UNE-EN IEC 60601-2-33:2024
Current
The latest, up-to-date edition.
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.)
Hardcopy , PDF
English
01-11-2024
201.1.1 ScopeReplacement: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 ObjectReplacement: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.
| Committee |
CTN 209/SC 62
|
| DocumentType |
Standard
|
| Pages |
156
|
| PublisherName |
Asociación Española de Normalización
|
| Status |
Current
|
| Standards | Relationship |
| EN IEC 60601-2-33:2024 | Identical |
| IEC 60601-2-33:2022 | Identical |
| BS EN IEC 60601-2-33:2024 | Equivalent |