scope:

This Particular Standard specifies the particular safety requirements, including essential performance, for ELECTROCARDIOGRAPHIC (ECG) MONITORING EQUIPMENT as defined in 2.101 and hereinafter also referred to as EQUIPMENT. This standard is applicable to EQUIPMENT used in a hospital environment.

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 monitors for home use. However, manufacturers should consider using relevant clauses of this standard as appropriate for their intended use.

ECG telemetry systems, ambulatory ("Holter") monitors and other ECG recording devices are outside the scope of this Particular Standard.