DIN EN ISO 17511:2021-11
In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples (ISO 17511:2020); German version EN ISO 17511:2021
| Fecha edición: |
2021-11-01
En Vigor
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| Idiomas disponibles: | Inglés, Alemán |
| Resumen: | This European Standard specifies how to assure the metrological traceability of values assigned to calibrators and control materials intended to establish or verify trueness of measurement, and provided by the manufacturers as part of, or to be used together with, in vitro diagnostic medical devices. Control materials that do not have an assigned value and are used only for assessing the precision of a measurement procedure, either its repeatability or reproducibility, are outside the scope of this European Standard. |
| Keywords: | Accuracy|Biochemicals|Biological materials|Calibration materials|Calibrator|CE marking|Characterisations|Characteristics|Check material|Chemical analysis and testing|Classification|Classification systems|Definitions|Descriptions|Diagnosis|Diagnosis (medical)|Diagnostic equipment|Evaluations|Human medicine|In vitro|In-vitro diagnostic|Laboratories|Laboratory medicine|Lists|Measured value|Measurement|Measuring systems|Measuring techniques|Medical devices|Medical sciences|Metrology|Recirculation|Samples|Size|Specification (approval)|Systemology|Traceability|Verification|Wear-quantity |
| ICS: | 11.100.10 - Sistemas de ensayo para diagnóstico in vitro |
| CTN: | |
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Equivalencia Internacional |
Idéntica EN ISO 17511:2021 Idéntica ISO 17511:2020 |
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Reemplazo Normas |
Reemplaza a DIN EN ISO 17511:2003-11 Reemplaza a DIN EN ISO 17511:2019-05 |
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