ISO 21151:2020
$36.40
Dispositifs médicaux de diagnostic in vitro — Exigences relatives aux protocoles d’harmonisation internationaux établissant la traçabilité métrologique des valeurs affectées aux étalons et aux échantillons humains
| Published By | Publication Date | Number of Pages |
| ISO | 2020-05 | 28 |
Le présent document spécifie les exigences relatives à un protocole mis en œuvre par un organisme international pour obtenir des résultats équivalents entre au moins deux DMDIV pour un même mesurande en l'absence de procédures de mesure de référence et de matériaux de référence certifiés ou d'étalons internationaux conventionnels adaptés à l'usage prévu. Dans ce cas, le protocole d'harmonisation définit le niveau de traçabilité métrologique le plus élevé pour le mesurande donné.
Le présent document peut être appliqué lorsque des matériaux de référence certifiés ou des étalons internationaux conventionnels existent, mais qu'ils ne sont pas adaptés à l'usage prévu, car ils ne sont pas, par exemple, commutables avec des échantillons d'origine humaine.
NOTE Le présent document se rapporte à un cas de traçabilité de valeurs mesurées et attribuées, décrit en 5.6 de l'ISO 17511:2020.
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