DSF/PREN 60601-2-44
Medical electrical equipment -- Part 2-44: Particular requirements for basic safety and essential performance of X-ray equipment for computed tomography
| Organization: | DS |
| Status: | inactive |
| Page Count: | 38 |
| 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 CT
SCANNERS, hereafter also referred to as ME EQUIPMENT.
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.
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.
The scope of this document is limited to head and/or body CT scanners characterised by an enclosure of the x-ray source(s) and imaging detector(s) in a common protective cover in the shape of a torus. It includes safety requirements for the X-RAY GENERATORS used in CT SCANNERS, including those where HIGH VOLTAGE GENERATORS are integrated with an X-RAY TUBE ASSEMBLY.
Because the content of IEC 60601-2-32 is now reflected in either the IEC 60601-1 Ed3 or this edition of IEC 60601-2-44, IEC 60601-2-32 shall not apply for CT SCANNERS.
Because this document includes safety requirements for the X-RAY GENERATOR, IEC 60601-2-7 shall not apply for computed tomography.
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