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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 040 Date of Recognition 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
§870.2920 Transmitters And Receivers, Electrocardiograph, Telephone Class 2 DXH
§870.2340 Electrocardiograph Class 2 DPS
§870.2340 Monitor, St Segment Class 2 MLC
§870.2340 Single Lead Over-The-Counter Electrocardiograph Class 2 OEY
§870.2300 Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) Class 2 DRT
§870.2300 Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) Class 2 MWI
§870.2300 System, Network And Communication, Physiological Monitors Class 2 MSX
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
FDA Technical Contact
 Konstantinos Makrodimitris
  FDA/OMPT/CDRH/ODE
  301-796-6946
  konstantinos.makrodimitris@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Software/Informatics
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