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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 034 Date of Entry 01/30/2014 
FR Recognition Number 3-118
Standard
ANSI AAMI  EC57:2012
Testing and reporting performance results of cardiac rhythm and ST-segment measurement algorithms
Scope/Abstract
This recommended practice establishes a method for testing and reporting the performance of algorithms used to detect cardiac rhythm disturbances, including the ST segment.
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
§870.1025 Detector And Alarm, Arrhythmia Class 2 DSI
§870.1025 Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) Class 2 MHX
§870.1025 Monitor, St Segment With Alarm Class 2 MLD
§870.2300 Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) Class 2 DRT
§870.2340 Electrocardiograph Class 2 DPS
§870.2340 Monitor, St Segment Class 2 MLC
§870.2800 Electrocardiograph, Ambulatory, With Analysis Algorithm Class 2 MLO
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm, Issued October 2003.

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Charles Ho
  FDA/OC/CDRH/OPEQ/OHTII/DHTIIA/
  301-796-6320
  charles.ho@fda.hhs.gov
Standards Development Organizations
ANSI American National Standards Institute https://www.ansi.org/
AAMI Association for the Advancement of Medical Instrumentation http://www.aami.org
FDA Specialty Task Group (STG)
Cardiovascular
*These are provided as examples and others may be applicable.
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