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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 032 Date of Recognition 08/06/2013 
FR Recognition Number 13-52
Standard
IEEE ISO 11073-10408 First edition 2010-05-01
Health informatics - Point-of-care medical device communication - Part 10408: Device specialization - Thermometer
Scope/Abstract
ISO/IEEE 11073-10408:2010 establishes a normative definition of communication between personal telehealth thermometer devices and computer engines (e.g., cell phones, personal computers, personal health appliances, and 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 behaviours in telehealth environments restricting optionality in base frameworks in favour of interoperability. This International Standard defines a common core of communication functionality for personal telehealth thermometers.

ISO/IEEE 11073-10408:2010 addresses a need for an openly defined, independent standard for controlling information exchange to and from personal health devices and computer engines.

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
§880.2910 Thermometer, Electronic, Clinical Class 2 FLL
Relevant FDA Guidance and/or Supportive Publications
Guidance on the Content of Premarket Nofication [510(k)] Submissions for Clinical Electronic Thermometers
FDA Technical Contact
 Lening Shen
  FDA/OMPT/CDRH/ODE/DAGID/GHDB/
  301-796-6291
  lening.shen@fda.hhs.gov
Standards Development Organizations
IEEE Institute of Electrical and Electronic Engineers https://www.ieee.org/
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Software/Informatics
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