DSF/FPREN 60601-2-33
Medical electrical equipment -- Part 2-33: Particular requirements for basic safety and essential performance of magnetic resonance equipment for medical diagnosis
| Organization: | DS |
| Status: | inactive |
| Page Count: | 102 |
| ICS Code (Diagnostic equipment): | 11.040.55 |
scope:
Subclause 1.1 of the general standard is replaced by:
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of
MR EQUIPMENT and MR SYSTEMS, hereafter referred to 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.
Specific requirements for INTERVENTIONAL MR EXAMINATIONS are not included in this standard,
HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard.
NOTE See also 4.2 of the General Standard.
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