EN 60601-2-44:2009

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

Publication date:   Aug 21, 2009

General information

90.93   Standard confirmed   Jan 5, 2026

CENELEC

CLC/TC 62 Electrical equipment in medical practice

European Norm

11.040.50   Radiographic equipment

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Scope

IEC 60601-2-44:2009 applies to the basic safety and essential performance of CT scanners. The scope of IEC 60601-2-44:2009 is limited to CT scanners intended to be used for both head and body 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. This third edition cancels and replaces the second edition published in 2001 and its Amendment 1 (2002). This edition constitutes a technical revision primarily related to radiation protection and control.

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

Harmonised Standard / Cited in the Official Journal

Life cycle

PREVIOUSLY

WITHDRAWN
EN 60601-2-44:2001/A1:2003

WITHDRAWN
EN 60601-2-44:2001

NOW

PUBLISHED
EN 60601-2-44:2009
90.93 Standard confirmed
Jan 5, 2026

CORRIGENDA / AMENDMENTS

PUBLISHED
EN 60601-2-44:2009/A11:2011

PUBLISHED
EN 60601-2-44:2009/A1:2012

PUBLISHED
EN 60601-2-44:2009/A2:2016

REVISED BY

IN_DEVELOPMENT
FprEN IEC 60601-2-44:2026