ANSI AAMI-EC11-2001 pdf download Diagnostic electrocardiographic devices
1 Scope
This standard establishes minimum safety and performance requirements for electrocardiographic (ECG) systems with direct writing devices which are intended for use, under the operating conditions specified in this standard, in the analysis of rhythm and of detailed morphology of complex cardiac complexes. Subject to this standard are all parts of the electrocardiographic system necessary to obtain the signal from the surface of the patient’s body, to amplify this signal, and to display it in a form suitable for diagnosing the heart’s electrical activity. This standard defines requirements for the electrocardiographic recording system, from the input electrodes 1) to the output display.
NOTE—The safety and performance criteria defined in this standard are intended principally for use in design qualification or evaluation by the manufacturer.
The referee test methods of section 4 are intended to provide means by which conformance with the standard can be established unambiguously. These tests are not intended for use in verifying the performance of individual devices, either for purposes of quality assurance inspections by the manufacturer or for purposes of routine inhospital inspections. Also, referee tests, by definition, allow for the use of alternative methods for design qualification, provided that the equivalence of the methods can be established in terms of comparability of test results with those of the referee methods.
1.1 Inclusions
Included within the scope of this standard are the following devices:
a) direct-writing electrocardiographs;
b) electrocardiographs used in other medical devices (e.g., patient monitors, defibrillators, stress testing devices), when such devices are intended for use in obtaining diagnostic ECG signatures;
c) electrocardiographs having a display that is remote from the patient (via cable, telephone, telemetry,or storage media), when such devices are intended for use in obtaining ECG signatures. These devices are subject to the functional performance requirements at the system output-input levels 2) .
1.2 Exclusions
Not included within the scope of this standard are:
a) devices that collect ECG data from locations other than the external surface of the body;
b) devices for interpretation and pattern recognition (e.g., QRS detectors,alarm circuits, rate meters,diagnostic algorithms);
c) fetal ECG monitors;
d) ambulatory monitoring electrocardiographic devices, including ECG recorders and associated scanning and read-out devices;
e) diagnostic electrocardiographic devices utilizing nonpermanent displays;