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Standard ÖVE/ÖNORMENIEC 80601-2-71 1.4.2026 preview

ÖVE/ÖNORMENIEC 80601-2-71

Medical electrical equipment -- Part 2-71: Particular requirements for the basic safety and essential performance of functional near-infrared spectroscopy (NIRS) equipment (( IEC 80601-2-71:2025) EN IEC 80601-2-71:2025) (german version)

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STANDARD published on 1.4.2026


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The information about the standard:

Designation standards: ÖVE/ÖNORMENIEC 80601-2-71
Publication date standards: 1.4.2026
SKU: NS-1266232
The number of pages: 68
Approximate weight : 204 g (0.45 lbs)
Country: Austrian technische Norm
Category: Technical standards ÖNORM

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Diagnostic equipment

Annotation of standard text ÖVE/ÖNORMENIEC 80601-2-71 :

Dieser Teil von IEC 80601 gilt für die BASISSICHERHEIT und die WESENTLICHEN LEISTUNGSMERKMALE von FUNKTIONELLEN NIRS-GERÄTEN entsprechend der Definition in 201.3.205, die dafür vorgesehen sind, selbständig oder als Teil eines ME-SYSTEMS verwendet zu werden, und die nachstehend als ME-GERÄTE bezeichnet werden. GEFÄHRDUNGEN, die sich aus der vorgesehenen physiologischen Wirkungsweise von ME-GERÄTEN oder MESYSTEMEN im Anwendungsbereich dieses Dokuments ergeben, sind nicht durch besondere Anforderungen in diesem Dokument erfasst, ausgenommen bei IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 und IEC 60601-1:2005/AMD2:2020, 7.2.13 und 8.4.1.

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