UNE EN IEC 60601-2-33:2024
Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis (Endorsed by Asociación Española de Normalización in November of 2024.)
Equipos electromédicos. Parte 2-33: Requisitos particulares para la seguridad básica y funcionamiento esencial de los equipos de resonancia magnética para diagnóstico médico (Ratificada por AENOR en noviembre de 2015.) (Ratificada por la Asociación Española de Normalización en noviembre de 2024.)
| Označení normy: | UNE EN IEC 60601-2-33:2024 |
| Počet stran: | 156 |
| Vydáno: | 2024-11-01 |
| Status: | Norma |
UNE EN IEC 60601-2-33:2024
201.1.1 Scope Replacement: This document applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MR EQUIPMENT and 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. 201.1.2 Object Replacement: The object of this document is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for MR EQUIPMENT to provide protection for the PATIENT and the MR WORKER. NOTE 1 This document presumes that the MR WORKERs are screened, trained and instructed in their duties.
