This European Standard specifies general requirements for in vitro diagnostic medical devices (IVD MDs) for
self-testing in order to ensure that IVD MDs for self-testing are safe and suitable for the purposes as specified by the
manufacturer.
This standard does not address medical aspects of IVD MDs for self-testing.
Diese ÖNORM legt Anforderungen an In-vitro-Diagnostika zur Eigenanwendung fest. Sie soll sicherstellen, dass In-vitro-Diagnostika zur Eigenanwendung sicher und für die vom Hersteller angegebenen Zwecke geeignet sind.