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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 13-75
ISO IEEE  11073-10102 First edition 2014-03-01
Health informatics - Point-of-care medical device communication - Part 10102: Nomenclature - Annotated ECG
ISO/IEEE 11073-10102:2014 extends the IEEE 11073-10101 Nomenclature by providing support for ECG annotation terminology. It may be used either in conjunction with other IEEE 11073 standards (e.g. ISO/IEEE 11073-10201:2001) or independently with other standards. The major subject areas addressed by the nomenclature include ECG beat annotations, wave component annotations, rhythm annotations, and noise annotations. Additional "global" and "per-lead" numeric observation identifiers, ECG lead systems, and additional ECG lead identifiers also are defined.
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
§870.2300 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
 Loriano Galeotti
 Konstantinos Makrodimitris
Standards Development Organizations
ISO International Organization for Standardization https://www.iso.org/
IEEE Institute of Electrical and Electronic Engineers https://www.ieee.org/
FDA Specialty Task Groups (STG)
Software/Informatics (primary)
*These are provided as examples and others may be applicable.