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EVS-EN 60601-1:2006

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005)

General information

Valid from 08.12.2006
Base Documents
IEC 60601-1:2005; EN 60601-1:2006; EN 60601-1:2006/AC:2010

Standard history

Status
Date
Type
Name
15.05.2024
Main + amendment
02.05.2024
Amendment
01.11.2021
Amendment
01.11.2021
Main + amendment
07.11.2014
Amendment
14.11.2013
Amendment
02.11.2011
Amendment
08.04.2010
Corrigendum
08.12.2006
Main + corrigendum
EN 60601-1 applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems. It is recognized that many items of medical electrical equipment and responsible organizations must depend on standards to ensure essential performance as well as basic safety. Such areas include the accuracy with which the equipment controls the delivery of energy or therapeutic substances to the patient, or processes and displays physiological data that will affect patient management.

EN 60601-1 can also be applied to equipment used for compensation or alleviation of disease, injury or disability. For certain types of medical electrical equipment, these requirements are either supplemented or modified by special requirements of a collateral or particular standard. The international standard has been approved in Europe as EN 60601-1:2006 without any changes.

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