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


Опште информације
Статус:Пројекат
Број страница:16
Метода усвајања:Proglašavanje
Језик:engleski
Издање:2.
Датум реализације:28.11.2025
Предвиђени датум наредне фазе:20.02.2026
Технички комитет:BAS/TC 25, Заштита здравља
Директиве:
2017/745, Уредба (ЕU) о медицинским средствима
ICS:
11.040.55, Диjaгнoстичкa oпрeмa

Абстракт
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.

Животни циклус
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Изворни документ и степен усаглашености
EN IEC 60601-2-33:2024, идентичан
IEC 60601-2-33:2022, идентичан


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