BS EN 60601-2-54:2009+A1:2015 Medical electrical equipment. Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy

BS EN 60601-2-54:2009+A1:2015

Medical electrical equipment. Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy

Status : Current, Superseded   Published : March 2010 Replaced By : BS EN 60601-2-54:2009+A2:2019



What is this standard about? 

BS EN 60601-2-54 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 2-54 outlines the most recent guidelines specific to the safe operation of radiography and radioscopy X-ray equipment. It complements BS EN 60601-1.

Who is this standard for?

  • Manufacturers, suppliers and operators of radiography and radioscopy equipment
  • All healthcare facilities/hospitals
  • Health and safety professionals
  • Healthcare regulatory bodies

Why should you use this standard? 

It applies to the basic safety and essential performance of equipment to be used for projection radiography and radioscopy. This edition of BS EN 60601-2-54 addresses the system level of X-ray equipment which consists of a combination of an X-ray generator, associated equipment and accessories. Component functions are addressed as far as necessary. 

The minimum safety requirements specified in this particular standard are considered to provide for a practical degree of safety in operation of radiography and radioscopy equipment. Requirements for additional provisions are covered by BS EN 60601-2-43.

What’s changed since the last update?

  • BS EN 60601-2-54 has been systematically reviewed by experts to ensure its continued market relevance and adherence to clinical best practice
  • Additions to specifications for cooling conditions, beam limiting devices and high voltage cable connections 
  • Amendments to specifications for X-ray source assembly and radiation management
  • Accompanying documentation must contain quality control procedures to be systematically performed on X-ray equipment 

Standard NumberBS EN 60601-2-54:2009+A1:2015
TitleMedical electrical equipment. Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
StatusCurrent, Superseded
Publication Date31 March 2010
Normative References(Required to achieve compliance to this standard)IEC 60336, IEC 60601-1-3:2008, IEC 62220-1:2003, EN 60601-1-3:2008/A1:2013/Corrigendum 1:2014, EN 60601-1:2005/Corrigendum 1:2010, EN 60601-1:2005, IEC/TR 60788:2004, EN 60806:2004, EN 60580:2000, EN 60601-1:2005/A1:2013/Corrigendum 1:2014, IEC 60601-1:2005/A1:2012, EN 60601-1:2005/A12:2014, EN 60601-1-3:2008/Corrigendum 1:2010, EN 60601-1-3:2008, EN 62220-1:2004, EN 60336:2005, IEC 60601-1-3:2008/A1:2013, IEC 60601-1:2005, EN 60601-1-3:2008/A1:2013, IEC 60806, EN 60601-1:2005/A1:2013, IEC 60580:2000
Informative References(Provided for Information)IEC 60601-2-7:1998, IEC 60627, IEC 60601-2-28:1993, IEC 60601-2-32:1994, IEC 60601-1-10, IEC 61267:2005, 93/42/EEC, EN 60601-1-12, EN 60601-2-28:1993, EN 60601-1-11, EN 60601-1-8:2007, EN 60601-2-7:1998, EN 60601-2-43:2000, EN 61267:2006, EN 60601-2-32:1994, IEC 60601-1-12, EN ISO 4090:2004, ISO 4090:2001, EN 60627:2001, IEC 60601-2-43, IEC 60601-1-11, EN 60601-1-10:2008, IEC 60601-1-8
Replaced ByBS EN 60601-2-54:2009+A2:2019
International RelationshipsEN 60601-2-54:2009/A1:2015,EN 61169-38:2009,IEC 60601-2-54:2009/AMD1:2015
Amended ByAmendment, July 2015; Corrigendum, April 2010
Draft Superseded By14/30296597 DC
DescriptorsClinical investigation instruments, Marking, Medical radiology, Electrical medical equipment, Equipment safety, Performance testing, Radiology apparatus (medical), Leakage currents, High-voltage equipment, Temperature rise, Safety devices, Electrical equipment, Performance, Radiation hazards, Medical equipment, Safety measures, X-ray apparatus, Instructions for use, Electrical safety, Medical radiography, Radiation measurement, Dielectric strength, Electronic equipment and components
Title in FrenchAppareils électromédicaux. Exigences particulières pour la sécurité de base et les performances essentielles des appareils à rayonnement X utilisés pour la radiographie et la radioscopie
Title in GermanMedizinische elektrische Geräte. Besondere Festlegungen für die Sicherheit und die wesentlichen Leistungsmerkmale von Röntgeneinrichtungen für Radiographie und Radioskopie
ISBN978 0 580 85671 6
File Size3.035 MB

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