Le présent document spécifie les exigences s'appliquant au contenu des notices d'utilisation pour les instruments de diagnostic in vitro incluant les appareils, les équipements, les calibrateurs et les matériaux de contrôle à usage professionnel.
Le présent document spécifie le contenu des manuels d'utilisation pour les instruments de diagnostic in vitro pour usage professionel.
ISO 18113-3:2009 specifies requirements for information supplied by the manufacturer of in vitro dignostic (IVD) instruments for professional use. ISO 18113-3:2009 also applies to apparatus and equipment intended to be used with IVD instruments for professional use. ISO 18113-3:2009 can also be applied to accessories, where appropriate.
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