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AAMI ANSI/AAMI 60601-2-47:2012/(R)2016

Medical electrical equipment—Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems
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AAMI ANSI/AAMI 60601-2-47:2012/(R)2016

Medical electrical equipment—Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems

PUBLISH DATE 2016
AAMI ANSI/AAMI 60601-2-47:2012/(R)2016
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.
SDO AAMI: Assoc. for the Advancement of Medical Instrumentation
Document Number 60601-2-47
Publication Date Dec. 1, 2016
Language en - English
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