CAN/CSA-Z23747:F18:2018 Edition
$33.15
Matériel d’anesthésie et de réanimation respiratoire – Débitmètres à débit de pointe expiratoire pour l’évaluation de la fonction pulmonaire chez les êtres humains respirant spontanément
| Published By | Publication Date | Number of Pages |
| CSA | 2018 | 44 |
Préface CSA
Ce document constitue la deuxième édition de CAN/CSA-Z23747, Matériel d’anesthésie et de réanimation respiratoire — Débitmètres à débit de pointe expiratoire pour l’évaluation de la fonction pulmonaire chez les êtres humains respirant spontanément. Il s’agit de l’adoption, avec exigences propres au Canada, de la norme ISO (Organisation internationale de normalisation) 23747 (deuxième édition, 2015-08-01), qui porte le même titre. Cette norme remplace l’édition antérieure publiée en 2008 qui portait la désignation CAN/CSA-Z23747 (norme ISO 23747:2007 adoptée).
Domaine d’application
La présente Norme internationale spécifie les exigences relatives aux débitmètres permettant le mesurage du débit de pointe expiratoire (pefm), destinés à l’évaluation de la fonction pulmonaire chez les êtres humains en respiration spontanée.
La présente Norme internationale couvre tous les dispositifs médicaux mesurant le débit de pointe expiratoire chez les êtres humains en respiratoire spontanée en tant que partie d’un dispositif médical intégré de fonctionnement des poumons ou en tant que dispositif médical indépendant.
Il est préférable que la planification et la conception des produits mettant la présente Norme internationale en application prennent en compte les effets du produit sur l’environnement pendant son cycle de vie. Les aspects environnementaux sont abordés dans l’Annexe E.
NOTE D’autres aspects concernant l’incidence sur l’environnement sont traités dans l’ISO 14971.
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