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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 032 Date of Recognition 08/06/2013 
FR Recognition Number 13-48
Standard
IEEE ISO 11073-10201 First edition 2004-12-15
Health informatics - Point-of-care medical device communication - Part 10201: Domain information model
Scope/Abstract
Within the context of the ISO/IEEE 11073 family of standards, this standard addresses the definition and structuring of information that is communicated or referred to in communication between application entities.

This standard provides a common representation of all application entities present in the application processes within the various devices independent of the syntax.

The definition of association control and lower layer communication is outside the scope of this standard.

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.
Relevant FDA Guidance and/or Supportive Publications
Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices - Guidance for Industry and FDA Staff, May 2005

Guidance for Off-the-Shelf Software Use in Medical Devices, September 1999

General Principles of Software Validation; Final Guidance for Industry and FDA Staff, January 2002
FDA Technical Contact
 Catherine Li
  FDA/OMPT/CDER/OTS/OCS/
  301-796-6304
  catherine.li@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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