Podrobnosti návrhu

Replacement:

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.

NOTE 1 See also 4.2 of the general standard.

The scope of this document is limited to CT scanners intended to be used for head and/or body imaging characterised by an enclosure of the X-ray source(s) and imaging detector(s) in a common protective cover in the shape of a toroid. 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.

NOTE 2 This standard does not intend to address interventional systems as described in IEC 60601-2-43 and cone-beam CT scanners integrated into a radiotherapy systems as described in IEC 60601-2-68 and dental cone-beam CT scanners as described in IEC 60601-2-63.

NOTE 3 The body includes cardiac, extremities, neck, etc.

The scope of this International Standard excludes radiotherapy simulators and systems where the image is created by a source other than an X-ray tube.