DIN EN 60601-2-27:2015-04

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.