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EVS-EN 61010-2-101:2017

Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-101: Particular requirements for laboratory equipment for in vitro diagnostic (IVD) medical equipment

General information
Valid from 02.03.2017
Base Documents
EN 61010-2-101:2017; IEC 61010-2-101:2015
Directives or regulations
None
Standard history
Status
Date
Type
Name
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prEN 61010-2-101:2017
02.03.2017
Main
01.04.2003
Main
This part 2 applies to equipment intended for in vitro diagnostic (IVD) medical purposes, including self-test IVD medical purposes. IVD medical equipment, whether used alone or in combination, is intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning one or more of the following: - a physiological or pathological state; or - a congenital abnormality; - the determination of safety and compatibility with potential recipients; - the monitoring of therapeutic measures. Self-test IVD medical equipment is intended by the manufacturer for use by lay persons in a home environment.
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