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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 051 Date of Recognition 01/14/2019 
FR Recognition Number 3-127
Standard
ANSI AAMI IEC 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
Scope/Abstract
EC 60601-2-47:2012 concerns the basic safety and essential performance of AMBULATORY ELECTROCARDIOGRAPHIC SYSTEMS. It amends and supplements the general standard IEC 60601-1 (third edition 2005). The requirements of this particular standard take priority over those of the general standard. 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.

b) systems that provide continuous analysis and only partial or limited recording not allowing a full re-analysis of the ECG.

The safety aspects of this standard apply to all types of systems falling in one of the above- mentioned categories. If the AMBULATORY ELECTROCARDIOGRAPHIC SYSTEM offers automatic ECG analysis, minimal performance requirements for measurement and analysis functions apply. MEDICAL ELECTRICAL EQUIPMENT covered by IEC 60601-2-25 and IEC 60601-2-27 are excluded from the scope of this standard. This standard does not apply to systems that do not continuously record and analyse the ECG (for example, 'intermittent event recorders'). This second edition cancels and replaces the first edition published in 2001. It constitutes a technical revision. This edition was revised to align structurally with the 2005 edition of IEC 60601-1.

Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Public Law, CFR Citation(s) and Procode(s)
Regulation Number Device Name Device Class Product Code
§870.2800 Electrocardiograph, Ambulatory, With Analysis Algorithm Class 2 MLO
§870.2300 Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) Class 2 MWI
Relevant FDA Guidance and/or Supportive Publications
There is no relevant guidance developed at this time.
FDA Technical Contact
 Shawn Forrest
  FDA/OMPT/CDRH/ODE/DCD/CDDB/
  301-796-5554
  shawn.forrest@fda.hhs.gov
Standards Development Organizations
AAMI Association for the Advancement of Medical Instrumentation http://www.aami.org
ANSI American National Standards Institute https://www.ansi.org/
IEC International Electrotechnical Commission http://www.iec.ch/
FDA Specialty Task Group (STG)
Cardiovascular
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