scope:

This particular standard applies to BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTROCARDIOGRAPHIC (ECG) MONITORING EQUIPMENT as defined in 201.3.63 and hereinafter also referred to as ME EQUIPMENT. This particular standard applies to ME EQUIPMENT used in a hospital environment as well as when used outside the hospital environment, such as in ambulances and air transport. This particular standard also applies 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 this particular standard. 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 using 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 this particular standard.