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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 040 Date of Entry 08/14/2015 
FR Recognition Number 13-76
Standard
ISO  11073-91064 First edition 2009-05-01
Health informatics - Standard communication protocol - Computer-assisted electrocardiography
Scope/Abstract
ISO 11073-91064:2009 specifies the common conventions required for the cart-to-host as well as cart-to-cart interchange of specific patient data (demographic, recording, ...), ECG signal data, ECG measurement and ECG interpretation results.
ISO 11073-91064:2009 specifies the content and structure of the information that is to be interchanged between digital ECG carts and computer ECG management systems, as well as other computer systems where ECG data can be stored.
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§870.2300 Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) Class 2 DRT
§870.2300 System, Network And Communication, Physiological Monitors Class 2 MSX
§870.2300 Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) Class 2 MWI
§870.2340 Electrocardiograph Class 2 DPS
§870.2340 Monitor, St Segment Class 2 MLC
§870.2920 Transmitters And Receivers, Electrocardiograph, Telephone Class 2 DXH
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and FDA Staff Class II Special Controls Guidance

Document: Arrhythmia Detector and Alarm, October 2003

Guidance for Industry: Diagnostic ECG Guidance (Including Non-Alarming ST Segment Measurement), November 5, 1998

Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
Guidance for Industry and FDA Staff, 2005

Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Guidance for Industry and Food and Drug Administration Staff, 2014

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
 Konstantinos Makrodimitris
  FDA/CDRH/OSPTI/DAHRSSP/
  301-796-6946
  konstantinos.makrodimitris@fda.hhs.gov
 Loriano Galeotti
  FDA/OC/CDRH/OPEQ/OHTII/DHTIIA/
  301-796-5279
  Loriano.Galeotti@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Groups (STG)
Software/Informatics (primary)
Cardiovascular
*These are provided as examples and others may be applicable.
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