UNE-EN IEC 60601-2-68:2025

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 SYSTEM. For example, the MANUFACTURER will provide an interactive interface for user interaction with the correction suggested by the system.

Add after third paragraph:

This particular standard does not apply to standard CT SCANNERS, which are not used for IGRT. However, if a CT SCANNER is used in the same room and is electrically, mechanically, or functionally, including the PATIENT SUPPORT, connected to with an EBE for IGRT then this particular standard applies.

If the X-IGRT EQUIPMENT is combined with an MEE, any requirement that is the same for the X-IGRT EQUIPMENT and the MEE, such as a PATIENT POSITIONER, does not to be tested twice, but can be accepted as tested by the MEE.

Requirements that are being tested according to another standard can be identified by the manufacturer and if identical do not require retesting, instead evidence can refer to corresponding test report.

This particular standard applies for X-RAY EQUIPMENT for RADIOGRAPHY, RADIOSCOPY, and COMPUTED TOMOGRAPHY used for IGRT.

Replace the existing fifth paragraph with:

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 the RESPONSIBLE ORGANIZATION by QUALIFIED PERSONS 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