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EVS-EN 60601-2-33:2010/A1:2015

Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis

General information
Valid from 08.06.2015
Base Documents
EN 60601-2-33:2010/A1:2015; IEC 60601-2-33:2010/A1:2013
Directives or regulations
93/42/EEC Medical devices (MDD)

Standard history

Status
Date
Type
Name
Main
prEN IEC 60601-2-33:2021
01.04.2019
Main + amendment
08.06.2015
Amendment
06.12.2010
Main
This International Standard applies to the  BASIC SAFETY and  ESSENTIAL PERFORMANCE of MR EQUIPMENT and MR SYSTEMS, hereafter referred to also as ME EQUIPMENT. This standard does not cover the application of MR EQUIPMENT beyond the INTENDED USE. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. The standard does not formulate  ESSENTIAL PERFORMANCE requirements related to INTERVENTIONAL MR EXAMINATIONS.
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