Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment.
This standard specifies basic safety requirements and essential performance for
electrocardiographic (ECG) monitoring equipment. It is applicable to ECG monitoring equipment
used in a hospital environment. If it is used outside the hospital environment, such as in
ambulances and air transport, the ECG monitoring equipment shall comply with this standard. This
standard is not applicable to electrocardiographic monitors for home use and ECG telemetry
systems. However, manufacturers should consider using relevant clauses of this standard as
appropriate for their intended use/intended purpose. Ambulatory ("Holter") monitors, fetal heart rate
monitors, pulse plethysmographic devices, and other ECG recording equipment are outside the
scope of this particular standard.
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