2. Getting involved
3. Standards Committees
4. DKE

DKE German Commission for Electrical, Electronic & Information Technologies of DIN and VDE

Overview

This International Standard covers technical aspects of medical diagnostic MR systems and the MR equipment that are necessary to ensure patient safety and to address the problems of MR operators involved in the operation, development, manufacture, installation, and maintenance of MR systems with regard to exposure to electromagnetic fields (EMF). The exposure limits for patients and MR operators are selected to protect these individuals from adverse health effects and unreasonable risks. This document assumes that MR operators are monitored in accordance with occupational safety and health requirements and are trained and instructed in accordance with their specific duties. The standard differs from DIN EN 60601-2-33 (VDE 0750-2-33):2017-11 as follows: a) alignment with IEC 60601-1:2005 and its two amendments, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020; b) addition of safety requirements for the magnetic emergency shutdown unit; c)explanation of noise protection measures for the patient and the MR operator; d) addition of noise emission specifications for exposure within the MR examination room in order to support the occupational health assessment by the responsible organization; e) addition of procedures with regard to compliance with thermal safety requirements for RF coils; f) specifications for RF excitation to align with the labeling requirements for conditionally MR safe medical devices; g) explanation of the requirements for labeling accessories as conditionally MR safe; h) adjustment of the static magnetic field limit value for the B₀ hazard zone to align with the limit values in other standards for medical devices (in particular pacemakers, ISO 14117), resulting in a new limit value of 0,9 mT; i) improved description of the magnetic field-related diagrams in the Compatibility Technical Specification Sheet (CTSS); j) the requirement for compatibility sequences (in the CTSS) for testing accessories by the MR manufacturer has been made optional, and it is expected to be removed in one of the next editions; k) a separate subclause with requirements for site planning documents containing safety information; l) requirements for the alarm (notification) function (patient to operator); m) introduction of MROC as a mandatory function for 1,5-T and 3-T systems in order to support the examination of patients with medical devices labeled as conditionally MR safe, provided that such imaging is not expressly contraindicated by the MR manufacturer; n) the symbols for RF coils in Table 201.A.102 have become mandatory, and the preferred and alternative symbols have been exchanged compared to the previous edition, so that the colored symbol is now preferred; o) determination of the B₁ stray field in 201.12.4.105.3.3 based exclusively on calculations.

Document: references other documents

Responsible national committee

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