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Standard ÖVE EN IEC 61010-2-101 1.1.2024 preview

ÖVE EN IEC 61010-2-101

Safety requirements for electrical equipment for measurement, control, and laboratory use -- Part 2-101: Safety requirements for in vitro diagnostic (IVD) medical equipment (EN IEC 61010-2-101:2022) (german version)

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STANDARD published on 1.1.2024


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The information about the standard:

Designation standards: ÖVE EN IEC 61010-2-101
Publication date standards: 1.1.2024
SKU: NS-1162600
The number of pages: 36
Approximate weight : 108 g (0.24 lbs)
Country: Austrian technische Norm
Category: Technical standards ÖNORM

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Diagnostic equipmentElectrical and electronic testing

Annotation of standard text ÖVE EN IEC 61010-2-101 :

Dieser Teil der IEC 61010 enthält besondere Sicherheitsanforderungen an Geräte, die für medizinische Zwecke der In-vitro-Diagnostik (IVD) bestimmt sind, einschließlich IVD-Geräte für Selbsttests. Er soll in Verbindung mit dem Risikomanagement des Herstellers verwendet werden, dieses aber nicht ersetzen. Ein medizinisches IVD-Gerät ist allein oder in Verbindung mit anderen Geräten bestimmungsgemäß zur In-vitro-Untersuchung von dem menschlichen Körper entnommenen Proben, einschließlich Blut- und Gewebe-proben, vorgesehen, um ausschließlich oder hauptsächlich Informationen über einen oder mehrere der folgenden Punkte zu gewinnen: - physiologische oder pathologische Zustände; - angeborene Missbildungen/Anomalien; - Prüfung auf Unbedenklichkeit und Verträglichkeit bei den potentiellen Empfängern; - Überwachung therapeutischer Maßnahmen. Ein medizinisches Eigendiagnose-IVD-Medizingerät zur Eigenanwendung ist vom Hersteller für die Verwendung durch Laien in einer häuslichen Umgebung bestimmt.

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