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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 034 FR Publication Date: 01/30/2014 

Part B: Supplementary Information

Recognition Number 3-118: AAMI / ANSI EC57:2012, testing and reporting performance results of cardiac rhythm and st-segment measurement algorithms. (Cardiovascular)

Date of Standard: 2012. 
Addresses of Standards Development Organizations:
 Association for the Advancement of Medical Instrumentation (AAMI)
  4301 North Fairfax Drive
  Suite 301
  Arlington, VA 22203
 
 American National Standards Institute (ANSI)
  25 West 43rd Street
  4th Floor
  New York, NY 10036
 
CDRH Office and Division associated with recognized standards:
OFFICE OF DEVICE EVALUATION (ODE)
DIVISION OF CARDIOVASCULAR DEVICES (DCD)
Devices Affected:
Arrhythmia detectors and alarms, cardiac monitors and electrocardiographs
Processes Affected:
510(k), PMA, PDP, IDE, HDE, Quality System Regulation
Type of Standard:
 National, Vertical, Test Methods
Extent of Recognition:
Complete standard and annexes
Related CFR Citations and Product Codes:
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 Guidance:
Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm; Guidance for Industry and FDA (10/28/2003)
FDA Technical Contacts:
 Charles Ho, Ph.D.
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 1318
  Silver Spring MD 20993
  301/796-6320
  email: charles.ho@fda.hhs.gov
 James Cheng
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 1326
  Silver Spring MD 20993
  301/796-6306
  email: james.cheng@fda.hhs.gov
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