BS EN 60601-2-68:2015 - Medical electrical equipment. Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment

BS EN 60601-2-68:2015

Medical electrical equipment. Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment

Status : Current, Under review   Published : June 2015

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IEC 60601-2-68:2014 applies to the basic safety and essential performance of X-ray based image-guided radiotherapy (IGRT) equipment for use with External Beam Equipment (EBE). This particular standard covers safety aspects of kilovoltage and megavoltage X-ray imaging devices in a known geometrical relationship with EBE for the purpose of IGRT. It covers aspects of communication and relationships between the EBE and X-ray imaging devices, attached or not directly attached to, but in the same radiation shielded area as, and dedicated for use only with, the EBE. This particular standard deals with equipment for real-time X-IGRT, online X-IGRT and offline X-IGRT. It covers procedures to reduce the risk of over-reliance on the X-IGRT EBE systems. For example the manufacturer will provide an interactive interface for user interaction with the correction suggested by the system.




Standard NumberBS EN 60601-2-68:2015
TitleMedical electrical equipment. Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment
StatusCurrent, Under review
Publication Date30 June 2015
Normative References(Required to achieve compliance to this standard)IEC 60601-1-3:2008, IEC 60601-1-6:2010, IEC 61262-7:1995, IEC 60601-1:2005/AMD1:2012, IEC 60731:2011, IEC 60601-1-6:2010/AMD1:2013, IEC 62563-1:2009, IEC/TR 60788:2004, EN 60601-2-4:2011, EN 60601-1-3:2008+corr. March:2010, EN 60601-1:2006+A1:2013, EN 60601-1:2006+A1/AC:2014, IEC 62274:2005, EN 60601-2-44:2009, EN 62274:2005, EN 60601-1-6:2010+A1:2015, IEC 60976:2007, EN 60601-1:2006+A12:2014, EN 61223-3-5:2004, IEC 62396-1:2012, EN 61217:2012, EN 60601-1-6:2010, EN 60601-2-44:2009+A11:2011, IEC 62366:2007, EN 60731:2012, IEC 61217:2011, EN 60976:2007, EN 62563-1:2010, IEC 60601-2-44:2012, IEC 60601-1:2005, EN 60601-1:2006+corr. March:2010, IEC 60601-2-4:2010, IEC 60601-2-1:2009, EN 60601-2-44:2009+A1:2012, EN 60601-1-3:2008, EN 60601-1:2006, IEC 61223-3-5:2004, EN 61262-7:1995, EN 62083:2009, IEC 62083:2009
Informative References(Provided for Information)IEC 60522:1999, IEC TR 60977, IEC 62220-1:2003, ICRU Report 51:1993, HD 60364-7-710:2012, 93/42/EEC, EN 60522:1999, ICRU Report 39:1985, ISO 9334:2012, ICRP Publication 60:1991, ICRU Report 35:1984, ICRP Publication 33:1982, IEC 60364-7-710:2002, EN 60336:2005, IEC 60336:2005, EN 62220-1:2004
International RelationshipsEN 60601-2-68:2015,IEC 60601-2-68:2014
Draft Superseded By12/30246621 DC
DescriptorsX-ray apparatus, Physiotherapy, Particle accelerators, Safety engineering, Safety measures, Radiation protection, Electron beams, Radiotherapy, Occupational safety, Electrical equipment, Electronic equipment and components, Electrical safety, Medical equipment, Electrical medical equipment, Medical radiology, Enclosures, Instructions for use, Radiation hazards, Electric enclosures, Protected electrical equipment, Leakage currents
ICS11.040.60
Title in FrenchAppareils électromédicaux. Exigences particulières pour la sécurité de base et les performances essentielles des appareils de radiothérapie à rayonnement X assistée par imagerie médicale, destinés à être utilisés avec les accélérateurs d'électrons, les appareils de thérapie par faisceau d'ions légers et les appareils de thérapie par faisceau de radionucléides
Title in GermanMedizinische elektrische Geräte. Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von rön tgenstrahlungsbasierten Geräten für die bildgesteuerte Strahlentherapie zur Verwendung mit Elektronenbeschleunigern, Leichtionen- Strahlentherapiesystemen und Radionuklid- Strahlentherapiesystemen
CommitteeCH/62/3
ISBN978 0 580 75388 6
PublisherBSI
FormatA4
DeliveryYes
Pages70
File Size1.619 MB
Price£260.00


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