Recognized Consensus Standards: Medical Devices

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

040

Date of Entry 08/14/2015

FR Recognition Number

13-75

Standard

ISO IEEE 11073-10102 First edition 2014-03-01
Health informatics - Point-of-care medical device communication - Part 10102: Nomenclature - Annotated ECG

Scope/Abstract

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

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 Organizations