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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 047 Date of Entry 08/21/2017 
FR Recognition Number 13-94
Standard
ISO IEEE  11073-10424 First edition 2016-06-15
Health informatics - Personal health device communication - Part 10424: Device specialization - Sleep Apnoea Breathing Therapy Equipment (SABTE) [Including TECHNICAL CORRIGENDUM 1 (2018)]
Scope/Abstract
Within the context of the ISO/IEEE 11073 family of standards for device communication, this standard establishes a normative definition of the communication between sleep apnoea breathing therapy equipment and managers (e.g., cell phones, personal computers, personal health appliances, set top boxes) in a manner that enables plug-and-play interoperability. It leverages appropriate portions of existing standards including ISO/IEEE 11073 terminology, information models, application profile standards, and transport standards. It specifies the use of specific term codes, formats, and behaviors in telehealth environments restricting optionality in base frameworks in favor of interoperability. This standard defines a common core of communication functionality for sleep apnoea breathing therapy equipment. In this context, sleep apnoea breathing therapy equipment are defined as devices that are intended to alleviate the symptoms of a patient who suffers from sleep apnoea by delivering a therapeutic breathing pressure to the patient. Sleep apnoea breathing therapy equipment are primarily used in the home health-care environment by a lay operator without direct professional supervision.
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§868.5905 Ventilator, Non-Continuous (Respirator) Class 2 BZD
Relevant FDA Guidance and/or Supportive Publications*
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
 Binoy Mathews
  FDA/OC/CDRH/OPEQ/OHTI/DHTIC
  301-796-6475
  Binoy.Mathews@fda.hhs.gov
 Rachana Visaria
  FDA/OC/CDRH/OPEQ/OHTI/DHTIC/
  240-402-5628
  Rachana.Visaria@fda.hhs.gov
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)
Anesthesiology
*These are provided as examples and others may be applicable.
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