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Geratherm
®
est certié selon la directive 93/42/CEE et la
norme EN ISO 13485, autorisant ainsi la société à appo-
ser la marque (organisme notié : TÜV Rhein-
land LGA Products GmbH).
Le tensiomètre électronique à écran de contrôle satisfait à:
Garantie de qualité
Management des
risques
ISO/EN 14971 Dispositifs Médicaux –
application du management des risques
aux dispositifs médicaux
Marquage
EN 980 - Symboles utilisés pour l’étique-
tage des dispositifs médicaux
Notice d’emploi
EN 1041 Informations fournies par le
fabricant de dispositifs médicaux
Exigences géné-
rales en matière
de sécurité
EN 60601-1 +A1 Dispositifs électro médi-
caux – Partie 1 : Dispositions générales
en matière de sécurité de base et de
performances essentielles
IEC/EN 60601-11 Dispositifs électro
médicaux - Partie 1-11: Dispositions
générales en matière de sécurité de base
et de performances essentielles – Norme
collatérale : Exigences pour les appareils
électro médicaux et les systèmes électro-
médicaux utilisés dans l’environnement
des soins à domicile
Compatibilité
électromagnétique
IEC/EN 60601-1-2 Appareils électro
médicaux - Partie 1-2 : exigences
générales pour la sécurité de base et les
performances essentielles
– Norme collatérale: compatibilité électro-
magnétique – Exigences et essais
Exigences en
matière de
performance
EN ISO 81060-1 Dispositifs non invasifs
de mesure de la tension artérielle – Partie
1 : Exigences et méthodes d’essai de
conception non automatisée (ISO 81060-1)
EN 1060-3 +A2 Tensiomètres non invasifs
– Partie 3 : Exigences complémentaires
concernant les systèmes électroméca-
niques de mesure de la tension artérielle
90

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