Recognized Consensus Standards

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

034

Date of Recognition 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

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
§870.2340	Electrocardiograph	Class 2	DPS
§870.2340	Monitor, St Segment	Class 2	MLC
§870.2300	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Class 2	DRT
§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

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.

FDA Technical Contact

 Charles Ho

  FDA/OMPT/CDRH/ODE/DCD/CDDB/

  301-796-6320

  charles.ho@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/

FDA Specialty Task Group (STG)

Cardiovascular