DIN EN 60601-2-33:2017-11

This standard covers technical aspects of medical diagnostic MR SYSTEMS and the MR DEVICES they contain that relate to the safety of PATIENTS examined using such a system, the safety of the MR OPERATORS entrusted with its operation, and the safety of the MR OPERATORS entrusted with the development, manufacture, installation and maintenance of the MR SYSTEM. Amendments 1 and 2 have been added to this standard. Amendment 1 has been published to align IEC 60601-2-33:2010 with the technical corrections of Supplement 1 (2012) to IEC 60601-1:2005. Amendment 2 has been prepared in order to raise the CONTROLLED OPERATING MODE FIRST LEVEL limit for the static field from 4T to 8T, taking into account the FDA, ICNIRP and other peer-reviewed scientific work. Furthermore, the fixed-parameter option (FPO:B) is introduced as a non-mandatory option to limit the output values (peak and effective value) of the high frequency and the gradient field for the examination of patients with MR-compatible implants. The text is therefore proposed for the instructions for use to serve as a guideline for the operator when examining patients with MR conditional implants and MR safe implants. The present standard amends and supplements DIN EN 60601-1 (VDE 0750-1):2013-12. The responsible committee is DKE/GK 813 "Elektrische und mechanische Sicherheit in der radiologischen Technik" ("Electric and mechanical safety in radiological technique") of the DKE (German Commission for Electrical, Electronic and Information Technologies) at DIN and VDE.