prBAS EN IEC 60601-2-33:2026
Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
General information
Status:Project
Number of pages:16
Adoption method:Proglašavanje
Language:engleski
Edition:2.
Realization date:28.11.2025
Forseen date for next stage code:20.02.2026
Technical committee:BAS/TC 25, Healthcare
Directives:
2017/745, Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
ICS:
11.040.55, Diagnostic equipment
Abstract
This document applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MAGNETIC RESONANCE (MR) EQUIPMENT and MAGNETIC RESONANCE (MR) SYSTEMS.
NOTE Where ME EQUIPMENT and ME SYSTEMS are used in the clause headings, this is to be understood to indicate MR EQUIPMENT and MR SYSTEMS.
This document does not cover the application of MR EQUIPMENT beyond the INTENDED USE.
If a clause or subclause is specifically intended to be applicable to MR EQUIPMENT only, or to MR 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 MR EQUIPMENT and to MR SYSTEMS, as relevant.
This document does not formulate additional specific requirements for MR EQUIPMENT or MR SYSTEMS used in INTERVENTIONAL MR EXAMINATIONS.
Lifecycle
...
Original document and degree of correspondence
EN IEC 60601-2-33:2024, identical
IEC 60601-2-33:2022, identical
Relation to BAS standards
Work material
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