BAS EN IEC 80601-2-71:2019
Medical electrical equipment - Part 2-71: Particular requirements for the basic safety and essential performance of functional near-infrared spectroscopy (NIRS) equipment
General Information
Status: Published
No. of pages: 45
Language: English
Edition: 1.
Adoption method: Endorsment
Publication date: 11.12.2019
Technical committee:
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Abstract
IEC 80601-2-71:2015(E) applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of FUNCTIONAL NIRS EQUIPMENT intended to be used by themselves, or as a part of an ME SYSTEM, for the production of FUNCTIONAL NIRS EQUIPMENT output for adjunctive diagnostic purposes, hereinafter referred to as ME EQUIPMENT.
Lifecycle
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Original document and degree of correspondence
- EN IEC 80601-2-71:2018, identical
- IEC 80601-2-71:2015, identical