Medical electrical equipment – Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
|Publication Date:||1 March 2011|
|ICS Code (Radiographic equipment):||11.040.50|
This particular standard applies to BASIC SAFETY and ESSENTIAL
PERFORMANCE of ELECTROCARDIOGRAPHIC
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
Ambulatory ("Holter") monitors, fetal heart rate monitoring, pulse plethysmographic devices, and other ECG recording equipment are outside the scope of this particular standard.