Select Page

IEC 60601-2-44 X-Ray Equipment for Computed Tomography Testing

Medical electrical equipment – Part 2-44: the basic safety and essential performance of X-ray equipment for computed tomography

IEC 60601-2-44 Scope:

IEC 60601 2 44 and EN 60601 2 44 testing applies to the basic safety and essential performance of CT scanners, hereafter also referred to as medical electronic equipment.

The scope of IEC 60601-2-44 is limited to CT scanners intended to be used for both head and body characterized 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 Requirements for X-ray generators and for associated equipment, which were previously specified in IEC 60601-2-7 and IEC 60601-2-32, have been included in either IEC 60601-1:2005 (Ed3) or this edition of IEC 60601-2-44. Therefore IEC 60601-2-7 and IEC 60601-2-32 are not part of the 3rd edition scheme for computed tomography.

The scope of EN 60601-2-44 excludes radiotherapy simulators and systems where the image is created by a source other than an X-ray tube.

Keystone Compliance assists manufacturers with IEC 60601-2-44 and EN 60601-2-44 test compliance. Please contact us for more information on how Keystone Compliance can assist you with identifying and fulfilling your IEC 60601-2-44 test lab needs.