DKE German Commission for Electrical, Electronic & Information Technologies of DIN and VDE
DIN EN IEC 60601-2-68
; VDE 0750-2-68:2025-12
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 therapy equipment (IEC 60601-2-68:2025); German version EN IEC 60601-2-68:2025
Medizinische elektrische Geräte - Teil 2-68: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von röntgenstrahlungsbasierten Geräten für die bildgesteuerte Strahlentherapie zur Verwendung mit Elektronenbeschleunigern, Leichtionen-Strahlentherapiesystemen und Radionuklid-Strahlentherapiesystemen (IEC 60601-2-68:2025); Deutsche Fassung EN IEC 60601-2-68:2025
Overview
IMAGE-GUIDED RADIOTHERAPY (IGRT) combines planar (2D) or volumetric (3D) imaging during the course of RADIOTHERAPY in order to adjust the provision of TREATMENT based on the anatomy and position of the PATIENT. This makes it possible for the OPERATOR or the TELETHERAPY RADIATION SYSTEM (EBE) to adjust application of the THERAPEUTIC RADIATION BEAM based on image information, such as the position of the TARGET VOLUME, critical organs, or other reference features, in order to compensate for anatomical changes - including movements of internal organs - or positioning inaccuracies in the TREATMENT setup. The greater accuracy and precision thus achieved allow for higher radiation doses aimed at the TARGET VOLUME and a reduction in the tolerance range of healthy cells in the peripheral region affected by the RADIATION. This is often used in conjunction with other monitoring devices. This document specifies requirements that MANUFACTURERS shall comply with in the design and construction of X-RAY IGRT SYSTEMS (X-IGRT SYSTEMS). This document covers safety aspects of kilovoltage (kV) and megavoltage (MV) X-ray imaging devices integrated in a specified geometrical relationship with EBE for the purpose of IGRT. This document does not apply to CT SCANNERS, X-RAY EQUIPMENT for RADIOGRAPHY, and X-RAY EQUIPMENT for RADIOSCOPY, which are not intended for use for IGRT. The standard differs from DIN EN 60601-2-68 (VDE 0750-2-68):2020-04 as follows: a) alignment with the new editions of the relevant standards: – IEC 60601-2-1:2020; – IEC 60601-2-44:2009, IEC 60601-2-44:2009/AMD1:2012 and IEC 60601-2-44:2009/AMD2:2016; – IEC 60601-2-64:2014; b) clarification of the use of IEC 60601-2-68 for CT SCANNERS, X-RAY EQUIPMENT for RADIOGRAPHY and RADIOSCOPY used in the same room with an EXTERNAL BEAM EQUIPMENT (EBE); c) introduction of updated requirements related to MECHANICAL HAZARDS, RADIATION HAZARDS, PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS), ACCOMPANYING DOCUMENTATION of an ME SYSTEM, and REMOTE OPERATION. The document 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.
Responsible national committee
DKE/GK 813 - Elektrische und mechanische Sicherheit in der radiologischen Technik
