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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 analyse it later on a separate unit, or record and analyse 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.
Author | ANSI/AAMI/IEC |
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Editor | AAMI |
Document type | Standard |
Format | File |
Confirmation date | 2017-01-06 |
ICS | 11.040.55 : Diagnostic equipment |
Replace | ANSI/AAMI EC 38 (2007) |
Cross references | IEC 60601-2-47 (2012-02), IDT |
Year | 2012 |
Document history | ANSI/AAMI/IEC 60601-2-47 (2012) |
Country | USA |
Keyword | ANSI 60601;ANSI/AAMI/IEC 60601;ANSI/AAMI/IEC 60601-2;60601;ANSI/AAMI/IEC 60601-2-47-2012 (R2016) |