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

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

Status : Current   Published : July 2009

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PDF

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HARDCOPY



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



Standard NumberBS EN 60601-2-44:2009+A2:2016
TitleMedical electrical equipment. Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography
StatusCurrent
Publication Date31 July 2009
Normative References(Required to achieve compliance to this standard)IEC 60601-1:2005/AMD1:2012, IEC 60601-1-3:2008/AMD1:2013, IEC 61223-3-5, ISO 12052:2017, EN 60601-1:2006, EN 60601-1-3:2008, IEC 60601-1:2005, IEC 61223-3-5:2004, IEC 60601-1-2:2014, EN 61223-3-5:2004
Informative References(Provided for Information)ICRP Publication 103:2007, ISO 7000:2004, EN 60601-2-7:1998, IEC 60417, ICRU Report 47:1992, IEC 60364-7-710:2002, IEC/TR 60513:1994, EN 60601-2-32:1994, 93/42/EEC, ISO 497:1973, IEC 60613:1989, EN 60613:1990, IEC 60601-2-7:1998, IEC 60601-2-32:1994
International RelationshipsEN 60601-2-44:2009/A2:2016,EN 60749-29:2011,IEC 60601-2-44:2009,IEC 60601-2-44:2009/AMD2:2016
Amended ByAmendment, July 2016; Amendment, June 2013
DescriptorsSafety measures, Flammability, X-rays, Medical equipment, Computed tomography, Tomography, Accuracy, Medical radiography, Electrical medical equipment, Electronic equipment and components, Ignitability, X-ray apparatus, Radiation measurement, Protected electrical equipment, Attenuation, Electrical equipment, Patient scanners, Electrical safety, Radiation hazards
ICS11.040.50
Title in FrenchAppareils electromédicaux. Exigences particulières pour la sécurité de base et les performances essentielles des équipements à rayonnement X de tomodensitométrie
Title in GermanMedizinische elektrische Geräte. Besondere estlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Röntgeneinrichtungen für die Computertomographie
CommitteeCH/62/2
ISBN978 0 580 90493 6
PublisherBSI
FormatA4
DeliveryYes
Pages68
File Size6.301 MB
Price£254.00


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