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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 13-47
IEEE ISO 11073-10101 First edition 2004-12-15
Health informatics - Point-of-care medical device communication - Part 10101: Nonmenclature
The scope of this standard is nomenclature architecture for point-of-care (POC) medical device communication (MDC). It consists of three parts: the body of the standard, which defines the overall architecture of the organization and relationships among nomenclature components; normative Annex A and Annex B, which provide specifications of semantics and syntaxes, respectively; and informative Annex C, the bibliography.

This standard is intended for use within the context of IEEE Std 1073,1 which sets out the relationship between this and other documents in the POC MDC series.

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)
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
 Sandy Weininger
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)