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E DIN EN IEC 80601-2-71 VDE 0750-2-71:2024-08

Medical electrical equipment

Part 2-71: Particular requirements for the basic safety and essential performance of functional near-infrared spectroscopy (NIRS) equipment

(IEC 62D/2062/CDV:2023); German and English version prEN IEC 80601-2-71:2023
Class/Status: Draft, valid
Released: 2024 -08 Published: 2024-07 -12
VDE Art. No.: 1701956
End of objection deadline: 2024-09-12

This document applies to the Basic Safety and Essential Performance of Functional NIRS Equipment, as defined in 201.3.205, intended to be used by itself, or as a part of an ME System hereinafter referred to as ME Equipment. The document has been prepared to address the relevant essential principles and labelling guidances of the International Medical Devices Regulators Forum (IMDRF) as indicated in Annex DD.

This Document is related to the following Topics (in bold):

11	HEALTH CARE TECHNOLOGY
11.020	Medical sciences and health care facilities in general
11.040	Medical equipment
11.060	Dentistry
11.080	Sterilization and disinfection
11.100	Laboratory medicine
11.140	Hospital equipment
11.180	Aids for disabled or handicapped persons

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Title		Format
	Prinz, Thorsten (Hrsg.) Entwicklung und Herstellung medizinischer Software Normen in der Medizintechnik VDE-Schriftenreihe – Normen verständlich, Band 171 2017, 219 pages, Din A5, Broschur Dieser Buchtitel ist auch als E-Book (PDF) erhältlich