DIN EN ISO 15193:2024-02
In vitro diagnostic medical devices - Requirements for reference measurement procedures (ISO/DIS 15193:2023); German and English version prEN ISO 15193:2023 / Note: Date of issue 2024-01-05*Intended as replacement for DIN EN ISO 15193 (2009-10).
| Fecha edición: |
2024-02-01
En Vigor
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| Idiomas disponibles: | Alemán, Inglés |
| Resumen: | This document specifies requirements for the content and format of a reference measurement procedure. This document applies to reference measurement procedures providing values of differential or rational quantities. This document is valid for any person, body, or institution, involved in one of the various branches of laboratory medicine, intending to write a document to serve as a reference measurement procedure. |
| Keywords: | Biochemicals|Biological materials|Biology|Characterisations|Characteristics|Chemical analysis and testing|Classification|Classification systems|Definitions|Diagnosis|Evaluations|Human medicine|Hygiene|In vitro|Infective materials|In-vitro diagnostic|Laboratories|Laboratory medicine|Lists|Marking|Measurement|Measuring systems|Measuring techniques|Medical sciences|Microbiology|Pathogenic bacteria|Reference materials|Reference measuring methods|Reference methods|Representations|Samples|Specification (approval)|Specimens|Systemology|Testing|Wear-quantity |
| ICS: | 11.100.10 - Sistemas de ensayo para diagnóstico in vitro |
| CTN: |
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