Medical electrical equipment Particular requirements for the basic safety and essential performance of electrocardiographs
Standards Australia
Adopts IEC 60601-2-25, 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 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:
a) the part of ME EQUIPMENT that provides vectorcardiographic loops;
b) ambulatory electrocardiographic ME EQUIPMENT covered by IEC 60601-2-47 where not
intended for obtaining ECG REPORTS for diagnostic purposes;
c) 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:
a) direct-writing ELECTROCARDIOGRAPHS;
b) other ME EQUIPMENT that produce ECG REPORTS for diagnostic purposes, e.g. patient monitors, defibrillators, exercise
testing 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.
| Document Type | Standard |
| Status | Current |
| Publisher | Standards Australia |
| Committee | HE-003 |
| Supersedes |
|
