BS EN 60601-2-44:2009
Medical electrical equipment - Particular requirements for basic safety and essential performance of X-ray equipment for computed tomography

Standard No.

BS EN 60601-2-44:2009

Release Date

2009

Published By

British Standards Institution (BSI)

Status

Be replaced 2009-07

Replace By

BS EN 60601-2-44:2009+A11:2011

Latest

BS EN 60601-2-44:2009+A2:2016

Replace

07/30136476 DC-2007 07/30166162 DC-2007 BS EN 60601-2-44:2001

Scope

Clause 1 of the general standard applies, except as follows: 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. The scope of this document 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 XRAY GENERATORS used in CT SCANNERS, including those where HIGH-VOLTAGE GENERATORS are integrated with an X-RAY TUBE ASSEMBLY.

BS EN 60601-2-44:2009 Referenced Document

• IEC 61223-3-5 Corrigendum 1 - Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance and constancy tests - Imaging performance of computed tomography X-ray equipment*， 2022-06-08 Update
• ISO 12052 Health informatics — Digital imaging and communication in medicine (DICOM) including workflow and data management*， 2017-08-17 Update

BS EN 60601-2-44:2009 history

• 2009 BS EN 60601-2-44:2009+A2:2016 Medical electrical equipment - Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography
• 2009 BS EN 60601-2-44:2009+A1:2012 Medical electrical equipment. Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography
• 2009 BS EN 60601-2-44:2009+A11:2011 Medical electrical equipment. Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography
• 2009 BS EN 60601-2-44:2009 Medical electrical equipment - Particular requirements for basic safety and essential performance of X-ray equipment for computed tomography
• 2002 BS EN 60601-2-44:2001 Medical electrical equipment - Particular requirements for safety - Particular requirements for the safety of X-ray equipment for computed tomography