BS EN 60601-2-25:2015 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTROCARDIOGRAPHS as defined in 201.3.63 intended by themselves or as a part of an ME SYSTEM, for the production of ECG REPORTS for diagnostic purposes, hereinafter referred to as ME EQUIPMENT.

Not included within the scope of this particular standard are:

• the part of ME EQUIPMENT that provides vectorcardiographic loops;
• ambulatory electrocardiographic ME EQUIPMENT covered by IEC 60601-2-47 where not intended for obtaining ECG REPORTS for diagnostic purposes;
• cardiac monitors covered by IEC 60601-2-27 where not intended for obtaining ECG REPORTS for diagnostic purposes.

NOTE 1 For example. ME EQUIPMENT includes:

• direct-writing ELECTROCARDIOGRAPHS;
• other ME EQUIPMENT that produce ECG REPORTS for diagnostic purposes, e.g. patient monitors, defibrillators, exercise testing devices;
• ELECTROCARDIOGRAPHS having a display that is remote from the PATIENT (e.g. via phone lines, networks or storage media).

These ME EQUIPMENT or ME SYSTEMS are within the scope of this particular standard excluding transmission media.

NOTE 2 ME EQUIPMENT that provide selection between diagnostic and monitoring functions shall meet the requirements of the appropriate standard when configured for that function.

ME EQUIPMENT intended for use under extreme or uncontrolled environmental conditions outside the hospital environment or physician's office, 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.


Cross References:
IEC 60601-1-2:2007
EN 60601-1-2:2007
EN 60601-1-2:2007/Corrigendum 1:2010
IEC 60601-2-2:2009
EN 60601-2-2:2009
EN 60601-2-2:2009+A11:2011
93/42/EEC
IEC 60601-2-27
EN 60601-2-27
IEC 60601-2-47
EN 60601-2-47


Replaces BS EN 60601-2-25:1996 and BS EN 60601-2-51:2003 which remain current

All current amendments available at time of purchase are included with the purchase of this document.