Standards Development

Scope

This document applies to X-ray imaging devices used for IGRT purposes, in medical practice and describes how measurements and test procedures shall be performed by the manufacturer (3.2.28) of X-ray image-guided radiotherapy equipment (3.2.49) but does not specify acceptance tests (3.2.1).

This International Standard specifies methods of testing and methods of disclosure of performance for X-ray image-guided radiotherapy equipment (3.2.49) for use with EXTERNAL BEAM EQUIPMENT (EBE (3.2.16)) for the purpose of IGRT (3.2.20) with, and in a known geometrical relationship with EBE (3.2.16) . It includes aspects of communication and relationships between the EXTERNAL BEAM EQUIPMENT and X-ray image-guided radiotherapy equipment (3.2.49) , attached or not directly attached to, but in the same RADIATION shielded area as, and dedicated for use only with, the EXTERNAL BEAM EQUIPMENT.

It specifies test procedures for the determination and disclosure of performance characteristics, knowledge of which is deemed necessary for proper selection, application, and use of X-ray image-guided radiotherapy equipment (3.2.49) and which are to be declared in the accompanying documentation (3.1.8) together with the greatest deviation or variation to be expected under specific conditions in normal use (3.2.33). A format for presentation of performance values is given in Annex A

It is not intended that this standard document should in any way inhibit the development of new designs of equipment (3.2.14) which may have operating modes and parameters different from those described herein, provided that such equipment (3.2.14) accomplias with the requirements of this standardspatients (3.1.5).

The essential performance is not addressed in this standard, it is addressed in the applicable particular standard IEC 60601-2-68:2014+A1:2024.