Abstract

This International Standard applies to the basic safety and essential performance of MRI based image guides radiotherapy equipment for use with external beam equipment (ebe). This particular standard covers safety aspects of MR equipment 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 MR equipment, 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 MRIGRT online MRIGRT and offline with both adapt to position. If a clause or subclause is specifically intended to be applicable to 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 MRIGRT equipment. This particular standard, with the inclusion of type tests and site tests, applies respectively to the manufacturer and some installation aspects of MRIGRT 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.

Begin

2024-08-15

Planned document number

DIN EN IEC 60601-2-92

Project number

02232507

Responsible national committee

DKE/GK 813 - Elektrische und mechanische Sicherheit in der radiologischen Technik