Recognized Consensus Standards: Medical Devices

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 Contacts

Loriano Galeotti

FDA/OC/CDRH/OPEQ/OHTII/DHTIIA/

301-796-5279

Loriano.Galeotti@fda.hhs.gov

Michael Raccuglia

FDA/OC/CDRH/OPEQ/OHTII/DHTIIA/

301-796-0008

Michael.Raccuglia@fda.hhs.gov

Standards Development Organizations