Medical Electrical Equipment - Electrocardiographic Monitoring Equipment HS: 9018; Radiographic equipment (ICS 11.040.50)
National Standard of the P.R.C., Medical Electrical Equipment Part 2-27: Particular Requirements for the Basic Safety and Essential Performance of Electrocardiographic Monitoring Equipment (62 page(s), in Chinese)
This part applies to the basic safety and essential performance of ECG monitoring equipment (ME equipment) defined in 201.3.63. This special standard applies to ME equipment used in hospital Settings as well as outside hospital Settings such as ambulances and air transport. This special standard is also applicable to ECG telemetry systems used in hospital Settings.