DSF/FprEN 60601-2-54
Medical electrical equipment -- Part 2-54: Particular requirements for basic safety and essential performance of X-ray equipment for radiography and radioscopy
| Organization: | DS |
| Status: | inactive |
| Page Count: | 70 |
| ICS Code (Radiographic equipment): | 11.040.50 |
scope:
Clause 1 of the general standard applies, except as follows:
201.1.1 Scope
Subclause 1.1 of the general standard is replaced by:
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ME EQUIPMENT and ME SYSTEMS intended to be used for projection RADIOGRAPHY and RADIOSCOPY. Requirements for provisions specific to ME EQUIPMENT and ME SYSTEMS intended to be used for interventional applications are included in the particular standard IEC 60601-2-43 with appropriate modifications or deletions relative to 60601-2-54 requirements.
ME EQUIPMENT and ME SYSTEMS intended to be used for bone or tissue absorption densitometry, computed tomography, mammography or dental applications are excluded from the scope of this international standard. The scope of this international standard also excludes radiotherapy simulators.
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.
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