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

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