AS/NZS IEC 60601.2.25:2016

Adopts IEC60601-2-25, Ed. 2.0 (2011), which applies to the basic safety and essential performance of electrocardiographs intended by themselves or as a part of a medical electrical system, for the production of electrocardiogram reports for diagnostic purposes.

This particular standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE ofELECTROCARDIOGRAPHS as defined in 201.3.63 intended by themselves or as a part of anME SYSTEM, for the production of ECG REPORTS for diagnostic purposes, hereinafter referred toas ME EQUIPMENT.Not included within the scope of this particular standard are:a) the part of ME EQUIPMENT that provides vectorcardiographic loops;b) ambulatory electrocardiographic ME EQUIPMENT covered by IEC 60601-2-47 where notintended for obtaining ECG REPORTS for diagnostic purposes;c) cardiac monitors covered by IEC 60601-2-27 where not intended for obtaining ECGREPORTS for diagnostic purposes.NOTE 1 For example. ME EQUIPMENT includes:a) direct-writing ELECTROCARDIOGRAPHS;b) other ME EQUIPMENT that produce ECG REPORTS for diagnostic purposes, e.g. patient monitors, defibrillators, exercisetesting devices;c) 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.

Originated in Australia as AS 3201.3-1971.
Previous and first New Zealand edition AS/NZS 3200.2.25:1993.
Jointly revised and redesignated as AS/NZS IEC 60601.2.25:2016.