Standard: AAMI EC38
MEDICAL ELECTRICAL EQUIPMENT – PART 2-47: PARTICULAR REQUIREMENTS FOR THE SAFETY, INCLUDING ESSENTIAL PERFORMANCE, OF AMBULATORY ELECTROCARDIOGRAPHIC SYSTEMS
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This Particular Standard specifies the particular safety requirements for AMBULATORY ELECTROCARDIOGRAPHIC SYSTEMS, as defined in 2.101.
Within the scope of this standard are systems of the following types:
a) systems that provide continuous recording and continuous analysis of the ECG allowing full re-analysis giving essentially similar results. The systems may first record and store the ECG and analyze it later on a separate unit, or record and analyze the ECG simultaneously. The type of storage media used is irrelevant with regard to this standard;
b) systems that provide continuous analysis and only partial or limited recording not allowing a full re-analysis of the ECG.
The safety aspects of this standard apply to all types of systems falling in one of the abovementioned categories.
If the ambulatory electrocardiographic system offers automatic ECG analysis, minimal performance requirements for measurement and analysis functions apply. Medical electrical equipment covered by IEC 60601-2-25 and IEC 60601-2-27 are excluded from the scope of this standard.
This standard does not apply to systems that do not continuously record and analyze the ECG (for example, ‘intermittent event recorders').
|Organization:||Association for the Advancement of Medical Instrumentation|
|Document Number:||aami ec38|
|Most Recent Revision:||YES|