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
What is this standard about?
BS EN 60601-2-44 is part of a series of international standards on medical electrical equipment, covering basic safety and essential performance for both equipment and systems. This latest update to Part 2-44 outlines guidelines relating specifically to CT scanners (X-ray equipment for computed tomography). It complements BS EN 60601-1.
Who is this standard for?
Manufacturers, suppliers and operators of CT scanners
All healthcare facilities/hospitals/intensive care units
Health and safety professionals
Regulatory bodies
Why should you use this standard?
This standard applies to the basic safety and essential performance of CT scanners – its scope 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.
What’s changed since the last update?
The standard has been systematically reviewed by experts to ensure its continued market relevance and adherence to clinical best practice
This edition constitutes a technical revision primarily related to radiation protection and control
The scope of this standard excludes radiotherapy simulators and systems where the image is created by a source other than an X-ray tube
BS EN 60601-2-44:2009+A2:2016 history
2009BS 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
2009BS 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
2009BS 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
2009BS EN 60601-2-44:2009 Medical electrical equipment - Particular requirements for basic safety and essential performance of X-ray equipment for computed tomography
2002BS EN 60601-2-44:2001 Medical electrical equipment - Particular requirements for safety - Particular requirements for the safety of X-ray equipment for computed tomography