Medical electrical equipment - Part 2-27: Particular requirements for the safety, including essential performance, of electrocardiographic monitoring equipment
|Publication Date:||1 August 2005|
|ICS Code (Radiographic equipment):||11.040.50|
This Particular Standard specifies the particular safety requirements, including essential performance, for ELECTROCARDIOGRAPHIC
If the EQUIPMENT is used outside the hospital environment, such as in ambulances and air transport, the EQUIPMENT shall comply with this standard.
NOTE Additional standards apply to the EQUIPMENT covering specifically use outside the hospital environment.
This standard is not applicable to electrocardiographic
ECG telemetry systems, ambulatory ("Holter") monitors and other ECG recording devices are outside the scope of this Particular Standard.