diagnóstico in vitro |
| CTN: |
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