NF EN ISO 80601-2-61

Medical electrical equipment — Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment

Le présent document s''applique à la sécurité de base et aux performances essentielles des oxymètres de pouls conçus pour une utilisation chez les êtres humains, ci-après dénommés appareils em. Les appareils nécessaires pour une utilisation normale, y compris le moniteur de l''oxymètre de pouls, le capteur de l''oxymètre de pouls et le câble de raccordement du capteur y sont inclus et les exigences s''appliquent de la même manière aux oxymètres de pouls, y compris aux moniteurs d''oxymètre de pouls, aux capteurs d''oxymètre de pouls et aux câbles de raccordement du capteur, qui ont été remis en état. Le présent document ne s''applique pas aux oxymètres de pouls destinés à être utilisés dans le cadre de recherches en laboratoire, de même qu''aux oxymètres nécessitant un échantillon de sang du patient.

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