DKE German Commission for Electrical, Electronic & Information Technologies of DIN and VDE
DIN IEC/TS 60601-4-2
; VDE V 0750-4-2:2025-06
Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems (IEC TS 60601-4-2:2024)
Medizinische elektrische Geräte - Teil 4-2: Leitfaden und Interpretation - Elektromagnetische Störgrößen: Leistungsmerkmale von medizinischen elektrischen Geräten und medizinischen elektrischen Systemen (IEC TS 60601-4-2:2024)
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Overview
This document applies to the performance of MEDICAL ELECTRICAL EQUIPMENT or a MEDICAL ELECTRICAL SYSTEM in the presence of EM DISTURBANCES. Hereafter, MEDICAL ELECTRICAL EQUIPMENT or a MEDICAL ELECTRICAL SYSTEM are referred to as ME EQUIPMENT or an ME SYSTEM, respectively. The object of this document is to provide guidance on the assessment of the performance of ME EQUIPMENT or an ME SYSTEM in the presence of EM DISTURBANCES. Functions that may not be related to basic safety or essential performance characteristics but are relevant to the intended use include, for example: - the ability to remotely print an ultrasound image; - the ability of a scale to measure a patient's weight; - the accuracy of the X-ray tube voltage in an X-ray machine for X-ray imaging and fluoroscopy with, for example, a margin of error of less than 5 %. A method for evaluating the ability of medical electrical equipment or a medical electrical system to function in the presence of common electromagnetic disturbances without impairment of performance.
Responsible national committee
DKE/UK 804.2 - Elektromagnetische Verträglichkeit medizinischer elektrischer Geräte und/oder Systeme
