DIN Standards Committee Health Technologies
DIN EN 60601-2-27
; VDE 0750-2-27:2015-04
Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment (IEC 60601-2-27:2011 + Cor.:2012); German version EN 60601-2-27:2014
Medizinische elektrische Geräte - Teil 2-27: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Elektrokardiographie-Überwachungsgeräten (IEC 60601-2-27:2011 + Cor.:2012); Deutsche Fassung EN 60601-2-27:2014
Overview
These particular requirements apply to basic safety including the essential performance characteristics of electrocardiographic (ECG) monitoring equipment as defined in 201.3.63, hereafter referred to as ME equipment. These particular requirements apply to ME equipment used both within and outside the hospital environment such as in ambulances and air transport. These particular requirements also apply to ECG telemetry systems used in a hospital environment. ME equipment intended for use under extreme or uncontrolled environmental conditions outside the hospital environment, such as in ambulances and air transport, shall comply with these particular requirements. Additional standards may apply to ME equipment for those environments of use. This standard is not applicable to electrocardiographic monitors for home use. However, manufacturers should consider the relevant clauses of this standard as appropriate for their intended use. Ambulatory ("Holter") monitors, fetal heart rate monitoring, pulse plethysmographic devices, and other ECG recording equipment are outside the scope of these particular requirements. The responsible committee is DKE/UK 812.1 "Diagnostik" ("Diagnostics") of the DKE (German Commission for Electrical, Electronic and Information Technologies) at DIN and VDE.
