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This standard covers the basic safety and essential performance of medical electrical equipment intended to defibrillate the heart by an electrical pulse via electrodes applied either to the patient's skin (external electrodes) or to the exposed heart (internal electrodes). This standard does not apply to implantable defibrillators, remote control defibrillators, external transcutaneous pacemakers, or separate cardiac monitors.
Author | ANSI/AAMI/IEC |
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Editor | AAMI |
Document type | Standard |
Format | File |
Confirmation date | 2015-12-30 |
ICS | 11.040.10 : Anaesthetic, respiratory and reanimation equipment |
Replace | ANSI/AAMI DF 80 (2003) |
Cross references | IEC 60601-2-4 (2010-12), IDT |
Year | 2010 |
Document history | ANSI/AAMI/IEC 60601-2-4 (2010) |
Country | USA |
Keyword | ANSI 60601;ANSI/AAMI/IEC 60601;ANSI/AAMI/IEC 60601-2;60601;ANSI/AAMI/IEC 60601-2-4-2010 (R2015) |