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Most recent
ANSI/AAMI/IEC 60601-2-47:2012 (R2016)
Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems
Specifies the basic safety and essential performance of ambulatory electrocardiographic (ECG) systems. 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; and b) systems that provide continuous analysis and only partial or limited recording not allowing a full re-analysis of the ECG.
Content Provider
Association for the Advancement of Medical Instrumentation [aami]
