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

Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography EN 60601-2-44:2009/A2:2016

Publication date:   Dec 15, 2016

General information

60.60 Standard published   Jun 3, 2016

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

Life cycle

PREVIOUSLY

PUBLISHED
EN 60601-2-44:2009

NOW

PUBLISHED
EN 60601-2-44:2009/A2:2016
60.60 Standard published
Jun 3, 2016