CSA ISO 15197:F15 (C2020):2015 Edition
$34.45
Systèmes d’essais de diagnostic in vitro – Exigences relatives aux systèmes d’autosurveillance de la glycémie destinés à la prise en charge du diabète sucré
| Published By | Publication Date | Number of Pages |
| CSA | 2015 | 65 |
Préface CSA
Ce document constitue la deuxième édition de la CAN/CSA-ISO 15197, Systèmes d'essais de diagnostic in vitro – Exigences relatives aux systèmes d'autosurveillance de la glycémie destinés à la prise en charge du diabète sucré. Il s'agit de l'adoption, sans modifications, de la norme ISO (Organisation internationale de normalisation) 15197 (deuxième édition, 2013-05-15) qui porte le même titre. Il remplace l'édition antérieure publiée en 2005 qui portait la désignation CAN/CSA-ISO 15197 (norme ISO 15197:2003 adoptée).
Cette norme a été élaborée conformément aux exigences du Conseil canadien des normes concernant les Normes nationales du Canada. Cette norme a été publiée en tant que Norme nationale du Canada par Groupe CSA.
Domaine d'application
La présente Norme internationale spécifie les exigences relatives aux systèmes de surveillance de la glycémie in vitro dans des échantillons de sang capillaire, aux procédures de vérification particulières, ainsi qu'à la validation de la performance par les utilisateurs prévus. Ces systèmes sont destinés à l'autosurveillance du diabète sucré par des personnes non initiées.
La présente Norme internationale est destinée aux fabricants de ces systèmes ainsi qu'aux organismes (autorités réglementaires et organismes d'évaluation de la conformité) ayant la responsabilité de l'évaluation des performances de ces systèmes.
La présente Norme internationale
– ne fournit pas d'évaluation complète de tous les facteurs susceptibles d'altérer la performance de ces systèmes
– ne concerne pas le mesurage de la glycémie dans un but de diagnostic du diabète sucré
– ne traite pas des aspects médicaux de la prise en charge du diabète sucré
– ne s'applique pas aux procédures de mesure dont les mesures sont lues sur une échelle ordinale (par exemple procédures de mesure visuelles, semi-quantitatives) ni aux systèmes de surveillance continue de la glycémie
– ne s'applique pas aux lecteurs de glycémie destinés à un usage médical autre que l'autosurveillance dans la gestion du diabète sucré.
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