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AAMI/IEC 60601-2-27:2011 (R2017)

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AAMI/IEC 60601-2-27:2011 (R2017)

Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment

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Specifies basic safety requirements and essential performance for electrocardiographic (ECG) monitoring equipment. It is applicable to ECG monitoring equipment used in a hospital environment. If it is used outside the hospital environment, such as in ambulances and air transport, the ECG monitoring equipment shall comply with this standard. This standard is not applicable to electrocardiographic monitors for home use and ECG telemetry systems. However, manufacturers should consider using relevant clauses of this standard as appropriate for their intended use/intended purpose.

Author ANSI/AAMI/IEC
Editor AAMI
Document type Standard
Format File
Confirmation date 2017-01-06
ICS 11.040.55 : Diagnostic equipment
Replace ANSI/AAMI EC 13 (2002)
Cross references IEC 60601-2-27 (2011-03), NEQ
Year 2011
Document history ANSI/AAMI/IEC 60601-2-27 (2011)
Country USA
Keyword ANSI 60601;ANSI/AAMI/IEC 60601;ANSI/AAMI/IEC 60601-2;60601;ANSI/AAMI/IEC 60601-2-27-2011 (R2016)