Medical electrical equipment - Part 2-68: 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
This International Standard 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. NOTE In this particular standard@ all references to installation refer to installation in the RESPONSIBLE ORGANIZATION'S premises