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

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  Keywords:

#mr #equipment #systems #subclause #clause

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosisIEC 60601IEC 60601-2-33:2010

  Purpose

Other names: IEC 60601-2-33:2010/A1:2013 Clause 1 of the general standard applies, except as follows: 201.1.1 Scope Replacement: 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 specific requirements for MR EQUIPMENT or MR SYSTEMS used in INTERVENTIONAL MR EXAMINATIONS.

  Publication

Friday 17th of November 2017

  Amendment

This standard is an amendment for "EN 60601-2-33:2010"

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