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Full Description

BS EN 60601-2-68:2015 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of X-ray based IMAGE-GUIDED RADIOTHERAPY equipment for use with EXTERNAL BEAM EQUIPMENT (EBE).

This particular standard covers safety aspects of kilovoltage (kV) and megavoltage (MV) 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 EXTERNAL BEAM EQUIPMENT 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 EXTERNAL BEAM EQUIPMENT.

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 EXTERNAL BEAM SYSTEM (X-IGRT EBS). For example the manufacturer will provide an interactive interface for user interaction with the correction suggested by the system.

If a clause or subclause is specifically intended to be applicable to X-IGRT EBE SYSTEMS the content of that clause or subclause will say so. If that is not the case, the clause or subclause applies only to X-IGRT EQUIPMENT.

This particular standard, with the inclusion of TYPE TESTS and SITE TESTS, applies respectively to the MANUFACTURER and some installation aspects of X-IGRT EBE SYSTEMS intended to be
  • for NORMAL USE, operated under the authority of appropriately licensed or QUALIFIED PERSONS by OPERATORS having the required skills for a particular medical application, for particular specified clinical purposes, e.g. STATIONARY RADIOTHERAPY or MOVING BEAM RADIOTHERAPY,
  • maintained in accordance with the recommendations given in the INSTRUCTIONS FOR USE,
  • subject to regular quality assurance performance and calibration checks by a QUALIFIED PERSON.



Cross References:
IEC 60601-1-3:2008
IEC 60601-1-6:2010
IEC 60601-1-6:2010/AMD1:2013
IEC 60601-1:2005
IEC 60601-1:2005/AMD1:2012
IEC 60601-2-1:2009
IEC 60601-2-4:2010
IEC 60601-2-44:2012
IEC 60731:2011
IEC/TR 60788:2004
IEC 60976:2007
IEC 61217:2011
IEC 61223-3-5:2004
IEC 61262-7:1995
IEC 62083:2009
IEC 62274:2005
IEC 62366:2007
IEC 62396-1:2012
IEC 62563-1:2009
EN 60601-1-3:2008
EN 60601-1-3:2008+corr. March:2010
EN 60601-1-6:2010
EN 60601-1-6:2010+A1:2015
EN 60601-1:2006
EN 60601-1:2006+corr. March:2010
EN 60601-1:2006+A1:2013
EN 60601-1:2006+A1/AC:2014
EN 60601-1:2006+A12:2014
EN 60601-2-4:2011
EN 60601-2-44:2009
EN 60601-2-44:2009+A11:2011
EN 60601-2-44:2009+A1:2012
EN 60731:2012
EN 60976:2007
EN 61217:2012
EN 61223-3-5:2004
EN 61262-7:1995
EN 62083:2009
EN 62274:2005
EN 62563-1:2010
93/42/EEC
IEC 60336:2005
IEC 60364-7-710:2002
IEC 60522:1999
IEC TR 60977
IEC 62220-1:2003
ISO 9334:2012
ICRP Publication 33:1982
ICRP Publication 60:1991
ICRU Report 35:1984
ICRU Report 39:1985
ICRU Report 51:1993
EN 60336:2005
HD 60364-7-710:2012
EN 60522:1999
EN 62220-1:2004


All current amendments available at time of purchase are included with the purchase of this document.
 

Document History

  1. BS EN 60601-2-68:2015

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    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

    • Most Recent
  2. BS 12/30246621 DC


    BS EN 60601-2-68. Medical electrical equipment. Particular requirements for basic safety and essential performance of X-ray Based Image Guided Radiotherapy Equipment for use with electron accelerators, light ion beam therapy systems and radionuclide beam therapy systems

    • Historical Version